Roche's Genen­tech goes on deal spree, un­veil­ing third deal on the same day

The busi­ness de­vel­op­ment ex­ec­u­tives at Roche’s Genen­tech have been busy shop­ping.

Af­ter an­nounc­ing tie-ups with So­sei Hep­tares and Sky­hawk on Tues­day, Genen­tech un­veiled yet an­oth­er deal: with Cleve­land-based biotech Con­velo Ther­a­peu­tics.

The com­pa­ny, found­ed in 2016 by Case West­ern Re­serve Uni­ver­si­ty School of Med­i­cine pro­fes­sors, has been en­list­ed to help Genen­tech de­vel­op med­i­cines with neu­ro­log­i­cal dis­or­ders such as mul­ti­ple scle­ro­sis. The Roche com­pa­ny al­ready sells the in­tra­venous ther­a­py Ocre­vus, which was ap­proved for re­laps­ing forms of mul­ti­ple scle­ro­sis as well as pri­ma­ry pro­gres­sive mul­ti­ple scle­ro­sis in 2017.

Char­ac­ter­is­tic of the Roche way, fi­nan­cial de­tails of the deal were sparse. Un­der the deal, Con­velo will re­ceive an undis­closed up­front pay­ment and re­search sup­port from Genen­tech, and the Roche com­pa­ny has an ex­clu­sive op­tion to ac­quire Con­velo for ad­di­tion­al undis­closed pay­ment and down­stream mile­stones, Con­velo said on Tues­day.

The name Con­velo is de­rived from a Latin word mean­ing “to wrap around” — and the com­pa­ny’s tech­nol­o­gy is en­gi­neered to re­gen­er­ate myelin around nerve cells to re­store neu­ro­log­i­cal func­tion.

Formed by spe­cial cells called oligo­den­dro­cytes, myelin in­su­lates nerve fibers to en­able the trans­mis­sion of elec­tri­cal sig­nals. In the healthy brain, oligo­den­dro­cyte prog­en­i­tor cells, a stem cell om­nipresent in the hu­man cen­tral ner­vous sys­tem, gen­er­ate new oligo­den­dro­cytes in a process known as myeli­na­tion. Con­velo’s plat­form is de­signed to stim­u­late these stem cells to form new myelin. In 2018, Con­velo raised $7.8 mil­lion in fund­ing led by Cleve­land Con­velo Hold­ings.

So­cial im­age: Genen­tech, AP Im­ages

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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Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.

Noubar Afeyan (Sebastien Micke/Paris Match/Contour by Getty Images)

As Mod­er­na rose, Flag­ship cashed in for $1.4B — with a lot more wealth still re­main­ing

For nearly a decade, Flagship poured record-setting levels of cash into Moderna, even as they faced setbacks on early programs and skeptics wondered whether the company’s science could ever match its hype.

Now that the science has delivered, Flagship is cashing in.

Over the last 13 months, since the World Health Organization declared a pandemic, Flagship has sold off Moderna shares worth $1.4 billion. The sales, first reported by Forbes, came as the Cambridge biotech’s shares soared from just under $20 per share on Jan. 3, 2020, to $169.50 when markets opened Thursday.

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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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Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.