News wrap: Equillium axes Metacrine merger; Two pharmas pen ADC deals

Immunobiology biotech Equillium announced a “mutual termination” of an anticipated merger with Rich Heyman-chaired Metacrine a little over three months after the initial announcement of the all-stock agreement.

According to SEC filings, neither Equillium nor Metacrine will pay a termination fee.

Bruce Steel

Equillium CEO Bruce Steel said in a statement on Dec. 23 that Equillium started looking into acquiring Metacrine in early 2022 in an attempt to add cash runway “in a very difficult financing market.” Back in September, the companies announced that a merger would add $33 million to Equillium’s balance sheet and extend the runway through 2024. But the company has since found a different partner in Ono Pharmaceutical.

“However, our recent strategic partnership with Ono Pharmaceutical is expected to extend our cash runway into 2025, and possibly further with potential option exercise and milestone payments,” Steel said.

Earlier this month, Equillium entered into an agreement with Ono that included a $26 million upfront payment. Ono will have the exclusive option to purchase the rights, including commercialization, to monoclonal antibody itolizumab in the United States, Canada, Australia and New Zealand.

There is a potential for up to another $138.5 million in milestone payments while Equillium continues R&D with itolizumab, including two studies of the drug’s impact on acute graft-versus-host disease and lupus nephritis.

— Katherine Lewin

Merck KGaA and Amgen dish cash for biotech ADCs

Merck KGaA is hedging its bets on the STING pathway. It has tapped Mersana Therapeutics for a two-target deal for STING agonist antibody drug conjugates, or ADCs, a type of treatment that arms an antibody, which acts as an internal compass, with a cell-killing drug.

Mersana will get $30 million upfront, and will be eligible for up to $800 million in potential downstream milestones plus royalties.

GSK also has a pact with Mersana on STING agonist ADCs. Last year, AstraZeneca signed a STING deal with F-star, and recently BioNTech signed a deal with Ryvu Therapeutics. But these deals come after others left the field. Novartis walked away from its STING program in 2019 and Nimbus also culled its efforts.

Separately, Amgen has enlisted South Korean biotech LegoChem Biosciences for a five-target ADC deal. The duo did not disclose the upfront payment, but said the deal could be good for $1.25 billion in total.

Last year, Czech-based Sotio Biotech also paid $29.5 million upfront for a deal with LegoChem. That deal similarly was for five targets and worth a potential $1 billion.

— Lei Lei Wu 

Peptides get the spotlight in new Merck deal

Merck is tapping a partner to explore peptide-drug conjugates, or PDCs.

Japan’s PeptiDream is tasked with identifying peptide candidates for use in PDCs in a new pact worth as much as $2.1 billion, including an unspecified upfront payment, plus milestones. Merck will get exclusive rights to conjugate those peptides to cytotoxic payloads — bringing the payloads to specific cells — and take charge of all development.

Merck and PeptiDream have been collaborating on peptide discovery since 2015.

PeptiDream itself lists a dozen of PDCs in its own pipeline for both diagnostic and therapeutic purposes, including a PD-L1 diagnostic PDC partnered with Bristol Myers Squibb and other undisclosed programs with Novartis and RayzeBio.

— Amber Tong

Intercept resubmits NASH drug to FDA

Intercept Pharmaceuticals is moving another hopeful step forward with obeticholic acid as a treatment for nonalcoholic steatohepatitis (NASH), a progressive liver disease.

The biotech announced just before Christmas that it had resubmitted a new drug application to the FDA for obeticholic acid following two positive analyses of its Phase III REGENERATE study. Liver scarring, stiffness and blood levels of liver enzymes all showed improvements in patients that took the drug.

If the agency gives the thumbs-up, it would be the first time that obeticholic acid has been approved for the treatment of NASH “by any regulatory authority in any geography,” according to Intercept. Obeticholic acid is already approved for primary biliary cholangitis as Ocaliva.

The PDUFA target review time by the FDA is expected to be six months, the company said.

The FDA rejected the drug in 2020 for liver scarring due to NASH after disappointing Phase III trials.

— Katherine Lewin

Zinc, silver nanocrystal drug fails Covid study

Clene Nanomedicine, which joined a long list of biotechs in testing compounds for Covid-19, has run into the same disappointing result as many others.

Its drug flunked a Phase II study involving non-hospitalized but symptomatic Covid-19 patients, the Salt Lake City-based biotech reported. The trial showed that the drug didn’t help patients’ symptoms resolve more quickly than a placebo.

Rob Etherington

In the trial, which was conducted in Brazil, 288 patients received either a low dose of Clene’s zinc and silver nanocrystal suspension, dubbed CNM-ZnAg, a high dose, or a placebo on top of standard supportive care for up to 21 days. They were then tracked through 28 days.

“No clinical benefit was observed versus placebo,” the company said.

“At this time, we will cease further development for COVID,” CEO Rob Etherington said in a statement.

Clene will focus on its lead asset, a gold nanocrystal-based drug, as a treatment for multiple sclerosis. The drug failed an ALS trial last year.

— Amber Tong

Brii drops one HIV candidate while FDA lifts hold on another

A year ago, in the wake of a safety scare around Merck’s HIV drug islatravir, the FDA placed a clinical hold on a prodrug of islatravir being developed by Brii Bio.

Brii Bio now says the agency has lifted the hold, clearing the way for a planned Phase I study that will test a lower once-weekly oral dose of BRII-732.

The biotech, which has presence in both Durham, NC and Beijing, China, said it’s also exploring partnership opportunities to continue developing the compound as a long-acting option for HIV patients.

Data from the healthy volunteers who were dosed before the study halted suggested an acceptable safety and tolerability profile, as well as promising pharmacokinetics, Brii added.

On the other hand, the same can’t be said about another HIV candidate, BRII-778. Brii said it is shuttering that program based on pharmacokinetic data from a completed Phase I study.

— Amber Tong

Minerva ‘disappointed’ in FDA’s refusal-to-file letter for schizophrenia symptoms treatment

The FDA told Minerva Neurosciences that its October refusal-to-file letter isn’t going away after a meeting in November.

Remy Luthringer

Minerva CEO Remy Luthringer said in a statement that he’s “disappointed” in the FDA’s spurning of roluperidone even after the Nov. 30 meeting to hash out the agency’s longstanding concerns.

Roluperidone is an experimental treatment for the symptoms of schizophrenia, such as the inability to complete tasks or feel pleasure, changes in sleep and a loss of interest and motivation in life.

Luthringer confirmed that the FDA “will not file our NDA for roluperidone for the treatment of negative symptoms of schizophrenia.”

The FDA has had concerns about the drug since 2020, but Minerva pushed ahead anyway. The FDA issued the letter only eight weeks after the company’s approval application in August 2022.

— Katherine Lewin

French Biotech gets a €40M credit to fund R&D

André Choulika

France-based cell and gene therapy biotech Cellectis has entered a €40 million ($42.7 million) credit facility agreement with the European Investment Bank. Cellectis will use the funds to further develop its pipeline of CAR-T cell candidates.

The cash will be divided into three tranches. Cellectis will receive €20 million in the first tranche, €15 million in the second and €5 million in the third. The release of the funds will also be subject to certain conditions, which were not detailed.

The financing “is minimally dilutive for our shareholders, is excellent news for Cellectis and a recognition of the work accomplished by our teams,” Cellectis CEO André Choulika said in a statement.

-Tyler Patchen

Novartis to pay $245M to put an end to antitrust litigation — report

Novartis will pay $245 million to bring an end to an antitrust case.

According to a report from Reuters, the payment will end accusations that Novartis tried to delay the launch of generic forms of its hypertension drug Exforge in the US. Reuters said the litigation came from a 2011 licensing agreement between Novartis and Par Pharmaceuticals. Both Novartis and Par were accused of entering into an illegal agreement to delay the launch of less expensive and generic forms of Exforge.

Reuters stated that the plaintiffs had accused Par of agreeing not to launch the generic for two years after one of Novartis’ patents had expired, with the Swiss pharma alleging to have also agreed to not compete with Par by launching its own Exforge generic during the 180-day “exclusivity period” after Par entered the market.

The case saw groups such as CVS, Kroger, Walgreens and Rite Aid in the list of plaintiffs when litigation kicked off in 2018.

–Tyler Patchen

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