Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In No­vem­ber, Pfiz­er dis­closed it’s spun out the Phase II dual JAK1/TYK2 in­hibitor to a start­up formed in col­lab­o­ra­tion with an un­named, ex­pe­ri­enced part­ner.

We now know who the part­ner is. And as Pfiz­er and Roivant of­fi­cial­ly take the wraps off Pri­o­vant Ther­a­peu­tics, the com­pa­nies re­veal that they have start­ed two reg­is­tra­tional tri­als of the drug, bre­poc­i­tinib, as part of a broad­er plan to de­vel­op a big, first-in-class fran­chise span­ning mul­ti­ple or­phan and spe­cial­ty au­toim­mune dis­eases.

Ben Zim­mer, a sea­soned mem­ber of the Roivant team, is lead­ing the ven­ture as CEO.

Pfiz­er li­censed com­mer­cial rights for both oral and top­i­cal bre­poc­i­tinib in the US and Japan to Pri­o­vant. The small biotech al­so scored rights to a TYK2 in­hibitor dubbed rop­sac­i­tinib.

Pri­o­vant is gun­ning for two ini­tial in­di­ca­tions: a Phase III study is test­ing oral bre­poc­i­tinib in der­mato­myosi­tis, an im­mune-me­di­at­ed dis­ease where pa­tients ex­pe­ri­ence skin rash and mus­cle weak­ness, with high­er risks of lung dis­ease and heart fail­ure; and it’s al­so en­rolling a Phase IIb study in sys­temic lu­pus ery­the­mato­sus.

Ruth Ann Vleugels

Ruth Ann Vleugels, di­rec­tor of the Con­nec­tive Tis­sue Dis­ease Clin­ics and Au­toim­mune Skin Dis­eases Pro­gram at Brigham and Women’s Hos­pi­tal/Har­vard Med­ical School, high­light­ed how dual TYK2/JAK1 in­hi­bi­tion “may re­sult in su­pe­ri­or block­ade of type I in­ter­fer­on, a key cy­tokine fam­i­ly im­pli­cat­ed in der­mato­myosi­tis patho­gen­e­sis.”

Matt Gline

Ever since its found­ing by Vivek Ra­maswamy eight years ago, Roivant has tried to build a busi­ness on flip­ping drugs from Big Phar­ma through a net­work of “vant” star­tups. And de­spite some spec­tac­u­lar ear­ly flops, in-li­cens­ing re­mains a crit­i­cal com­po­nent of cur­rent CEO Matt Gline’s vi­sion for Roivant to be­come a new kind of phar­ma — a plan that Pfiz­er could clear­ly get be­hind as CSO Mikael Dol­sten praised Roivant’s “track record in late-stage in­flam­ma­tion and im­munol­o­gy drug de­vel­op­ment.”

The part­ners didn’t dis­close any fi­nan­cials around the deal or how much it’s ded­i­cat­ing to Pri­o­vant; Pfiz­er is re­tain­ing a 25% stake in Pri­o­vant.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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