Ox­ford Vacmedix moves can­cer vac­cines for­ward with $12.5M from South Ko­rea, Chi­na

South Ko­rea and Chi­nese in­vestors have sunk a col­lec­tive $12.5 mil­lion in­to an Ox­ford Uni­ver­si­ty spin­out that promis­es a more ef­fi­cient and cheap­er way to make can­cer vac­cines.

Shisong Jiang

The fi­nanc­ing round po­ten­tial­ly opens up the Ko­re­an mar­ket for Ox­ford Vacmedix (OVM), which al­ready out-li­censed its re­com­bi­nant over­lap­ping pep­tide tech­nol­o­gy to a joint ven­ture reg­is­tered in Hong Kong. Much of the sci­ence, how­ev­er, ac­tu­al­ly takes place in Changzhou (be­tween Nan­jing and Shang­hai), where an OVM cen­ter has been con­duct­ing ear­ly-stage val­i­da­tion of the tech­nol­o­gy de­vel­oped by sci­en­tif­ic founder and CSO Shisong Jiang.

He found a way to pro­duce over­lap­ping pep­tides in a bac­te­r­i­al sys­tem, rather than syn­the­siz­ing them chem­i­cal­ly, re­sult­ing in an end­less stream of re­com­bi­nant pro­tein and the over­lap­ping pep­tides.

Jiang, who earned his med­ical de­gree in Chi­na, came to Ox­ford by way of the Lon­don School of Hy­giene and Trop­i­cal Med­i­cine and Har­vard’s Dana Far­ber Can­cer In­sti­tute, where he com­plet­ed his PhD and did post-doc work, re­spec­tive­ly. He start­ed down the road of en­tre­pre­neur­ship in 2012 and im­me­di­ate­ly looked to Chi­na for growth op­por­tu­ni­ties.

Both pri­vate in­vestors — with back­grounds in con­struc­tion/en­gi­neer­ing and ad­ver­tis­ing, re­spec­tive­ly — and the gov­ern­ment chipped in for the Changzhou fa­cil­i­ty, and have come back for this round of fi­nanc­ing.

An­tho­ny Coombs

They are joined by Can­cer ROP, a South Ko­re­an health­care in­sti­tu­tion that re­cent­ly start­ed fo­cus­ing on can­cer drugs. It is al­so close­ly as­so­ci­at­ed with one of the biggest hos­pi­tal groups in the coun­try, Ox­ford Vacmedix di­rec­tor An­tho­ny Coombs told End­points News, which can help the biotech iden­ti­fy where its can­cer vac­cines can best be used.

“We look for­ward to a pro­duc­tive and mu­tu­al­ly ben­e­fi­cial part­ner­ship with OVM es­pe­cial­ly in glob­al clin­i­cal tri­al as­pects and con­fi­dent that we can sup­port the con­tin­ued growth and de­vel­op­ment of the com­pa­ny,” said Can­cer ROP CEO Wang-Jun Lee in a state­ment.

The new funds will car­ry OVM through pre­clin­i­cal de­vel­op­ment to the be­gin­ning of Phase I tri­als in two lead pro­grams: OVM-100 is an HPV vac­cine tar­get­ing cer­vi­cal can­cer, while OVM-200 at­tacks sol­id tu­mors with an apop­to­sis in­hibitor called sur­vivin. (The PhI tri­als are ex­pect­ed to com­mence this year.) The biotech is al­so hop­ing to de­vel­op its man­u­fac­tur­ing ca­pac­i­ties from lab to pro­duc­tion scale, at which point it plans to out­source the work to a UK con­tract man­u­fac­tur­ing or­ga­ni­za­tion.

Asian mon­ey has been flow­ing around the UK.

When British Prime Min­is­ter There­sa May vis­it­ed Chi­na last month, Chi­nese in­vestors pledged $1.3 bil­lion to UK life sci­ence in­vest­ments, and Bei­jing’s Ts­ingHua Uni­ver­si­ty un­veiled a joint ear­ly-stage re­search cen­ter with Cam­bridge’s Trin­i­ty Col­lege. South Ko­rea’s largest ven­ture cap­i­tal firm, Ko­rea In­vest­ment Part­ners, backed UK syn­thet­ic bi­ol­o­gy play­er Prokar­i­um in a $10 mil­lion round an­nounced just days ago.

”(T)here’s a lot of ap­petite in Asia (…) peo­ple are very in­ter­est­ed to ac­tu­al­ly en­gage with the re­al­ly good aca­d­e­m­ic work that’s be­ing done in Ox­ford,” Coombs said.

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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Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

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.