Har­bour Bio­Med nets $75M in Se­ries B+ as first glob­al tri­al gets un­der­way

Near­ly two years af­ter draw­ing an $85 mil­lion Se­ries B, Shang­hai-based Har­bour Bio­Med has an­nounced a new large fund­ing round.

In what they’re billing as a “Se­ries B+,” Har­bour has raised $75 mil­lion to help push the biotech’s an­ti­bod­ies fur­ther in the clin­ic and de­vel­op more in-house can­di­dates. The round in­clud­ed new in­vestors such as SK Hold­ings, Greater Bay Area Fund and Efung Cap­i­tal, who joined re­turn­ing funds Leg­end Cap­i­tal, Ad­van­Tech and GIC, al­so known as Sin­ga­pore’s sov­er­eign wealth fund.

At­ul Desh­pande

“The lat­est fund­ing round is ac­tu­al­ly a con­tin­u­a­tion of the pre­vi­ous fund­ing round,” At­ul Desh­pande, Har­bour’s top US ex­ec­u­tive, told End­points News. “Many of these in­vestors were ac­tu­al­ly in­ter­est­ed in in­vest­ing in the B round, but due to var­i­ous rea­sons, they weren’t able to, so they came back to us and we ex­tend­ed the fund­ing to com­plete just a cou­ple weeks ago.”

Har­bour’s as­cent has been rapid, at least when mea­sured ge­o­graph­i­cal­ly. The com­pa­ny was found­ed by Jing­song Wang, the for­mer head of Sanofi’s Chi­na R&D who left the French drug­mak­er at the end of 2015 to con­sult for At­las Ven­tures. In 2016, he found­ed Har­bour Bio­Med in Shang­hai and, with ven­ture back­ing, pur­chased an At­las-backed com­pa­ny called Har­bour An­ti­bod­ies.

The At­las com­pa­ny, based in Cam­bridge and Rot­ter­dam, had de­vel­oped a plat­form of trans­genic mice and had been out-li­cens­ing it to biotechs and Big Phar­mas, in­clud­ing Pfiz­er and Eli Lil­ly. Wang thought he could turn that plat­form in­to an in-house pipeline, Desh­pande said. The move al­so in­stant­ly gave his Har­bour a foot­print on the three con­ti­nents — a foot­print the com­pa­ny hasn’t failed to play up.

Jing­song Wang

“Well, with op­er­a­tions in the US, EU and Chi­na, I be­lieve Har­bour Bio­Med is al­ready an MNC [mul­ti-na­tion­al cor­po­ra­tion], right?” Wang told Phar­ma Board­room last year, in re­sponse to a ques­tion about what Har­bour can do that mul­ti-na­tion­als like Sanofi can’t.

While de­vel­op­ing their in-house ca­pac­i­ty, Wang be­gan seek­ing as­sets that could be brought in­to the clin­ic more quick­ly. He inked an up-to $350 mil­lion deal on a PD-L1 with Chi­nese biotech Kelun, a col­lab­o­ra­tion with the South Ko­re­an biotech HanAll on a pair of an­ti­bod­ies for au­toim­mune and in­flam­ma­to­ry dis­eases, and a deal with Glen­mark (now Ich­nos) on a bis­pe­cif­ic for sol­id tu­mors. The two HanAll drugs quick­ly en­tered the clin­ic in three dif­fer­ent tri­als in Chi­na.

The new fund­ing will par­tial­ly go to fi­nanc­ing their first glob­al tri­al for their first in-house can­di­date. That drug, HBM4003, is a CT­LA-4 in­hibitor for ad­vanced sol­id tu­mors. It dif­fers from tra­di­tion­al CT­LA-4 drugs, such as Yer­voy, in that in­stead of con­sist­ing of four dif­fer­ent chains — the two light chains and two heavy chains that make up most an­ti­bod­ies — it on­ly has the heavy chains.

These an­ti­bod­ies are sig­nif­i­cant­ly small­er than their cousin, Desh­pande said, and showed bet­ter ef­fi­ca­cy and safe­ty in pre­clin­i­cal mod­els than their con­ven­tion­al coun­ter­parts. The mech­a­nism be­hind that, though, is not com­plete­ly clear. The first tri­al, which just got FDA ap­proval to open sites in the US, will hope­ful­ly pro­vide a bet­ter an­swer.

“We don’t know yet,” Desh­pande said.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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From left: Rajul Jain, Stefan Vitorovic, Arjun Goyal, Arie Belldegrun, Jean-Philippe (JP) Kouakou-Zebouah, Helen Kim

Arie Bellde­grun's Vi­da Ven­tures goes back to the well with $825M mega­fund and its eyes set on more in­no­v­a­tive meds

Among the list of bright names in biopharma, few shine brighter than Kite founder and serial entrepreneur Arie Belldegrun, who has rattled off a remarkable run of success in recent years. Now, a Belldegrun investment team is locking up a massive third fund to keep chasing the cutting edge in therapeutics.

Vida Ventures closed its third investment fund at a whopping $825 million — its largest yet — as the ever-expanding VC firm hits 30 companies in its portfolio developing new routes to hard-to-treat diseases, the company said Thursday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.