Proven­tion Bio inks Chi­na deal for au­toim­mune pro­gram; Ky­owa Kirin re­leas­es pos­i­tive topline da­ta in atopic der­mati­tis

Proven­tion Bio is mak­ing its way in­to Chi­na with a new deal an­nounced Wednes­day.

The Red Bank, NJ-based biotech has agreed to a deal with a sub­sidiary of Huadong Med­i­cine to work on PRV-3279, a bis­pe­cif­ic an­ti­body-based mol­e­cule tar­get­ing CD32B and CD79B, in Chi­na, Hong Kong, Macau and Tai­wan. Proven­tion will get $6 mil­lion up­front and up to $11.5 mil­lion in fund­ing over the next three years to cov­er ex­pect­ed re­search costs.

The deal al­so in­cludes reg­u­la­to­ry and com­mer­cial mile­stones of up to $172 mil­lion. Proven­tion will re­tain all rights to PRV-3279 in the rest of the world.

Proven­tion’s the­o­ry be­hind the ex­per­i­men­tal drug is to en­gage both the CD32B and CD79B re­cep­tors to trig­ger in­hi­bi­tion of B cell func­tion and sup­press the im­mune sys­tem from at­tack­ing its own body. It’s cur­rent­ly in a Phase I tri­al for sys­temic lu­pus ery­the­mato­sus, a chron­ic au­toim­mune dis­or­der char­ac­ter­ized by an over­ac­ti­va­tion of B cells.

Wednes­day’s news comes a few months be­fore Proven­tion’s lead pro­gram teplizum­ab is due for a PDU­FA de­ci­sion in Type 1 di­a­betes at the FDA. The biotech picked up the drug in 2018, eight years af­ter it was dumped by Eli Lil­ly. — Max Gel­man

Ky­owa Kirin pro­gram meets pri­ma­ry in AD study

Japan­ese phar­ma Ky­owa Kirin has new pos­i­tive da­ta out Thurs­day for mod­er­ate to se­vere atopic der­mati­tis.

The com­pa­ny’s KHK4083 pro­gram met the pri­ma­ry end­point, with all co­horts achiev­ing sta­tis­ti­cal sig­nif­i­cance in per­cent change from base­line in Eczema Area and Sever­i­ty In­dex (EASI) af­ter 16 weeks. Ky­owa al­so not­ed the pro­gram passed in two key sec­ondary end­points, and saw fur­ther im­prove­ment in ef­fi­ca­cy af­ter week 16.

KHK4083 is a mon­o­clon­al an­ti­body tar­get­ing OX40 hop­ing to sup­press in­flam­ma­to­ry re­spons­es in a range of au­toim­mune dis­eases. Ky­owa says OX40 plays an im­por­tant role in main­tain­ing T cell pro­lif­er­a­tion and sur­vival, and this study helps val­i­date it as an ap­pro­pri­ate tar­get for AD.

Full re­sults will be shared “in the near fu­ture,” Ky­owa R&D chief Yoshi­fu­mi Torii said in a state­ment. — Max Gel­man

Chi­nese AI play­er gets $30M Se­ries A

NeoX Biotech an­nounced last week it had raised $30 mil­lion in a Se­ries A fund­ing round.

The Chi­nese com­pa­ny plans to use funds main­ly to en­hance its AI drug R&D plat­form, ac­cel­er­ate pre­clin­i­cal de­vel­op­ment and ex­pand in­ter­na­tion­al busi­ness co­op­er­a­tion. NeoX says its tech can help op­ti­mize the drug dis­cov­ery process and make it more ef­fi­cient.

“We are fo­cus­ing on cut­ting-edge drug modal­i­ties, such as mul­ti­spe­cif­ic mol­e­cules and bi­o­log­ics,” CEO Michael Chen said in a state­ment. “We use our next-gen­er­a­tion neo­Plat­form to de­sign new drug modal­i­ties and to tru­ly ‘think out of the box’, in an ef­fort to ad­dress un­drug­gable tar­gets.”

The fi­nanc­ing was co-led by Sky9 Cap­i­tal and 5Y Cap­i­tal (for­mer­ly known as Morn­ing­side Ven­ture Cap­i­tal), with par­tic­i­pa­tion from BAI Cap­i­tal and Ver­tex Ven­tures along­side ex­ist­ing in­vestors Vi­sion Plus Cap­i­tal and Se­quoia Cap­i­tal Chi­na. — Max Gel­man

Fred Hutch spin­out lands seed round for AI tech

Fred Hutchin­son Can­cer Re­search Cen­ter spin­out Ozette has nabbed a $6 mil­lion seed round to de­vel­op its AI plat­form de­signed to au­to­mate cell analy­sis.

The biotech, in­cu­bat­ed at the Allen In­sti­tute for Ar­ti­fi­cial In­tel­li­gence (AI2), says its Im­mune Mon­i­tor­ing Plat­form can ex­tract in­fo from sin­gle-cell da­ta across in­stru­ments, ex­per­i­ments and dis­ease states, con­dens­ing a man­u­al, la­bor-in­ten­sive process from months to hours.

“We’ve spent a decade work­ing at Fred Hutch to cat­alyze high-di­men­sion­al com­pu­ta­tion­al sin­gle-cell analy­sis in acad­e­mia and in­dus­try. To­day we can see the com­po­si­tion of the im­mune sys­tem at a much high­er res­o­lu­tion,” Greg Fi­nak, CTO and co-founder, said in a state­ment. “This deep­er lev­el of in­sight is crit­i­cal to de­vel­op­ing ef­fec­tive dis­ease treat­ments with few­er side ef­fects and that is some­thing every­one can feel good about.”

The seed round was led by Madrona Ven­ture Group, with help from the Allen In­sti­tute and Vul­can Cap­i­tal. — Nicole De­Feud­is

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Jim Green­wood opens new pol­i­cy shop, with an eye on drug price con­trols; Mod­er­na, CRISPR, Mus­tang re­ceive tax breaks in Mass­a­chu­setts

Capitol Hill heavyweight Jim Greenwood is taking his decades of experience in the intertwining worlds of biopharma and Congress to the law firm DLA Piper, where he’s opening up a new policy and regulatory practice alongside former Pfizer lawyer Geoffrey Levitt.

As Congress wrangles over how to bring down drug prices, the former BIO CEO told Endpoints News in an interview that his top three priorities will be, “Price controls, price controls and price controls.”

Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.