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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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