Robert Langer (Barry Chin/The Boston Globe via Getty Images)

MIT’s fa­bled bil­lion­aire sci­en­tist Robert Langer is step­ping in to of­fer a key as­sist to Ovid CEO Je­re­my Levin

Je­re­my Levin

Je­re­my Levin’s biotech start­up Ovid suf­fered a crip­pling blow late last year when the CEO was forced to con­cede that the crit­ics were right all along and his lead drug was a bust in a late-stage test. But he’s gained an im­por­tant as­sist in get­ting back up again and re­fo­cus­ing on oth­er drugs in the pipeline.

Fa­bled MIT in­ves­ti­ga­tor and se­r­i­al en­tre­pre­neur Robert Langer has signed on to chair the sci­en­tif­ic board for Ovid, of­fer­ing some guid­ance a day af­ter Levin of­fi­cial­ly iced both pro­grams for OV101. Ovid li­censed out their sec­ond drug in the pipeline to Take­da, leav­ing a pre­clin­i­cal ef­fort in place for a slate of drugs that in­cludes OV882, a short hair­pin RNA ther­a­py tar­get­ing UBE3A gene ex­pres­sion in neu­rons.

It turns out, that’s a sweet spot for Langer, one of the most dec­o­rat­ed sci­en­tists in the drug hunt­ing busi­ness. I asked Langer about it via email. His re­ply:

I’ve al­ways been in­ter­est­ed in brain dis­eases. I hate to see peo­ple suf­fer. So if I can help – even a lit­tle – that’s re­al­ly im­por­tant to me. I’ve al­so been very im­pressed with Je­re­my – ever since I spent time with him in Is­rael a num­ber of years ago – when I re­ceived the Wolf Prize in chem­istry and he was CEO of Te­va.

Any­one even slight­ly fa­mil­iar with biotech will rec­og­nize Langer’s name. From his perch at MIT he’s helped start more than 30 biotechs, of­ten helmed by one of his post­docs. He was an ear­ly backer of Mod­er­na’s, along­side Har­vard sci­en­tist Tim Springer, act­ing as an aca­d­e­m­ic co-founder of the mR­NA up­start. And like Springer, he gar­nered an ear­ly stake in Mod­er­na that has made him a bil­lion­aire.

That may not car­ry a lot of weight with in­vestors, though. Ovid’s shares are down 4% af­ter the open­ing bell on Tues­day.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,200+ biopharma pros reading Endpoints daily — and it's free.

A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

George Golumbeski (Credit: ARCH Ventures)

George Golumbes­ki signs on at a Eu­ro­pean spe­cial­ist VC firm with $265M to bet on ge­net­ic dis­eases

Since decamping from Celgene during a management overhaul close to three years ago, George Golumbeski has been channeling years of connections and dealmaking experience to a select group of company boards as a self-styled independent biotech exec — while dabbling in a somewhat behind-the-scenes role in venture capital at places like ARCH and Vertex Ventures.

He’s now adding one more gig to that menu, this time to scout promising startup ideas for genetic diseases.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,200+ biopharma pros reading Endpoints daily — and it's free.