Chi­nese an­ti­body play­er chas­es Hong Kong IPO with lead Rit­ux­an chal­lenger ready for late-stage test

On­col­o­gy R&D has boomed in Chi­na with a sta­ble of home­grown biotechs churn­ing out late-stage clin­i­cal hope­fuls. Much of those have been so-called “me-too” drugs, and now an­oth­er biotech is look­ing for a pub­lic raise with Roche block­buster Rit­ux­an’s mar­ket in its sights.

Bei­jing Mab­works Biotech has sub­mit­ted its ap­pli­ca­tion to trade on the Hong Kong Ex­change as it pre­pares to take its “third-gen­er­a­tion” CD20 an­ti­body in­to Phase III tri­als for fol­lic­u­lar lym­phoma and dif­fused large-B cell lym­phoma, the drug­mak­er said in a fil­ing with the ex­change Sun­day.

In ad­di­tion to its lead can­di­date, MIL62, an an­ti­body us­ing a sim­i­lar mech­a­nism to Roche’s Gazy­va, MIL has five oth­er clin­i­cal drugs in the fold and an­oth­er six mol­e­cules in pre­clin­i­cal de­vel­op­ment. So far, the most is known about MIL62, which Mab­works hopes will even­tu­al­ly find a mar­ket in FL and DL­B­CL as well as a slate of au­toim­mune con­di­tions.

Mab­works’ largest share­hold­er — with near­ly 40% of vot­ing rights — is Li Feng, a gen­er­al part­ner at Hu­atai Fi­nan­cial Hold­ings and the leader of the com­pa­ny’s largest stock­hold­er syn­di­cate. Feng joined the com­pa­ny back in 2012 when she and her team brought over the IP re­spon­si­ble for MIL62 in ex­change for 12.76% vot­ing rights.

Mab­works’ drug dis­cov­ery plat­form takes two tacks: cre­at­ing an­ti­bod­ies that stim­u­late NK and T cells for tu­mor-spe­cif­ic cy­to­tox­i­c­i­ty and aim­ing for mul­ti­ple tar­gets at once. MIL62, what Mab­works is call­ing the first third-gen CD20 an­ti­body de­vel­oped in Chi­na now in late-stage test­ing, is be­ing stud­ied both by it­self and in com­bi­na­tion with a un­spec­i­fied BTK in­hibitor to treat DL­BC, and com­bined with Bris­tol My­ers Squibb’s Revlim­id in FL.

Ac­cord­ing to the biotech’s fig­ures, the an­ti-CD20 mar­ket in Chi­na could grow to about $4 bil­lion by 2030 at an­nu­al growth of 20.9%, cre­at­ing a mean­ing­ful mar­ket op­por­tu­ni­ty for its lead drug. While Rit­ux­an is stan­dard of care as a com­bo in first-line DL­B­CL, Mab­works thinks there is still a strong mar­ket for its an­ti­body with 33% of pa­tients not re­spond­ing to that reg­i­men. Mean­while 20% of first-line FL pa­tients even­tu­al­ly re­lapse, Mab­works said, of­fer­ing an­oth­er sig­nif­i­cant pa­tient pop­u­la­tion.

With a stur­dy pipeline, Mab­works could be the lat­est Chi­nese-bred on­col­o­gy play­er to earn a mas­sive IPO, par­tic­u­lar­ly af­ter biotechs like BeiGene, Zai Lab and Hutchmed have scored huge rais­es — and val­u­a­tions — on the ex­change.

On­col­o­gy on the whole has been a gold mine for both na­tive Chi­nese com­pa­nies and West­ern phar­mas look­ing to in­no­vate in an emerg­ing mar­ket. No­var­tis, As­traZeneca and Roche, for in­stance, have all been in on the par­ty, prop­ping up com­mer­cial­iza­tion in East Asia and abroad. Mean­while, the teams at Hutchmed, Jun­shi Bio­sciences and oth­ers are chas­ing the US mar­ket with their own can­di­dates. On that front, BeiGene struck gold first with PD-1 in­hibitor Brukin­sa’s ap­proval in late 2019.

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.

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.

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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