Adap­ti­m­mune gets a par­tial hold on piv­otal T-cell study, but it seems OK to breathe now

The FDA is tap­ping the brakes on one of Adap­ti­m­mune T-cell stud­ies, look­ing for some clar­i­fi­ca­tions be­fore it gives the green light to start test­ing NY-ESO SPEAR T-cell ther­a­py in myx­oid round cell li­posar­co­ma.

No doubt there were a few skipped heart beats among in­vestors, but the UK biotech $ADAP hur­ried on to ex­plain that reg­u­la­tors are sim­ply look­ing to get a few an­swers for a reg­is­tra­tion tri­al that has yet to start re­cruit­ing pa­tients.

Im­muno-on­col­o­gy has ex­plod­ed in re­cent years, in a good way. New play­ers like Adap­ti­m­mune have at­tract­ed bil­lions in in­vest­ment cash. But as Juno demon­strat­ed re­cent­ly with its lead CAR-T study, a sud­den halt fol­low­ing the death of pa­tients can raise ques­tions about the en­tire field.

It’s im­por­tant to note, though, that the FDA lift­ed its hold on Juno just days af­ter im­pos­ing a clin­i­cal hold on the study, sat­is­fied that the biotech had an­swered its ques­tions about safe­guard­ing pa­tients from any fur­ther un­nec­es­sary risk. And Bank of Amer­i­ca an­a­lysts note that this pause is not tied to the use of flu­dara­bine, which Juno says was re­spon­si­ble for killing sev­er­al pa­tients.

“We spoke with man­age­ment who re­it­er­at­ed that the in­for­ma­tion re­quest­ed by FDA is clar­i­fi­ca­tion of de­f­i­n­i­tions rather than re­lat­ed to flu­dara­bine use or CMC man­u­fac­tur­ing is­sues that have plagued oth­er T cell ther­a­pies. ADAP plans to re­spond to the FDA short­ly and ex­pects the FDA to take 30 days to re­view their re­spons­es, re­sult­ing in a de­lay in the tri­al time­line.”

What­ev­er the case, Adap­ti­m­mune shares slipped 4% in af­ter mar­ket trad­ing as some ner­vous in­vestors fret­ted.

James No­ble, Adap­ti­m­mune CEO

“Adap­ti­m­mune is run­ning a num­ber of dif­fer­ent stud­ies with its NY-ESO pro­gram and con­tin­ues to en­roll pa­tients in syn­ovial sar­co­ma, ovar­i­an, and lung can­cer tri­als in the U.S.,” said James No­ble, Adap­ti­m­mune CEO, in a state­ment. “We have been in di­a­logue with the FDA since achiev­ing break­through sta­tus ear­li­er this year and this par­tial clin­i­cal hold re­quires a num­ber of ques­tions to be an­swered be­fore we can start a new MR­CLS tri­al in­tend­ed to be used for reg­is­tra­tion pur­pos­es. We will be pro­vid­ing a full re­sponse to the FDA short­ly and will up­date the mar­kets when we have fur­ther news to re­port.”

Adap­ti­m­mune’s lead pro­gram is a SPEAR T-cell ther­a­py tar­get­ing the NY-ESO can­cer anti­gen. The com­pa­ny is a spe­cial­ist in TCR tech.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Novus Ther­a­peu­tics plunges deep in­to pen­ny stock ter­ri­to­ry af­ter failed ear tri­al

After a more than 15-year run, a California-based biotech is exploring options, including a sale, after its lead experimental therapy failed an exploratory mid-stage study in patients with middle ear infections characterized by a build-up of fluid behind the eardrum.

The company, initially called Tokai Pharmaceuticals but which subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM).