Thomas Gajewski, David Steinberg. (CRI, Pyxis)

Bay­er, Long­wood back star re­searcher's deep dive in­to the tu­mor mi­croen­vi­ron­ment for new I/O tar­gets

From PD-1 tar­get­ing to the RAS path­way to the STING com­plex, Thomas Gajew­s­ki has spent the past two decades of his ca­reer de­cod­ing the var­i­ous ways the im­mune sys­tem can be un­leashed to de­fend against can­cer. So when the Uni­ver­si­ty of Chica­go pro­fes­sor comes around to putting all his find­ings in­to a new plat­form for find­ing new tar­gets, VCs and phar­ma groups alike pay at­ten­tion.

“He’s been study­ing T cells for 20 years, plus he’s one of the world’s lead­ers if not the world leader in the space,” David Stein­berg, part­ner at Long­wood Fund, said. “Fur­ther­more, let me add he did a lot of the foun­da­tion­al re­search and al­so some of the sem­i­nal clin­i­cal tri­als in the ex­ist­ing set of I/O agents. He un­der­stands the space re­al­ly well, he un­der­stands the cur­rent strengths, and I think he un­der­stood re­al­ly well what was miss­ing, so he knew where to look.”

Long­wood is launch­ing Pyx­is On­col­o­gy with Gajew­s­ki and John Flavin, a sea­soned life sci­ences en­tre­pre­neur and for­mer ven­ture cap­i­tal­ist him­self. The ini­tial Se­ries A comes in at $22 mil­lion; Leaps by Bay­er took the lead­ing role while Agent Cap­i­tal, Ipsen and Long­wood chipped in.

As can be ex­pect­ed from a start­up that’s rapid­ly beef­ing up its op­er­a­tions and so­lid­i­fy­ing its IP foun­da­tion, Stein­berg, the CEO, is tight-lipped about the ex­act na­ture of their work ex­cept that they are brand new tar­gets that, to the best of their knowl­edge, are not in any dis­closed clin­i­cal pipelines any­where.

By ex­am­in­ing the tu­mor mi­croen­vi­ron­ment, he added, Gajew­s­ki had been able to iden­ti­fy new bi­o­log­i­cal phe­nom­e­na me­di­at­ing the ac­tion be­tween the tu­mor and the T cell — po­ten­tial­ly un­lock­ing a sec­ond lev­el of T cell in­hi­bi­tion by can­cer.

Jak Knowles Bay­er

Click on the im­age to see the full-sized ver­sion

Bay­er jumped right on board, VP of ven­ture in­vest­ments Jak Knowles said.

Hav­ing on­ly first met with Stein­berg in April, “this is ac­tu­al­ly, I think, the deal that we’ve closed the fastest since Leaps’ ex­is­tence,” he told me.

While Pyx­is is start­ing out on the tried and true path of an­ti­body de­vel­op­ment, he be­lieves it can be­come an even big­ger play in the I/O field by find­ing the next tar­get for a T cell or NK cell-based ther­a­py.

But it’s still ear­ly days, and both the com­pa­ny and the syn­di­cate are clear­ly tak­ing it step by step. Pyx­is now has more board mem­bers and sci­en­tif­ic ad­vi­sors than staffers, but Stein­berg plans to bal­ance that out by ramp­ing up to 15 to 20.

The SAB com­pris­es:

  • Michael Atkins, Deputy Di­rec­tor of the George­town-Lom­bar­di Com­pre­hen­sive Can­cer Cen­ter and the Scholl Pro­fes­sor and Vice-Chair of the De­part­ment of On­col­o­gy at George­town Uni­ver­si­ty School of Med­i­cine.
  • Lisa But­ter­field, VP of the Park­er In­sti­tute for Can­cer Im­munother­a­py and Ad­junct Pro­fes­sor of Mi­cro­bi­ol­o­gy and Im­munol­o­gy at the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co.
  • Alan Ko­r­man, Se­nior Vice Pres­i­dent of Hu­man Im­munol­o­gy at Vir Biotech­nol­o­gy and For­mer Vice Pres­i­dent of Im­muno-On­col­o­gy Dis­cov­ery at Bris­tol-My­ers Squibb.
  • Ja­son Luke, As­so­ci­ate Pro­fes­sor of Med­i­cine and Di­rec­tor of the Can­cer Im­munother­a­peu­tics Cen­ter at the Uni­ver­si­ty of Pitts­burgh School of Med­i­cine.

Mean­while, Knowles and his Bay­er col­league Lu­cio Ian­none will serve on the board, chaired by Flavin, to ad­vise on po­ten­tial col­lab­o­ra­tions and com­bos.

“Part of the rea­son we were ex­cit­ed to work with both Bay­er and Ipsen on this is be­cause it’s sort of re­in­force­ment of the in­ter­est and ex­cite­ment about these kinds of ap­proach­es from with­in the phar­ma in­dus­try,” Stein­berg said.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can created herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

Rich Heyman (ARCH)

Rich Hey­man joins PMV Phar­ma, a p53 biotech, as it adds $70 mil­lion in Se­ries D

Less than a year after pulling in an impressive $62 million Series C round, PMV Pharma is back at it again.

The Cranbury, NJ-based biotech announced Monday an additional $70 million in Series D financing as it seeks to develop cancer therapies targeting p53 mutations. Additionally, PMV also introduced longtime biotech entrepreneur Rich Heyman as chairman of the board of directors.

“This financing provides PMV Pharma with the resources to expand our pipeline and to potentially advance multiple p53 therapies into the clinic,” said PMV president and CEO David Mack in a statement.

Covid-19 roundup: Eli Lil­ly retro­fits RVs for first-of-its-kind an­ti­body tri­al with NIH; Am­gen, Ab­b­Vie, Take­da team on a drug

Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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Tony Coles, Cerevel Therapeutics CEO

Adding $445M, Tony Coles and his big Pfiz­er neu­ro spin­out hitch a ride to Wall Street on Per­cep­tive’s SPAC

Two years ago, after Pfizer abruptly shut down its entire neuroscience division, Bain Capital bet $350 million that those assets were still worth something and packaged them into a new biotech: Cerevel Therapeutics. A year later, they got seasoned executive Tony Coles, who had recently jumped back into the C-suite of another neuroscience startup, to run the company.

Now Coles is steering Cerevel public, in what he says is the largest ever transaction of its kind. Cerevel has agreed to merge with Perceptive Advisors’ specialty acquisition company ARYA II. Between the roughly $125 million Perceptive raised through ARYA and an additional investment of $320 million Bain Capital, Perceptive and — yes, really — Pfizer, among others, Cerevel will now move forward with an added $445 million in its coffers.

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Sanofi un­der for­mal in­ves­ti­ga­tion for De­pakine al­le­ga­tions; Beam li­cens­es CAR-T tech from Ox­ford Bio­med­ica

Sanofi is facing a formal investigation on manslaughter charges, due to accusations that its epilepsy drug Depakine caused birth malfunctions and slow neurological development when taken during pregnancy.

The French pharma was formally charged in February, years after evidence surfaced that the drug, sodium valproate, posed neurodevelopmental risks. Sodium valproate first hit the market in 1967 for the treatment of epilepsy and bipolar disorder, and is currently prescribed in more than 100 countries.

Days af­ter seal­ing Sanofi pact, Kymera beats a path to the Nas­daq with $100M IPO pitch

Back in March, when Kymera Therapeutics closed $102 million in Series C funding led by Biotechnology Value Fund and Redmile Group, CEO Nello Mainolfi noted the protein degradation player was “at the cusp of transitioning” into a fully integrated R&D company. Five months and a major Sanofi pact later, he’s back asking for another little push to get there.

Kymera has penciled in $100 million in its first IPO pitch — although given the public market’s seemingly insatiable appetite for biotechs these days the final figure is anyone’s guess.