Epizyme hits the ground run­ning with sec­ond — and cru­cial — OK for Tazverik, in fol­lic­u­lar lym­phoma

When Epizyme scored the first-ever ap­proval for tazeme­to­stat, in ep­ithe­lioid sar­co­ma, ex­ecs made it clear it was on­ly an ap­pe­tiz­er, some­thing to whet the ap­petites of reg­u­la­tors, in­vestors and physi­cians to the po­ten­tial of the methyl­trans­ferase in­hibitor. Five months lat­er, they are ready to serve the main course.

She­fali Agar­w­al

The biotech got all the help from the FDA to ex­pand the la­bel for Tazverik, go­ing through pri­or­i­ty re­view to land an ac­cel­er­at­ed ap­proval in two in­di­ca­tions of fol­lic­u­lar lym­phoma:

  • Adult pa­tients with re­lapsed or re­frac­to­ry FL whose tu­mors are pos­i­tive for an EZH2 mu­ta­tion as de­tect­ed by an FDA-ap­proved test and who have re­ceived at least two pri­or sys­temic ther­a­pies
  • Adult pa­tients with re­lapsed or re­frac­to­ry FL who have no sat­is­fac­to­ry al­ter­na­tive treat­ment op­tions

The OK was an­chored on over­all re­sponse rate and du­ra­tion of re­sponse in a Phase II, which en­com­passed both mu­tat­ed and wild-type EZH2.

“As a re­minder, in the EZH2 MT co­hort, the re­sponse rate was 69%, while in the EZH2 WT co­hort, the re­sponse rate was rough­ly half, at 35%,” SVB Leerink an­a­lyst An­drew Berens wrote at the news of the pri­or­i­ty re­view. “While we think that the ben­e­fit in the wild-type pa­tients is still com­pelling enough for some pa­tients to con­sid­er ther­a­py, it is less com­pelling than that seen in the EZH2m co­hort.”

Robert Baze­more

That could mean that in prac­tice, clin­i­cians will want a EZH2 test be­fore pre­scrib­ing the drug, re­duc­ing the sig­nif­i­cance of the broad la­bel.

As such, he mod­els $17.5 mil­lion in FL sales and $5.6 mil­lion of ES sales for 2020.

CMO She­fali Agar­w­al, though, is clear­ly pleased with what they achieved with the “very ef­fi­cient” NDA, lever­ag­ing da­ta that have al­ready been sub­mit­ted with the ES pack­age. Es­pe­cial­ly con­sid­er­ing that FL, a sub­type of non-Hodgkin lym­phoma that ac­counts for 20% to 30% of cas­es, is of­ten con­sid­ered a chron­ic dis­ease.

“In our view, there re­mains no clear stan­dard of care in the re­lapsed and/or re­frac­to­ry FL pop­u­la­tion as not all pa­tients ben­e­fit from to­day’s avail­able ther­a­pies,” she said in a state­ment. “Based on this la­bel, physi­cians will have the abil­i­ty to use their clin­i­cal dis­cre­tion to pre­scribe TAZVERIK for their re­lapsed or re­frac­to­ry pa­tients re­gard­less of EZH2 mu­ta­tion­al sta­tus and with­out re­gard to a spe­cif­ic line of treat­ment where oth­er op­tions are not sat­is­fac­to­ry.”

CEO Robert Baze­more added that Epizyme has al­ready “seam­less­ly” ex­pand­ed the com­mer­cial team, armed with what they be­lieve is a no­table safe­ty pro­file and com­pelling op­tion for oral, at-home ad­min­is­tra­tion.

A full ap­proval will hinge up­on a 500-pa­tient con­fir­ma­to­ry tri­al Epizyme is con­duct­ing that pairs Tazverik with Revlim­id and rit­ux­imab (Rit­ux­an) for FL pa­tients in the sec­ond or lat­er lines.

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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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.

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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