Baiteng Zhao and Tae Han (ProfoundBio)

With Eli Lil­ly's back­ing, a team of Seagen vet­er­ans with ADC chops is look­ing to crash the Chi­nese on­col­o­gy par­ty

With an in­dus­try­wide pipeline quick­ly gath­er­ing steam, the Chi­nese on­col­o­gy mar­ket has be­come a red-hot mar­ket for West­ern in­vestors as well as Big Phar­ma part­ners look­ing for the next big thing. One way to get there is to get in ear­ly, and now Eli Lil­ly’s Asian in­vest­ment arm is stak­ing its claim with a team of Seagen vet­er­ans.

Pro­found­Bio, a Suzhou, Chi­na, and Wash­ing­ton State-based on­col­o­gy play­er, has raised a $55 mil­lion Se­ries A with back­ing from lead in­vestors Lil­ly Asia Ven­tures and LYFE Cap­i­tal to ad­vance its an­ti­body-drug con­ju­gate and im­muno-on­col­o­gy plat­form in­to clin­i­cal de­vel­op­ment, the com­pa­ny said Tues­day.

The pro­ceeds will be ded­i­cat­ed to ad­vanc­ing the com­pa­ny’s dis­cov­ery pipeline in­to hu­man tri­als, po­ten­tial­ly with­in the year, prop­ping up a new Chi­nese on­col­o­gy play­er amid a blos­som­ing field for R&D.

“We made sig­nif­i­cant progress with our lead pro­grams and nov­el tech­nol­o­gy plat­forms since the com­ple­tion of Se­ries Pre-A fi­nanc­ing,” Pro­found CEO Bait­eng Zhao said in a state­ment. “The ad­di­tion­al fund­ing will al­low us to fur­ther strength­en and ex­pand our in­te­grat­ed R&D ca­pa­bil­i­ty, grow and broad­en our in­no­v­a­tive prod­uct pipeline, and pre­pare for mul­ti­ple IND sub­mis­sions in 2022 and be­yond.”

Xi­ao Shang

For Lil­ly’s Asian ven­ture arm, Pro­found rep­re­sents an op­por­tu­ni­ty to dive in­to a cor­ner of the mar­ket where drug­mak­ers like Japan’s Dai­ichi Sankyo have found suc­cess. Third-gen AD­Cs and be­yond have re­ceived a ton of in­ter­est from Big Phar­ma as re­searchers have found new ways to ad­min­is­ter the ther­a­pies with­out the dele­te­ri­ous side ef­fects en­dem­ic to the field. Dai­ichi’s multi­bil­lion-dol­lar col­lab­o­ra­tion with British drug­mak­er As­traZeneca is an ob­vi­ous road sign for the field writ large.

Mean­while, Pro­found’s lead­er­ship team, chock full of Seagen vets, gave its newest round of in­vestors hope the drug­mak­er could have the R&D chops. Zhao, COO Tae Han and CTO Xi­ao Shang all pre­vi­ous­ly worked at Seagen and helped de­vel­op the biotech’s two ap­proved AD­Cs, Ad­cetris and Pad­cev, the lat­ter a col­lab­o­ra­tion drug with Japan­ese firm Astel­las.

“Pro­found­Bio’s found­ing team are in­dus­try vet­er­ans with rich ex­pe­ri­ence, deep know-how and a FDA drug ap­proval track record es­tab­lished dur­ing their tenure at the glob­al leader of ADC drug de­vel­op­ment,” Lil­ly Asia Ven­tures man­ag­ing part­ner Fei Chen said in a state­ment.

If that ex­pe­ri­ence does come to bear, it would set Pro­found­Bio up as a se­ri­ous on­col­o­gy play­er amid a re­nais­sance for the Chi­nese mar­ket, which has emerged as a ma­jor fo­cus area for West­ern in­vestors and Big Phar­ma part­ners giv­en the speed of growth in the space.

Fei Chen

Drug­mak­ers like BeiGene, Zai Lab and Jun­shi Bio­sciences have all earned in­ter­est from the West af­ter the for­mer’s BTK in­hibitor Brukin­sa broke the mold as the first Chi­nese-de­vel­oped on­col­o­gy drug to re­ceive an FDA ap­proval back in late 2019. Many of those play­ers are look­ing to break in­to the US, the sin­gle largest drug mar­ket on Earth, but R&D has al­so tak­en a dis­tinct­ly lo­cal fla­vor as Chi­na’s NM­PA has brought its on­col­o­gy tri­al stan­dards up to snuff and drug­mak­ers look to cor­ner East Asian pa­tients.

Jun­shi and Co­herus, for in­stance, are ad­vanc­ing their own PD-1 drug for na­sopha­ryn­geal can­cer, a dis­ease that pre­dom­i­nant­ly af­fects pa­tients in East Asia, to a US fil­ing. If it earns an even­tu­al ap­proval, it would mark a mile­stone for Chi­nese drug­mak­ers: the first FDA drug ap­proved based sole­ly on piv­otal da­ta from Chi­nese tri­als.

Pro­found’s Se­ries A round was al­so joined by Se­quoia Cap­i­tal Chi­na and Oriza as well as ex­ist­ing in­vestors K2VC, Gaorong Cap­i­tal, and Chang’an Cap­i­tal.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

Bio­gen, Ei­sai are push­ing for an­oth­er ac­cel­er­at­ed Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

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Samantha Du, Zai Lab CEO (Zai Lab)

Saman­tha Du's Zai Lab inks sur­pris­ing re­search col­lab with Schrödinger for DNA dam­age drug

Headed by Samantha Du, Chinese oncology specialist Zai Lab has made no qualms about its aggressive in-licensing strategy to drive Western drugs into regional markets. That strategy has been profitable so far, but that doesn’t mean Du’s team isn’t willing to try something new.

In a surprising volte-face, Zai Lab has signed its name to a research collaboration with physics-based discovery outfit Schrödinger looking for an oncology candidate targeting the DNA damage repair pathway, the partners said Wednesday.

Jeffrey Bluestone, Sonoma CEO (Photo credit: Steve Babuljak)

Jeff Blue­stone just raised $265M to de­vel­op cu­ra­tive cell ther­a­pies. We asked him how

Jeff Bluestone had some big goals in mind when he decided to make a switch from a decades-long career in academia and non-profit research to a biotech startup CEO. And now — 18 months after the $40 million launch party — he has a whole lot more money on hand to pay for the considerable amount of work ahead at Sonoma Biotherapeutics.

This morning Bluestone is taking the wraps off a $265 million B round after boosting the core syndicate of A-list investors he started with. Even by today’s standards, that sum dwarfs the kind of $100 million-plus megarounds that have become standard fare in biotech over the last 2 years.

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

UP­DAT­ED: Sanofi buys mR­NA play­er Trans­late Bio for $3.2B. And the price fits a pop­u­lar range for biotech M&A

Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio $TBIO a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines, Sanofi closed the deal with a buyout early Tuesday, spending $38 a share in a $3.2 billion buyout.

Translate’s stock $TBIO soared after the market closed Monday when Reuters reported the first word of the acquisition just hours ahead of the formal announcement. The wire service, though, didn’t have a price to report in its scoop, and investors chased the stock up 78% in the wild ride that followed. Once the price was announced, gains shriveled to 29% ahead of the bell.

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