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FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker

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FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker

April 22, 2021: “The U.S. FDA granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR (which contain abnormalities that affect the proper repair of DNA inside the cell), as determined by an FDA-approved test.

“Today’s approval of Jemperli is evidence of the FDA’s progress in applying precision medicine to expand treatment options for patients with cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

“This immunotherapy was specifically studied to target dMMR endometrial cancer and leverages scientific knowledge surrounding the mechanism of immunotherapy response in this unmet medical need population.”

Endometrial cancer is the most common gynecologic malignancy in the United States and its prevalence is increasing.

Approximately 75% of endometrial cancers are diagnosed at an early stage and are typically curable with surgery.

However, women with advanced and recurrent endometrial cancer have limited therapeutic options following front-line standard treatment with a platinum-containing chemotherapeutic regimen.

Approximately 25% to 30% of patients with advanced endometrial cancer have dMMR tumors.

Jemperli works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). Jemperli helps the body’s immune system in its fight against cancer cells by blocking this pathway.

The safety and efficacy of Jemperli was studied in a single-arm, multi-cohort clinical trial. Of the 71 patients with dMMR recurrent or advanced endometrial cancer who received Jemperli in the trial, 42.3% had a complete response (disappearance of tumor) or a partial response (shrinkage of tumor) to treatment with Jemperli. For 93% of responders, the response lasted for six months or more.

Common side effects of Jemperli include fatigue, nausea, diarrhea, anemia and constipation.

Jemperli can cause serious conditions known as immune-mediated side effects, including inflammation of healthy organs such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies) and kidneys (nephritis).

Patients who experience severe or life-threatening infusion-related reactions should stop taking Jemperli. Women who are pregnant or breastfeeding should not take Jemperli because it may cause harm to a developing fetus or newborn baby.

The safety and effectiveness of Jemperli in pediatric patients are not known.

Jemperli received Priority Review designation and Breakthrough Therapy designation for this indication.

Priority Review designation directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications.

Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

Jemperli was approved for this new indication using the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is unmet medical need and a drug is shown to have certain effects that are reasonably likely to predict a clinical benefit to patients.

Further clinical trials may be required to verify and describe anticipated clinical benefits of Jemperli and the sponsor is currently conducting these trials in additional patients with dMMR endometrial tumors.

The FDA granted approval to GlaxoSmithKline.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

https://www.fda.gov/news-events/press-announcements/fda-approves-immunotherapy-endometrial-cancer-specific-biomarker

WHO launches effort to stamp out malaria in 25 more countries by 2025

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WHO launches effort to stamp out malaria in 25 more countries by 2025

April 21, 2021: Ahead of World Malaria Day, marked annually on 25 April, WHO congratulates the growing number of countries that are approaching, and achieving, zero cases of malaria.

A new initiative launched aims to halt transmission of the disease in 25 more countries by 2025.

Of the 87 countries with malaria, 46 reported fewer than 10 000 cases of the disease in 2019 compared to 26 countries in 2000. By the end of 2020, 24 countries had reported interrupting malaria transmission for 3 years or more. Of these, 11 were certified malaria-free by WHO.

“Many of the countries we are recognizing today carried, at one time, a very high burden of malaria.

Their successes were hard-won and came only after decades of concerted action” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Together, they have shown the world that malaria elimination is a viable goal for all countries.”

Key drivers of success

Though each country’s elimination journey is unique, common drivers of success have been seen across all regions. 

“Success is driven, first and foremost, by political commitment within a malaria-endemic country to end the disease,” said Dr Pedro Alonso, Director of the WHO Global Malaria Programme.

“This commitment is translated into domestic funding that is often sustained over many decades, even after a country is malaria-free,” he added.

Most countries that reach zero malaria have strong primary health care systems that ensure access to malaria prevention, diagnosis and treatment services, without financial hardship, for everyone living within their borders – regardless of nationality or legal status.

Robust data systems are also key to success, together with strong community engagement.

Many countries that eliminate malaria have relied on dedicated networks of volunteer health workers to detect and treat the disease in remote and hard-to-reach areas.

New report: “Zeroing in on malaria elimination”

Through the E-2020 initiative, launched in 2017, WHO has supported 21 countries in their efforts to get to zero malaria cases within the 2020 timeline.

A new WHO report summarizes progress and lessons learned in these countries over the last 3 years. 

According to the report, 8 of the E-2020 member countries reported zero indigenous cases of human malaria by the end of 2020:  Algeria, Belize, Cabo Verde, China, El Salvador, the Islamic Republic of Iran, Malaysia and Paraguay.  In Malaysia, the P. knowlesi parasite, normally found in monkeys, infected approximately 2600 people in 2020.

A number of other countries made excellent progress: Timor-Leste reported only 1 indigenous case, while 3 other countries – Bhutan, Costa Rica and Nepal – reported fewer than 100 cases.

Building on the successes of the E-2020, WHO has identified a new group of 25 countries that have the potential to stamp out malaria within a 5-year timeline.

Through the E-2025 initiative, launched today, these countries will receive specialized support and technical guidance as they work towards the target of zero malaria.

Malaria elimination in the Greater Mekong

In the face of the ongoing threat of antimalarial drug resistance, countries of the Greater Mekong subregion have also made major strides towards their shared goal of elimination by 2030.

In the 6 countries of the subregion – Cambodia, China (Yunnan Province), Lao People’s Democratic Republic, Myanmar, Thailand and Viet Nam – the reported number of malaria cases fell by 97% between 2000 and 2020. Malaria deaths were reduced by more than 99% in this same period of time, from 6000 to 15.

Tackling malaria during a global pandemic

In 2020, COVID-19 emerged as a serious challenge to malaria responses worldwide. Since the early days of the pandemic, WHO has urged countries to maintain essential health services, including for malaria, while ensuring that communities and health workers are protected from COVID-19 transmission.

Heeding the call, many malaria-endemic countries mounted impressive responses to the pandemic, adapting the way they deliver malaria services to the COVID-19 restrictions imposed by governments.

As a result of these efforts, the worst-case scenario of a WHO modelling analysis was likely averted.

The analysis found that if access to nets and antimalarial medicines was severely curtailed, the number of malaria deaths in sub-Saharan Africa could double in 2020 compared to 2018.

However, more than one year into the pandemic, substantial disruptions to health services persist across the globe. \

According to the results of a new WHO survey, approximately one third of countries around the world reported disruptions in malaria prevention, diagnosis and treatment services during the first quarter of 2021.  

In many countries, lockdowns and restrictions on the movement of people and goods have led to delays in the delivery of insecticide-treated mosquito nets or indoor insecticide spraying campaigns.

Malaria diagnosis and treatment services were interrupted as many people were unable – or unwilling – to seek care in health facilities.

WHO is calling on all people living in malaria affected countries to “beat the fear”: people with a fever should go to the nearest health facility to be tested for malaria and receive the care they need, within the context of national COVID-19 protocols.

https://www.who.int/news/item/21-04-2021-world-malaria-day-who-launches-effort-to-stamp-out-malaria-in-25-more-countries-by-2025

Novo Nordisk to initiate phase 3a development in obesity with oral semaglutide

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Novo Nordisk to initiate phase 3a development in obesity with oral semaglutide

 April 21, 2021: “Novo Nordisk announced the decision to enter phase 3a development in obesity with oral semaglutide 50 mg.

The decision follows the completion of the STEP phase 3a clinical programme with once-weekly subcutaneous (sc) semaglutide 2.4 mg.

Novo Nordisk intends to initiate a pivotal phase 3a programme with approximately 1,000 people with obesity or overweight with comorbidities. The global 68-week trial is planned for initiation in the second half of 2021 and will investigate the efficacy and safety of oral semaglutide compared to placebo.

Related News: Novo-Nordisk’s semaglutide 2.4 mg achieved and maintained a significant amount of weight loss in 68-week trial
Novo Nordisk’s wins big obesity ambitions take shape with semaglutide
Novo Nordisk invests DKK 500 million in expanding tablet production facilities in Denmark


“There is a significant unmet medical need within obesity treatment today.

With oral semaglutide we aim to introduce a convenient and effective treatment option for people with obesity and healthcare providers enabling broader use of anti-obesity medication,” said Martin Holst Lange, executive vice president, Development at Novo Nordisk.

“As a complement to our injectable anti-obesity medications, oral semaglutide has the potential to help more people living with obesity achieve weight loss goals and improve their health.”

https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=55895

Lilly and Incyte’s Baricitinib Improved Hair Regrowth for Alopecia Areata Patients

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Lilly and Incyte’s Baricitinib Improved Hair Regrowth for Alopecia Areata Patients

April 20, 2021: Eli Lilly and Company and Incyte announced results from a second Phase 3 trial (BRAVE-AA1) evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA). The data are consistent with findings from the first Phase 3 clinical trial, BRAVE-AA2, top-lined earlier this year.

In both investigational trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint of hair regrowth across the two dosing regimens at Week 36 compared to patients treated with placebo.

AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress, and currently has no therapies approved by the U.S.FDA.

“There is a pressing need for approved treatment options for people suffering from alopecia areata as existing topicals and steroids do not provide meaningful improvement for many patients,” said Maryanne Senna, M.D., dermatologist and assistant professor of dermatology at Harvard Medical School and clinical trial investigator of BRAVE-AA1.

“I am pleased to see such positive results from these important trials of baricitinib offering a much-needed potential breakthrough treatment option for this disease.” 

The BRAVE-AA trial program was designed to evaluate the efficacy and safety of baricitinib in adult patients with severe AA.

The program consists of two trials: BRAVE-AA1 and BRAVE-AA2. BRAVE-AA1 is a multicenter, randomized, double-blind, placebo-controlled adaptive Phase 2/3 trial.

Based on interim results of the Phase 2 portion of BRAVE-AA1 at Week 12, baricitinib 2-mg and 4-mg once-daily doses were selected for further evaluation in the Phase 3 portion of the study.

BRAVE-AA2 is a multicenter, randomized, double-blind, placebo-controlled study evaluating the baricitinib 2-mg and 4-mg dosing regimens versus placebo.

Both studies included adults with severe alopecia, defined in the BRAVE clinical trials as a Severity of Alopecia Tool (SALT) score ≥ 50 (i.e., who had ≥ 50% scalp hair loss), in addition to a current episode of AA lasting at least six months but no more than eight years.

Related News: Lilly and Incyte announce results from baricitinib’s COV-BARRIER study in hospitalized COVID-19 patients
First JAK-Inhibitor Baricitinib Demonstrate for Hair Regrowth in Phase 3 Trial

BRAVE-AA1 and BRAVE-AA2 Study Results
In both studies, over the nine-month treatment period, patients with severe AA treated with baricitinib 2-mg and 4-mg doses experienced significantly greater scalp hair regrowth compared to patients treated with placebo based on physician’s assessment.

Results of BRAVE-AA1 showed that at Week 36, the proportion of patients reaching 80 percent or more scalp hair coverage was achieved by 35 percent (p≤0.001) of patients treated with baricitinib 4-mg/day, 22 percent (p≤0.001) of patients treated with baricitinib 2-mg/day and five percent of patients in the placebo group, meeting the primary endpoint.

BRAVE-AA2 showed that at Week 36 the proportion of patients reaching 80 percent or more scalp hair coverage was achieved by 33 percent (p≤0.001) of patients treated with baricitinib 4-mg/day, 17 percent (p≤0.001) of patients treated with baricitinib 2-mg/day and three percent of patients in the placebo group, meeting the primary endpoint.   

Across both studies, the proportion of patients self-reporting at least 80 percent scalp hair coverage was significantly greater in the 2-mg and 4-mg groups compared to placebo (p≤0.001) by Week 36.

The most common treatment-emergent adverse events (TEAEs) in BRAVE-AA1 and BRAVE-AA2 included upper respiratory tract infections, headache and acne. No deaths or venous thromboembolic events (VTEs) were reported in the trials.

The safety profile of baricitinib in the two studies was consistent with its known safety profile in patients with rheumatoid arthritis (RA) and atopic dermatitis (AD).

Lilly will present detailed data from these studies at scientific meetings later this year and submit the results to peer-reviewed journals. Based on these results, Lilly plans to submit a supplemental New Drug Application (sNDA) to the FDA for baricitinib in AA in the second half of 2021, followed by submissions to other regulatory agencies around the world. In Q1 2020, baricitinib received Breakthrough Therapy designation from the FDA for the treatment of AA.

“The positive results from our Phase 3 trials of baricitinib in alopecia areata bring us one step closer to potentially providing an approved treatment option to people affected by this serious autoimmune disease,” said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly.

“We look forward to discussing with global regulators data from the BRAVE-AA clinical trial program for this important potential treatment, which could be the first approved for people living with alopecia areata.”

Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. Baricitinib is approved and commercially available as OLUMIANT in the U.S. and more than 70 countries as a treatment for adults with moderately to severely active RA and in Europe and Japan for the treatment of adult patients with moderate to severe AD who are candidates for systemic therapy.

AA is the second potential treatment indication in dermatology for baricitinib.”

https://investor.lilly.com/news-releases/news-release-details/lilly-and-incytes-baricitinib-improved-hair-regrowth-alopecia

Chemotherapy-free treatment option to be offered to patients with England’s most common leukaemia

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Chemotherapy-free treatment option to be offered to patients with England’s most common leukaemia

April 21, 2021: A brand new oral treatment for an incurable blood cancer has been recommended for NHS use by NICE.

Acalabrutinib, taken as a twice daily tablet, is recommended as an option for adults with untreated chronic lymphocytic leukaemia (CLL).

CLL is a malignant disorder of white blood cells and is the most common type of leukaemia in England. An estimated 2,395 patients will be eligible for treatment with acalabrutinib every year.

NICE has recommended the use of acalabrutinib, as a monotherapy option for adults with:

  • a 17p deletion or TP53 mutation, or
  • no 17p deletion or TP53 mutation, and fludarabine plus cyclophosphamide and rituximab (FCR), or bendamustine plus rituximab (BR) is unsuitable.

It can also be considered as an option for adults who have previously been treated for CLL.

Today’s decision means that people with CLL who have high-risk disease or cannot have standard chemotherapy can be offered the monotherapy treatment acalabrutinib which can be taken at home.

This is particularly beneficial during the current COVID-19 pandemic because it means that untreated CLL patients who would previously need to visit a hospital to have a combination therapy involving an intravenous administration no longer need to do so.

Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE, said: “Chronic lymphocytic leukaemia has a debilitating effect on the daily lives of those living with it.

As the most common type of leukaemia in England, more targeted treatment options are very much needed and welcomed.

“Acalabrutinib is considered by patient experts who submitted evidence to NICE’s independent appraisal committee to be generally well tolerated and could cause fewer side effects than existing NHS treatments.

“Evidence submitted to our independent appraisal committee showed that acalabrutinib is clinically effective in chronic lymphocytic leukaemia and that it will improve the quality of life for those living with this condition. We are therefore very pleased to make this positive recommendation.”

A 30-day pack of acalabrutinib capsules, also known as Calquence and developed by AstraZeneca, costs £5,059. The company has a confidential commercial arrangement which allows NHS organisations to access the drug at a discount.

Each year it is estimated there are around 3,800-4,500 new cases of CLL. Men are nearly twice as likely to have CLL as women, with more than a third of cases occurring in people aged 75 and over.”

https://www.nice.org.uk/news/article/acalabrutinib-for-treating-chronic-lymphocytic-leukaemia-ta689

GW Pharma receives EU approval for EPIDYOLEX® for treatment of seizures

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GW Pharma receives EU approval for EPIDYOLEX® for treatment of seizures

April 20, 2021: “GW Pharmaceuticals, a world leader in discovering, developing and delivering regulatory approved cannabis-based medicinesannounces that the European Commission has approved the Type II variation application for EPIDYOLEX® (cannabidiol) as an adjunctive treatment of seizures associated with TSC, for patients two years of age and older.

This approval, which represents the third indication for GW’s cannabidiol in Europe, paves the way for the expanded launch of the medicine across Europe.

“This is an exciting moment for patients, and their families, who are affected by this debilitating disease and may benefit from this treatment.

This approval is the result of the continued dedication of GW and the physician and patient communities to address this serious unmet medical need,” said Justin Gover, GW’s Chief Executive Officer.

“We now look forward to working with each European member state to make EPIDYOLEX® available to appropriate patients across Europe, as quickly as possible.”

Dr. Volker Knappertz, GW’s Chief Medical Officer, said, “We are excited by the news of this approval by the European Commission and the benefits EPIDYOLEX could bring to the community. The clinical data supporting EPIDYOLEX in TSC provides hope of a better quality of life for patients.

Related News: UK down-schedules Epidyolex to lowest level for controlled drugs

This medicine provides more choice for physicians managing seizures associated with TSC and has the potential to benefit the thousands of patients who do not respond to the current standard of care.”

Professor Alexis Arzimanoglou, Coordinator of the European Reference Network for Rare and Complex Epilepsies ERN EpiCARE (University Hospitals of Lyon, France), added, “Those suffering from TSC and those involved in their care will welcome this European approval.

Given the demonstrated efficacy and safety profile of EPIDYOLEX, this important development could offer a much-needed treatment option to those most in need.”

The approval is based on data from a positive Phase 3 safety and efficacy study evaluating 25 mg/kg/day of GW’s cannabidiol.

The study met its primary endpoint, which was the reduction in seizure frequency compared to baseline of cannabidiol vs placebo, with seizure reduction of 49% in patients taking cannabidiol 25 mg/kg/day compared with 27% for placebo (p=0.0009).

All key secondary endpoints were supportive of the effects on the primary endpoint. The safety profile observed was consistent with findings from previous studies, with no new safety risks identified.

TSC is a condition that causes mostly benign tumours to grow in vital organs of the body, including the brain, skin, heart, eyes, kidneys and lungs, and in which epilepsy is the most common neurological feature. TSC is typically diagnosed in childhood.

GW’s cannabidiol was originally approved by the European Medicines Agency (EMA) in September 2019 under the tradename EPIDYOLEX® as an adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older.”

https://ir.gwpharm.com/news-releases/news-release-details/gw-pharmaceuticals-receives-european-commission-approval-0

Amgen Successfully Completes Acquisition Of Five Prime Therapeutics

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Amgen Successfully Completes Acquisition Of Five Prime Therapeutics

April 16, 2021: “Amgen announced that it has successfully completed its previously announced tender offer to purchase all outstanding shares of common stock of Five Prime Therapeutics, a clinical-stage biotechnology company focused on developing immuno-oncology and targeted cancer therapies, for $38.00 per share in cash.

The aggregate consideration to be paid by Amgen to complete the tender offer and the subsequent merger is approximately $1.9 billion without giving effect to related transaction fees and expenses.

“Five Prime fits squarely within Amgen’s leading oncology portfolio and includes bemarituzumab, a Phase 3 trial-ready, first-in-class program for gastric cancer, the third leading cause of cancer mortality worldwide,” said Robert A. Bradway, chairman and chief executive officer at Amgen.

“Working with the dedicated professionals joining us from Five Prime, we plan to quickly move bemarituzumab into a Phase 3 study, bringing it one step closer to helping patients suffering from gastric cancer.”

Amgen’s existing and complementary development capabilities in metastatic gastric and gastroesophageal junction cancers together with its biologics manufacturing expertise and global commercial footprint will help bemarituzumab reach patients in markets such as Japan, South Korea, and Latin America, where the prevalence of gastric cancer is high. 

Amgen will continue to review additional Five Prime oncology assets for the Amgen pipeline.

As of the expiration of the tender offer, approximately 40,392,569 shares were validly tendered and not properly withdrawn in the tender offer, representing approximately 87.8% of Five Prime’s outstanding shares, according to the depositary of the tender offer.

The condition to the tender offer that at least one share more than 50% of Five Prime’s issued and outstanding shares be validly tendered and not properly withdrawn prior to the expiration of the tender offer has been satisfied.

As a result, Amgen has accepted for payment all such validly tendered shares and will promptly (and in any event within two business days) pay for all such validly tendered shares.

Following the completion of the tender offer, Franklin Acquisition Sub, Inc., a wholly owned subsidiary of Amgen, merged with and into Five Prime, with Five Prime surviving the merger.

As a result of the merger effected today, all remaining eligible Five Prime shares have been converted into the right to receive $38.00 per share in cash, minus any applicable withholding taxes and without interest, the same price that was paid in the tender offer (eligible shares exclude those for which holders properly demanded and perfected appraisal rights under Delaware law and those held by Amgen or its wholly owned subsidiaries or Five Prime).”

https://www.amgen.com/newsroom/press-releases/2021/04/amgen-successfully-completes-acquisition-of-five-prime-therapeutics

JCVI issues new advice on COVID-19 vaccination for pregnant women

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JCVI issues new advice on COVID-19 vaccination for pregnant women

April 16, 2021: There have been no specific safety concerns identified with any brand of coronavirus (COVID-19) vaccines in relation to pregnancy. 

Real-world data from the United States shows that around 90,000 pregnant women have been vaccinated, mainly with mRNA vaccines including Pfizer-BioNTech and Moderna, without any safety concerns being raised.

Based on this data, the Joint Committee on Vaccination and Immunisation (JCVI) advises that it’s preferable for pregnant women in the UK to be offered the Pfizer-BioNTech or Moderna vaccines where available.

There is no evidence to suggest that other vaccines are unsafe for pregnant women, but more research is needed.

The advice, published in Public Health England’s Green Book, a clinical professional guide for vaccinators in the UK, still advises that pregnant women should discuss the risks and benefits of vaccination with their clinician, including the latest evidence on safety and which vaccines they should receive.

Professor Wei Shen Lim, COVID-19 Chair for JCVI, said:

We encourage pregnant women to discuss the risks and benefits with their clinician – those at increased risk of severe outcomes from COVID-19 are encouraged to promptly take up the offer of vaccination when offered.

There have been no specific safety concerns from any brand of COVID-19 vaccines in relation to pregnancy.

There is more real-world safety data from the US in relation to the Pfizer-BioNTech and Moderna vaccines in women who are pregnant – therefore, we advise a preference for these to be offered to pregnant women.

All vaccines being used in the UK have undergone robust clinical trials and have met the Medicines and Healthcare products Regulatory Agency (MHRA)’s strict standards of safety, effectiveness and quality.

Dr Mary Ramsay, Head of Immunisation at Public Health England (PHE), said:

The available data on the Pfizer-BioNTech and Moderna vaccines provides confidence that they can be offered safely to pregnant women.

The COVID-19 vaccines continue to save thousands of lives and it is important that we encourage as many people as possible to take up the offer when it is their turn.

Dr Edward Morris, President of the Royal College of Obstetricians and Gynaecologists (RCOG), said:

We are grateful to the JCVI for taking into consideration our evidence and updating the guidance around the COVID-19 vaccine in pregnancy.

Vaccination offers pregnant women the best protection from COVID-19, which can be serious in some women.

We believe it should be a woman’s choice whether to have the vaccine or not after considering the benefits and risks and would encourage pregnant women to discuss with a trusted source like their GP, obstetrician or midwife, or a healthcare professional in a vaccination centre.

This move will empower all the pregnant women in the UK to make the decision that is right for them, at the same time that the non-pregnant population in their age group receive protection from COVID-19.

Data shows that vaccines are effective in protecting people from serious illness from COVID-19. Though uncommon, severe illness due to COVID-19 is more likely in later pregnancy. Pregnant women who do get symptomatic COVID-19 infection are 2 to 3 times more likely to give birth to their baby prematurely.

The greatest risk factor for severe outcomes from COVID-19 is age, which is why pregnant women should be invited for vaccination along with their age or clinical risk group.

Women who are planning pregnancy, are in the immediate postpartum, or are breastfeeding can be vaccinated with any vaccine, depending on their age and clinical risk group.

The JCVI will continue to closely monitor the evidence on COVID-19 vaccination in pregnancy and will update its advice as required.

The COVID-19 vaccination programme has been a huge success, with recent PHE analysis showing the vaccines have prevented 10,400 deaths in those aged 60 and older in England up to the end of March.

The JCVI advised last week that, as a precaution, it is preferable for people under the age of 30 with no underlying health conditions to be offered an alternative to the AstraZeneca vaccine where possible.”

https://www.gov.uk/government/news/jcvi-issues-new-advice-on-covid-19-vaccination-for-pregnant-women

Phico Therapeutics gains £13.1m grant to advance antibacterial therapy

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Phico Therapeutics gains £13.1m grant to advance antibacterial therapy

March 19, 2021: “Phico Therapeutics Ltd, a biotechnology company
developing engineered phage technology as the basis of a new generation of antibiotics to overcome antibacterial resistance, has been awarded a grant of up to $18.2 million USD (circa. £13.2 million GBP) from Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership dedicated to accelerating antibacterial research to tackle the global rising threat
of drug-resistant bacteria.

The funding will support the progression of Phico’s lead product SASPject™
PT3.9 through clinical trials with $5.3 million USD (circa. £3.8 million GBP) available immediately and a further $12.9 million (circa. £9.4 million GBP) contingent on reaching specific project milestones.

SASPject PT3.9 has been developed for the intravenous treatment of hospital infections due to the bacterium, Pseudomonas aeruginosa using Phico’s SASPject platform.

The platform utilises unique antibacterial small acid-soluble spore proteins (SASP) which target selected bacterial species to inactivate bacterial DNA, stopping them from metabolising or reproducing.

The Phase I clinical trials will be first-in-man, intravenous studies and will focus on establishing the safety and kinetics of PT3.9 in healthy volunteers and, potentially, patients with ventilated hospital acquired pneumonia and ventilator associated pneumonia.

P. aeruginosa is a leading cause of pneumonia in hospital patients, especially those on a ventilator.

The increasing incidence of strains showing multi-drug antibiotic resistance has resulted in the U.S.Centers for Disease Control and Prevention classifying P. aeruginosa as a serious threat to human health.

With antimicrobial resistance also listed as a Top 3 Global Health Threat by the World Health
Organisation, the SASPject platform could provide a new range of innovative antibiotic treatments to help overcome this challenge.

Dr. Heather Fairhead, Phico Founder and CEO said: “To receive funding from CARB-X is important validation for our SASPject technology platform and its potential in fighting bacterial resistance.

It has been awarded at the end of a thorough due diligence process which reinforces the credibility of the company and our team – I am delighted to now look forward to progressing our lead product to clinical trials and developing a product pipeline that will advance the science of antibacterial therapy and in time, save millions of lives round the world.”

“Phico’s innovative approach delivers the antibiotic effect of SASPs by using engineered bacteriophages to precisely target P. aeruginosa infections in the lungs,” said Erin Duffy, R&D Chief of CARB-X.

“This approach has the potential to target bacteria without damaging other cells, and
without contributing to the rise of resistance.

If successful, this new intravenous drug could transform the way patients with ventilator-associated pneumonia are treated in hospitals, and save lives.”

https://www.phicotx.co.uk/wp-content/uploads/2021/04/Phico-Tx_Press-Release_-CARB-X-grant_FINAL-for-distribution_19-04-2021.pdf

EU approves second indication of Sarclisa® for relapsed multiple myeloma

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EU approves second indication of Sarclisa® for relapsed multiple myeloma

April 19 2021: “The European Commission approved Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with relapsed multiple myeloma who have received at least one prior therapy.

This marks the second EC approval of Sarclisa in combination with a standard of care regimen in less than 12 months.

“As there is no cure for multiple myeloma and patients often experience disease relapse, we must persist in our pursuit for additional treatment options. Nearly 30% of patients treated with the Sarclisa regimen had a profound response with undetectable levels of multiple myeloma,” said Philippe Moreau, M.D., Department of Hematology, University Hospital of Nantes, France. 

“This new therapeutic regimen has the potential to become a standard of care for patients with relapsed multiple myeloma, who now have another treatment option earlier in the progression of their disease.”

This EC approval closely follows the U.S. Food and Drug Administration (FDA) approval of Sarclisa for a similar indication in March 2021.

In June 2020, Sanofi announced Sarclisa received EC approval in combination with another standard of care regimen, pomalidomide and dexamethasone (pom-dex), for the treatment of adult patients with relapsed and refractory MM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.

“The EC approval of Sarclisa in combination with carfilzomib and dexamethasone means patients living with multiple myeloma in Europe can now receive Sarclisa in combination with two standard of care treatment regimens,” said Peter C. Adamson, Global Development Head, Oncology and Pediatric Innovation at Sanofi. 

“The carfilzomib and dexamethasone combination represents an important standard of care in Europe. 

The Phase 3 IKEMA trial’s finding that the addition of Sarclisa to this regimen reduced the risk of progression or death by nearly half formed the basis for this important EC approval.”

Sarclisa Efficacy and Safety Profile in Difficult-to-Treat Patients

This approval is based on data from the Phase 3 IKEMA study, a randomized, multi-center, open label clinical trial that enrolled 302 patients with relapsed MM across 69 centers spanning 16 countries.

The primary endpoint of IKEMA was progression free survival (PFS).

While median PFS, defined as time to disease progression or death, for Kd was 19.15 months, the median PFS for patients receiving Sarclisa added to carfilzomib and dexamethasone (Sarclisa combination therapy; n=179) had not been reached at the time of the pre-planned interim analysis.

Related News: FDA approves Sarclisa® with carfilzomib & dexamethasone for multiple myeloma

CHMP recommends approval of Sarclisa® with carfilzomib and dexamethasone for relapsed multiple myeloma

EC approves Sarclisa® for adults with relapsed and refractory multiple myeloma

Sarclisa combination therapy reduced the risk of disease progression or death by 47% (hazard ratio 0.531, 99% CI 0.318-0.889, p=0.0007) versus standard of care Kd alone in patients with MM.

Secondary endpoints of the IKEMA trial assessed the depth of response for Sarclisa combination therapy compared to Kd, including overall response rate (ORR), complete response (CR), very good partial response (VGPR) and minimal residual disease (MRD)-negative response.

The ORR remained similar for each arm at 86.6% for the Sarclisa combination therapy versus 82.9% for Kd but was not statistically significant.

The rate of CR was 39.7% in the Sarclisa combination therapy arm and 27.6% in the Kd arm. The rate of VGPR or better was 72.6% for patients receiving Sarclisa combination therapy and 56.1% for patients receiving Kd.

MRD-negativity was observed in 29.6% of patients in the Sarclisa combination therapy arm versus 13% of patients in the Kd arm, indicating that nearly 30% of patients treated with Sarclisa combination therapy achieved undetectable levels of MM at 10-5 sensitivity as measured by next generation sequencing (NGS).

At the time of the interim analysis, overall survival (OS) data were still immature.

The most frequent adverse reactions (≥20%) were infusion reactions (45.8%), hypertension (36.7%), diarrhea (36.2%), upper respiratory tract infection (36.2%), pneumonia (28.8%), fatigue (28.2%), dyspnea (27.7%), insomnia (23.7%), bronchitis (22.6%), and back pain (22.0%).

Serious adverse reactions occurred in 59.3% of patients receiving Sarclisa combination therapy and in 57.4% of patients receiving Kd. The most frequent serious adverse reaction was pneumonia (21.5%).”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-04-19-07-00-00-2212005

AstraZeneca receives US clearance of proposed acquisition of Alexion

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AstraZeneca receives US clearance of proposed acquisition of Alexion

April 16, 2021: “AstraZeneca’s proposed acquisition of Alexion Pharmaceuticals, Inc (Alexion) has achieved an important step toward completion, having cleared US Federal Trade Commission review.

This follows the conclusion of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Additional global regulatory clearances are pending, including but not limited to the UK, EU and Japan.

Marc Dunoyer, Executive Director and Chief Financial Officer, said: “These clearances further advance us towards closing our acquisition of Alexion. 

We remain focused on the next chapter for AstraZeneca and Alexion, building on our combined expertise in immunology and precision medicines and our shared ambition to bring more innovative medicines to patients worldwide. We look forward to working closely with other global authorities as we progress toward this goal.”

The proposed acquisition, first announced in December 2020, would enhance the Company’s scientific presence in immunology by adding Alexion’s innovative complement-technology platforms and strong pipeline.

Rare diseases represent a high-growth disease area with rapid innovation and significant unmet medical need.

The acquisition remains expected to close in Q3 2021, subject to receipt of additional global regulatory clearances and approval by shareholders of both companies with shareholder voting anticipated on 11 May 2021.

Subject to a successful completion of the acquisition, a dedicated business unit will be created, known as ‘Alexion, The AstraZeneca Rare Disease Unit’,headquartered in Boston, US.

AstraZeneca will have an enhanced global footprint and broad coverage across primary, speciality and highly specialised care, and is expected to deliver double-digit revenue growth through 2025, double-digit core EPS accretion for the first three years as well as strong cash flow with an ambition to increase the dividend.

Rare diseases
Over 7,000 rare diseases are known today, and only c.5% have US Food and Drug Administration-approved treatments.

Demand in the global rare disease space is forecasted to grow by a low double-digit percentage in the future.

Important additional information
In connection with AstraZeneca’s proposed acquisition of Alexion (the Acquisition), AstraZeneca filed a registration statement on Form F-4 (the Registration Statement), which has been declared effective by the United States Securities and Exchange Commission, and which includes a document that serves as a prospectus of AstraZeneca and a proxy statement of Alexion (the proxy statement/prospectus).

Alexion filed the proxy statement/prospectus as a proxy statement and AstraZeneca filed the proxy statement/prospectus as a prospectus with the SEC on 12 April 2021, and each party will file other documents regarding the Acquisition with the SEC.

Investors and security holders of Alexion are urged to carefully read the entire Registration Statement and proxy statement/prospectus and other relevant documents filed with the SEC when they become available, because they will contain important information.

Investors and security holders may obtain the Registration Statement and the proxy statement/prospectus free of charge from the SEC’s website or from AstraZeneca or Alexion as described in the paragraphs below.

Important notices relating to financial advisors
Evercore Partners International LLP (Evercore), which is authorised and regulated by the FCA in the United Kingdom, is acting exclusively for AstraZeneca and no one else in connection with the Acquisition and the matters referred to in this announcement and will not regard any other person as a client in relation to the matters set out in this announcement (whether or not a recipient of this announcement) and will not be responsible to anyone other than AstraZeneca for providing the protections afforded to its clients, nor for providing advice in relation to the Acquisition or any other matter referred to in this announcement.

Neither Evercore nor any of its subsidiaries, holding companies, branches or affiliates owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client in connection with the Acquisition or any statement contained in this announcement or otherwise.

Apart from the responsibilities and liabilities, if any, which may be imposed on Evercore by the Financial Services and Markets Act 2000 (FSMA), or the regulatory regime established thereunder, or under the regulatory regime of any jurisdiction where exclusion of liability under the relevant regulatory regime would be illegal, void or unenforceable, neither Evercore nor any of its affiliates accepts any responsibility or liability whatsoever for the contents of this announcement, and no representation, express or implied, is made by it, or purported to be made on its behalf, in relation to the contents of this announcement, including their accuracy, fairness, sufficiency, completeness or verification of any statement contained in this announcement or any other statement made or purported to be made by it, or on its behalf, in connection with AstraZeneca or the matters described in announcement, and nothing in this announcement is, or shall be relied upon as, a promise or representation in this respect, whether as to the past or the future.

To the fullest extent permitted by applicable law, each of Evercore and its affiliates accordingly disclaim all and any responsibility or liability whether arising in tort, contract or otherwise (save as referred to above) which they might otherwise have in respect of this announcement or any statement contained in this announcement.

Centerview Partners UK LLP (Centerview Partners), which is authorised and regulated by the FCA in the United Kingdom, is acting exclusively for AstraZeneca and no one else in connection with the Acquisition and the matters referred to in this announcement and will not regard any other person as a client in relation to the matters set out in this announcement (whether or not a recipient of this announcement) and will not be responsible to anyone other than AstraZeneca for providing the protections afforded to its clients, nor for providing advice in relation to the Acquisition or any other matter referred to in this announcement.

Neither Centerview Partners nor any of its subsidiaries, holding companies, branches or affiliates owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client in connection with the Acquisition or any statement contained in this announcement or otherwise.

Apart from the responsibilities and liabilities, if any, which may be imposed on Centerview Partners by the FSMA, or the regulatory regime established thereunder, or under the regulatory regime of any jurisdiction where exclusion of liability under the relevant regulatory regime would be illegal, void or unenforceable, neither Centerview Partners nor any of its affiliates accepts any responsibility or liability whatsoever for the contents of this announcement, and no representation, express or implied, is made by it, or purported to be made on its behalf, in relation to the contents of this announcement, including their accuracy, fairness, sufficiency, completeness or verification of any statement contained in this announcement or any other statement made or purported to be made by it, or on its behalf, in connection with AstraZeneca or the matters described in this announcement, and nothing in this announcement is, or shall be relied upon as, a promise or representation in this respect, whether as to the past or the future.

To the fullest extent permitted by applicable law, each of Centerview Partners and its affiliates accordingly disclaim all and any responsibility or liability whether arising in tort, contract or otherwise (save as referred to above) which they might otherwise have in respect of this announcement or any statement contained in this announcement.

Forward-looking statements
This announcement contains certain forward-looking statements with respect to the operations, performance and financial condition of the AstraZeneca Group, including, among other things, statements about expected revenues, margins, earnings per share or other financial or other measures, as well as the ability of the parties to consummate the Acquisition on a timely basis or at all, the ability of the parties to satisfy the conditions precedent to consummation of the Acquisition, including the ability to secure the required regulatory approvals on the terms expected, at all or in a timely manner, the ability of AstraZeneca to successfully integrate Alexion’s operations, and the ability of AstraZeneca to implement its plans, forecasts and other expectations with respect to Alexion’s business after completion of the Acquisition and realise expected synergies.

Although the AstraZeneca Group believes its expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted.

The forward-looking statements reflect knowledge and information available at the date of preparation of this announcement and the AstraZeneca Group undertakes no obligation to update these forward-looking statements.

The AstraZeneca Group identifies the forward-looking statements by using the words ‘anticipates’, ‘believes’, ‘expects’, ‘intends’ and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond the AstraZeneca Group’s control, include, among other things: the risks set out in Part II (Risk Factors) of the AstraZeneca shareholder circular published on 12 April 2021; failure or delay in delivery of pipeline or launch of new medicines; failure to meet regulatory or ethical requirements for medicine development or approval; failure to obtain, defend and enforce effective intellectual property (IP) protection and IP challenges by third parties; competitive pressures including expiry or loss of IP rights, and generic competition; price controls and reductions; economic, regulatory and political pressures; uncertainty and volatility in relation to the UK’s exit from the EU; failures or delays in the quality or execution of commercial strategies; failure to maintain supply of compliant, quality medicines; illegal trade in medicines; reliance on third-party goods and services; failure in information technology, data protection or cybercrime; failure of critical processes; uncertainty of expected gains from productivity initiatives; failure to attract, develop, engage and retain a diverse, talented and capable workforce, including following completion of the Acquisition; failure to adhere to applicable laws, rules and regulations; the safety and efficacy of marketed medicines being questioned; adverse outcome of litigation and/or governmental investigations, including relating to the Acquisition; failure to adhere to increasingly stringent anti-bribery and anti-corruption legislation; failure to achieve strategic plans or meet targets or expectations; failure in financial control or the occurrence of fraud; unexpected deterioration in AstraZeneca’s or Alexion’s financial position; the COVID-19 global pandemic; the risk that a condition to the closing of the Acquisition may not be satisfied, or that a regulatory approval that may be required for the Acquisition is delayed or is obtained subject to conditions that are not anticipated; the risk that AstraZeneca is unable to achieve the synergies and value creation contemplated by the Acquisition, or that AstraZeneca is unable to promptly and effectively integrate Alexion’s businesses; and the risk that management’s time and attention are diverted on Acquisition-related issues or that disruption from the Acquisition makes it more difficult to maintain business, contractual and operational relationships.

Neither AstraZeneca nor any of its associates or directors, officers or advisers provides any representation, assurance or guarantee that the occurrence of the events expressed or implied in any forward-looking statements in this announcement will actually occur.

You are cautioned not to place undue reliance on these forward-looking statements.

Other than in accordance with their legal or regulatory obligations (including under the Listing Rules, the Disclosure and Transparency Rules and the Prospectus Regulation Rules of the FCA), AstraZeneca is under no obligation, and AstraZeneca expressly disclaims any intention or obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/us-clearance-of-proposed-acquisition-of-alexion.html

Update of the WHO guidance on the treatment of drug susceptible tuberculosis

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Update of the WHO guidance on the treatment of drug susceptible tuberculosis

April 16, 2021: The WHO is convening a Guideline Development Group (GDG) to advise on updates needed to its recommendations on the treatment of drug susceptible tuberculosis (TB).

Drug susceptible TB affects approximately 7 million people annually. It is currently treated with four first line TB medicines for a period of six months.

Approximately 85% of patients who take the six-month regimen will have a successful treatment outcome.

Ensuring access to effective treatment is a key component of the End TB Strategy, which includes a priority indicator that 90% or more of patients should have a successful treatment outcome.

Despite its effectiveness, the current treatment regimen of six months remains too long for many patients.

In recent years, research efforts have been directed towards finding safe and effective shorter regimens.

New evidence from a randomized controlled trial on a 4-month treatment regimen containing a fluoroquinolone and high dose rifapentine has recently become available to WHO.

This will be the evidence that will be reviewed and considered by the GDG.

WHO last updated its guidance on the treatment of drug susceptible TB in 2017.

At this time WHO issued a recommendation against the use of shorter fluoroquinolone containing regimens as the evidence did not support that these regimens were more effective than the six-month regimen.

However, it is now time to review the evidence on shorter regimens again, to provide users worldwide with the most up to date evidence-informed guidance on how to treat drug susceptible TB.

The GDG meeting will be held online in late April 2021, in accordance with WHO requirements for the development of evidence-informed policy guidance.

The updated recommendations will be released in 2021, as part of the treatment module of the WHO consolidated guidelines on tuberculosis.

https://www.who.int/news/item/16-04-2021-update-of-the-who-guidance-on-the-treatment-of-drug-susceptible-tuberculosis

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