Chi­na's biotech pipeline is brim­ming with PD-1/L1 check­points. Are they re­al­ly need­ed?

The big US and Eu­ro­pean mar­kets aren’t the on­ly place where PD-1/L1 check­point drugs are crowd­ing in. Be­gin­ning lat­er this year, the da­ta an­a­lyt­ics firm Pharm­Cube re­ports, Keytru­da and Op­di­vo should both be green light­ed for mar­ket­ing in Chi­na. And they’ll like­ly be swift­ly fol­lowed by 4 Chi­nese bio­phar­mas an­gling for their own share of the mar­ket — with a dozen more be­hind them prepar­ing to make an im­pact on Chi­na and the world.

Pharm­Cube tells End­points News that In­novent Bi­o­log­ics, Shang­hai Jun­shi, BeiGene (Cel­gene’s part­ner) and Jiang­su Hen­grui are all be­ing tipped for a mar­ket launch in the first half of 2019. Bris­tol-My­ers Squibb has lined up a shot at non-small cell lung can­cer, Mer­ck has melanoma, In­novent has Hodgkin lym­phoma, while Shang­hai Jun­shi al­so has melanoma.

And Jiang­su Hen­grui and BeiGene? Says Pharm­Cube: “We’re not sure, they both have NSCLC, esophageal can­cer and he­pa­to­cel­lu­lar can­cer in Phase III.”

There are 5 check­points on the US mar­ket, with Re­gen­eron $REGN and Sanofi $SNY like­ly to grab sixth place soon. But the Can­cer Re­search In­sti­tute re­cent­ly count­ed 164 pro­grams around the world, with 1,502 clin­i­cal tri­als un­der­way in­volv­ing a PD-1/L1, with 1,105 com­bo stud­ies in the pipeline. And these Chi­nese com­pa­nies are com­ing on strong, with the 4 lead­ers fol­lowed by 13 more out­fits col­lec­tive­ly cov­er­ing 6 Phase I drugs, 3 more pro­grams about to en­ter clin­i­cal tri­als and 9 at the IND stage.

The un­part­nered as­sets on the list be­low could make for in­ex­pen­sive part­ner­ships among West­ern com­pa­nies look­ing for their own clin­i­cal-stage PD-1/L1 drugs to add to their pipelines.

All of these oth­er check­points could help swamp a field, where gen­er­a­tion one drugs are be­ing threat­ened with com­modi­ti­za­tion. And that in turn is dri­ving a fren­zy of com­bi­na­tion stud­ies us­ing a va­ri­ety of new drugs that can pro­vide a crit­i­cal as­sist to the PD-1/L1s, along with oth­er, more tar­get­ed drugs.

They are not all prob­lem free. Hen­grui’s lead check­point is part­nered with In­cyte $IN­CY, but was linked to a unique and mild side ef­fect — grade 1 and 2 he­man­giomas, small, non-can­cer­ous vas­cu­lar skin growths — that made it un­ap­peal­ing for com­bi­na­tion work in a high­ly com­pet­i­tive field, forc­ing In­cyte to add Macro­Gen­ics as a new part­ner.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Bio­haven adds near­ly $1B in Nurtec deals with Roy­al­ty Phar­ma, Sixth Street

Biohaven just added nearly $1 billion to their balance sheet.

On Friday morning, the neuroscience biotech announced a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of their new migraine drug, Nurtec. Biohaven will sell a sliver of its royalties on Nurtec and 3% of the royalties on their experimental migraine drug zavegepant to Royalty Pharma as part of a larger agreeement that will pay $450 million. At the same time, the company announced they took out a $500 million loan from Sixth Street.

Ab­b­Vie set­tles in­sur­ance fraud suit, agrees to tweak nurse am­bas­sador pro­gram; CStone aims for NSCLC OK with pos­i­tive PhI­II da­ta

AbbVie has resolved a California lawsuit alleging insurance fraud in the promotion of its cash cow Humira, paying $24 million to settle things with the state’s insurance regulator.

The settlement comes almost four years after a whistleblower first reported AbbVie’s practice of deploying registered nurses to visit patients at home or call them by phone to ensure that Humira prescriptions are filled. AbbVie was also charged with providing illegal kickbacks to doctors in an attempt to encourage them to prescribe Humira for a range of anti-inflammatory diseases.

Per­cep­tive fields SPAC #3 as an­oth­er group of biotechs scoops up $364M in lat­est Nas­daq romp

There’s no sign that the windfall of cash dropping biotech’s way on Wall Street is abating. Three more biopharmas priced IPOs on Thursday and Friday morning, riding a historic boom with a $364 million payoff.

London-based biotech Freeline Therapeutics took home the lion’s share of the cash with $159 million after pricing 8,823,529 shares at $18 a pop. Checkmate Pharmaceuticals, of Cambridge, MA, raised $75 million with an offer of 5 million shares at $15 — right at the midpoint of its range. And Arya Sciences Acquisition Corp III, the third in a series from Perceptive, priced 13,000,000 shares at $10 per share.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Alex­ion cre­ates new post for chief di­ver­si­ty of­fi­cer; Bar­ry Greene step­ping down at Al­ny­lam, Yvonne Green­street named as suc­ces­sor

Alexion has carved out a new position for chief diversity officer and filled it with an inside promotion.

Uzair Qadeer will now be responsible for their “diversity, inclusion and belonging” strategy, looking to reshape the biotech’s corporate culture. A veteran of Deloitte and Bristol Myers Squibb, Qadeer was working on executive coaching and helping create the diversity program he now leads.