Mount­ing a pre­lim­i­nary ef­fort to catch up with oth­er phar­ma gi­ants in the on­colyt­ic virus space, As­traZeneca has found a part­ner in France’s Trans­gene.

In the deal, the biotech — which is al­ready al­lied with Bris­tol-My­ers Squibb and Pfiz­er/Mer­ck KGaA on com­bi­na­tion pro­grams with its in-house ther­a­peu­tic vac­cines — will come up with five new armed on­colyt­ic vac­cinia virus can­di­dates. As­traZeneca is start­ing small with $10 mil­lion up­front and just $3 mil­lion in pre­clin­i­cal suc­cess mile­stones, but promis­es an undis­closed li­cense fee for each clin­i­cal can­di­date they ul­ti­mate­ly de­cide to co-de­vel­op.

Jean-Charles So­ria

The phar­ma gi­ant $AZN will al­so be able to choose the trans­genes to be en­cod­ed with­in the virus, a key ad­di­tion that pro­vides added fire­pow­er to the im­mune sys­tem against the tu­mor.

Long rec­og­nized as a tool to di­rect­ly kill can­cer cells, on­colyt­ic virus­es gained trac­tion in re­cent years af­ter re­search sug­gests that by burst­ing can­cer cells and re­leas­ing anti­gens with­in, they can al­so trig­ger an im­mune re­sponse. That makes them a po­tent im­munother­a­pies on its own as well as an ide­al pair­ing agent for the next gen­er­a­tion of I/O com­bos.

As­traZeneca first got its hands on an on­colyt­ic virus in 2015 when it inked a li­cens­ing agree­ment with Om­nis Phar­ma­ceu­ti­cals (now Vyr­i­ad), but it told Bio­Cen­tu­ry that “there are cur­rent­ly no on­go­ing AZ-spon­sored clin­i­cal tri­als of the can­di­date.”

Jean-Charles So­ria, SVP of As­traZeneca’s new­ly named on­col­o­gy unit, added they have “an ex­cit­ing port­fo­lio of mol­e­cules that we be­lieve may aug­ment on­colyt­ic virus ac­tiv­i­ty.”

Oth­er big play­ers such as Mer­ck, J&J, Pfiz­er and Boehringer have each bagged or seed­ed their own on­colyt­ic virus projects on the foot­steps of Am­gen’s T Vec, along­side biotech play­ers like PsiOxus, un­der­scor­ing the mo­men­tum of the next wave.

Mean­while, Trans­gene will con­tin­ue plough­ing on its in-house pipeline and promis­es to send a few more drugs to the clin­ic in 2020.

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Regeneron entered the PD-(L)1 game late, so they devised a two-pronged strategy to catch up with Big Pharma rivals: They would push it into cancers where PD-1s had yet been tested, and they would prove that it’s as powerful in the big indications as any other on the market.

They cleared a hurdle on the first goal Friday, showing a 31% response in patients with the rare skin cancer basal cell carcinoma. And with the data they’re rolling out Monday, Regeneron cancer chief Israel Lowy is ready to declare success on the second.

Following in the steps of Moderna and Pfizer, the other two American drugmakers currently in Phase III trials for their Covid-19 vaccines, AstraZeneca posted its own study protocols over the weekend. The move is the latest in a series of rare peeks behind the curtain, as such blueprints are typically shared once such trials are completed.

“Given the unprecedented global impact of the Coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial. As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials. AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company said in a statement.

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.