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

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.