Can South Dakota's transgenic cows help treat the flu?; A speedy review for Merck's Prevnar rival in kids
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.