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.

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.

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.

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.