Tar­get­ing the tricky PI3K path­way in can­cer, MEI gets $75M to push pro­gram through reg­is­tra­tion study

MEI Phar­ma $MEIP, a small pub­lic com­pa­ny in San Diego, has raised $75 mil­lion in a pri­vate sale of stock to push for­ward its PI3K in­hibitor — a class of drugs with a mixed his­to­ry — to treat a com­mon non-Hodgkin lym­phoma.

The com­pa­ny ac­quired the pro­gram back in 2013 from San Fran­cis­co-based Path­way Ther­a­peu­tics, and has brought the oral drug to clin­i­cal proof-of-con­cept tri­als in both fol­lic­u­lar lym­phoma and in­do­lent lym­phoma and dif­fuse large B-cell lym­phoma.

Daniel Gold

MEI’s pres­i­dent and CEO Daniel Gold said the new funds will get its PI3K in­hibitor (called ME-401) in­to a reg­is­tra­tion study.

The PI3K field — once a hot prospect in R&D — has lost a bit of its al­lure in re­cent years. The path­way is one of the most fre­quent­ly dys­reg­u­lat­ed path­ways in can­cer, and there­fore more than 40 com­pounds tar­get­ing the path­way have been test­ed in clin­i­cal tri­als in­volv­ing pa­tients with a range of dif­fer­ent can­cers. The clin­i­cal de­vel­op­ment of many of these agents, how­ev­er, has stymied be­fore reach­ing late-stage tri­als. Plus, the an­ti­tu­mor ac­tiv­i­ty ob­served thus far has been lim­it­ed, and some tox­i­c­i­ties were found to be pro­hib­i­tive.

Not to men­tion, Gilead’s Zy­delig got slapped with a black box warn­ing for dan­ger­ous side ef­fects, and the rest of the field is still quite ear­ly in de­vel­op­ment.

Still, the FDA has ap­proved some PI3K’s that have en­joyed suc­cess. Just last fall, Bay­er’s Aliqopa (co­pan­lis­ib) got the FDA OK, set­ting it­self up as a po­ten­tial ri­val to Im­bru­vi­ca. In ad­di­tion, Ve­rastem, a com­pa­ny near Boston, has filed for ap­proval of Ab­b­Vie’s castoff du­velis­ib, tack­ling chron­ic lym­pho­cyt­ic leukemia, small lym­pho­cyt­ic lym­phoma, and fol­lic­u­lar lym­phoma.

MEI Phar­ma — along with sev­er­al oth­ers — doesn’t ap­pear to be cowed by chal­lenges in the space.

“With this fi­nanc­ing in­volv­ing lead­ing health­care in­vest­ment firms, we are well fund­ed to progress a ro­bust port­fo­lio of po­ten­tial first-in-class and best-in-class on­col­o­gy drugs,” Gold said in a state­ment. “With the start of a planned reg­is­tra­tion study of ME-401, we an­tic­i­pate hav­ing two pro­grams in piv­otal tri­als by the end of 2018.”

The com­pa­ny’s pri­vate place­ment was led by Vi­vo Cap­i­tal and CAM Cap­i­tal. Oth­er par­tic­i­pants in­clud­ed New En­ter­prise As­so­ci­ates, Per­cep­tive Ad­vi­sors, The Biotech­nol­o­gy Val­ue Fund, Box­er Cap­i­tal of Tavi­s­tock Group, and Amzak Health, as well as oth­er new and ex­ist­ing in­vestors.

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.

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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Eisai and METAvivor plan to debut the latest 'This is MBC' campaign at the San Antonio Breast Cancer Symposium (SABCS).

Ei­sai re-ups metasta­t­ic breast can­cer aware­ness cam­paign with strik­ing pa­tient pho­tographs

Eisai is debuting the newest ads in its long-running “This is MBC” campaign this week. In what’s become an annual tradition, Eisai and metastatic breast cancer advocacy partner METAvivor will show the striking photographs of people living with metastatic breast cancer first at the San Antonio Breast Cancer Symposium (SABCS).

The new “Imagine” campaign features 12 patients photographed around waterfalls to symbolize that same kind of sudden drop into a pool that MBC causes in a person’s life, said Beth Fairchild, co-founder of #CancerCulture who was the president of METAvivor six years ago when the campaign began. Fairchild, who is living with MBC, has helped create all of the annual “This is MBC” campaigns.

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Pfiz­er and BioN­Tech look to toss Mod­er­na patent suit, call­ing claims 'unen­force­able'

Pfizer and BioNTech took a swing at Moderna’s Covid-19 patent claims in Massachusetts federal court on Monday, calling them “invalid,” “overbroad” and “unenforceable.”

The defendants also filed counterclaims against the Cambridge, MA-based biotech, seeking a dismissal of the case, recovery of court fees and an official judgment invalidating Moderna’s claims.

Moderna sued Pfizer and BioNTech back in August, alleging that the partners’ Covid-19 vaccine Comirnaty copied parts of Moderna’s vaccine technology patented before the pandemic, when it was developing an mRNA vaccine for MERS, another respiratory illness.

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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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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Bob Duggan, Summit Therapeutics co-CEO

Bounc­ing from ma­jor set­back, Sum­mit hands out $500M cash for can­cer drug — thanks to a loan from bil­lion­aire CEO

After hitting a dead end with Summit Therapeutics’ lead program, Bob Duggan has found the drug that he believes will usher into a compelling second act. So compelling, in fact, that it involves $500 million cash — and he’s taking money out of his own pocket to fund the deal.

Striking a partnership with Akeso Therapeutics out of China, Summit is bringing in a bispecific antibody that blocks both PD-1 and VEGF called ivonescimab. Akeso, which has a PD-1/CTLA-4 bispecific approved in China, has already taken ivonescimab into multiple clinical trials, including a Phase III in lung cancer.

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Glen­mark hit with warn­ing let­ter over pro­ce­dures, qual­i­ty con­trol is­sues at In­dia man­u­fac­tur­ing plant

The generics producer Glenmark Pharmaceuticals has been handed a warning letter by US regulators.

The letter, which was sent to the manufacturer on Nov. 22, noted issues from an inspection over the summer at Glenmark’s facility in the town of Colvale, India, in the state of Goa.

According to the letter, the FDA found that Glenmark’s investigation of rejected batches of drugs “failed to extend to other batches, dosage strengths, and drug products.” The warning letter also noted that the site had failed to establish “adequate written procedures” for production and process control to ensure drugs have the correct strength, quality and purity.

Klick Health is lighting the way, literally, this holiday season to encourage connection for lonely seniors in long-term care facilities.

Klick Health an­nu­al hol­i­day spot­light se­nior lone­li­ness and the pow­er of con­nec­tion

Every year Klick Health leans into a cause for the holidays, and this year it’s highlighting the sometimes lonely season for seniors. So Klicksters, as employees call themselves, decided to brighten one nursing home community in hopes of inspiring others to do the same.

Klick literally lit up the Tony Stacey Centre for Veterans Care, a long-term care home in Toronto where 75% of residents receive no visitors during the holiday season. The agency brought staff and family along with lighting crews and musicians for a “Light the Way” event, creating a video of the experience debuting on Tuesday.

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