Park­er In­sti­tute-al­lied Tes­sa grabs an $80M round for its next-gen can­cer cell ther­a­pies

Last sum­mer the Park­er In­sti­tute for Can­cer Im­munother­a­py raised eye­brows in R&D cir­cles with its an­nounce­ment that it was al­ly­ing it­self with a lit­tle-known biotech based on Sin­ga­pore that was tak­ing a nov­el ap­proach to adop­tive cell ther­a­pies. Now, the biotech — Tes­sa Ther­a­peu­tics — has raised $80 mil­lion from a well-heeled group that in­cludes the sov­er­eign wealth fund for Sin­ga­pore to fin­ish a Phase III quest aimed at one of the Holy Grails of can­cer R&D.

John Con­nol­ly

The big idea at Tes­sa is that it knows how to adapt virus-spe­cif­ic T cells to tar­get vi­ral­ly-as­so­ci­at­ed tu­mors like cer­vi­cal and head and neck can­cer, swarm­ing the cells. And done prop­er­ly, it could prove an open door to go be­yond some of the as­ton­ish­ing suc­cess­es that CAR-T drugs have had in blood can­cers in­to sol­id tu­mors.

“As much as its tech­no­log­i­cal as­pect, it’s al­so a philo­soph­i­cal align­ment,” Fred Rams­dell, the vice pres­i­dent for re­search at the Park­er In­sti­tute, told me at the time. “They have a very good sci­en­tif­ic un­der­pin­ning. They know what they’re do­ing; very well round­ed….You nev­er know, but it looks re­al­ly quite good.”

Han Chong Toh

The work at Tes­sa is led by chief sci­en­tif­ic of­fi­cer John Con­nol­ly, a Bay­lor vet, and CMO Han Chong Toh, the deputy di­rec­tor of the Na­tion­al Can­cer Cen­tre Sin­ga­pore and one of the top can­cer in­ves­ti­ga­tors in the re­gion. That all clear­ly helped en­cour­age one of the biggest ven­ture rounds seen in the re­gion this year.

Tes­sa turned up at AS­CO in ear­ly June with Phase II da­ta on 35 pa­tients with rare cas­es of Stage 4c na­sopha­ryn­geal car­ci­no­ma, or NPC, as­so­ci­at­ed with Ep­stein-Barr virus. It was, said Con­nol­ly, “beau­ti­ful sur­vival da­ta.” Their con­clu­sion:

The 2- and 3-year over­all sur­vival rates were 62.9% and 37.1% re­spec­tive­ly, which rep­re­sent the best re­port­ed sur­vival out­come for first-line treat­ment of ad­vanced NPC when com­pared to his­tor­i­cal clin­i­cal tri­als.

Tes­sa has al­so been lin­ing up new tech on on­colyt­ic virus­es and chimeric anti­gen re­cep­tors for its next-gen work. And now it has more mon­ey for the next stage of the jour­ney from a sig­nif­i­cant group of Asian in­vestors.

Sin­ga­pore-based Temasek, a sov­er­eign wealth fund for the city-state, led the round and was joined by ED­BI, Karst Peak Cap­i­tal, He­li­co­nia, Her­i­tas and oth­er in­vestors.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serves, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Or­biMed, bio­phar­ma's biggest in­vestor, clos­es $3.5B in three new pri­vate funds

One of the world’s leading biopharma investors has pulled in its next rounds of cash, with the funds planned to go to dozens of companies around the world.

OrbiMed raised $3.5 billion across three private investment funds, it announced Monday, as it continues building on its long track record in healthcare and biopharma. All in all, the firm expects to invest in at least 60 companies across the US, Asia and Europe.

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