Wom­en's health biotech nabs new an­timi­cro­bial treat­ment; Ovid finds part­ner for neu­ro­science col­lab­o­ra­tion

Daré Bio­science is on the move.

The biotech put out word ear­ly Wednes­day morn­ing that it’s signed a li­cens­ing agree­ment with Hen­nepin Life Sci­ences. Daré now has ex­clu­sive glob­al rights to de­vel­op and com­mer­cial­ize treat­ments de­liv­er­ing glyc­erol mono­lau­rate, or GML. GML is a new an­timi­cro­bial for a va­ri­ety of vagi­nal health con­di­tions — in­clud­ing bac­te­r­i­al, fun­gal and vi­ral in­fec­tions.

The biotech claims that due to its mech­a­nism of ac­tion, there is “lit­tle chance” of an­tibi­ot­ic re­sis­tance as a re­sult of this drug.

In vit­ro test­ing, ac­cord­ing to Daré, showed the drug to be ef­fec­tive at in­hibit­ing the growth of ma­jor strains of Can­di­da caus­ing vul­vo­vagi­nal can­didi­a­sis (VVC), as well as Gard­nerel­la vagi­nalis, one of the bac­te­ria as­so­ci­at­ed with bac­te­r­i­al vagi­nosis.

Patents cov­er­ing the li­censed tech­nol­o­gy have been grant­ed with terms through 2034, and ad­di­tion­al patents pend­ing would have terms through 2040. Fi­nan­cial de­tails were not in­clud­ed in Daré’s re­lease.

CEO Sab­ri­na John­son said in a state­ment that “we be­lieve that an an­timi­cro­bial pro­vid­ing a broad spec­trum of ac­tiv­i­ty against bac­te­ria and fun­gi, but with a low po­ten­tial for de­vel­op­ing re­sis­tance, rep­re­sents a unique mul­ti-tar­get de­vel­op­ment can­di­date for our port­fo­lio.” — Paul Schloess­er

Ovid Ther­a­peu­tics part­ners up with gene ther­a­py start­up

Ovid Ther­a­peu­tics, which has had its share of stum­bles in the past, is part­ner­ing up with a gene ther­a­py start­up for new brain drugs.

Ac­cord­ing to a press re­lease, Ovid is part­ner­ing with Gen­sa­ic to de­vel­op up to three gene-based treat­ments for neu­ro­log­i­cal con­di­tions that Ovid is look­ing to go af­ter. The deal will see Ovid re­ceiv­ing the rights to li­cense any gene ther­a­pies that emerge from the deal, with Ovid al­so in­vest­ing $5 mil­lion in the start­up as well as in­vest­ing in any fu­ture fund­ing rounds from Gen­sa­ic.

Ovid needs a strong pick-me-up, as ear­li­er this year the com­pa­ny an­nounced it was chop­ping 20% of its work­force to ex­tend its cash run­way “past 2024.” In 2021, Ovid of­floaded its first lead pro­gram for gabox­adol (OV101) af­ter the tri­al foundered.

Ovid’s stock price $OVID has been down 41% since this time last year, and the com­pa­ny hopes to get back on track with this lat­est de­vel­op­ment.

Gen­sa­ic was seed­ed in 2021 as M13 Ther­a­peu­tics and is cur­rent­ly based in the Cam­bridge, MA biotech start­up in­cu­ba­tor Lab­Cen­tral. Over the past two years, the com­pa­ny has won awards in start­up com­pe­ti­tions for its re­search in­to gene ther­a­py de­liv­ery. — Tyler Patchen

Apel­lis’ ther­a­py ef­fec­tive in ad­vanced AMD

Apel­lis Phar­ma­ceu­ti­cals an­nounced long-term da­ta for its C3 ther­a­py, in­trav­it­re­al pegc­eta­coplan, for pa­tients with ge­o­graph­ic at­ro­phy (GA), an ad­vanced form of dry age-re­lat­ed mac­u­lar de­gen­er­a­tion.

The top-line da­ta at 24 months from its Phase III DER­BY and OAKS tri­als showed that the dos­es over time re­sult­ed in a clin­i­cal­ly mean­ing­ful re­duc­tion in GA le­sion growth from base­line com­pared to sham, where the doc­tor goes through the mo­tions with­out ac­tu­al­ly per­form­ing the treat­ment.

“The vi­sion loss caused by GA is dev­as­tat­ing for pa­tients, tak­ing away their abil­i­ty to per­form crit­i­cal dai­ly tasks like dri­ving, read­ing, and rec­og­niz­ing faces. It is very ex­cit­ing to fi­nal­ly be on the brink of the first po­ten­tial GA treat­ment with pegc­eta­coplan,” said Eleonara Lad, lead in­ves­ti­ga­tor for the OAKS study.

Be­tween months 18-24, the ef­fi­ca­cy of pegc­eta­coplan treat­ment ef­fi­ca­cy ac­cel­er­at­ed com­pared to the pre­vi­ous six months, with re­duc­tions of GA le­sion growth ver­sus sham. The com­pa­ny not­ed in a news re­lease that pegc­eta­coplan has the po­ten­tial to be­come the first-ever treat­ment for GA, which is a lead­ing cause of blind­ness. — Aayushi Prat­ap

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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89bio to net $275M from stock of­fer­ing; As­sem­bly Bio to pause work on one HBV in­hibitor pro­gram

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.

Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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