Cell/Gene Tx channel feed

Patrick Lucy, Lykan Bioscience CEO

Two CD­MOs come to­geth­er as they look to ex­pand their reach in cell ther­a­py man­u­fac­tur­ing

As the cell therapy field has matured, the manufacturing of such therapies becomes a greater focus for companies small and large. Amid this growth, two CDMOs have come together in a merger to expand their reach.

Lykan Bioscience, based in Massachusetts, and RoslinCT, based in Edinburgh, UK, will become a single advanced therapies CDMO. The newly combined group will offer process development expertise as well as cGMP manufacturing for a broad range of autologous and allogeneic cell therapies, along with gene editing and induced pluripotent stem cell (iPSC) capabilities for cell therapy development. Financial terms of the deal were not disclosed.

Alexandria Forbes, MeiraGTx CEO (Hollie Adams/Bloomberg via Getty Images)

Gene ther­a­py biotech us­es its man­u­fac­tur­ing sites as col­lat­er­al to net a $100M loan

Gene therapy biotech MeiraGTx is looking to get some quick cash and is putting up its manufacturing facilities to do it.

On Wednesday the company announced that it had clinched a loan with affiliates of Perceptive Advisors for up to $100 million, with the biotech getting $75 million upon closing.

According to CEO Alexandria Forbes, the biotech secured the capital by putting up its manufacturing facilities for collateral, which will extend the company’s cash runway for the next two years and into Q4 of 2024. The Sam Waksal-founded biotech intends to use the cash primarily to continue development of its pipeline, preclinical programs and technology platforms.

Mark Gergen, Poseida CEO

Roche wades deep­er in­to the al­lo­gene­ic CAR-T field, re­serv­ing bil­lions for its next ear­ly-stage part­ner

Roche has taken its next big step into the allogeneic CAR-T field, this time tying up alongside Poseida Therapeutics $PSTX with $220 million in upfront and quick cash in a trademark oncology alliance that comes with a mother lode of milestones.

The deal — which includes $110 million for the upfront plus $110 million in near-term cash — offers the pharma giant dibs on a slate of off-the-shelf CAR-Ts for hematologic malignancies, including P-BCMA-ALLO1 for multiple myeloma, now in a Phase I study, and P-CD19CD20-ALLO1, an allogeneic dual CAR-T for the treatment of B-cell malignancies with an IND expected in 2023. But they will also work on more targets together — hammering out new research tech along the way — as the Poseida team takes the lead on early-stage tests and Roche carves out responsibility for the pivotal plays.

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John Evans, Beam Therapeutics CEO

Not yet in the clin­ic, Beam’s base-edit­ed, off-the-shelf CAR-T put on hold

On Friday, the FDA slapped a hold on Beam Therapeutics’ preclinical off-the-shelf CAR-T therapy, the biotech announced this morning.

At the end of June, the base editing biotech submitted its application to begin clinical trials for its CAR-T therapy in patients with relapsed/refractory T-cell acute lymphoblastic leukemia and lymphoma — aggressive white blood cell cancers that do not respond well to treatment.

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Paul Dabrowski, Synthego CEO (Photo by Noam Galai/Getty Images for TechCrunch)

Af­ter net­ting $200M, Syn­thego to break ground on its man­u­fac­tur­ing fa­cil­i­ty

California-based biotech Synthego has been mainly focused on developing CRISPR-based tools to help researchers in academia and biotech, but its latest move now is turning its attention more towards manufacturing.

The company has broken ground on a 20,000-square-foot manufacturing facility in the San Francisco Bay Area, expanding its GMP capacity by 30 times, Synthego said in an email to Endpoints News. The facility is also going to manufacture materials for translational and clinical research development for cell and gene therapies as well.

Diana Brainard, AlloVir CEO

Gilead again backs AlloVir's T cell ther­a­py in $127M di­rect of­fer­ing

Gilead and a host of other companies are once again backing T cell immunotherapy biotech AlloVir in a direct offering that will provide the drugmaker with nearly $127 million in proceeds to get its lead therapy to market.

Already stocked with $172 million at the end of June, the Massachusetts biotech wants the additional money to bankroll its three ongoing Phase III trials of its allogeneic T cell therapy posoleucel. The new funds will also support global regulatory filings for the therapy, the company said Wednesday.

Lachlan MacKinnon (L) and Adrian Woolfson (Replay)

With AAV al­ter­na­tive and DNA writ­ing tech, a new hub-and-spoke start­up wants to ‘de­moc­ra­tize’ gene ther­a­pies

When Adrian Woolfson was head of R&D at Sangamo, he began contemplating starting his own company. His goal? Solve some of the key challenges plaguing genomic medicine he’d seen while working on a wide spectrum of Sangamo’s programs.

Then, he met Lachlan MacKinnon, a biotech investor, in London, and the two realized they shared a similar vision, despite their “orthogonal” backgrounds, he told Endpoints News.

Artist's rendering of Astellas' South San Francisco campus, set to open in 2023

Astel­las gath­ers scat­tered cell and gene ther­a­py, BD units in new $70M South San Fran­cis­co hub

Bringing all its West Coast-based units under one roof, Astellas has unveiled plans to pour $70 million into a new biotech campus in South San Francisco.

With cell and gene therapies as the dominant theme, the Japanese pharma spotlighted Astellas Gene Therapies and Xyphos Biosciences, which is developing cell therapies for solid tumors, as the two big subsidiaries that will occupy the space. Those working in the business development team and the Rx+ Business Accelerator are also set to move in with them.

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Michael Parini, Freeline Therapeutics CEO

Small UK biotech touts long-term da­ta for he­mo­phil­ia B gene ther­a­py as it at­tempts a come­back

As it continues pushing its hemophilia B gene therapy toward the FDA, small biotech Freeline Therapeutics is hoping new long-term data will boost its case.

A single shot of Freeline’s gene therapy, called FLT180a, led to durable responses for at least two years, according to researchers from Freeline and the University College London. Nine of 10 patients, all adult men, maintained their factor IX activity at a median follow-up of 27.2 months, with one patient seeing a response as far out as 42.4 months. Researchers published their findings in the New England Journal of Medicine.

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Sek Kathiresan, Verve CEO

Ver­tex taps Verve for gene edit­ing pact — buy­ing a chunk of shares — as Sek Kathire­san steers base edit­ing in­to clin­ic

Although Verve Therapeutics did not come up with a gene editing technology itself, its work applying base editing in cardiovascular diseases — going from launch to first-in-human dosing in just over three years — has caught the eye of Vertex.

Vertex is handing over $25 million in cash plus a $35 million equity investment to ally itself with Verve around an in vivo gene editing program for an undisclosed liver disease.

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