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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Kelly Martin, Radius Health CEO

VC firms take os­teo­poro­sis drug­mak­er Ra­dius Health pri­vate for al­most $900M

After attacks from activist investors and disappointing returns on share prices, Radius Health has now agreed to new ownership, a direction resulting in leaving the Nasdaq.

Radius Health, a biotech out of Massachusetts with one approved product in its arsenal, announced Thursday morning that it agreed to be acquired by two VC firms: Gurnet Point Capital and Patient Square Capital. The deal, worth around $890 million, will include debt assumption and the payout of $1 CVR per share for investors. And on top of that, OrbiMed is providing debt financing.

Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.