Jaime Shamonki, Generate CMO

Already sitting on a major stem cell bank, Generate looks to grow its regenerative medicines business

Generate Life Sciences is the largest private newborn stem cell biorepository, and with the announcement of its own in-house manufacturing facility, the company is looking to grow its regenerative medicine pipeline.

Generate has established a facility in La Jolla, CA, to provide end-to-end manufacturing for newborn stem cell biologics. The site will allow Generate to evolve as it adds a personalized therapeutics developer to its current business model. The new site has been designed to harness mesenchymal stem cells from the tissue of the umbilical cord.

“With this facility, we will have the in-house capability to take these stem cells through the complete process of collection, cryogenic storage and ultimately biologics manufacturing,” CMO Jaime Shamonki said in a press release. “This will allow us to power our studies in a much more efficient and streamlined manner and help us better serve the families who have stored over 1.2 million stem cell units with us.”

Shamonki and her team have the chance to do something special: They’re working to find a treatment for “long Covid,” or the lingering side effects from the disease.

But while coming up with a long-term solution to a problem that’s sure to impact people around the world for years to come is important, there’s an added benefit to the project. The chief medical officer for Generate Life Sciences gets to learn how the cells reprogram the immune system, and direct those findings toward discovering cures for autoimmune diseases, Lyme disease and chronic fatigue syndrome.

Earlier in June, Generate acquired Cell Care international cord blood banking group, with includes Cell Care in Australia, and Insception Lifebank and Cells for Life in Canada. The move helps Generate become more global with its reach, and provides access to families in Canada and Australia.

The company’s reach now stretches across three countries, including the US.

Stem cells from umbilical cords offer anti-inflammatory and tissue reparative properties. Generate is in the middle of studies right now that are looking at targeting autoimmune disease, neurological diseases and lung diseases. After backing out of the Covid-19 vaccine field due to overcrowding, Generate established a trial for patients with respiratory complications stemming from the virus using a therapy derived from newborn stem cells. It’s also looking at clinical trials for a treatment for Type 1 diabetes.

“We are seeing this rapid change in our scientific orientation of how they can be used, so previously it was transplants but sort of low-incidence conditions for how things could be treated this way, like thank god childhood leukemia is not all that common,” Shamonki said. “But now we’re looking at regenerative medicine indications.”

The company is trying to invest in both clinical trials with academic partners and their own manufacturing facilities, to enable the donor families to easily access their own units, if needed for therapies in the future. With Generate’s acquisition of Cell Care international, it will allow for expanded access to donated tissue and cord blood from a larger pool, as well as utilize its scientific and regulatory knowledge specific to each country.

“It’s really all about delivering value to the families who’ve banked newborn stem cells with us, as opposed to trying to get 10 biologics to see what we can get through Phase III and what sticks,” Shamonki said.

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.

Matt Gline (L) and Pete Salzmann

UPDATED: Roivant bumps stake in Immunovant with a $200M deal. But with M&A off the table, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multibillion-dollar buyout of an mRNA pioneer after falling behind in the race for a Covid-19 jab — report

It looks like 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 a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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UPDATED: Watch out GlaxoSmithKline: AstraZeneca's once-failed lupus drug is now approved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mRNA vaccines are created equal. Does it matter?; Neuro is back; Private M&A affair; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bristol Myers pulls lymphoma indication for Istodax after confirmatory trial falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's oncology head Rick Pazdur defends the accelerated approval pathway, claiming it is 'under attack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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FTC pulls remaining case against AbbVie; New EU clinical trials system coming in 2022; Abingworth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.

Alan Hirzel, Abcam

Drug supplier Abcam brings a longtime collaborator in house as part of $340M buyout pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.