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

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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.

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Bo Cumbo, AavantiBio CEO (file photo)

Bo Cum­bo jumps from the top com­mer­cial post at Sarep­ta to the helm of a gene ther­a­py start­up with some in­flu­en­tial back­ers, big plans and $107M

After a 7-year stretch building the commercial team at Sarepta, longtime drug salesman Bo Cumbo is jumping to the entrepreneurial side of the business, taking the helm of a startup that’s got several deep-pocket investors. And he’s not just bringing his experience in selling drugs.

He tells me that when he told Sarepta CEO Doug Ingram about it, his boss got excited about the venture and opted to jump in with a $15 million investment from Sarepta to add to the launch money, alongside 3 of the busiest investors in biotech.

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Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

Chi­nese in­vestors wa­ger $105M on an IPO-bound biotech look­ing to push RNAi as main­stream can­cer ther­a­py

Shortly after Sirnaomics brought in a $47 million Series C for its small interfering RNA pipeline last year, Patrick Lu — the founder, president and CEO — was asked to outline the scientific advances that will be necessary to make better drugs out of RNA tech.

“The next step in the evolution of RNAi as a leading therapeutic will be the ability to safely target organs outside the liver such as lung, brain, etc,” he had offered. “This will revolutionize disease treatments if the industry can demonstrate similar data sets for non-liver targets as we have seen in liver-based diseases.”