Four years af­ter near-death ex­pe­ri­ence, PhI­II da­ta bring good news for No­vavax

No­vavax is cel­e­brat­ing tri­al re­sults again four years af­ter a Phase III fail­ure in RSV sent their stock price off a cliff.

The com­pa­ny an­nounced that their re­com­bi­nant flu vac­cine NanoFlu met all pri­ma­ry and sec­ondary end­points in a Phase III study of 2,652 adults old­er than 65. The num­bers, No­vavax sug­gest­ed, should al­low them to clear reg­u­la­to­ry hur­dles and snag the biotech’s first ap­proval since its found­ing in 1987.

“With these da­ta, we now have a clear path for­ward to li­cen­sure with our dif­fer­en­ti­at­ed re­com­bi­nant in­fluen­za vac­cine,” CEO Stan­ley Er­ck said in a state­ment. “We ex­pect that both Fast Track des­ig­na­tion and the ac­cel­er­at­ed ap­proval path­way from the FDA will help No­vavax bring NanoFlu to mar­ket as quick­ly as pos­si­ble to ad­dress the se­ri­ous pub­lic health threat of in­fluen­za.”

Stan­ley Er­ck

The study was a non-in­fe­ri­or­i­ty tri­al test­ing NanoFlu head-to-head with Sanofi’s best-sell­ing Flu­zone. The com­pa­ny, though, did not re­lease the sta­tis­tics for the pri­ma­ry end­points. In­stead, they re­leased the sec­ondary end­points, which tests in part how the vac­cine per­forms against a wild-type virus that has drift­ed from the pre­vi­ous year, ar­gu­ing that those num­bers bet­ter re­flect the re­al world. They showed NanoFlu in­duced pa­tients to build more an­ti­bod­ies against the wild-type virus than Flu­zone.

The com­pa­ny said the safe­ty pro­files were sim­i­lar but ac­knowl­edged NanoFlu brought “a mod­est in­crease in lo­cal ad­verse events.”

The read­out comes near­ly four years af­ter an RSV read­out popped the in­dus­try’s ex­pec­ta­tions for No­vavax and its nanopar­ti­cle vac­cine plat­form.  The biotech had re­ceived an $89 mil­lion grant from the Bill and Melin­da Gates Foun­da­tion to de­vel­op the vac­cine for res­pi­ra­to­ry syn­cy­tial virus, which re­mains a lead­ing hos­pi­tal­iz­er for ba­bies in Eu­rope and oth­er parts of the globe and is a fre­quent tar­get for vac­cine mak­ers. Mod­er­na, Cure­Vac and Sanofi each have pro­grams.

That tri­al didn’t meet any pri­ma­ry or sec­ondary end­points and trig­gered an 84% one-day drop in the stock price, from $155 per share to $24. The stock fell again af­ter an­oth­er RSV fail­ure last Feb­ru­ary. Once at $2 bil­lion, its mar­ket cap hov­ers around $550 mil­lion.

The flu is the main pro­gram out­side of RSV, al­though the com­pa­ny has re­cent­ly re­ceived out­side back­ing for an emer­gency coro­n­avirus vac­cine ef­fort.

So­cial im­age: Stan­ley Er­ck (Cindy Bertaut, Glo­gau Pho­tog­ra­phy)

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.

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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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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US sup­ports ex­ten­sion for Covid-19 IP waiv­er de­ci­sion

After much debate, the US government is now calling for a deadline extension to discuss a controversial potential IP waiver for Covid-19 diagnostics and therapeutics.

Over the last five months, the Office of the United States Trade Representative said it has consulted with members of Congress, public health advocates, organized labor groups, academics, think tanks, companies and trade associations on the WTO’s recent TRIPS agreement, which established a 5-year waiver of certain patent requirements on Covid-19 vaccines.

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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.