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.

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

Grifols once paid Aradigm $26 million for a stake in its inhaled antibiotics. But with Aradigm now in bankruptcy, the Spanish drugmaker is dishing out a final $3.2 million to buy it all.

The fire sale — which comes one year after Aradigm filed for Chapter 11 following a regulatory trifecta for disaster — will see Grifols obtain assets and IP to Apulmiq (formerly Pulmaquin and Linhaliq in Europe), Lipoquin and free ciprofloxacin. In addition to waiving its claims in the bankruptcy case, Grifols also agreed to milestone payments up to $3 million more upon any regulatory approvals.

Almost a year and a half after DBV Technologies pulled its peanut allergy immunotherapy patch from FDA review, the biotech will get their day in court. The FDA has scheduled an advisory committee hearing for May 15.

In the two-horse race to develop the first immunotherapy for peanut allergy, DBV had the early lead, filing an NDA for their patch in 2018. But on December 20 of that year, the company withdrew their application after, they said, meeting with regulators and determining they had not submitted “sufficient detail regarding data on manufacturing procedures and quality controls.” Aimmune filed their BLA 3 days later and won approval as the first immunotherapy for peanuts this month.

→ Days after Kura Oncology announced the departure of co-founder Antonio Gualberto, we finally know where he wound up. Eisai subsidiary H3 Biomedicine has recruited him as CMO to finding the right patients to its four clinical-stage small molecule assets hitting genomic drivers of cancer.

“Challenges of these and many other precision medicine approaches are on one hand technical — a need for robust and precise diagnostics — and on the other hand derived by the challenge to alter standard clinical practice in settings where patient screening, e.g. by tumor DNA sequencing, is not standard practice,” he wrote to Endpoints News on his way back to Boston from Eisai’s Tokyo offices. “Only compelling clinical activity can drive clinicians and pathologists to modify standard clinical practice.”