Biotech sci­en­tist/en­tre­pre­neur Saurabh Sa­ha makes an un­usu­al re­turn to the arms of a big — and ex­ces­sive­ly dis­creet — R&D group

Over the past few years we’ve seen a grow­ing ex­o­dus of R&D ex­perts out of big bio­phar­ma groups and in­to the rapid­ly grow­ing ranks of biotech star­tups. Now, one of the biggest play­ers in the on­col­o­gy field is get­ting at least one suc­cess­ful biotech sci­en­tist and en­tre­pre­neur to make an un­usu­al re­turn trip and come back in­to the fold of a ma­jor re­search or­ga­ni­za­tion.

Saurabh Sa­ha

This morn­ing Bris­tol-My­ers Squibb $BMY put out word that the com­pa­ny had hired Saurabh Sa­ha to run the trans­la­tion sci­ence group for the com­pa­ny, which is re­spon­si­ble for triag­ing pre­clin­i­cal work of in­ter­est and steer­ing the most promis­ing pro­grams to­ward the clin­ic.

Sa­ha — a 40-year-old Johns Hop­kins grad, where he worked in Bert Vo­gel­stein’s lab — once up­on a time la­bored in­side No­var­tis’ glob­al ops, be­fore leav­ing for a string of new jobs in biotech. Nine years ago he set up a trans­la­tion­al re­search and de­vel­op­ment or­ga­ni­za­tion called Bio­Med Val­ley Dis­cov­er­ies. Then his role as a ven­ture part­ner at the pro­lif­ic At­las Ven­ture led him to be­come chief med­ical of­fi­cer at Syn­log­ic, fol­lowed by a brief but wild­ly suc­cess­ful stint as CEO of Delinia.

Back at the be­gin­ning of this year Cel­gene stepped up with a $775 mil­lion deal to ac­quire Delinia — with $300 mil­lion of that in cash — just four months af­ter Sa­ha lined up a $35 mil­lion round to back a pre­clin­i­cal au­toim­mune drug that showed promise in con­trol­ling reg­u­la­to­ry T cells, restor­ing im­mune tol­er­ance and home­osta­sis.

Odd­ly, Bris­tol-My­ers has de­cid­ed to keep Sa­ha un­der wraps for this an­nounce­ment, not al­low­ing in­ter­views. That’s too bad, as com­pa­nies like Bris­tol-My­ers could use all the fresh, in­tel­li­gent faces it can get to per­suade in­vestors that there’s rea­son to be­lieve new stuff is com­ing along to whip up some ex­cite­ment.

As big bio­phar­ma of­fers re­peat­ed ev­i­dence of the kind of cash-con­strained, slow mov­ing en­vi­ron­ments that re­searchers have chafed against, high-risk biotechs with op­por­tu­ni­ty for rapid re­wards and cash wind­falls have of­fered a com­pelling bea­con for some high pro­file ex­ecs. What­ev­er Sa­ha’s rea­sons, any­thing he says that might per­suade sci­en­tists to re­con­sid­er that could on­ly ben­e­fit an in­dus­try where the trends have so far point­ed in on­ly one di­rec­tion.

That’s par­tic­u­lar­ly true for the trans­la­tion­al side of the busi­ness.

Sa­ha is stay­ing in the Boston area, where Bris­tol-My­ers is build­ing a new R&D cen­ter.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

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.

Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.