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

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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Chi­nese biotech teams with Lil­ly on car­diometa­bol­ic dis­eases; Sen­ate fi­nance chair goes af­ter BMS

Chinese biotech Abbisko Therapeutics is teaming up with Eli Lilly on a new collaboration.

The pair announced Monday they will partner on cardiometabolic diseases and go after an unnamed target, with Abbisko eligible for up to $258 million in milestones. Abbisko will handle primarily the discovery work with input from Lilly, after which Lilly will have the option to further develop and potentially bring the program to market.