Steve Kaf­ka joins Sec­tion 32 as man­ag­ing part­ner; Take­da auc­tions off $660M drug port­fo­lio in bid to re­duce post-Shire M&A debt load

Steven Kaf­ka

→ For­mer Thrive CEO and part­ner at Third Rock Ven­tures, Steve Kaf­ka, has hopped aboard Sec­tion 32 as a man­ag­ing part­ner. With­in his new role, Kaf­ka “will fo­cus on sup­port­ing and ex­pand­ing the firm’s in­vest­ment port­fo­lio and pres­ence in Boston.” Cur­rent­ly, Kaf­ka serves as the ex­ec­u­tive chair­man at Thrive and at ArcherDX and he will con­tin­ue to serve with­in these roles. Kaf­ka’s pre­vi­ous stints in­clude roles as pres­i­dent and COO at Foun­da­tion Med­i­cine and serv­ing in po­si­tions at Aileron Ther­a­peu­tics, In­fin­i­ty Phar­ma­ceu­ti­cals, Mil­len­ni­um Phar­ma­ceu­ti­cals, Strate­gic De­ci­sions Group and For­rester Re­search.

Take­da has grabbed $660 mil­lion to help pay down the big debt it took on to buy Shire. Ger­many’s Sta­da is pick­ing up the port­fo­lio of phar­ma­ceu­ti­cals— in­clud­ing OTC prod­ucts —in the deal, which marks Take­da’s 4th auc­tion since clos­ing the Shire buy­out. Take­da has gar­nered $6.5 bil­lion of the $10 bil­lion it’s set its sights on for debt re­duc­tion.

→ High-fly­ing Chi­nese biotech BeiGene $BGNE has li­censed Asian rights to a pre­clin­i­cal can­cer drug out of Seat­tle Ge­net­ics. There are no specifics on what this drug is, but Seat­tle Ge­net­ics stands to earn up to $160 mil­lion from BeiGene if it pans out. They didn’t break out the up­front. Seat­tle Ge­net­ics $SGEN is hang­ing on to US rights for this ther­a­py.

En­gi­tix, Inc has been award­ed with a gold­en tick­et —pro­vid­ing one year of lab bench space and shared lab­o­ra­to­ry and of­fice space — to Lab­Cen­tral by Take­da Phar­ma­ceu­ti­cal. The com­pa­ny says that the gold­en tick­et will help fur­ther ad­vance its “hu­man ex­tra­cel­lu­lar ma­trix (ECM) re­search in fi­bro­sis and sol­id tu­mors dis­ease pro­gres­sion.”

CO­DA Bio­ther­a­peu­tics — de­vel­op­ing a chemo­ge­net­ic gene ther­a­py plat­form to treat in­tractable neu­ro­log­i­cal dis­eases — has closed its Se­ries A fi­nanc­ing round, bag­ging a to­tal raised amount of $34 mil­lion. The com­pa­ny’s ex­ist­ing in­vestor, Ver­sant Ven­tures, led the round and was joined by ex­ist­ing in­vestors MPM Cap­i­tal and Astel­las Ven­ture Man­age­ment.

→ Al­lo­gene and im­mune cell ther­a­py com­pa­ny, Notch Ther­a­peu­tics, have en­tered in­to an ex­clu­sive world­wide col­lab­o­ra­tion and li­cense agree­ment to re­search and de­vel­op in­duced pluripo­tent stem cell (iP­SC) Al­lo­CAR ther­a­py prod­ucts for ini­tial ap­pli­ca­tion in non-Hodgkin lym­phoma, leukemia and mul­ti­ple myelo­ma. Un­der the part­ner­ship, the com­pa­nies “will cre­ate al­lo­gene­ic cell ther­a­py can­di­dates from T cells or nat­ur­al killer (NK) cells us­ing Notch’s En­gi­neered Thymic Niche (ETN) plat­form.” The col­lab­o­ra­tion comes two months af­ter Al­lo­gene teamed up with re­searchers from Stan­ford Uni­ver­si­ty to in­ves­ti­gate a nu­cle­ic acid de­liv­ery sys­tem that more ef­fec­tive­ly, safe­ly and flex­i­bly de­liv­ers in­tra­cel­lu­lar RNA or DNA in­to lym­pho­cytes, in­clud­ing T cells.

Black Belt TX and Prax­is Biotech are team­ing up in a strate­gic part­ner­ship to dis­cov­er and de­vel­op new small mol­e­cule ther­a­peu­tics to undis­closed tar­gets which are aimed at mod­u­lat­ing key con­trol mech­a­nisms in the stress re­sponse path­ways in can­cer.

→ As re­port­ed by Busi­ness Quar­ter (BQ), Ox­ford Drug De­sign has bagged £2.2 mil­lion in a fi­nanc­ing round. The round was led by new and ex­ist­ing in­vestors — the An­gel Co­Fund and o2h Ven­tures — along with grant fund­ing from the UK De­part­ment of Health and So­cial Care’s UK-Chi­na re­search com­pe­ti­tion. This brings the com­pa­ny’s to­tal 2019 fund­ing to over £9m.

 

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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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 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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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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