Tes­sa gets RMAT des­ig­na­tion for new CAR-T; FDA ad­comm nar­row­ly votes to ex­pand Eli Lil­ly NSCLC la­bel

Tes­sa Ther­a­peu­tics has re­ceived a Re­gen­er­a­tive Med­i­cine Ad­vanced Ther­a­py des­ig­na­tion for its ex­per­i­men­tal CAR-T ther­a­py. The ther­a­py, which showed a 67% com­plete re­sponse rate in two tri­als cov­er­ing 27 pa­tients, is be­ing de­vel­oped for re­lapsed and re­frac­to­ry Hodgkin’s lym­phoma. A piv­otal Phase II tri­al is ex­pect­ed for fall of this year.

Jim Wil­son’s pre­clin­i­cal biotech — fo­cused on de­vel­op­ing gene ther­a­pies for rare CNS dis­or­ders — has ex­pand­ed its pro­posed share of­fer­ing for its up­com­ing IPO. It now plans to raise $170 mil­lion by of­fer­ing 10 mil­lion shares at a price range of $16 to $18. Pre­vi­ous­ly it had set the goal at $126 mil­lion by of­fer­ing 7.4 mil­lion shares with­in the same price range. At the mid­point, the Philadel­phia, PA-based com­pa­ny could com­mand a ful­ly di­lut­ed mar­ket val­ue of $757 mil­lion, ac­cord­ing to Re­nais­sance Cap­i­tal. Found­ed in 2017, Pas­sage Bio will make its de­but on the Nas­daq un­der the sym­bol $PASG.

→ Six weeks af­ter post­ing dis­ap­point­ing re­sults from a Phase II cys­tic fi­bro­sis tri­al, Eloxx Phar­ma is cut­ting staff to save cash and hir­ing a new chief ex­ec­u­tive. Thir­teen staffers will lose their jobs, al­though it’s not clear from which lev­els. Gre­go­ry Williams, a for­mer Med­i­cines Com­pa­ny ex­ec­u­tive, has been pro­mot­ed to CEO as part of the shake­up, as long­time biotech ex­ec­u­tive Rob Ward sees the ex­it. The com­pa­ny’s stock has tum­bled pre­cip­i­tous­ly over the last 2 years, but they’re hop­ing an­oth­er CF Phase II read­out ex­pect­ed for the first half of this year will boost their sails.

→ Of the $2.5 bil­lion that the Trump ad­min­is­tra­tion has re­quest­ed from Con­gress to bat­tle the coro­n­avirus in the US, more than $1 bil­lion will be ded­i­cat­ed to cre­at­ing a vac­cine, Bloomberg re­port­ed. Ther­a­peu­tic pro­grams were al­so among the pri­or­i­ties.

Puma Biotech­nolo­gies has re­ceived a sup­ple­men­tal ap­proval for its ty­ro­sine ki­nase in­hibitor ner­a­tinib. The drug, which had been ap­proved un­der the brand name Ner­l­ynx as an ad­ju­vant treat­ment for ear­ly-stage HER2 pos­i­tive breast can­cer, can now be used on ad­vanced and metasta­t­ic HER2 pos­i­tive pa­tients who have re­ceived at least 2 pri­or an­ti-HER2 ther­a­pies in the metasta­t­ic set­ting.

→ An FDA ad­vi­so­ry com­mit­tee nar­row­ly vot­ed 6-5 in fa­vor of ex­pand­ing the ap­proval of Eli Lil­ly‘s can­cer drug Cyra­mza. Al­ready ap­proved as a ther­a­py for sev­er­al can­cers, in­clud­ing cer­tain forms of non-small cell lung can­cer, the drug is up for re­view as part of a com­bi­na­tion treat­ment for metasta­t­ic EGFR-mu­tat­ed NSCLC. The com­mit­tee con­sid­ered re­sults from a 449-per­son Phase III tri­al in which pa­tients on the drug lived 7 months longer than those on place­bo. The FDA gen­er­al­ly fol­lows com­mit­tee de­ci­sions but is not ob­lig­at­ed to do so.

As­cle­tis Phar­ma an­nounced it is ad­vanc­ing on a clin­i­cal tri­al test­ing a com­bi­na­tion of Gano­vo, a he­pati­tis drug, and ri­ton­avir, an HIV drug, against nov­el coro­n­avirus pneu­mo­nia af­ter 3 pa­tients were dis­charged from the hos­pi­tal fol­low­ing treat­ment. Ri­ton­avir is one of sev­er­al HIV pro­tease in­hibitors be­ing test­ed against the virus, known as SARS-CoV2. An ar­ti­cle in Na­ture Re­views Drug Dis­cov­ery in ear­ly Feb­ru­ary not­ed these drugs were po­ten­tial­ly ef­fec­tive, but it’s not yet clear how well they will in­hib­it the pro­teas­es in coro­n­avirus­es, which be­long to a dif­fer­ent fam­i­ly than HIV pro­teas­es. The ar­ti­cle al­so men­tioned he­pati­tis C drugs as po­ten­tial treat­ments.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,200+ biopharma pros reading Endpoints daily — and it's free.

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

Cameron Durrant, Humanigen CEO (Columbia University Technology Ventures via YouTube)

Cameron Dur­rant hus­tled his way from the OTC side­lines right in­to the Covid-19 drug race. Death or glo­ry lies straight ahead

Over the past few months, Covid-19 has gone from being a monolithic threat to one of the biggest overnight boons the biopharma industry has ever seen. And amid all the furor over Moderna’s swelling stock price, plenty of chatter over what new drugs and vaccines will cost and investors’ uninhibited zeal for all things related to pandemic products, it’s been one little biotech’s golden ticket back from the land of the living dead.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Credit: AP Images

Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,200+ biopharma pros reading Endpoints daily — and it's free.

FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,200+ biopharma pros reading Endpoints daily — and it's free.

Adam Keeney (NodThera)

As NL­RP3 play­ers head for first clin­i­cal face-off, No­vo, Sanofi fu­el trans-At­lantic con­tender with $55M

In the relative short history of inflammasome research, Adam Keeney sees two time points marking major breakthroughs: the early 2000s, when the role of inflammasomes as a major innate immunity node was elucidated; and 2015, when Pfizer found out a compound it thought was targeting IL-1 actually blocks NLRP3. Keeney’s biotech, NodThera, was founded the year after alongside several others to create its own superior small molecule drugs.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,200+ biopharma pros reading Endpoints daily — and it's free.