PACT Phar­ma bags $75M for neoanti­gen TCR work, man­u­fac­tur­ing; Bay­er grabs ex­per­i­men­tal con­tra­cep­tive from Daré

→ With a new pres­i­dent and chief tech­ni­cal of­fi­cer in place, next-gen T cell ther­a­py play­er PACT Phar­ma has $75 mil­lion in fresh fi­nanc­ing to ex­pand the scope of its nascent clin­i­cal pro­grams and open its own man­u­fac­tur­ing fa­cil­i­ty in South San Fran­cis­co. By iso­lat­ing spe­cif­ic neoanti­gen re­cep­tors in pa­tients that ap­pear to be dri­ving an im­mune re­sponse, PACT promis­es to tack­le some of the tough­est sol­id tu­mors pre­vi­ous­ly im­pen­e­tra­ble to cell ther­a­pies. Vi­da Ven­tures, which has close ties to promi­nent cell ther­a­py biotechs such as Kite and Al­lo­gene, led the Se­ries C round. CTO Tim Moore, who jumped from Kite last Oc­to­ber, will su­per­vise ef­forts to au­to­mate some pro­duc­tion and an­a­lyt­ics process “to re­duce cy­cle time and man­u­fac­tur­ing costs.”

→ Large CRO Charles Riv­er is en­ter­ing a mul­ti-year drug dis­cov­ery col­lab­o­ra­tion with Take­da, fo­cus­ing on four ar­eas the Japan­ese drug­mak­er cham­pi­ons — on­col­o­gy, gas­troen­terol­o­gy, neu­ro­science and rare dis­ease. Un­der the deal, Charles Riv­er gets an undis­closed up­front fee from Take­da, and is el­i­gi­ble to re­ceive de­vel­op­ment pay­ments of up to $50 mil­lion per can­di­date as well as po­ten­tial com­mer­cial mile­stones of up to $120 mil­lion plus roy­al­ties on launched prod­ucts.

Bay­er has inked a li­cens­ing agree­ment with Daré Bio­science for com­mer­cial­iza­tion rights of an in­ves­ti­ga­tion­al hor­mone-free month­ly vagi­nal con­tra­cep­tive, Ovaprene, in the US. San Diego-based Daré will re­ceive an undis­closed up­front and $20 mil­lion if Bay­er de­cides to ex­er­cise its op­tion, plus mile­stones that add up to $310 mil­lion. The biotech ex­pects to launch a piv­otal study in the sec­ond half of 2020.

→ Af­ter tout­ing in­ter­im Phase II re­sults on its lead COPD drug last March, Verona Phar­ma has chalked up an­oth­er win in the next stage. The com­pa­ny re­port­ed pos­i­tive da­ta in the 4-week Phase IIb study eval­u­at­ing neb­u­lized en­sifen­trine (0.375 mg, 0.75 mg, 1.5 mg and 3.0 mg) or place­bo as an add-on treat­ment to tiotropi­um (Spiri­va Respi­mat), a long-act­ing an­ti-mus­carinic (“LAMA”) bron­chodila­tor mar­ket­ed by Boehringer In­gel­heim. The pri­ma­ry end­point was met at all dos­es, with sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in lung func­tion at week 4.

Al­lo­gene and Spring­Works Ther­a­peu­tics — two not­ed star­tups de­vel­op­ing port­fo­lios of drugs flow­ing from Pfiz­er are team­ing up to eval­u­ate Al­lo­gene’s BC­MA Al­lo­CAR T ther­a­py, AL­LO-715, in com­bi­na­tion with Spring­Works’ gam­ma sec­re­tase in­hibitor (GSI), nirogace­s­tat, in pa­tients with re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma. Un­der the terms of agree­ment, Al­lo­gene will spon­sor and con­duct the Phase I study — which is ex­pect­ed to com­mence in the sec­ond half of 2020.

→ Back in No­vem­ber 2018, Eli Lil­ly showed their faith in NextCure by drop­ping $40 mil­lion in up­front and eq­ui­ty cash. Now, Lil­ly is ter­mi­nat­ing the deal, ef­fec­tive as of March 3, 2020.

→ For his lat­est com­pa­ny cre­ation, Vivek Ra­maswamy is look to serve the peo­ple who serve drug­mak­ers. Loka­vant’s stat­ed goal is to cen­tral­ize da­ta from over 1,000 tri­als “to pow­er a ma­chine learn­ing mod­el that an­tic­i­pates tri­al risk, pro­vides risk mit­i­ga­tion strate­gies, and pre­dicts the im­pact of mit­i­ga­tion strat­e­gy im­ple­men­ta­tion. Rhit Nam­bisan, head of dig­i­tal prod­uct at Roivant, will serve as pres­i­dent. The new com­pa­ny has al­so en­tered its first mul­ti-year en­ter­prise li­cense agree­ment with Parex­el, which re­cent­ly inked a re­al world ev­i­dence pact with an­oth­er Roivant sub­sidiary, Data­vant.

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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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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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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Sum­i­to­vant sub­sidiaries En­zy­vant and Al­ta­vant merge in­to com­bined com­pa­ny

Two Sumitovant Biopharma entities are merging under one name, effective immediately.

Enzyvant Therapeutics and Altavant Sciences announced they have merged to form a singular entity focused on developing therapies for patients with rare diseases. The combined company will keep the name Enzyvant and along with clinical development will eventually include in-house manufacturing.

Bill Symonds, the current CEO of both Altavant and Enzyvant, is now CEO of the merged company.