AnHeart Therapeutics co-founder and CEO Jerry Wang (L); co-founder and CBO Lihua Zheng (R)

Lin­ing up a fil­ing for lead ROS1 in­hibitor, transpa­cif­ic on­col­o­gy biotech An­Heart Ther­a­peu­tics rais­es $61M

In Chi­na, the char­ac­ter 安, pro­nounced An in Eng­lish phon­ics, has a few dif­fer­ent trans­la­tions — yet they all come to the same gen­er­al mean­ing: calm, safe, com­fort­able.

And for pre­ci­sion on­col­o­gy biotech An­Heart Ther­a­peu­tics, that Chi­nese char­ac­ter helps to de­fine the com­pa­ny’s ob­jec­tive.

“In Chi­nese, the pro­nun­ci­a­tion ac­tu­al­ly means some­thing — [it] has spe­cial mean­ing: calm, safe, com­fort­able. So it’s re­al­ly — you have a very calm heart, com­fort­able heart full of pa­tients. So we try to make med­i­cine so the pa­tient can feel com­fort­able, feel safe. Feel calm,” An­Heart CBO and co-founder Li­hua Zheng told End­points News.

The low pro­file, Chi­nese-New York biotech an­nounced this morn­ing that it has fin­ished an over­sub­scribed Se­ries B — net­ting $61 mil­lion in its largest raise to date. The round, led by new in­vestor Oc­ta­gon Cap­i­tal, tagged a few oth­er in­vestors in the fi­nanc­ing, in­clud­ing Eli Lil­ly-linked In­novent, SagePart­ners and Lau­ri­on Cap­i­tal. This new raise brings An­Heart to a to­tal raise of $100 mil­lion since its in­cep­tion — but that cash flow won’t last the biotech too long. The com­pa­ny has ex­pand­ed sig­nif­i­cant­ly since Jan­u­ary, go­ing from 27 em­ploy­ees across its of­fices in Chi­na and New York in Jan­u­ary to 65 em­ploy­ees as of Mon­day.

In­side the New York of­fices of An­Heart Ther­a­peu­tics. (Michael Na­gle)

Click on the im­age to see the full-sized ver­sion

With cur­rent plans to ex­pand the com­pa­ny to 100 em­ploy­ees next year, the $61 mil­lion is on­ly slat­ed to last An­Heart 12-18 months, Zheng said. And An­Heart will start look­ing to fill a Se­ries C some­time in Q2 next year.

The biotech, found­ed in De­cem­ber 2018 af­ter in-li­cens­ing their three cur­rent drug can­di­dates from Dai­ichi Sankyo — re­tain­ing glob­al rights for two of the can­di­dates and ex-Japan rights for the third — has a cur­rent lead can­di­date known as tale­trec­tinib, a com­bi­na­tion ROS1 and NTRK in­hibitor that is in Phase II tri­als for NSCLC. Ac­cord­ing to Zheng, the Phase II tri­als can be con­sid­ered reg­is­tra­tional as the po­ten­tial pop­u­la­tion to study with cer­tain mu­tat­ed NSCLC may be too lim­it­ed for Phase III re­search.

And for Zheng, what makes tale­trec­tinib unique is that for pa­tients with ROS1 mu­ta­tions in their can­cer, the drug can over­come phys­i­cal re­sis­tance to crizo­tinib, an ear­li­er-gen­er­a­tion NSCLC treat­ment that tar­gets pri­mar­i­ly ALK mu­ta­tions, with a mi­nor fo­cus on ROS1 mu­ta­tions. And that phys­i­cal re­sis­tance in pa­tients with mu­tat­ed-NSCLC has been doc­u­ment­ed and stud­ied over the last decade.

For drug ap­proval, while Zheng did not pro­vide specifics, he did say that the gen­er­al time­line is it ex­pects to file an NDA in Chi­na some­time in Q2 or Q3 next year — with the US be­ing a year af­ter that.

And re­gard­ing any plans to ex­pand An­Heart’s pipeline be­yond the three cur­rent can­di­dates, An­Heart has start­ed de­vel­op­ment on some in-house pro­grams, but those tar­gets re­main undis­closed.

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

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President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

Drag­on­fly chief: Bris­tol My­ers shouldn’t blame IL-12’s clin­i­cal per­for­mance for de­ci­sion to scrap the deal — eco­nom­ics played a key role

Bristol Myers Squibb says the IL-12 drug they were developing out of Dragonfly Therapeutics was scrubbed from the pipeline for a simple reason: It didn’t measure up on clinical performance.

But Bill Haney, the CEO of Dragonfly, is taking issue with that.

The early-stage drug, still in Phase I development, has passed muster with Bristol Myers’ general clinical expectations, advancing successfully while still in Phase I, he says.

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Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

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Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

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Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Robert Califf on Capitol Hill, Feb. 8, 2023 (Drew Angerer/Getty Images)

FDA com­mis­sion­er floats ideas on how to bet­ter han­dle the pan­dem­ic

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

Sanofi is renewing its #VaccinesForDreams campaign with more stories, such as Juan's in Argentina (Sanofi)

Sanofi re­news so­cial cam­paign to re­mind that vac­cines let peo­ple ‘Dream Big’

Sanofi is highlighting people’s dreams — both big and small — to make the point that vaccines make them possible.

The renewed “Dream Big” global social media campaign’s newest dreamer is Juan, a teacher in the Misiones rainforest in Argentina whose story is told through videos on Instagram and Sanofi’s website with the hashtag #VaccinesForDreams.

The campaign ties to Sanofi’s broader umbrella initiative “Vaccine Stories” to promote the value of vaccines and drive awareness of the need for improved vaccination coverage.

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