Now that the FDA has authorized the use of Pfizer Inc.-Biontech SE’s Covid-19 vaccine as a booster for older Americans and certain individuals at high risk for exposure or serious infection, the CDC’s Advisory Committee on Immunization Practices (ACIP) is meeting to provide its recommendations on how the booster should be used in clinical practice. If the CDC accepts those recommendations, they will serve as guidelines rather than dictates. In opening the ACIP meeting Sept. 23, CDC Director Rochelle Walensky clarified the goal of the booster, saying it is to protect as many people as possible from COVID-19 infections, hospitalizations and death. That’s broader than the objective ACIP members identified a day earlier.

Black box warnings and risky CNS efforts weigh heavily on biopharma stocks

For the first time since February, the BioWorld Biopharmaceutical Index (BBI) took a sharp plummet with shares falling in the last few weeks for 18 of the 22 stock components. Big pharma companies, as well as Biogen Inc., Alnylam Pharmaceuticals Inc. and Incyte Corp., showed the biggest declines since the end of August, while Abcellera Biologics Inc. and Sarepta Therapeutics Inc. represent two of only three stocks that began to climb their way back uphill. BBI shares appear to be following the same downward path as the Dow Jones Industrial Average. Since Aug. 31, BBI is at 3.21%, down from 10.21% last month, while DJIA is at 11.93%, down from 15.53%. The Nasdaq Biotechnology Index has also fallen, albeit more slightly, to 11.77% from 12.37%.

Immunocore’s phase III in melanoma shows survival benefit

New phase III data from Immunocore Ltd. Holdings plc comparing tebentafusp with investigator’s choice in treating first-line metastatic uveal melanoma showed the therapy is the first systemic treatment with a survival benefit in the indication. The study showed statistically and clinically meaningful improvement in overall survival (OS). The OS hazard ratio in the intent-to-treat population favored tebentafusp (HR=0.51; p< 0.0001) over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). Tebentafusp, a bispecific using a soluble T cell receptor attached to an anti-CD3 immune effector function, targets gp100, an antigen expressed in melanocytes and melanoma. The results from the randomized, open-label study were published in The New England Journal of Medicine.

saRNA newcomer Vaxequity lands Astrazeneca as partner

LONDON – Self-amplifying RNA (saRNA) specialist Vaxequity Ltd. has sealed a commercialization deal with Astrazeneca plc after delivering safety data in a phase I/II trial of the technology in a COVID-19 vaccine. The collaboration will provide Vaxequity with research and development funding, to be followed by further milestones that could total up to $195 million for each of a possible 26 drug targets, potentially in excess of $5 billion. There also will be royalties on sales of any products that make it to market.

Activist investor Bluebell is latest to call for ‘sleeping’ GSK’s CEO to quit

A second activist investor has questioned the leadership of Glaxosmithkline plc’s CEO Emma Walmsley, after Bluebell Capital Partners Ltd. took a reported £10 million (US$13.7 million) stake in the embattled U.K. pharma. GSK is gearing up to split into two next year, spinning off its consumer health business and creating a specialist pharma company more focused on R&D. But activist investor Elliott Management earlier this year took an undisclosed stake in the big pharma and is using its influence to question the leadership of Walmsley, who took over in April 2017. Now Bluebell has also called for Walmsley to leave in a letter to GSK’s chairman Sir Jonathan Symonds, saying that the company is moving too slowly to make the necessary changes to improve its value.

Cstone presents positive phase III data of sugemalimab for NSCLC

Cstone Pharmaceuticals Co. Ltd. released positive data from the phase III trial of sugemalimab plus chemotherapy for first-line treatment of patients with stage IV non-small cell lung cancer (NSCLC). “The final progression-free survival [PFS[ analysis of Gemstone-302 showed that sugemalimab plus chemotherapy was associated with a significant improvement of PFS in patients with both squamous and non-squamous NSCLC, compared with placebo plus chemotherapy. An encouraging trend in overall survival was observed with an estimated two-year overall survival rate close to 50%,” said Caicun Zhou, principal investigator of the phase III trial.

Also in the news

AB Science, Abcellera, Apitope International, Appili, Aptinyx, Arranta Bio, Ascendis, Ascentage, Awakn Life Sciences, Ayala, Bellus Health, Bioinnovation Institute, Biovaxys, Cantargia, Clene, Cytovation, Daré, Elicio, Endeavor, Eurocine, Everest Medicines, Garuda, Genedit, Horizon, Immunocore, Incyte, Inhibikase, Innovation, Innovent, Liechti Lab, Lion TCR, Merck, Mindmed, Mosaic Immunoengineering, Nicox, Novan, Novavax, Point, Psybio, Q Biomed, Quell, Rezolute, Rhythm, Second Genome, Serum Institute of India, Stealth, Synlogic, Tarsier, TFF, Tonix, Transcode, Valneva, Vesselon, Wake Network, Worg