Chengbin Wu (CEO of EpimAb)

Trans-Pa­cif­ic bis­pe­cif­ic play­er caps 'very chal­leng­ing' pan­dem­ic year with $120M to gain a foothold among the gi­ants

It’s a nar­ra­tive that we’ve seen over and over again this past year: Covid-19 threw a mon­key wrench in­to clin­i­cal tri­al plans of drugs in oth­er dis­ease ar­eas, forc­ing com­pa­nies to im­pro­vise.

But for EpimAb, the trou­bles were com­pound­ed: The US-Chi­na biotech had care­ful­ly se­lect­ed one clin­i­cal cen­ter in Guang­dong that lung can­cer pa­tients used to vis­it from all over Chi­na, but ear­ly trav­el re­stric­tions vast­ly cut down the num­ber they could re­cruit in­to their Phase I/II tri­al. Mean­while, in the US, clin­i­cal tri­al sites es­sen­tial­ly went in­to hi­ber­na­tion mode, CEO Cheng­bin Wu said in an in­ter­view with lo­cal me­dia last Ju­ly, quash­ing their hopes of gath­er­ing Phase I/II da­ta for the lead bis­pe­cif­ic by the end of 2020 — not to men­tion steer­ing a sec­ond pro­gram in­to the clin­ic.

“It has been very chal­leng­ing for us, just like for oth­er com­pa­nies,” Wu told End­points News.

Just like oth­er biotech en­tre­pre­neurs, though, he had no trou­ble go­ing back to the well for a re­fu­el. The Ab­bott vet has now raised $120 mil­lion for a Se­ries C, de­signed to let CMO (and No­var­tis vet) Bin Peng com­plete the first tri­al and steer two more through the clin­ic, while work­ing on a slate of pre­clin­i­cal ther­a­pies cre­at­ed on his bis­pe­cif­ic tech plat­form.

Chi­na Mer­chants Bank In­ter­na­tion­al and Mi­rae As­set Fi­nan­cial Group co-led the round, flanked by Ho­ny Cap­i­tal, Cor­morant As­set Man­age­ment, Yanchuang Cap­i­tal, Oc­ta­gon Cap­i­tal, Hong Kong mogul Adri­an Cheng and Shang­Bay Cap­i­tal. Ex­ist­ing in­vestors al­so re­turned for more, in­clud­ing Decheng Cap­i­tal, SDIC Fund, Sher­pa Health­care Part­ners and Hidrag­on Cap­i­tal.

De­spite the slow­down, EpimAb did man­age to hit some of the oth­er goals it set back in June 2019 fol­low­ing a $74 mil­lion Se­ries B raise, Wu said.

The con­struc­tion at their Suzhou chem­istry, man­u­fac­tur­ing and con­trols fa­cil­i­ty is now com­plete, wean­ing them off con­tract man­u­fac­tur­ers and de­vel­op­ers in push­ing pre­clin­i­cal projects; EMB-02, the PD-1/LAG-3 bis­pe­cif­ic, has been cleared by the FDA to be test­ed in the US; while EMB-06, a T cell en­gag­ing bis­pe­cif­ic that tar­gets CD3 and BC­MA, has re­ceived the tri­al green light in Aus­tralia.

For the lead EMB-01 pro­gram tar­get­ing EGFR and c-MET, a site at Dana-Far­ber has re­cent­ly been added to the tri­al ros­ter, hope­ful­ly ac­cel­er­at­ing the Phase II por­tion that’s ex­pect­ed to start this year.

Like the big­wigs they’re go­ing up against — such as J&J and Re­gen­eron, which have each de­liv­ered “strong clin­i­cal da­ta” sup­port­ing their the­sis — EpimAb be­lieves that si­mul­ta­ne­ous­ly tar­get­ing two can­cer anti­gens would both ad­dress can­cer re­sis­tance and reach a broad­er group of pa­tients to be­gin with. By uti­liz­ing the FIT-Ig plat­form, which Wu co-in­vent­ed, the com­pa­ny be­lieves it has made the bis­pe­cif­ic gen­er­a­tion process sim­pler and faster.

Stephan Lensky

“We are the on­ly for­mat that has no link­ers, no mu­ta­tions, no sin­gle chain Fv, al­so no non-Ig com­po­nents,” Stephan Lensky, the COO and CBO, pre­vi­ous­ly told End­points. “It ba­si­cal­ly has the fun­da­men­tal el­e­ments of an an­ti­body in it, and be­cause of the sym­met­ric na­ture of the mol­e­cule it’s al­so very straight for­ward to man­u­fac­ture.”

With 140 em­ploy­ees spread be­tween the US and Chi­na, EpimAb al­so isn’t let­ting the pan­dem­ic stop its mo­tion to­ward a pub­lic ex­change, whether it be Nas­daq or HKEX.

“We’re ac­tive­ly eval­u­at­ing our path to IPO right now,” Wu said. “While we’re look­ing at a range of sce­nar­ios, our base case is to do a pre-IPO round this year and then IPO at some point in 2022. We’re keep­ing all our op­tions open in terms of ge­og­ra­phy right now.”

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.

Why re­mote drug man­u­fac­tur­ing eval­u­a­tions won't re­al­ly re­duce FDA's back­log of in­spec­tions

For the first several months of the pandemic last spring, the FDA continued to plow through its user fee-enabled work on new drug and biologic applications, meeting nearly all of its goal dates.

But by last fall and into the winter, complete response letters and other delays began arriving in companies’ mailboxes as the agency struggled to catch up to a growing backlog of both domestic and foreign drug manufacturing inspections.

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