Junshi CEO Ning Li (Junshi)

Rac­ing ahead of Mer­ck and In­novent, Jun­shi de­clares PhI­II suc­cess on can­cer that won them 'break­through' sta­tus

Ear­ly this month, the FDA hand­ed Jun­shi Bio­sciences an agency first: A break­through des­ig­na­tion for a PD-(L)1 ther­a­py out of Chi­na. Now, the Shang­hai-based biotech is de­clar­ing piv­otal suc­cess.

Jun­shi said Tues­day that, in an in­ter­im analy­sis, their lead drug Tori­pal­imab had im­proved pro­gres­sion free sur­vival for pa­tients with re­cur­rent or metasta­t­ic forms of a rare can­cer called na­sopha­ryn­geal car­ci­no­ma. Jun­shi did not re­lease any num­bers, but the 2-year-long Phase III study, com­par­ing chemother­a­py and tori­pal­imab to chemo alone,  had been set to en­roll 280 pa­tients.

The biotech said they would sub­mit for ap­proval in Chi­na short­ly, with oth­er coun­tries fol­low­ing soon af­ter. The news po­si­tions Jun­shi to be the first to gain ap­proval in a tu­mor that, while over­looked through much of the PD-1 race, is al­so now be­ing pur­sued by Mer­ck and In­novent.

Jun­shi has long been one of the top PD-1 com­peti­tors in Chi­na. In 2018, they won the coun­try’s first home-grown PD-1 ap­provals, tak­ing home a $394 mil­lion IPO in the process, beat­ing out In­novent and BeiGene. BeiGene, though, snared the first US ap­proval for a Chi­nese drug de­vel­op­er and In­novent has part­nered with Eli Lil­ly to get their own US okay.

PD-1s are en­trenched enough by now that break­through des­ig­na­tions — for US or ex-US com­pa­nies — is a rar­i­ty but Jun­shi won one by chas­ing a ma­lig­nan­cy that few oth­er PD-1 de­vel­op­ers had pur­sued. Na­sopha­ryn­geal car­ci­no­ma, one of a hand­ful that can be trig­gered by Ep­stein-Barr virus, is most com­mon in South­east Asia and ex­ceed­ing­ly rare in the US.

No­var­tis in­clud­ed it in stud­ies that test­ed their check­point in­hibitors on a range of sol­id tu­mors and the Na­tion­al Can­cer In­sti­tute even ran a 45-per­son study test­ing Op­di­vo in the in­di­ca­tion — find­ing a 20.5% re­sponse rate — but Jun­shi was one of on­ly a cou­ple com­pa­nies to bring it in­to Phase III.

It was part of CEO Ning Li’s strat­e­gy to fo­cus on rar­er can­cers, par­tic­u­lar­ly ones that are some­what more com­mon in Chi­na. The com­pa­ny es­ti­mates there were about 129,000 new cas­es of the tu­mor in 2018. Al­though many pa­tients have their can­cers treat­ed and cleared ear­ly, those di­ag­nosed once the tu­mor has metas­ta­sized face a more dif­fi­cult prog­no­sis. Jun­shi es­ti­mates a 5-year sur­vival rate of un­der 10% for those with ad­vanced dis­ease.

Jun­shi isn’t alone, though, in chas­ing the in­di­ca­tion. In­novent and an­oth­er Chi­nese drug de­vel­op­er, Jiang­su Hen­gRui Med­i­cine, have each put their PD-1s in Phase III stud­ies for na­sopha­ryn­geal car­ci­no­ma and in the US, Mer­ck has en­rolled 233 pa­tients in a tri­al they launched in 2015. It is sched­uled to be com­plet­ed lat­er this year.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Am­gen sev­ers 14-year Cy­to­ki­net­ics part­ner­ship, bail­ing on ome­cam­tiv af­ter mixed PhI­II re­sults

Amgen is shrugging off a 14-year development alliance and the tens of millions of dollars spent to develop a new heart drug at Cytokinetics after a Phase III trial turned up weak data — leaving Cytokinetics to soldier on alone.

Omecamtiv mecarbil technically worked, meeting the primary composite endpoint in the Phase III GALACTIC-HF study. But it missed a key secondary endpoint, which analysts had been following as a key marker for success — reduction of cardiovascular (CV) death. While Cytokinetics celebrated the results, its stock tanked 43% upon the news, and analysts warned of an uncertain path ahead. Now, Amgen wants out.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

News brief­ing: Ab­b­Vie part­ner Teneo­bio ex­pands tech li­cense with CAR-T play­er Po­sei­da; Ar­genx buys PRV from Bay­er for $98M

Teneobio may be best known for its pact with AbbVie and Gilead, but before its big break the bispecific player had licensed its antibodies for a different use: as binders in CAR-T therapies being developed by Poseida.

Now, the biotechs are expanding their partnership, with Poseida exercising four options to deploy Teneobio’s heavy chain only domain antibodies commercially.

The commercial licensing fees remained under wraps, but Teneobio is eligible for $250 million in milestones for these CAR-Ts against undisclosed targets.