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.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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Douglas Love, Annexon CEO (Annexon)

IPO bound? A Bay Area biotech grabs a mega-round on the road to a piv­otal neu­rode­gen­er­a­tion pro­gram

South San Francisco-based Annexon has added $100 million to its cash reserves, along with a new roster of marquee investors backing their play on the classical complement pathway involved in neurodegeneration. And that may well fit the profile for an IPO — though right now everything seems to be working on that score.

Eighteen months after Bain and their syndicate partners put up $75 million to fuel clinical work, Annexon is back at the trough. And this time they’re adding Redmile Group for the lead role, with supporting investments from these new arrivals: BlackRock, Deerfield Management Company, Eventide Asset Management, Farallon Capital Management, Janus Henderson Investors and Logos Capital.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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