Lonnie Moulder (L) and Hua Mu

UP­DAT­ED: Lon­nie Moul­der woos a sea­soned de­vel­op­ment ex­pert from Hill­house­'s US/Chi­na play to helm his start­up

Back in 2010, when Tesaro was still a nascent biotech start­up, Lon­nie Moul­der re­mem­bers tak­ing due dili­gence trips to Chi­na to meet and un­der­stand com­pa­nies that could be po­ten­tial com­mer­cial­iza­tion part­ners for their im­muno-on­col­o­gy pro­grams. One of them was Hutchi­son Chi­na MediTech, or Chi-Med, which was then led by CEO Saman­tha Du and CMO Hua Mu.

A lot has changed since then.

Tesaro end­ed up strik­ing a pact with Zai Lab — Du’s pi­o­neer­ing US/Chi­na biotech — be­fore get­ting snapped up by Glax­o­SmithK­line for $5 bil­lion. Chi-Med has just re­named it­self to HutchMed. Moul­der him­self set up his lat­est biotech start­up, dubbed Zenas, to have a go at a ver­sion 2.0 of the glob­al ap­proach he had ex­per­i­ment­ed with at Tesaro.

And Mu has just been re­cruit­ed as the pres­i­dent, CEO and act­ing chief med­ical of­fi­cer of Zenas, where he will be tasked with over­see­ing a de­vel­op­ment-stage pipeline in im­munol­o­gy. Joe Farmer, a for­mer col­league of Moul­der’s at Tesaro, is al­so com­ing on board as chief busi­ness and ad­min­si­tra­tive of­fi­cer.

“As a cross bor­der com­pa­ny, it’s im­por­tant to us that we have the right mix of ex­ec­u­tives that have deep ex­pe­ri­ence and knowl­edge in both West­ern mar­kets, specif­i­cal­ly the US, and al­so in Chi­na,” Moul­der, who’s mov­ing from in­ter­im CEO to the ex­ec­u­tive chair­man seat, told End­points News.

With 20 peo­ple split be­tween Shang­hai and state­side, Zenas is fo­cused on mov­ing the mol­e­cules it’s li­censed in­to clin­i­cal tri­als through 2022. Some of them will be ex­e­cut­ed in Chi­na on­ly, while the rest will have glob­al plans an­chored by Chi­nese sites.

Just be­fore he jumped ship, Mu had helped Hill­house Cap­i­tal put to­geth­er an­oth­er cross bor­der com­pa­ny at Over­land Phar­ma, hail­ing a new kind of in-li­cens­ing mod­el that promised West­ern biotech en­tre­pre­neurs a way in­to Chi­na that was at once faster, more flex­i­ble and at a larg­er scale. The propo­si­tion was at­trac­tive enough that ADC Ther­a­peu­tics and Al­lo­gene both signed on for joint ven­ture deals.

“In the past, I think the fo­cus was more on the ex­e­cu­tion, op­er­a­tional fu­tures, right, be­cause those as­sets had al­ready mit­i­gat­ed risk be­fore,” Mu said at the time, giv­ing the ex­am­ple of Ze­ju­la, which Zai Lab li­censed from Tesaro when it was in Phase III. “The key was how to ex­e­cute the pro­gram, de­vel­op­ment and reg­is­tra­tion in Chi­na.”

These days, he added, “it’s more so­phis­ti­cat­ed as we talk about one of our fo­cus is on those tru­ly in­no­v­a­tive, for ex­am­ple first in class drugs ei­ther just POC or near POC, rel­a­tive­ly ear­li­er. In this way, the two sides of the col­lab­o­ra­tion, they have to work more close­ly. In oth­er words, it re­quires greater in­te­gra­tion of the glob­al ex­per­tise ex­pe­ri­ence and the lo­cal ex­per­tise.”

Be­fore tak­ing on the in­ter­im CEO/CMO role at Over­land, Mu has held a se­ries of top roles at Sim­cere, WuXi, Bio­gen and Genen­tech. His de­par­ture leaves co-founder Ed Zhang sole­ly in charge. Al­ready the COO and CBO, Zhang has al­so been ap­point­ed in­ter­im CEO while a new CMO should ar­rive in the com­ing weeks.

“We are grate­ful to Hua for all of his con­tri­bu­tions to help­ing get Over­land off the ground,” he wrote in an email to End­points. “His de­par­ture from Over­land was re­cent and un­der a mu­tu­al agree­ment. We wish him all the best with his new role at Zenas.”

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.

Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.

Luisa Salter-Cid, Pioneering Medicines CSO (Credit: Bristol Myers Squibb via Twitter)

Luisa Salter-Cid joins long­time Bris­tol My­ers col­lab­o­ra­tor Paul Bion­di at Flag­ship's new drug brew­ery

Paul Biondi is gaining a familiar research chief at his corner of Flagship Pioneering.

The ambitious VC — famous for bold platform plays such as Moderna — said Luisa Salter-Cid is joining Pioneering Medicines as CSO, with the mandate of leveraging the platforms of various Flagship portfolio companies to conceive new treatments.

The two had crossed paths at Bristol Myers Squibb, where Biondi brought in a series of new drugs throughout his prolific business development stretch while Salter-Cid worked her way up the ladder to become head of immunology, small molecule immuno-oncology and genomics discovery.

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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