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.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Douglas Love, Annexon CEO (Annexon)

IPO bound? A Bay Area biotech grabs a mega-round on the road to a piv­otal neu­rode­gen­er­a­tion pro­gram

South San Francisco-based Annexon has added $100 million to its cash reserves, along with a new roster of marquee investors backing their play on the classical complement pathway involved in neurodegeneration. And that may well fit the profile for an IPO — though right now everything seems to be working on that score.

Eighteen months after Bain and their syndicate partners put up $75 million to fuel clinical work, Annexon is back at the trough. And this time they’re adding Redmile Group for the lead role, with supporting investments from these new arrivals: BlackRock, Deerfield Management Company, Eventide Asset Management, Farallon Capital Management, Janus Henderson Investors and Logos Capital.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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Dan Gold, MEI Pharma CEO

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.