Deer­field strikes up new deal with Co­lum­bia Uni­ver­si­ty; Ovid CEO Je­re­my Levin joins BIO as new board chair

→ In its lat­est deal, health­care in­vest­ment firm Deer­field Man­age­ment and Co­lum­bia Uni­ver­si­ty have col­lab­o­rat­ed to launch Hud­son Heights In­no­va­tions “to cat­alyze the de­vel­op­ment of nov­el ther­a­peu­tics out of the re­search labs of Co­lum­bia Uni­ver­si­ty”. Deer­field and its part­ners will pro­vide up to $130 mil­lion in ini­tial fund­ing to back the ini­tia­tive for over 10 years. 

Lee Gold­man Co­lum­bia

“Much of our re­search is aimed at un­der­stand­ing at the mol­e­c­u­lar lev­el how dis­eases de­vel­op and how we can in­ter­vene with drugs or oth­er ther­a­peu­tics,” said Lee Gold­man, dean of the fac­ul­ties of health sci­ences and med­i­cine and chief ex­ec­u­tive of Co­lum­bia Uni­ver­si­ty Irv­ing Med­ical Cen­ter.

In March, Deer­field com­mit­ted $100 mil­lion to a new trans­la­tion­al re­search al­liance with Har­vard Uni­ver­si­ty and in ear­ly No­vem­ber, last year, Dana-Far­ber and Deer­field struck a deal to col­lab­o­rate on an $80 mil­lion ini­tia­tive aimed at cre­at­ing a new pipeline of ther­a­pies. In the past, Deer­field has struck deals with the Broad In­sti­tute of MIT and Har­vard and UNC-Chapel Hill.

Je­re­my Levin Ovid

As arranged, BIO elect­ed Ovid CEO Je­re­my Levin as its new board chair. The pop­u­lar in­dus­try ex­ec and for­mer CEO of Te­va $TE­VA Levin is tak­ing over from Al­ny­lam $AL­NY chief John Maraganore.

On­colyt­ics Biotech $ON­CY — who is cur­rent­ly de­vel­op­ing its in­tra­venous­ly de­liv­ered im­muno-on­colyt­ic virus, pelare­o­rep — has en­tered a co-de­vel­op­ment agree­ment for the drug in com­bi­na­tion with pa­cli­tax­el and an­ti-Pd-L1 an­ti­body avelum­ab with Mer­ck KGaA, Darm­stadt, Ger­many and Pfiz­er $PFE. The com­bi­na­tion will be used to treat hor­mone-re­cep­tor pos­i­tive, hu­man epi­der­mal growth fac­tor 2-neg­a­tive (HR+ / HER2-) metasta­t­ic breast can­cer. The costs of the Phase II clin­i­cal tri­al will be shared be­tween On­colyt­ics and Pfiz­er. 

→ The Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions (CEPI) has award­ed Themis Bio­science with up to $21 mil­lion of non-di­lu­tive cap­i­tal for its Phase III clin­i­cal tri­al of its Chikun­gun­ya vac­cine (MV-CHIK) un­der a sec­ond part­ner­ing agree­ment with CEPI with sup­port from the EU’s Hori­zon 2020 pro­gramme. “Clin­i­cal tri­al ap­pli­ca­tions will be sub­mit­ted to reg­u­la­to­ry au­thor­i­ties in the sec­ond half of 2019, with the tri­al ini­ti­a­tion ex­pect­ed short­ly there­after. The piv­otal mul­ti-cen­ter Phase III tri­al will be launched in Eu­rope, US and the Amer­i­c­as and will al­so test a sin­gle-shot reg­i­men,” the com­pa­ny said.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.


ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology


ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development


CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Ted Ashburn. Oncorus

Cowen, Per­cep­tive lead $79.5M Se­ries B for 's­tand­out' biotech shep­herd­ing on­colyt­ic virus to clin­ic

As several Big Pharma players secure biotech partners in the oncolytic virus space for new immuno-oncology combos, Cowen and Perceptive Advisors have come out with their own bet on a startup that promises to shine.

The marquee investors are joining MPM, Deerfield, Celgene, Astellas, Arkin and UBS in backing the drug developer, Oncorus, which will now deploy the $79.5 million in Series B cash toward clinical development of its lead program. Other new investors include Surveyor Capital, Sphera Funds, IMM Investment, QUAD Investment Management, UTC Investment, SV Investment Corp and Shinhan Investment-Private Equity, the last five of which are Korean-based funds.

Fu­til­i­ty analy­sis au­gurs de­feat in piv­otal tri­al test­ing of Nu­Cana's lead drug in metasta­t­ic pan­cre­at­ic can­cer

Nearly two years after making its public debut, UK-based NuCana’s mission to make chemotherapies more potent and safer was dealt a blow, after a pivotal study testing its lead experimental drug halted enrollment in a hard-to-treat advanced form of cancer, following a futility analysis.

The drug, Acelarin, is being evaluated for use in metastatic pancreatic cancer patients who were not considered suitable for combination chemotherapy. In the late-stage ACELARATE study — which compared the experimental drug against the chemotherapy gemcitabine — 200 patients had been enrolled by the sponsor, Clatterbridge Cancer Centre, before an analysis from an independent safety and data monitoring panel suggested the study’s main goal would not be met.

UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.