Pro­tein degra­da­tion pi­o­neer C4 Ther­a­peu­tics nabs $170M; Barcelona start­up has €30M to go af­ter can­cer metas­tases

→ Pro­tein degra­da­tion has been good to C4 Ther­a­peu­tics. The Wa­ter­town, MA-based biotech just raised $170 mil­lion. That in­cludes a $150 mil­lion B round as well as $20 mil­lion in ven­ture debt from Per­cep­tive. “This fund­ing comes at a sig­nif­i­cant junc­ture, as our com­pa­ny is mov­ing to a clin­i­cal stage,” says CEO Marc Co­hen. “We plan on fil­ing our first IND by the end of this year and ex­pect to have four drug can­di­dates in the clin­ic by the end of 2022.” The syn­di­cate is big. The round was co-led by ex­ist­ing in­vestor Co­bro Ven­tures and new in­vestor Per­cep­tive Ad­vi­sors. New eq­ui­ty in­vestors in the round in­clud­ed Adage Cap­i­tal Man­age­ment, Ax­il Cap­i­tal, Bain Cap­i­tal Life Sci­ences, Com­modore Cap­i­tal, 3E Bioven­tures Cap­i­tal, HBM Health­care In­vest­ments, Lightchain Cap­i­tal, Lo­gos Cap­i­tal, Mizuho Se­cu­ri­ties Prin­ci­pal In­vest­ment, Nex­tech, RA Cap­i­tal Man­age­ment, RTW In­vest­ments, Sphera Funds Man­age­ment, Tai­wa­nia Cap­i­tal Man­age­ment, Yon­jin Ven­ture, and funds and ac­counts man­aged by T. Rowe Price As­so­ci­ates and Janus Hen­der­son In­vestors. Ex­ist­ing in­vestors al­so par­tic­i­pat­ed.

→ A Barcelona-based start­up with its own ap­proach to metas­ta­sis has just raised a €30 mil­lion launch round. Ona Ther­a­peu­tics has round­ed up the mon­ey from Asabys Part­ners and new in­vestors Al­ta Life Sci­ences, Bpifrance – In­no­Bio 2, Fund+ and Ys­ios Cap­i­tal. The biotech is found­ing on key find­ings by co-founder Sal­vador Az­nar-Ben­i­tah, who showed that metasta­t­ic cells are ad­dict­ed to fat — un­like pri­ma­ry tu­mors, which feasts most­ly on sug­ar. While many can­cer drug de­vel­op­ers have tend­ed to lump pri­ma­ry tu­mors and metas­tases to­geth­er, “we see it as a dif­fer­ent type of beast,” CEO Va­lerie Van­hooren told End­points News. The Abl­ynx vet ex­pects the cash to take them through a large proof-of-con­cept bas­ket tri­al in­volv­ing up to 150 pa­tients, from which Ona will se­lect the most promis­ing in­di­ca­tions to pur­sue for its an­ti­bod­ies.

→ Hop­ping on the SPAC band­wag­on, RA Cap­i­tal has filed for a $100 mil­lion IPO for its blank check com­pa­ny. Pe­ter Kolchin­sky is Ther­a­peu­tics Ac­qui­si­tion’s CEO and chair­man — which in ef­fect means he will lead the search for a promis­ing biotech to buy and flip to the Nas­daq. Spe­cial pur­pose ac­qui­si­tion com­pa­nies have be­come a trendy ve­hi­cle among mar­quee health­care in­vestors, with Chardan and RTW al­ready ex­e­cut­ed the merg­ers that their SPACs were set up for.

→ Shen­zhen, Chi­na-based Im­mvi­ra has raised $58 mil­lion to fund de­vel­op­ment of its on­colyt­ic virus­es, which promis­es to repli­cate bet­ter, kill can­cer cells more ef­fec­tive­ly, and in­duce more im­mune re­sponse than the pre­vi­ous gen­er­a­tion. Its lead can­di­date has launched clin­i­cal stud­ies in Aus­tralia, Chi­na and the US. Hua­gai Cap­i­tal led the round, with par­tic­i­pa­tion from Apri­cot Cap­i­tal and Cowin Cap­i­tal.

→ Can CAR-T be part of the an­swer to an HIV cure? A group of UCLA re­searchers have re­ceived a $13.65 mil­lion grant from the NIH to find out. By mod­i­fy­ing a pa­tient’s own stem cells to re­sist HIV in­fec­tion and hunt down in­fect­ed cells, the treat­ment would ide­al­ly repli­cate the ef­fect of a stem cell trans­plan­ta­tion.

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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Michael Shpigelmacher

Khosla joins bet on un­con­ven­tion­al start­up look­ing to send drug de­liv­er­ing ro­bots in­to the brain

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepeneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film Fantastic Voyage, the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his own account, along with some seed cash from friends and family.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, 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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Mesoblast gets a $110M life­line from Surg­Cen­ter De­vel­op­ment; uniQure still un­sure if gene ther­a­py spurred can­cer event

Mesoblast faced rough waters in 2020, but on Monday were thrown a financial lifeline.

The Australian stem cell therapy player has raised $110 million in a private placement, the company announced, offering 60 million shares to the US investor group SurgCenter Development. SurgCenter received the shares at a 6.5% discount from Mesoblast’s closing price on Feb. 25.

Mesoblast plans to use the funds to boost supply of its lead candidate remestemcel-L ahead of what they hope is a potential approval in pediatric GvHD when they return to the FDA, as well as advancing manufacturing and development of their rexlemestrocel-L platform for chronic heart failure and chronic low back pain.

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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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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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.