With an FDA decision looming, Dynavax is shopping a deal on Heplisav — report

Late Friday Reuters reported that Dynavax Technologies $DVAX was shopping its hepatitis B vaccine Heplisav in the wake of a positive FDA panel review and a shot at a near-term FDA approval.

Eddie Gray, Dynavax CEO

Quoting sources, the wire service reported that Dynavax is engaged in a strategic review, with a chance of bagging a sale or licensing pact that could bring in a substantial amount of cash. Reuters added that there is no guarantee of a deal, as Dynavax reiterated that it’s planning a market launch for 2018. A company spokesperson added: “We continue to evaluate any interest from potential partners as part of our long-term strategic planning.”

RBC’s Matthew Eckler took a look at the story and noted:

The Reuters article mirrors prior management commentary from when we saw them two weeks ago (link to prior note), in which they highlighted ongoing efforts to prepare for a 1Q18 US launch, while also remaining open to partnership or divestiture. Notably, management highlighted the consolidated nature of the US vaccine market, in which only a handful of companies (GSK, JNJ, MRK, PFE, SNY, etc.) have existing capabilities to commercialize Heplisav. So although we think that management is amenable to partnering/selling Heplisav (assuming agreement on price of course), we also think it’s important to remain cognizant of the unique dynamics of the vaccine market relative to other areas such as oncology.

Dynavax’s investors have been on a slow-motion roller coaster ride that’s lasted for years, with two earlier rejections from the FDA.

Efficacy was never really in doubt this last time around. The data are solid. But there was plenty of fretting about Heplisav’s safety profile, after regulators spotlighted an imbalance of deaths and cardiac events which has never been explained. The internal FDA review forced the stock $DVAX down 10%, but it rocketed up 80% after the experts weighed in on ways that the biotech could keep a careful eye on the health of the people taking their vaccine.

Whether the FDA signs off on that and green-lights the vaccine, after posting a solid set of data in comparison with GlaxoSmithKline’s Engerix-B, is now the big question. The agency only rarely bucks its outside experts, and the mandate at the agency now is definitely in favor of approvals over delay.

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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Moderna takes on a low-risk pact with CAR-T player Autolus for mRNA-based cancer drugs

Moderna’s Covid-19 vaccine has transformed the once-backwater biotech into one of the most highly valued drugmakers in the world in the span of a year. But what does the future hold for Moderna’s star turn? A small-scale discovery pact could offer a clue.

Moderna will hold exclusive rights to four mRNA-based immuno-oncology candidates using proprietary binding tech from Autolus, a biotech best known for its work on “off-the-shelf” CAR-T therapies, the partners said Monday.

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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Ipsen continues its shopping spree with a $1B-plus deal for Exicure's next-gen oligonucleotides

Ipsen has been on a deal-making spree the last few weeks, shelling out more than a billion dollars in two separate deals to work on a mid-stage levodopa-induced dyskinesia (LID) candidate and a preclinical BAX inhibitor in several cancers. But on Monday, the company inked its largest collaboration deal yet.

Ipsen is putting down $20 million upfront and up to $1 billion in biobucks for exclusive options to two of Exicure’s discovery-stage spherical nucleic acid (SNA) treatments for Huntington’s disease and Angelman syndrome.

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

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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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