Relmada to explore psychedelic avenue in pursuit of depression treatment; Italian manufacturer joins NYSE

There has been a surge in investment in psychedelic biotechs in recent years, and Relmada Therapeutics is hopping on board.

CNS-focused Relmada will pay a total of $15 million upfront — a mix of cash and equity purchase — to grab rights to a new psilocybin and derivate program from Arbormentis everywhere except Asia. The goal will be to develop treatments for neurological and psychiatric disorders by combining the assets with its own knowledge of neuroplasticity.

Neuroplasticity is a key part of Relamada’s lead program, REL-1017. In October 2019, Relmada presented data from its Phase II clinical trial of REL-1017 as an adjunctive treatment in patients with treatment-resistant depression. The study evaluated the safety, tolerability and efficacy of two doses of REL-1017, 25 mg once a day and 50 mg once a day. Findings show that both patients dosed with the 25 mg and 50 mg of REL-1017 experience statistically significant improvement of their depression compared to subjects in the placebo group on all efficacy measures. REL-1017 is currently in Phase III trials for treatment of depression. — Josh Sullivan

Italian syringe manufacturer joins NYSE

Italian drug delivery company Stevanato Group has priced its IPO at $21 per share, the company announced last Thursday.

The company will be listed on the New York Stock Exchange under the ticker $STVN. The offering is set to close today. Bank of America Securities, Morgan Stanley and Jefferies are lead book-running managers for the offering. The deal is good for $672 million, and underwriters have a 30-day option to buy up to another 4,800,000 shares.

The former glassware manufacturer came into the healthcare industry in 1970. It develops glass and plastic drug containment as well as diagnostics systems for preclinical to commercial-stage clients.

Shares were down 19% to $17.05 on the first day of trading, and were at $19.35 at the opening bell Tuesday morning. In the company’s F-1 filing, it estimated that the total addressable market was more than $11 billion, and includes pre-fillable syringes, drug delivery systems and molecular diagnostics. — Josh Sullivan

Post hoc analysis turns up encouraging survival numbers for AB Science’s ALS study

AB Science’s clinical trials for masitinib may be on hold, but that’s not stopping the French biotech from touting new data from older studies.

In a post hoc analysis involving a select group of amyotrophic lateral sclerosis patients who got masitinib through compassionate use following the end of the Phase II/III AB10015 study, AB Science says adding masitinib to the standard riluzole treatment extended survival by 25 months. The median OS was 69 for those 50 patients, versus 44 months for patients who were treated with riluzole alone (p=0.037).

To see this result, the company focused on those with “mild or moderate ALS,” meaning those who had not suffered a complete loss or severe impairment of ALSFRS-related functionality at the time they started masitinib.

Notably, no effect was observed for the overall group — either on survival or the original primary endpoint of improvement on the ALSFRS scale.

As part of a sprawling development program with a checkered track record, AB Science is planning a confirmatory Phase III study focusing on the mild to moderate group, pending the completion of its ongoing safety review. — Amber Tong

GenFleet partners with AI company Insilico

In a move that will bring together two sets of computational platforms to develop new oncology and immunology programs, GenFleet Therapeutics and Insilico Medicine are partnering up.

GenFleet will complement its R&D systems with Insilico’s end-to-end drug discovery platform, which is powered by artificial intelligence. This will allow for the exploration of structure-activity relationship between target proteins and drug molecules, the company said.

In the press release, GenFleet co-founder Qiang Lu said:

GenFleet’s portfolio strategy is heavily based on solid technical capabilities, and since its inception, GenFleet has been leveraging such top-notch capabilities world-wide. Through the integration of conventional biotech approaches with emerging technologies such as AI and computational biology, we expect that our R&D capability and efficacy will get a tremendous boost through optimization of target screening, molecular design, real world clinical research, among others. We are very excited to form a collaboration with such leading companies as Insilico, and we look forward to some ‘game-changers’ out of it.

Insilico’s discovery engine Chemistry42 allows for the design of molecules with properties that don’t exist in the known chemical space, and InClinico predicts clinical trial outcome.

CEO Alex Zhavoronkov praises GenFleet as “one of the most innovative biotechnology companies in China now working on unleashing the power of world-class artificial intelligence systems to discover and develop cutting-edge therapeutics.” — Josh Sullivan

J&J mulling spinoff to diminish award for asbestos plaintiffs

J&J is looking to created a new business to offload liabilities from litigation stemming from a lawsuit connected to asbestos in its baby powder, Reuters reported Saturday.

The company could still abandon the plan. J&J is up against legal action from tens of thousands of patients who say that its baby powder and other talc products had asbestos and caused cancer. Women with ovarian cancer and others battling mesothelioma are among the plaintiffs in the case.

If J&J were to go forward with the breakout company, the potential payouts could be much smaller for plaintiffs, if they are to win in court. The company is considering using Texas’ “divisive merger” law, which allows a company to split into two entities.

The company has a market value of $443 billion. The US Supreme Court turned away J&J’s appeal of a Missouri court ruling that handed plaintiffs who alleged that the baby powder caused ovarian cancer $2 billion in June. — Josh Sullivan

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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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.

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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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.