Merck and Moderna partner to develop and sell cancer vaccine

14 October | DEALS

Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). In 2016, the companies entered a strategic partnership to develop novel messenger RNA (mRNA) based PCVs. They subsequently expanded the collaboration to include the development of antigen mRNA cancer vaccines in 2018.

Under the latest deal terms, Merck will pay Moderna $250m to exercise its option for mRNA-4157/V940. The vaccine has been designed to stimulate an immune response by producing T-cell responses depending on the mutational signature of a patient’s tumour. It is currently being assessed in combination with Merck’s anti-PD-1 therapy, Keytruda, as an adjuvant treatment for high-risk melanoma patients in a Phase II clinical trial being conducted by Moderna.

28 October | DEALS

PTC and Blackstone enter financing partnership of up to $1bn

PTC Therapeutics has signed a strategic financing partnership worth up to $1bn with funds managed by Blackstone to back the development of the former’s innovative product pipeline. Under the deal, funds managed by Blackstone Life Sciences and Blackstone Credit will make initial funding worth $500m to PTC, which comprises $350m in low-cost, low-dilution capital at closing.

This alliance takes advantage of the several therapeutic platforms of PTC and its established track record of providing transformative therapies to patients with rare diseases. Translarna, Emflaza, Upstaza, sepiapterin and vatiquinone are used as collateral for the tailored senior secured term loan investment from Blackstone.

4 November | REGULATORY

WHO grants prequalification for Sinovac’s varicella vaccine

The World Health Organization (WHO) has granted prequalification for Sinovac Biotech’s live attenuated varicella vaccine. With the latest development, the vaccine became the first Chinese varicella shot to be prequalified by the WHO. It is also the company’s fourth vaccine to receive approval from the health agency. 

According to the data from a Phase III efficacy clinical trial, the seroconversion rate was found to be 97.1% in a group of children aged one to 12 years old who received the vaccine. The vaccine also demonstrated an efficacy of 87.1% and 89.2% against varicella and breakthrough varicella, respectively.

10 November | REGULATORY

UK MHRA approves Pfizer-BioNTech’s bivalent Covid-19 booster

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 and BA.5 sub-variants. Indicated for usage as a booster in people aged 12 years and older, the modified vaccine is the second bivalent shot of the companies to obtain approval in the region. Each booster dosage contains 15μg targeting the original strain of the virus while the other half acts on Omicron (BA.4-5). The common side effects reported with the new bivalent vaccine were similar to those observed for other vaccine versions.

1 November | REGULATORY

FDA grants Fast Track status for Dyne’s Duchenne muscular dystrophy therapy

The US FDA has granted Fast Track designation for Dyne Therapeutics’ Dyne-251 to treat Duchenne muscular dystrophy (DMD) mutations amenable to exon 51 skipping. Dyne-251 comprises a phosphorodiamidate morpholino oligomer (PMO) conjugated to a fragment antibody (Fab) that attaches to the transferrin receptor 1 (TfR1) expressed highly on muscle.

It can permit targeted muscle tissue delivery and boost exon skipping in the nucleus, aiding muscle cells to produce a shortened, functional dystrophin protein for halting or reversing the progression of the disease. It attained exon skipping, particularly in the heart and diaphragm, muscles in DMD patients.  At present, DYNE-251 is being analysed in the international Phase I/II DELIVER trial.

8 November | DEALS

Viatris to acquire Oyster Point and Famy Life Sciences

Viatris has signed definitive agreements to acquire Oyster Point Pharma and Famy Life Sciences in a deal totalling nearly $700m-$750m in cash to establish an ophthalmology franchise. According to the deal, all outstanding shares of Oyster Point will be acquired by Viatris for a price of $11 for each share in cash at closing, plus a non-tradeable contingent value right (CVR) for up to $2 for each share.

A commercial-stage biopharmaceutical firm, Oyster Point discovers, develops and commercialises therapies for treating ophthalmic ailments. Oyster Point Pharma introduced Tyrvaya, a nasal spray approved by the US FDA to treat dry eye disease, in November last year.

In Brief

Nimbus and Lilly partner for metabolic disease therapy development

Nimbus Therapeutics and Eli Lilly and Company (Lilly) have signed a research partnership and licence agreement to develop and market new therapies that activate a specific AMPK isoform to treat metabolic diseases. The company will lead the research activities, while Lilly will undertake the global development and marketing activities.

BMS reports 3% decline in total revenues in Q3 2022

Bristol Myers Squibb (BMS) has reported a 3% decline in total revenues to $11.2bn in the third quarter (Q3) of 2022 as against $11.6bn in the year-ago quarter. The decline in Q3 revenue was driven by the latest LOE products, chiefly Revlimid, and impacts from foreign exchange.

Ochre Bio raises funds to develop RNA therapies for liver diseases

Biotechnology company Ochre Bio has raised $30m in a Series A financing round to develop RNA therapies for chronic liver diseases. It also intends to turn the insights from its research into RNA-based drug candidates, and they will be tested in human livers at the company’s recently opened ‘Liver ICUs’ in the US.

Merck reports 14% rise in worldwide sales in Q3 2022

Merck (MSD outside North America) has reported a 14% rise in worldwide sales to $15bn in the third quarter (Q3) of 2022 as against $13.15bn in the year-ago quarter. For the quarter, pharmaceutical sales were recorded at $13bn compared to $12.7bn in Q3 2021, indicating a 13% growth. Sales from Lagevrio alone contributed to $436m.

27 October | REGULATORY

FDA accepts Seres’ rCDI therapeutic BLA for priority review

The US Food and Drug Administration (FDA) has accepted Seres Therapeutics’ Biologics License Application (BLA) for SER-109 to prevent recurrent C. difficile infection (rCDI) for priority review. 

A decision from the regulatory agency on approval for the therapy is anticipated on 26 April next year. Additionally, the FDA said that it is not presently planning to organise an Advisory Committee Meeting to discuss the BLA for SER-109. An investigational, oral microbiome therapy candidate, SER-109 has purified Firmicutes spores to treat rCDI. In July last year, the company and Nestlé Health Science signed an agreement to co-market SER-109 in the US and possibly in Canada.

20 October | DEALS

Advaxis enters merger deal with biotech firm Ayala

Ayala Pharmaceuticals has signed a definitive merger agreement with biotechnology company Advaxis. The latter’s immunotherapies are based on a technology that leverages engineered Listeria monocytogenes.

The business combination would result in a merged company that will mainly focus on developing and marketing Ayala’s AL102 and Advaxis’ ADXS-504. A lead candidate of Ayala, AL102 is intended to treat desmoid tumours, while ADXS-504 is being developed for prostate cancer. AL102 is being assessed in the Phase II/III RINGSIDE trial for desmoid tumours. 

In brief

Nimbus and Lilly partner for metabolic disease therapies development

Nimbus Therapeutics and Eli Lilly and Company (Lilly) have signed a research partnership and licence agreement to develop and market new therapies that activate a specific AMPK isoform to treat metabolic diseases. The company will lead the research activities, while Lilly will undertake the global development and marketing activities.

BMS reports 3% decline in total revenues in Q3 2022

Bristol Myers Squibb (BMS) has reported a 3% decline in total revenues to $11.2bn in the third quarter (Q3) of 2022 as against $11.6bn in the year-ago quarter. The decline in Q3 revenue was driven by the latest LOE products, chiefly Revlimid, and impacts from foreign exchange.

Ochre Bio raises funds to develop RNA therapies for liver diseases

Biotechnology company Ochre Bio has raised $30m in a Series A financing round to develop RNA therapies for chronic liver diseases. It also intends to turn the insights from its research into RNA-based drug candidates, and they will be tested in human livers at the company’s recently opened ‘Liver ICUs’ in the US.

Merck reports 14% rise in worldwide sales in Q3 2022

Merck (MSD outside North America) has reported a 14% rise in worldwide sales to $15bn in the third quarter (Q3) of 2022 as against $13.15bn in the year-ago quarter. For the quarter, pharmaceutical sales were recorded at $13bn compared to $12.7bn in Q3 2021, indicating a 13% growth. Sales from Lagevrio alone contributed to $436m.