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.

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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