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

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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Mark McKenna, Prometheus Biosciences chairman & CEO

With clear PhII win in IBD, Prometheus thwarts Pfiz­er com­par­isons as it fol­lows Hu­mi­ra 'play­book'

Prometheus Biosciences reported a clear Phase II win in two inflammatory bowel disease conditions in a clinical development race with Pfizer, planting the biotech’s flag in a field of antibodies attempting to go against black box-cornered JAK inhibitors and AbbVie’s Humira.

Shares $RXDX have soared since the summer — a small dip last week notwithstanding when rival Pfizer teamed up with Roivant on a new company for their competing anti-TL1A monoclonal antibody. And they skyrocketed once again Wednesday morning, climbing from $36 apiece to more than $100 on the back of two Phase II studies: one placebo-controlled in ulcerative colitis and the other an open-label trial in patients with Crohn’s disease.

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