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News brief­ing: Pre­ci­sion Med­i­cine Group ac­quires cell and gene ther­a­py-fo­cused ser­vices firm Pro­ject Far­ma; Roost­er­Bio and Sar­to­rius col­lab on gene ther­a­py man­u­fac­tur­ing

As more and more players pursue cell and gene therapies, companies are looking for ways to keep up on the manufacturing end.

On Thursday, Precision Medicine Group took the wraps off a deal to buy out Project Farma, a bioengineering services firm that supports the manufacturing and scale-up of cell and gene therapies. Project Farma will join Precision for Medicine, PMG’s research and development services arm.

News brief­ing: Mer­ck picks up SHP2 op­tion from Tai­ho-As­tex deal; Taysha ex­pands part­ner­ship with UT South­west­ern

Taiho and Astex have extended their collaboration with Merck, granting the pharma an exclusive license to their joint SHP2 program.

Wednesday’s extension stems from the agreement the three companies signed in Jan 2020. Taiho and Astex will receive an undisclosed option fee and be eligible for further undisclosed milestones and royalty payments. Merck will be solely responsible for the global development of the program and funding all further research.

News brief­ing: Ab­b­Vie se­lects first tar­get for Drag­on­fly part­ner­ship; Cog­ni­to nets BDD for Alzheimer's treat­ment de­vice

Dragonfly’s partnership with AbbVie is beginning to bear fruit.

AbbVie has selected its first NK cell engager-based immunotherapy as part of the deal, triggering an undisclosed opt-in payment, the companies announced Tuesday. AbbVie will gain exclusive worldwide rights to develop and commercialize products directed to this first target, which is also undisclosed, and Dragonfly becomes eligible for future milestones and royalties.

News brief­ing: Chi-Med en­trusts In­ma­gene with four pre­clin­i­cal pro­grams; Xofluza nets EU ap­proval for flu pre­ven­tion

Longtime OrbiMed partner Jonathan Wang is starting the year off at his latest venture, Inmagene, with a slate of new preclinical drug candidates.

The four programs come from Chi-Med, which the CEO praises as “one of China’s flagship biopharmaceutical companies.”

Chi-Med is granting Inmagene exclusive options to develop these drugs for immunology diseases but retaining the first right to commercialization in mainland China. For each of the candidates that its biotech partner exercises an option on, Chi-Med can receive up to $95 million in development milestones and $135 million in commercial milestones.

News brief­ing: Sanofi ponies up more mon­ey to ex­pand pro­tein degra­da­tion col­lab with Nurix; Bio­gen fires shot at No­var­tis in new Spin­raza tri­al

Sanofi has agreed to shell out an additional $22 million — bringing its total cash investment to $77 million — to expand a discovery pact with Nurix Therapeutics for up to five targeted protein degradation candidates, the companies said Thursday.

The pharma giant and small biotech originally tied up in December 2019, agreeing to pursue three of Nurix’s candidates, which use E3 ligases to selectively target protein receptor sites. That deal came with up to $2.5 billion in future milestones — a figure that stayed the same with Sanofi’s expansion of the deal.

News brief­ing: Pfiz­er kick­starts PhI­II tri­al for DMD gene ther­a­py, out­rac­ing Sarep­ta; Teva's re­for­mu­lat­ed schiz­o­phre­nia shot touts win in late-stage study

In the race to bring the first gene therapy for Duchenne muscular dystrophy into a Phase III trial, Pfizer has come out on top over competitor Sarepta, dosing its first patient in the CIFFREO study, the pharma giant said Thursday.

CIFFREO is expected to enroll 99 male patients, ages 4 through 7, across 55 clinical trial sites in 15 countries, Pfizer said. The first of those patients were administered Pfizer’s therapy, dubbed PF-06939926, on Dec. 29 at a Barcelona site.

News brief­ing: Dew­point scores an­oth­er Big Phar­ma deal, this time with Pfiz­er; Kite joins forces with Ox­ford Bio­Ther­a­peu­tics

Over the last 13 months, Dewpoint Therapeutics has scored big partnerships with Bayer and Merck, aiming to pioneer a new field of biology called biomolecular condensates. On Wednesday, the biotech reeled in another big pharma deal.

Dewpoint agreed to a research collaboration with Pfizer on Wednesday for the development of therapies for myotonic dystrophy type 1, a rare genetic disorder. The deal can be worth up to $239 million when accounting for all milestones.

News brief­ing: Mar­ius sub­mits NDA for oral hy­pog­o­nadism ther­a­py; Cell­tri­on's bil­lion­aire founder steps down

US regulators will soon be looking at a new testosterone replacement therapy, if Marius Pharmaceuticals has its way.

The Raleigh, North Carolina-based biotech submitted on Tuesday an NDA for Kyzatrex, an oral testosterone undecanoate soft gelatin capsule aiming to treat both primary and secondary hypogonadism in men. Should the FDA accept the application for priority review, Marius expects a PDUFA date to follow roughly six months later.

News brief­ing: 10 years lat­er, teplizum­ab gets a sec­ond shot at an FDA OK; J&J files for ami­van­tam­ab ap­proval in Eu­rope

Teplizumab’s 10-year trek back into the R&D spotlight is getting another assist from the FDA.

The agency has provided a brief priority review schedule for the type 1 diabetes drug, according to Provention Bio. And that sets up a July 2 PDUFA date for a drug that already won the agency’s breakthrough therapy status.

Teplizumab had lingered for years in limbo after Eli Lilly decided to punt on the drug following a pivotal failure in diabetes. But its scientific discoverer, longtime UCSF vet and now biotech entrepreneur Jeffrey Bluestone, never lost hope. He found new believers at Provention, who picked up rights to the drug and quickly made their way back to the FDA.

News brief­ing: In­cyte bankrolls an ear­ly-stage myelofi­bro­sis pair-up with Jakafi; In­no­Care gets Chi­nese ap­proval for lead drug

Looking to further bolster its blockbuster franchise for Jakafi, Incyte has struck a deal to partner up on a new combination approach to treating myelofibrosis.

Incyte is bankrolling a Phase Ib study combining Jakafi with CK0804, Cellenkos’ “cryopreserved CXCR4 enriched, allogeneic, umbilical cord blood-derived T-regulatory cells.” The smaller biotech will carry out the study, leaving Incyte with an option to swoop in and pick up sole development and commercialization rights — if it all works out.

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