AstraZeneca (AZ) and Daiichi Sankyo have shared positive results from a late-stage study of their HER2-directed antibody drug conjugate Enhertu (trastuzumab deruxtecan) in a subset of breast cancer patients.

The phase 3 DESTINY-Breast06 has been comparing the drug against chemotherapy in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-low or HER2-ultralow advanced or metastatic breast cancer.

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths globally, with more than two million cases of the disease diagnosed in 2022.

HR-positive, HER2-negative is the most common breast cancer subtype, with up to 65% of these cases estimated to be HER2-low and an additional 25% may be HER2-ultralow.

There were no targeted therapies specifically approved for patients with HER2-low expression prior to the approval of Enhertu in HER2-low metastatic breast cancer last year, and there are still no targeted therapies specifically authorised for those with HER2-ultralow expression.


Read more: https://pmlive.com/pharma_news/astrazeneca-daiichi-sankyos-enhertu-shows-promise-in-phase-3-breast-cancer-study/

AstraZeneca/Daiichi Sankyo’s Enhertu shows promise in phase 3 breast cancer study - PMLiVE

More than two million cases of breast cancer were diagnosed globally in 2022

Researchers from the Francis Crick Institute, the National Cancer Institute of the US National Institutes of Health and Aalborg University in Denmark have revealed that vitamin D encourages the growth of a type of gut bacteria in mice, which provides better cancer immunity.
The study published in Science found that vitamin D increases the amount of Bacteroides fragilis, providing better immunity to cancer in mice with transplanted tumours.
Cancer, including female breast, lung, bowel and prostate cancers, was responsible for more than 18 million new cases worldwide in 2020, according to Cancer Research UK.
After giving mice a diet rich in vitamin D, researchers discovered they had better immune resistance to experimentally transplanted cancers and improved responses to immunotherapy treatment.
Furthermore, this effect was seen when gene editing was used to remove a protein that binds to vitamin D in the blood and keep it away from tissues.
Researchers found that vitamin D acts on epithelial cells in the intestine and increases the amount of a bacteria known as Bacteroides fragilis, which offered mice better immunity to cancer as the transplanted tumours didn’t grow as much.
After giving mice Bacteroides fragilis, researchers observed better resistance to tumour growth compared to mice on a vitamin D-deficient diet.
Previous, inconclusive research has already suggested a link between vitamin D deficiency and cancer risk in humans.
Researchers explored this link by analysing a dataset from 1.5 million people in Denmark, which highlighted a link between lower vitamin D levels and a higher risk of cancer.

Read more: https://pharmatimes.com/news/study-reveals-vitamin-d-altered-mouse-gut-bacteria-provides-better-cancer-immunity/

Study reveals vitamin D-altered mouse gut bacteria provides better cancer immunity - PharmaTimes

Bacteroides fragilis in the gut improves immunity and immunotherapy treatment responses

Novartis and PeptiDream have expanded their peptide discovery collaboration with a new agreement worth over $2.8bn.
The multi-programme agreement will see PeptiDream use its proprietary Peptide Discovery Platform System technology to identify and optimise macrocyclic peptides against targets chosen by Novartis.
These peptides will then be conjugated to radionuclides, which Novartis refers to as ‘radioligand therapies (RLTs)’, or other applications for therapeutic and diagnostic purposes.
In exchange, PeptiDream will receive an upfront payment of $180m and will be eligible to receive up to $2.71bn in future milestone payments, as well as tiered royalties.
The deal expands Novartis and PeptiDream’s peptide-drug conjugate (PDC) collaboration announced in 2019 and builds on the partners’ ongoing discovery efforts, originally initiated in 2010.
Shiva Malek, global head of oncology research at Novartis, said: “We are enthusiastic about the progress we’ve made with PeptiDream through our long-standing research collaboration and look forward to continuing our work together as we strive to create impactful new therapies for patients.
“Our expanded partnership reflects our shared commitment to pioneering science that broadens the scope of transformative therapeutic approaches such as RLT.”
Similarly to antibody-drug conjugates, PDCs are designed to deliver drugs to cancer cells while sparing healthy tissues.
PeptiDream’s chief executive officer, Patrick Reid, said: “We are delighted to further expand our long-standing macrocyclic peptide discovery collaboration with Novartis, adding additional peptide RLT and other programmes to our strong partnership.
“As macrocyclic peptides continue to be the ideal vectors for the targeted delivery of a variety of therapeutic payloads, PeptiDream continues to build an extensive pipeline of partnered as well as internal peptide-conjugate programmes.”

Read more: https://pmlive.com/pharma_news/novartis-and-peptidream-expand-peptide-discovery-collaboration-in-deal-worth-over-2-8bn/

Novartis and PeptiDream expand peptide discovery collaboration in deal worth over $2.8bn - PMLiVE

The agreement builds on the companies’ peptide-drug conjugate collaboration announced in 2019

Researchers with McMaster University and Denmark-based pharmaceutical company ALK-Abello A/S have made a groundbreaking discovery: a new cell that remembers allergies.The discovery gives scientists and researchers a new target in treating allergies and could lead to new therapeutics. The research, published in Science Translational Medicine, coins the brand-new cell as a type-2 memory B cell (MBC2)."We've discovered a type of memory B cell that had unique characteristics and a unique gene signature that has not been described before," says Josh Koenig, assistant professor with McMaster's Department of Medicine and co-lead of the study. "We found allergic people had this memory B cell against their allergen, but non-allergic people had very few, if any."
B cells are a type of immune cell that makes antibodies. These cells help fight off infections but can also cause allergies.
"Let's say you're allergic to peanuts. Your immune system, because of MBC2, remembers that you're allergic to peanuts, and when you encounter them again, it creates more of the antibodies that make you allergic," Koenig says.
To come to this discovery, researchers created tetramers—a type of fluorescent molecule—out of allergens like Birch pollen and peanuts to locate difficult-to-find memory B cells. Koenig and his team previously wrote the instruction manual on how to use tetramers to locate these elusive cells.
Researchers further leveraged samples from ALK clinical trialswith tablet sublingual immunotherapy, which allows for sequencing large amounts of IgE-producing B cells.
Using cutting-edge technology such as single-cell transcriptomics and deep sequencing of antibody gene repertoires on clinical trial samples, they were able to make direct connections between MBC2 and IgE, the type of antibody that triggers the allergic reaction. This provided necessary context, ultimately revealing the MBC2 as the home of allergy.

Read more: https://medicalxpress.com/news/2024-02-cell-allergies.html

Researchers discover new cell that remembers allergies

Researchers with McMaster University and Denmark-based pharmaceutical company ALK-Abello A/S have made a groundbreaking discovery: a new cell that remembers allergies.

RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, certain populations are at a higher risk for severe disease, such as older adults, the immunocompromised and those with underlying medical conditions.
Arexvy has already been approved in the US, Europe and several other countries to protect adults aged 60 years and older against RSV-caused lower respiratory tract disease (LRTD).
GSK’s application to extend the indication is supported by results from a late-stage trial evaluating the immune response and safety of Arexvy in adults aged 50 to 59 years, including those at increased risk for RSV-LRTD due to underlying medical conditions.
The company recently shared positive results from the trial, which showed that Arexvy elicited an immune response in this population, including those with chronic pulmonary disease, cardiovascular disease, kidney disease, liver disease or diabetes, that was non-inferior to that observed in adults aged 60 and above.
The co-primary endpoint was also met for the broader group of adults in this age group, GSK said in the October readout, adding that safety and reactogenicity data was consistent with results from the initial phase 3 programme of Arexvy.

Read more: https://www.pmlive.com/pharma_news/gsks_rsv_vaccine_granted_fda_priority_review_for_use_in_adults_aged_50_to_59_years_1507886

GSK’s RSV vaccine granted FDA priority review for use in adults aged 50 to 59 years - PMLiVE

GSK’s RSV vaccine granted FDA priority review for use in adults aged 50 to 59 years - PMLiVE

European Innovation Council Accelerator finances treatment development drive for condition
The European Innovation Council (EIC) Accelerator is providing €16m to support the development of therapy to slow the progression of Parkinson's disease.
GeneCode will receive the financing to support the Kevad Bio project, which is being developed in collaboration with Argobio, and is divided into a €1.7m grant and €14.3m in equity investments.
GeneCode is a company focused on the development of disease-modifying therapeutics to combat neurodegeneration, while Argobio is a start-up that concentrates on progressing innovation.
For the critical second 2023 EIC Accelerator ‘cut-off’ in March this year, well over 500 businesses submitted a complete application. Consequently, a set of 51 companies across 17 different countries were selected during a competitive process to receive the vital funding.
The funding provided to GeneCode amounts to €16m – under EIC Accelerator, a single project can receive a maximum of €17.5m.
Professor Mart Saarma, GeneCode supervisory board member, reflected: “If we can contribute to improving the quality of life of people affected by the disease through our treatment, it will be a great achievement. Renowned specialists from GeneCode and Argobio, as well as several researchers from the Universities of Tartu and Helsinki and international CROs, are contributing to this effort daily.”
He added: “We are now in the position to start preparations to achieve the IND-ready status to apply for a licence for clinical trials.”

Read more: https://www.pharmatimes.com/news/genecode_receives_record_parkinsons_funding_1494255

GeneCode receives record Parkinson’s funding - PharmaTimes

European Innovation Council Accelerator finances treatment development drive for condition - News - PharmaTimes

The collaboration aims to develop novel preclinical models with a view to identifying new treatments

Almirall – a company which concentrates on medical dermatology – has linked up with the Centre for Genomic Regulation. The collaboration aims to develop novel preclinical models with a view to identifying new treatments for non-melanoma skin cancer (NMSC).

The condition poses a considerable health challenge, with basal cell carcinoma and squamous cell carcinoma representing 70% and 25% of NMSC cases, respectively.

The partnership – led by Almirall's investigators Dr Cristina Gutiérrez and Dr Amadeu Gavaldà – will also incorporate CRG group leader and ICREA research professor Luciano Di Croce and his team.

In partnership, they will establish experimental models that enable the validation of new therapeutic approaches and therapies for these diseases.

The collaboration has emerged following the request for proposals from AlmirallShare – the company's open innovation platform dedicated to discovering treatments for skin diseases.

The platform was launched in 2017 in order to make dermatological study collaborations more straight forward and the development of new skin condition treatments more rapid.

Professor Di Croce was optimistic about the collaboration: “NMSC is not an aggressive cancer, meaning it has been historically difficult to model this disease in the lab. However, important technological advances combined with multiple 'omics’ approaches allow now to create truly functional scientific models for this skin cancer.”

Read more: https://www.pharmatimes.com/news/centre_for_genomic_regulation_and_almirall_join_forces_on_skin_cancer_treatments_1492027

Centre for Genomic Regulation and Almirall join forces on skin cancer treatments - PharmaTimes

The collaboration aims to develop novel preclinical models with a view to identifying new treatments - News - PharmaTimes

Hi everyone, I'm happy to join you here. hope to find interesting topics to talk about and share interesting information.

Novo Nordisk said on Tuesday it would cut U.S. list prices for several insulin drugs by up to 75% next year, joining rival Eli Lilly as drugmakers come under pressure for high prices of the life-sustaining treatment.
The moves follow President Joe Biden's Inflation Reduction Act last year that capped insulin prices for Medicare recipients at $35 per month, but that does not extend to patients without insurance.
Novo will reduce the list price of its NovoLog insulin by 75%, and for Novolin and Levemir by 65%. The Danish drugmaker said the financial impact of the move was uncertain.
The company also said it would reduce the list price of unbranded insulin products to match lowered price of respective branded insulin products.
Eli Lilly and Co said earlier this month that it would cut the list prices for its most commonly prescribed insulin products by 70% from the fourth quarter of this year.
"I think it is a relatively natural consequence of what we have seen their competitor Eli Lilly do. We know there has been political pressure on this issue in general, it is a focus area in the U.S., especially for uninsured patients," Jyske Markets analyst Henrik Hallengreen Laustsen told Reuters.

Read more: https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisk-cut-price-insulin-by-up-75-wsj-2023-03-14/

Novo Nordisk joins Lilly in plans to slash U.S. insulin prices | Reuters

Novo Nordisk said on Tuesday it would cut U.S. list prices for several insulin drugs by up to 75% next year, joining rival Eli Lilly as drugmakers come under pressure for high prices of the life-sustaining treatment.

Candidate AP30663 is an inhibitor for the conversion of atrial fibrillation to a normal sinus rhythm
Acesion Pharma – a company focused on novel therapies for atrial fibrillation (AF) – has announced positive results from a phase 2 trial of its candidate, AP30663. The therapy is a first-in-class SK ion channel inhibitor for the conversion of AF to a normal sinus rhythm.
The trial was placebo-controlled, randomised, double-blind and multi-national. The study enrolled 63 patients with a current episode of AF – the most common cardiac arrhythmia – and examined the performance of two intravenous doses of AP30663 compared to the placebo.
Meanwhile, the primary endpoint was the proportion of patients with AF conversion to sinus rhythm within 90 minutes of infusion commencing.
In addition, the research employed a ‘Bayesian analysis’ involving a probability less than 99.9% of a true AF conversion rate greater than the placebo across the two doses. The results from the Bayesian analysis were supported by a traditional analysis of the primary endpoint, demonstrating significant P-values for each dose compared to the placebo.
The safety profile was also consistent with that observed in previous phase 1 trials with AP30663, while the therapy was well tolerated, with no serious adverse events reported among the groups. The main safety concern with available AF treatments – ventricular arrhythmias – were not apparent throughout the trials.
John Camm, emeritus professor of clinical cardiology at St George’s University of London, reflected: “There is a great unmet need for safer AF treatments that can decrease the risk for patients, but also remove barriers for physicians wanting to keep their patients in sinus rhythm by treating them with an antiarrhythmic drug. This novel mechanism holds the promise to deliver on these aspects.”

Read more: https://www.pharmatimes.com/news/acesion_announces_positive_atrial_fibrillation_study_1489340

Acesion announces positive atrial fibrillation study - PharmaTimes

Candidate AP30663 is an inhibitor for the conversion of atrial fibrillation to a normal sinus rhythm - News - PharmaTimes

Ipsen has revealed follow-up results from its phase 3 CheckMate-9ER trial. The study demonstrated that Cabometyx in combination with nivolumab provides survival benefits after three-years of treating advanced renal cell carcinoma (RCC), compared to sunitinib.
During the CheckMate -9ER trial, overall survival benefits were maintained during three-years of follow-up. Meanwhile, median overall survival was significantly higher for patients on Cabometyx (also known as cabozantinib) together with nivolumab versus sunitinib.
Accounting for around 90% of cases, RCC is the most common type of kidney cancer. When detected at an early stage, the five-year survival rate is high, but for people living with advanced or late-stage metastatic RCC the survival rate is considerably lower – around 12%.
The study results were also assessed by the following International Metastatic Renal Cell Carcinoma Database Consortium risk scores. Benefits were duly identified with Cabometyx in combination with nivolumab across all efficacy measures, regardless of IMDC risk.
Steven Hildemann, executive vice president at Ipsen, explained: “The results from the CheckMate -9ER study continue to demonstrate sustained, now three-year long-term benefits for people living with advanced renal cell carcinoma across the most meaningful efficacy measures and risk scores, adding to the body of evidence we have for Cabometyx plus nivolumab.

Read more: https://www.pharmatimes.com/news/positive_results_for_ipsens_cabometyx_in_combination_with_nivolumab_1486624

Positive results for Ipsen’s Cabometyx in combination with nivolumab - PharmaTimes

Benefits were identified with Cabometyx in combination with nivolumab across all efficacy measures - News - PharmaTimes

Phase 3 study demonstrated that efanesoctocog alfa met both primary and secondary endpoints

Research has demonstrated positive safety, efficacy and pharmacokinetic credentials of Sanofi’s efanesoctocog alfa drug.

The therapy is an investigational treatment for haemophilia A and the data showed that it delivered a normal to near-normal factor activity levels for the most of the week during a once-a-week dosing pattern.

Haemophilia A is a lifelong, rare and genetic condition affecting the ability of a person’s blood to clot, and occurs in about one in 5,000 male births every year, while being uncommon in females. Individuals can experience bleeding episodes that can cause irreversible joint damage, severe pain and life-threatening haemorrhages.

Data from the vital XTEND-1 phase 3 study demonstrated that efanesoctocog alfa – also known as ALTUVIIIO – met both primary and secondary endpoints, showing clinically meaningful prevention of bleeds and superior bleed protection compared to prior factor VIII prophylaxis treatment.

Dietmar Berger, global head of development and chief medical officer at Sanofi, reflected: “We are steadfast in our commitment to developing novel treatment options that have a meaningful impact for patients.”

He added: “We are hopeful that efanesoctocog alfa will help deliver on this goal by offering unprecedented factor activity levels with once-weekly dosing, fulfilling its potential as a best-in-class therapy for haemophilia A.”

Read more: https://www.pharmatimes.com/news/sanofis_efanesoctocog_alfa_may_be_game-changer_for_haemophilia_a_patients_1486092

Sanofi’s efanesoctocog alfa may be game-changer for haemophilia A patients - PharmaTimes

Phase 3 study demonstrated that efanesoctocog alfa met both primary and secondary endpoints - News - PharmaTimes

Roche’s Xofluza (baloxavir marboxil) has been approved by the European Commission (EC) to treat and prevent uncomplicated influenza in children aged one year and over.
With the EC’s decision, Xofluza is now the first single-dose, oral influenza medicine approved in Europe for children.
The approval was based on phase 3 trial results taken from miniSTONE-2, which assessed the use of Xofluza in children, and BLOCKSTONE, which assessed Xofluza in both adults and children as a preventive treatment for households.
The miniSTONE-2 study met its primary endpoint of safety and demonstrated that Xofluza reduced the length of time that influenza was released from the body by more than two days compared with oseltamivir.
Time to alleviation of influenza signs and symptoms were comparable between Xofluza and oseltamivir, Roche reported, at 138 hours and 150 hours, respectively.
In the BLOCKSTONE study, Xofluza demonstrated a statistically significant prophylactic effect after a single oral dose, by reducing the risk of developing influenza after exposure to an infected household member by 86% versus placebo.
Commenting on the decision, Levi Garraway, Roche’s chief medical officer and head of global product development, said: “We are delighted that the EC has approved Xofluza for children aged one year and above, as influenza can be particularly dangerous for younger children.

Read more: https://www.pmlive.com/pharma_news/roches_influenza_medicine_approved_by_ec_for_children_1485236

Roche’s influenza medicine approved by EC for children - PMLiVE

Roche’s influenza medicine approved by EC for children - PMLiVE

Collaboration involves the development, optimisation and production of proprietary enzymes

Carbios – a company which focuses on the lifecycle of plastics and textiles – and Novozymes, which specialised in biological solutions, have announced a long-term global strategic partnership.

The collaboration involves the long-term production and supply of Carbios’ proprietary PET-degrading enzymes at an industrial scale. Indeed, it represents the world’s first biological PET-recycling plant, due to start production in 2025 in Longlaville, France.

Construction will begin later in 2023 with both building and operating permits having been filed with local authorities. The processing capacity is set to be 50,000 tonnes of waste every year.

Carbios and Novozymes first established a partnership in 2019 to develop enzyme-based solutions and address the considerable sustainability challenge of plastic pollution, both within PET-recycling and PLA-biodegradation.

Under the new agreement, Carbios and Novozymes will extend their collaboration to develop, optimise and produce enzymes that will subsequently be supplied by Novozymes to all licensees of Carbios’ technology.

Hans Ole Klingenberg, vice president, marketing agricultural and industrial biosolutions at Novozymes, reflected: “We are excited to advance our collaboration with Carbios by signing this exclusive agreement and to support the next phase of scaling this new business of biological plastic recycling.”

Read more: https://www.pharmatimes.com/news/carbios_and_novozymes_form_biorecycling_strategic_partnership_1485234

Carbios and Novozymes form biorecycling strategic partnership - PharmaTimes

Collaboration involves the development, optimisation and production of proprietary enzymes - News - PharmaTimes

https://youtu.be/AiRqVn21dKw

The oldest cryo-preserved human returns to life! Cryo Freeze Laboratory, Finland - YouTube

Don’t get frozen in time! Only one man has returned from cryopreservation, not out of desire but as an act of duty to mankind.Often our lives remain frozen r...

A world-first trial has been launched in the UK that could see stem cell transplants offered as a first-line treatment to patients with aggressive forms of multiple sclerosis (MS).
The £2.3m StarMS study will be the first to compare the efficacy of autologous haematopoietic stem cell transplantation (AHSCT) with four other drug treatments demonstrating positive results in clinical trials: alemtuzumab, ocrelizumab, ofatumumab and cladribine.
AHSCT is an intensive treatment which essentially rebuilds a patient’s immune system using stem cells harvested from their own blood and bone marrow to reset it to a point before it caused MS.
Led by Sheffield Teaching Hospitals NHS Foundation Trust in partnership with the University of Sheffield's Clinical Trials Unit, the trial will run across 19 UK sites, randomly allocating each participant to receive a stem cell transplant or one of the disease modifying therapies.
The trial will build on the results of the MIST trial, published in 2018, which was the first in the world to show that stem cell transplantation could reverse disability in patients with MS.
AHSCT was also shown in the trial to work better than the disease-modifying drugs available at the time in reducing the risk of disability accumulation in patients with the highly active form of the disease.
The new StarMS trial, which is being funded through a National Institute for Health and Care Research and Medical Research Council partnership, will bring this research up to date and compare the effectiveness and safety of AHSCT against the four other drug treatments.
MS is a disabling, unpredictable disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. The disease affects approximately 100,000 people in the UK, and 2.3 million globally.

Read more:
https://www.pmlive.com/pharma_news/world-first_trial_launches_in_uk_to_assess_stem_cell_transplants_as_first-line_ms_treatment_1482517

World-first trial launches in UK to assess stem cell transplants as first-line MS treatment - PMLiVE

World-first trial launches in UK to assess stem cell transplants as first-line MS treatment - PMLiVE

Scientists have discovered a new treatment that slows the progression of neurodegenerative disease in mice. The breakthrough research may offer hope in tackling currently untreatable conditions such as Alzheimer’s disease (AD).
The study, led by researchers at the University of Glasgow’s new Advanced Research Centre (ARC). discovered that by using a novel drug – which selectively activates a brain protein called the M1-receptor – the lifespan of mice suffering from neurodegeneration could be extended.
At present, treatments for AD can only target symptoms, including memory impairment, and previous attempts to establish a drug that can slow down the disease have been unsuccessful.
The study demonstrates how many of the features of human AD, including memory loss and brain inflammation, could be treated in mice when they were given the new drug, known as a positive allosteric modulator or M1-PAM. The study also indicated that, in addition to treating symptoms, M1-PAMs may also be able to slow the overall progression of the disease.

https://www.pharmatimes.com/news/research_provides_hope_for_patients_with_neurodegenerative_disease_1480816

Research provides hope for patients with neurodegenerative disease - PharmaTimes

Findings highlight a potential new drug candidate that may delay disease progression - News - PharmaTimes

The U.S. health regulator on Tuesday issued an emergency use authorization to Roche's test for the detection of DNA from monkeypox virus in swab specimens collected from people suspected of the virus infection.
The tests will be conducted on the Swiss company's cobas systems, which can also detect HIV, hepatitis B and C viruses.
The Food and Drug Administration said testing will be limited to laboratories that meet the requirements to perform moderate or high complexity tests.
While around 80,000 cases of monkeypox have been reported in nearly 100 countries since the outbreak started earlier this year, the number of cases have declined from the peak in August. Over 28,000 cases have been reported in the United States in the outbreak this year, including two deaths.

Read more:
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-authorizes-roches-monkeypox-test-2022-11-15/

U.S. FDA authorizes Roche's monkeypox test | Reuters

The U.S. health regulator on Tuesday issued an emergency use authorization to Roche's test for the detection of DNA from monkeypox virus in swab specimens collected from people suspected of the virus infection.

Janssen – a pharmaceutical arm of Johnson & Johnson – has announced that Tecvayli (teclistamab-cqyv) has been approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM).
Specifically, patients treated with Tecvayli must have received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.
The FDA’s decision is supported by evidence from the pivotal phase 2 MajesTEC-1 clinical trial in RRMM patients who had received a median of five prior lines of therapy.
An overall response rate of 61.8% was achieved in the study, notably with 28.2% of patients achieving a complete response or better, the company reported.
The median time to first response was 1.2 months and, with a median follow-up of 7.4 months, the estimated duration of response rate was 90.6% at six months and 66.5% at nine months.

Read more: https://www.pmlive.com/pharma_news/janssens_tecvayli_granted_fda_approval_for_multiple_myeloma_1479795

Janssen’s Tecvayli granted FDA approval for multiple myeloma - PMLiVE

Janssen’s Tecvayli granted FDA approval for multiple myeloma - PMLiVE

Merck & Co – known as MSD outside the US and Canada – has exercised its option to jointly develop and commercialise personalised cancer vaccine (PCV), mRNA-4157/V940, with Moderna in accordance with the terms of its existing collaboration and licence agreement.
Under the agreement, originally established in 2016 and amended in 2018, Moderna will receive an upfront payment of $250m from Merck, with the two companies sharing the costs and any profits equally under this worldwide collaboration.
PCVs are designed to prime the immune system so that a patient can generate a tailored antitumour response to their tumour mutation signature to treat their cancer.
mRNA-4157/V940 is currently being evaluated in combination with Keytruda, Merck’s anti-PD-1 therapy, in a phase 2 clinical trial being conducted by Moderna for the adjuvant treatment of patients with high-risk melanoma. Keytruda was selected as the comparator in the trial because it is considered a standard-of-care for high-risk melanoma patients, the companies outlined.
In the trial, following complete surgical resection, patients were randomised to receive mRNA-4157/V940 (nine doses every three weeks) and Keytruda (200mg every three weeks) versus Keytruda alone for approximately one year until disease recurrence or unacceptable toxicity.
The primary endpoint of the trial is recurrence-free survival, with secondary endpoints including distant metastasis-free survival and overall survival. The trial is fully enrolled and primary data is expected in the fourth quarter of 2022.

Read more: https://www.pmlive.com/pharma_news/merck_and_moderna_to_jointly_develop_personalised_cancer_vaccine_in_$250m_deal_1456720

GSK’s Boostrix (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed [Tdap]) has been approved by the US Food and Drug Administration (FDA) for immunisation during the third trimester of pregnancy to help prevent pertussis (whooping cough) in infants less than two months of age, the company announced.

Pertussis is a highly contagious respiratory infection caused by the bacterium Bordetella pertussis. Severity of the disease varies, but infants are at a high risk of complications because their immune systems are still developing.

According to the Centers for Disease Control and Prevention, 4.2% of the total cases of pertussis reported in the US in 2021 were in infants younger than six months of age and approximately 31% required hospitalisation.

“While vaccination is the best method for providing protection, infants younger than two months of age are too young to be protected by the childhood pertussis vaccine series. This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy,” explained Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Read more: https://www.pmlive.com/pharma_news/gsks_boostrix_approved_by_fda_for_use_during_pregnancy_to_prevent_whooping_cough_in_infants_1456660

GSK’s Boostrix approved by FDA for use during pregnancy to prevent whooping cough in infants - PMLiVE

GSK’s Boostrix approved by FDA for use during pregnancy to prevent whooping cough in infants - PMLiVE

The study will focus on checkpoint inhibitor refractory non-small cell lung cancer

Tilt Biotherapeutics – a clinical-stage biotechnology company developing cancer immunotherapies – has announced that it has signed a second clinical trial collaboration and supply agreement with MSD, a trade name of Merck.

The partnership will involve a new clinical trial evaluating TILT-123 – the company’s oncolytic adenovirus with two human cytokines – in combination with Keytruda, also known as pembrolizumab. This treatment is MSD’s anti-PD-1 therapy.

The phase 1, open label, dose escalation trial will include 12 to 24 patients with immune checkpoint inhibitor refractory non-small cell lung cancer (NSCLC). It is the latest trial that builds on the company’s emerging data on the use of TILT-123, which is currently in trials for several other indications where promising results of intravenous usability have motivated the expansion of the portfolio of trials.

Tilt’s chief executive officer, Akseli Hemminki, said: “We already have clinical trials running in Europe and the US in several cancer types, including ovarian cancer, head and neck cancer, and melanoma. We are planning several more, one of which is this new collaboration in NSCLC with our collaborator MSD.

Read more:
https://www.pharmatimes.com/news/tilt_collaborates_with_msd_on_immunotherapy_clinical_trial_1455923

Tilt collaborates with MSD on immunotherapy clinical trial - PharmaTimes

The study will focus on checkpoint inhibitor refractory non-small cell lung cancer - News - PharmaTimes

The European Medicines Agency (EMA) on Monday recommended a COVID-19 booster designed to combat the currently circulating Omicron BA.4/5 subvariants, days after endorsing a pair of boosters tailored to target the older BA.1 Omicron variant.
The latest recommendation is for a so-called bivalent vaccine developed by Pfizer (PFE.N) and BioNTech (22UAy.DE), which targets BA.4/5 as well as the strain of the virus that originally emerged in China in December 2019 targeted by earlier COVID vaccines.
The EMA recommendation is to authorize the retooled booster shots for people aged 12 and above who have received at least primary vaccination against COVID. The final go-ahead will be subject to European Commission approval, which is expected to come in shortly.
If authorized, the BA.4/5-tailored booster will be available in days to all 27 EU member states, Pfizer said in a statement on Monday.
While existing coronavirus vaccines provide good protection against hospitalization and death, their effectiveness, particularly against infection, was reduced as the virus evolved.

Read more: https://www.reuters.com/business/healthcare-pharmaceuticals/eu-regulator-backs-pfizers-omicron-adapted-vaccine-booster-2022-09-12/

EU regulator backs Pfizer/BioNTech BA.4/5-adapted COVID booster | Reuters

The European Medicines Agency (EMA) on Monday recommended a COVID-19 booster designed to combat the currently circulating Omicron BA.4/5 subvariants, days after endorsing a pair of boosters tailored to target the older BA.1 Omicron variant.

Fourth award from the Bill & Melinda Gates Foundation will support artemisinin research

Manus Bio – the leading biomanufacturer of natural products – has received a fourth award from the Bill & Melinda Gates Foundation to develop a scalable production route for the potential antimalarial therapy, artemisinin.

The $2m award will enable Manus Bio to begin scaling up the unique biological process it has developed towards the key chemical intermediate, dihydroartemisinic acid. Economical and scalable access to this compound will enable process simplification for large-scale commercial manufacturing of artemisinin.


Artemisinin is an effective compound in malaria treatments. The World Health Organization recommends artemisinin or one of its derivatives formulated in combination therapies as frontline treatments for all cases of malaria.

It has traditionally been extracted from the ‘Artemisia annua’, however, availability of the plant is subject to agricultural instabilities and vulnerabilities. The artemisinin precursor, dihydroartemisinic acid, can alternatively be produced using fermentation, which provides a more stable and sustainable source for making artemisinin than through agricultural extraction.

Read more: https://www.pharmatimes.com/news/manus_bio_receives_additional_funding_to_combat_malaria_1454225

Manus Bio receives additional funding to combat malaria - PharmaTimes

Fourth award from the Bill & Melinda Gates Foundation will support artemisinin research - News - PharmaTimes

Merck – known as MSD outside the US and Canada – has received fast track designation from the US Food and Drug Administration (FDA) for MK-2060, an investigational anticoagulant therapy for the reduction of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD).

ESRD, also called end-stage kidney disease or kidney failure, occurs when chronic kidney disease — the gradual loss of kidney function — reaches an advanced state to the point that the kidneys can no longer function on their own.

While anticoagulants such as factor Xa inhibitors work well in lower-risk patients, there remains a need for treatments that can prevent blood clots in individuals who have higher bleeding risks.

Factor XI, however, is a protein in the blood which is transformed into its active enzyme form – factor XIa – as part of the blood coagulation cascade, and has been identified for potentially safer anticoagulant drugs as factor XI deficiency or inhibition is associated with little or no bleeding.

MK-2060 is a novel inhibitor of factor XI, administered intravenously, and designed to work through a dual mechanism of action both blocking the activation of factor XI as well as the downstream activity of activated protein.

The therapy is currently being investigated in a phase 2 study to evaluate the efficacy and safety of two different doses of MK-2060 in participants with ESRD receiving haemodialysis via an arteriovenous graft (AVG).

Read more: https://www.pmlive.com/pharma_news/merck_granted_fast_track_designation_by_fda_for_end-stage_renal_disease_therapy_1453905

Merck granted fast track designation by FDA for end-stage renal disease therapy - PMLiVE

Merck granted fast track designation by FDA for end-stage renal disease therapy - PMLiVE