Wednesday brought another win for South Dakota’s biggest transgenic cow so far.
SAB Biotherapeutics, which develops treatments by collecting and distilling antibodies from cows with humanized immune systems, announced that its antibody treatment for flu passed an early-stage challenge study.
Volunteers were intentionally exposed to the flu virus and then given infusions of the SAB antibody treatment or placebo. Those who received the antibody treatment saw a significantly greater reduction in viral load and symptoms than those who received placebo. The company didn’t release numbers but said the p-value was 0.026.
SAB will move the antibody into a Phase II study next year. A handful of other companies are also working on anti-flu antibodies, most notably Vir, which has two assets in Phase II, although both have been delayed by the pandemic and the global decline of flu infections.
SAB differs from Vir’s approach in that it uses polyclonal antibodies, or a collection of antibodies, rather than monoclonal antibodies, i.e. a single antibody. The idea is that polyclonal antibodies can be more effective by attacking the virus from different angles, also making it harder for the virus to escape.
The company’s Covid-19 program showed positive results in Phase II.
A speedy review for Merck’s Prevnar rival in children
Merck has one approval for its new pneumococcal vaccine. It may soon be on its way to a second.
The NJ pharma announced Wednesday that the FDA gave the 15-valent vaccine, known as Vaxneuvance, priority review for approval in infants and children up to 17 years of age. The designation sets up an FDA decision by April 1, 2022.
The submission is based on data from studies showing that Vaxneuvance works just as well at protecting kids from 13 strains of bacteria as Pfizer’s blockbuster Prevnar-13. But, as in adults, in the real world, Merck will have to compete with Pfizer’s next-generation Prevnar-20.
Most experts and analysts expect Prevnar-20 will become the most commonly used vaccine, because it offers a wider breadth of protection than Vaxneuvance.
MEI Pharma and Kyowa Kirin offer first data after $100M cash pact
A year and a half ago, Kyowa Kirin gave struggling microcap MEI Pharma $100 million upfront and over $500 million to partner on what they saw as a promising PI3K drug.
That deal delivered its first glimpse of dividends Wednesday, as the two companies announced interim results from a Phase II study in lymphoma. Just over 70% of the 91% of patients who completed the trial saw their tumors shrink by more than a third and 35.2% saw their tumors vanish entirely.
The effects were long-lasting enough that, after 8.4 months follow-up, not enough patients had stopped responding for investigators to determine a median duration of response.
The drug, known as zandelisib, does come with safety concerns, as many previous PI3K molecules have. Just under 10% of patients in the trial stopped treatment because of a drug-related side effect.
While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.
Stéphane Bancel, Moderna CEO
Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.
Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?
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The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.
For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ‘069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.
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Philip Dormitzer, new GSK global head of vaccines R&D
GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.
Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.
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Michael Handley, Statera Biopharma CEO
Last summer, when Cytocom merged with Cleveland BioLabs to grab a spot on Nasdaq, it also inherited an intriguing rare disease program that was under clinical hold. With a new name and brand, the company says it’s ready to bring that program back to the forefront.
The FDA has lifted its clinical hold on entolimod, a toll-like receptor 5 (TLR5) agonist being developed for patients exposed to lethal amounts of radiation, the company — now called Statera Biopharma — announced on Wednesday.
Lan Huang, BeyondSpring CEO
BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?
The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.
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The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.
While noting the lack of transparency hindered the report’s results, ICER said that the ‘great majority’ of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines ‘fair access.’
Reshma Kewalramani, Vertex CEO (Vertex via YouTube)
Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.
The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.
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