On­coSec signs on Dana-Far­ber as CAR-T part­ner; Do­va racks up an­oth­er Doptelet ap­proval

Dana-Far­ber is lend­ing a hand to lit­tle On­coSec’s nascent ef­fort to de­vel­op CAR-T ther­a­pies for sol­id tu­mor can­cers. The San Diego biotech has worked out an ex­clu­sive li­cens­ing deal with Wayne Maras­co — an ex­pert in an­ti­body en­gi­neer­ing — to ap­ply his method of link­ing two sin­gle-chain vari­able frag­ment (scFv) in a bis­pe­cif­ic CAR-T such that the T cells are on­ly ac­ti­vat­ed when both tar­gets are en­gaged, there­by lim­it­ing off-tu­mor tox­i­c­i­ty. On­coSec’s fi­nan­cial con­tri­bu­tion in the re­search, which in­volves test­ing the ex­per­i­men­tal treat­ment so­lo and in com­bi­na­tion with Ta­vo in triple-neg­a­tive breast can­cer, will be “mod­est” and spread over sev­er­al years, CEO Daniel O’Con­nor said.

→ Af­ter win­ning the FDA nod for low blood platelet count (throm­bo­cy­tope­nia) in adults with chron­ic liv­er dis­ease (CLD) who are sched­uled to un­der­go a med­ical or den­tal pro­ce­dure, the la­bel of Do­va Phar­ma­ceu­ti­cal’s Doptelet on Thurs­day was ex­pand­ed to in­clude pa­tients with chron­ic im­mune throm­bo­cy­tope­nia (ITP) who have had an in­suf­fi­cient re­sponse to a pre­vi­ous treat­ment. The com­pa­ny’s shares $DO­VA leapt about 27.5% to $13.50 in morn­ing trad­ing. The FDA’s en­dorse­ment comes about a week af­ter Eu­ro­pean reg­u­la­tors al­so backed the drug for use in se­vere throm­bo­cy­tope­nia in adult pa­tients with CLD who are sched­uled to un­der­go an in­va­sive pro­ce­dure. Mean­while, late-stage da­ta from a study eval­u­at­ing the drug’s use in chemother­a­py-in­duced throm­bo­cy­tope­nia are ex­pect­ed in the first half of 2020.

→ The re­cent­ly-pub­lic Ver­ri­ca Phar­ma­ceu­ti­cals$VR­CA ex­per­i­men­tal drug, VP-102, has cleared a mid-stage study in pa­tients with com­mon warts. The drug’s “ef­fi­ca­cy and tol­er­a­bil­i­ty has been fur­ther con­firmed with the pos­i­tive Phase II COVE-1 tri­al in com­mon warts, and is now de-risked in an ad­di­tion­al in­di­ca­tion. We be­lieve this pro­vides ad­di­tion­al (and not mod­eled) up­side for VR­CA as our val­u­a­tion tar­gets are based pure­ly on VP-102 in mol­lus­cum con­ta­gio­sum which re­mains on track for a po­ten­tial H2:2020 launch,” Cowen an­a­lysts wrote in a note. The com­pa­ny said it is on track to sub­mit an ap­pli­ca­tion to mar­ket the drug for pa­tients with mol­lus­cum con­ta­gio­sum — a vi­ral skin in­fec­tion some­times called wa­ter warts — lat­er this year.

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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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.

Eu­ro­pean Com­mis­sion lays ground­work to un­wind Il­lu­mi­na's $7B+ Grail merg­er

The European Commission has recommended steps that — though not yet final — would require Illumina to “swiftly” unwind its controversial $7.1 billion Grail buyout.

The Commission delivered a “statement of objections” on Monday, detailing the process Illumina would need to take in divesting Grail, its blood testing spinout launched in 2016. Illumina re-acquired Grail back in August, despite criticism from both the FTC and EU.