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.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.

In addition to the serious and fatal toxicities of duvelisib, FDA speakers at the ODAC meeting pointed to an evolved treatment landscape for CLL and SLL, with targeted BTK or BCL2 inhibitors (front-line or second-line), and data pointing to a “potential detriment” in overall survival for duvelisib. But some ODAC members noted that the detriment was likely small and that there is some efficacy even as the data are difficult to interpret.

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