New cell ther­a­py play­er launch­es with $57M from mar­quee in­vestors to go af­ter 'de­fin­i­tive' tu­mor tar­gets

A crew of Am­gen and Kite vets is pub­licly throw­ing their new start­up in­to the cell ther­a­py hat — though they are say­ing lit­tle out­side of the ba­sics and $57 mil­lion in Se­ries A cash.

Alexan­der Kamb

The Col­umn Group, Vi­da Ven­tures, Sam­sara Bio­Cap­i­tal and Nex­tech In­vest are back­ing A2 Bio­ther­a­peu­tics’ quest to find new ways of en­gag­ing im­mune cells in se­lec­tive­ly at­tack­ing can­cer. To do so, the biotech is work­ing with two tar­get class­es: pep­tide MHC tar­gets and tar­gets that are “ir­re­versibly lost in tu­mor cells.” The for­mer builds on an in­creas­ing­ly pop­u­lar strat­e­gy of lo­cat­ing neoanti­gens for T cells to home in on, while the lat­ter is in­spired by a mech­a­nism used by nat­ur­al killer cells.

“A2 Bio­ther­a­peu­tics has po­tent, high­ly se­lec­tive binders that we com­bine in­to mol­e­c­u­lar con­structs to in­te­grate mul­ti­ple sig­nals and po­ten­tial­ly pro­vide a large ther­a­peu­tic win­dow,” said CSO Alexan­der Kamb, who co-found­ed the biotech af­ter a stint as SVP of re­search at Am­gen. They could be an­ti­body and T-cell re­cep­tor frag­ments, ac­cord­ing to its state­ment.

Scott Forak­er

Scott Forak­er, his for­mer col­league at the Big Biotech, re­cent­ly signed on as pres­i­dent and CEO.

Work­ing out of Agoura Hills, Cal­i­for­nia, their team of 40 ex­pects to ush­er the first prod­uct can­di­date in­to the clin­ic next year. Its four pro­grams in de­vel­op­ment span can­cer testis anti­gen for sol­id tu­mors; “tar­gets lost” anti­gens for sol­id tu­mors; neoanti­gens for head and neck can­cer; and neoanti­gens for pan­cre­at­ic, col­orec­tal and lung can­cer.

Michelle Kreke

It al­so plans on con­struct­ing a man­u­fac­tur­ing fa­cil­i­ty — ar­guably the most im­por­tant core com­pe­ten­cy that dif­fer­en­ti­ates one cell ther­a­py play­er from an­oth­er — in 2020 with the mind­set of ul­ti­mate­ly pro­duc­ing its own com­mer­cial sup­ply. The site would sup­port an au­tol­o­gous ap­proach, though A2 Bio didn’t spec­i­fy what kind of cells it would use as the source.

Their lead in tech­ni­cal ops is Michelle Kreke, who was cred­it­ed for lead­ing chem­istry, man­u­fac­tur­ing and con­trols for the pi­o­neer­ing CAR-T Yescar­ta.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.
The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.
The insider take at the agency includes a note on two new safety signals seen in the big cardio outcomes study of the omega-3 fatty acid drug that shocked many analysts with a solid set of efficacy data. There’s a key concern over whether the use of mineral oil in the placebo skewed LDL levels in such a way that tilted the data in Amarin’s favor.
The FDA overview was written by John Sharretts, the acting deputy director in the Division of Metabolism and Endocrinology Products. 
On the safety side, the internal review focused on a 3.1% versus 2.1% rate of adjudicated events of atrial fibrillation or atrial flutter requiring hospitalization. But they also say a-fib shouldn’t confound the benefit-safety of the drug — given the improvement on MACE — or prevent its use. And then there was also a higher rate of bleeding events in the drug arm.

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Ed­i­tas and Cel­gene sub Juno are tack­ling hottest im­munother­a­py cells

As the first CRISPR-edited cancer patients watch their treatments unfold, one of the first CRISPR companies is rejigging a major oncology deal.

Editas Medicine is amending its long-running collaboration with Celgene and their subsidiary Juno Therapeutics. The new deal will expand the focus of their work to cover a subset of immune cells that have become an increasingly hot target for immunotherapy: gamma-delta cells.

Prakash Raman. Flagship

Flag­ship woos No­var­tis top deal­mak­er Prakash Ra­man in move to get the BD ball rolling ear­ly

Flagship Pioneering likes to be ahead of its times — so far ahead, perhaps, that it is often challenging to find partners for their startups while the scientific scaffolding is underway. But Prakash Raman is here to change that.

Raman, who most recently headed up business development at the Novartis Institutes for BioMedical Research, became Flagship’s first chief business development officer two weeks ago. By acting as a “central resource” for the 100 companies in the venture fund’s portfolio, he hopes to help entrepreneurs and management teams strategize about dealmaking to capture value beyond the near-term validation of their platform technologies, Raman told Endpoints News.

FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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Bill Haney, Skyhawk

Cel­gene ex­ecs shell out $92M cash for a pair of R&D deals that will fit per­fect­ly in their new home at Bris­tol-My­ers

With Bristol-Myers Squibb’s Celgene buyout all but complete, the BD teams are working in perfect synchrony now. The Celgene side is going back to Skyhawk, a darling of the crowd that set out to drug RNA, and they’re adding a suite of new programs that mesh perfectly with the new regime in charge.

Celgene is shelling out $80 million in a cash upfront to add oncology, immuno-oncology and autoimmune diseases to the initial roundup of neurological targets mapped early in Skyhawk’s existence.

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Reata's bar­dox­olone of­fers promise in pa­tients with rare kid­ney dis­or­der

After surprising Wall Street with positive data on its drug, omaveloxolone, in patients suffering from a notoriously hard-to-treat degenerative neuromuscular disorder last month, Reata Pharma on Monday unveiled pivotal results from a trial testing another drug, bardoxolone, in patients with a rare, genetic form of chronic kidney disease for which there exist no approved therapies.

Bardoxolone, like Reata’s other lead drug — omaveloxolone — is a small molecule engineered to bind to a gene called Keap1 to enhance the activity of the protein Nrf2 in order to defuse inflammation.

Kad­mon wax­es rhap­sod­ic on cGVHD re­sults as race with Jakafi heats up

A year ago, Kadmon piqued cautious interest and sent its stock up 20% when it announced positive results from a tiny proof-of-concept study on a new, chronic graft-versus-host-disease treatment. Now interim results are out on the pivotal, and not just the biotech’s executives are gushing about it.

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