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.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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Michael Egholm, Standard BioTools president and CEO (IsoPlexis)

Eli Cas­din co-leads $250M in­fu­sion in­to mi­croflu­idics play­er that land­ed NIH fund­ing for Covid-19 test­ing

In about 17 months, Fluidigm has gone from working with sharks to Vikings.

The South San Francisco-based company, which landed NIH money in a Shark Tank-style program for Covid-19 testing, announced that it will take on an investment worth $250 million from Casdin Capital and Viking Global Investors. It will also rebrand, and call itself Standard BioTools. The investment will help the company focus on the highest growth areas of discovery and development and expand its CRO and CMO service providers. Right now, the company’s customer reach is limited to basic research, it said.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.