News brief­ing: Boehringer In­gel­heim ex­pands pro­tein degra­da­tion ef­forts; Pfiz­er en­lists a new AI part­ner

Boehringer In­gel­heim is ex­pand­ing its ef­forts in pro­tein degra­da­tion, sign­ing a pact with the Aus­tri­an biotech Prox­y­gen to de­vel­op a tech­nol­o­gy known as “mol­e­c­u­lar glue de­graders.”

Sim­i­lar to the PRO­TACS that com­pa­nies have fo­cused on to date, mol­e­c­u­lar glue de­graders are de­signed to bridge pro­teins to the body’s own in­ter­nal dis­pos­al sys­tem, al­low­ing re­searchers to tar­get pro­teins that can’t be hit by tra­di­tion­al small mol­e­cules. The mul­ti­ple myelo­ma drugs Revlim­id and Po­m­a­lyst work in this man­ner. Found­ed in 2016, Prox­y­gen has worked to de­vel­op meth­ods of sys­tem­at­i­cal­ly find­ing new ones.

The col­lab­o­ra­tion will fo­cus on can­cer, an ear Boehringer has di­rect­ed much of its pro­tein degra­da­tion work to date. In 2016, the Ger­man com­pa­ny be­came one of the first Big Phar­mas to go in on the field, sign­ing a can­cer pact with the Uni­ver­si­ty of Dundee.  — Ja­son Mast

FDA rolls out red car­pet for Scynex­is’ su­per bug an­tibi­ot­ic.

Scynex­is is get­ting a ready wel­come as it heads for its first an­ti-fun­gal ap­proval.

The New Jer­sey biotech an­nounced Mon­day that its ap­pli­ca­tion for ap­proval for the drug ibrex­a­fungerp for vagi­nal yeast in­fec­tions had been ac­cept­ed and giv­en pri­or­i­ty re­view by the agency. The drug suc­ceed­ed in a 376-per­son Phase III tri­al last year, clear­ing pa­tients of in­fec­tion bet­ter than in­fec­tion.

Vagi­nal yeast in­fec­tion has long been their lead in­di­ca­tions, but Scynex­is al­so be­came fa­mous last year for hav­ing one of the drugs in de­vel­op­ment for Can­di­da Au­ris, a fun­gal in­fec­tion that has cropped up around the world, alarm­ing health of­fi­cials. Stud­ies in that in­di­ca­tion are on­go­ing. — Ja­son Mast

4D is ready to throw down as the red-hot biotech IPO mar­ket rocks on

4D Mol­e­c­u­lar Ther­a­peu­tics is lin­ing up the lat­est IPO in the trendy gene ther­a­py field.

The AAV biotech is look­ing to raise $100 mil­lion-plus from the IPO, auc­tion­ing off close to 5 mil­lion shares at a range of $20 to $25 a share.

Those up­sized num­bers put 4D back in the hunt for the 9-fig­ure sum it had in mind when the ex­ecs first filed to go pub­lic in the fall of 2019.

There have been 82 biotech IPOs count­ed in the US this year, a record num­ber that brought in a chart-top­ping $15 bil­lion in pro­ceeds. And Nas­daq clear­ly isn’t ready to close the win­dow on 2020. — John Car­roll

Pfiz­er col­labs with AI play­er PostEra to de­vel­op new pre­clin­i­cal drug mod­els

Pfiz­er has a new part­ner in the nascent field of gen­er­a­tive chem­istry.

The big phar­ma is team­ing up with PostEra, a San Fran­cis­co com­pa­ny found­ed last year that fo­cus­es on the AI-in­flu­enced field and spe­cial­izes in min­ing large datasets. Fi­nan­cial terms of the deal were not dis­closed, but PostEra re­ceived an up­front pay­ment with po­ten­tial mile­stones avail­able down the road. PostEra not­ed that it will re­tain own­er­ship rights to all al­go­rithms de­vel­oped dur­ing the col­lab­o­ra­tion.

PostEra has de­vel­oped a ma­chine learn­ing-based plat­form that it says de­signs mol­e­c­u­lar struc­tures with op­ti­mized po­ten­cy and drug-like prop­er­ties. Ul­ti­mate­ly, PostEra hopes that its mod­el can help ac­cel­er­ate the drug de­vel­op­ment process.

Mon­day’s col­lab­o­ra­tion will pair Pfiz­er’s vast reach and re­sources with PostEra’s tech­nol­o­gy, in an ef­fort to both ad­vance the field of gen­er­a­tive chem­istry and pro­duce scal­able mod­els for in-house, pre­clin­i­cal drug dis­cov­ery projects.

The com­pa­ny orig­i­nal­ly spawned out of aca­d­e­m­ic re­search from the Uni­ver­si­ty of Cam­bridge. Ear­li­er this year, PostEra al­so launched Covid Moon­shot, a crowd­sourced ini­tia­tive to speed the de­vel­op­ment of an an­tivi­ral for Covid-19. — Max Gel­man

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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