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Monday, April 15, 2024

Genentech Walks Away From $3B Allogeneic T-Cell Pact with Adaptimmune

 Roche subsidiary Genentech has ended its strategic collaboration and licensing agreement for the development of allogeneic T-cell therapies with Adaptimmune Therapeutics, the UK-based biopharma announced on Friday.

Genentech partnered with Adaptimmune in September 2021, paying $150 million upfront and pledging $150 million more over the next five years. Accounting for additional development, regulatory and commercial milestone payments across several programs, the deal had a potential value of more than $3 billion, plus royalties.

The agreement had two main components: allogeneic T-cell therapies for up to five cancer targets and personalized allogeneic T-cell-based programs. Both were still in the discovery phase at the time of the termination, according to Adaptimmune’s website.

An SEC filing last week revealed that the partnership will officially terminate in 180 days, after which Adaptimmune will no longer be entitled to milestone payments, nor will it have development obligations. Beyond the upfront payment, the company has received $35 million under the collaboration.

Adaptimmune did not reveal a specific reason for the termination in its announcement but said that the company “remains focused” on its lead candidate afamitresgene autoleucel (afami-cel), an autologous T-cell therapy candidate that is currently being reviewed by the FDA for advanced synovial sarcoma.

The biopharma completed its rolling Biologics License Application for afami-cel in December 2023, touting strong data from the Phase II SPEARHEAD-1 study, a single-arm, open-label study testing the investigational T-cell therapy in patients with advanced synovial sarcoma and myxoid/round cell liposarcoma. The FDA’s verdict is due on August 4, 2024.

Results from the study were published in The Lancet on Saturday, showing an overall response rate of 39% in patients with synovial sarcoma. More than 70% of patients developed cytokine release syndrome, though only one case was deemed to be grade 3. There were no treatment-related deaths reported.

“We had a very valuable collaboration with our partner Genentech, and we continue to believe in the long-term potential of our iPSC-based allogeneic platform,” Adaptimmune CEO Adrian Rawcliffe said in a statement. “We have the resources to deliver afami-cel to market as planned.”

Adaptimmune will hold an Investor Day event on April 18, during which it plans to provide more details regarding the commercial launch of afami-cel.

For Genentech, the termination of the Adaptimmune pact comes days after it announced a 3% workforce reduction across multiple departments. Around 400 patients at the subsidiary will be affected, though no roles at its parent company Roche will be terminated, according to a spokesperson.

https://www.biospace.com/article/genentech-walks-away-from-3b-allogeneic-t-cell-pact-with-adaptimmune-/

Roche Bispecific T-Cell Engager Improves Survival in Lymphoma, Teeing up Label Expansion

 Roche's Genentech subsidiary on Monday announced that its bispecific T-cell engager Columvi (glofitamab) improved survival in a Phase III lymphoma trial, with the company planning to seek a full, expanded label in a potential challenge to AbbVie and Genmab’s Epkinly (epcoritamab). 

Columvi targets CD3 on T cells and CD20 on B cells, which are malignant in some blood cancers. The bispecific mechanism is designed to put T cells in a position to kill cancerous B cells. Roche received accelerated FDA approval in June 2023 and kept collecting Phase III data to confirm the effects of the therapy.

Roche designed the Phase III trial to compare the effects of Columvi and Rituxan (rituximab) in 270 patients with diffuse large B-cell lymphoma (DLBCL) who had received at least one prior line of therapy and were ineligible for autologous stem cell transplants. Participants received either Columvi or Rituxan on top of a regimen of two chemotherapy drugs, gemcitabine and oxaliplatin.

Overall survival was significantly longer in the Columvi cohort than the Rituxan arm, causing the study to hit its primary endpoint. Roche has yet to share the survival data or discuss the secondary endpoints. The company said the Columvi-chemotherapy combination “appeared consistent” with the safety profiles of the individual medicines without providing additional details.

Roche will share the data at an upcoming medical meeting and plans to submit the results to regulatory authorities. The submissions could enable the Swiss drugmaker to convert the accelerated FDA approval into a full authorization and extend the label to cover earlier lines of treatment.

The FDA granted Roche accelerated approval in people who have received two or more lines of systemic therapy. Roche Pharmaceuticals CEO Teresa Graham said on an earnings call in February 2024 that the launches of Columvi and Lunsumio, another lymphoma drug authorized in later-line patients, “continue to go well” but predicted that upcoming readouts could unlock the products’ full commercial potential.

“I think we have always said that the real opportunity for these drugs is moving into earlier lines of treatment,” Graham said. “We would expect CHF 200 million ($219 million) of additional sales here in the third-line plus indications. But we do get that second line DLBCL data for both of these products this year, and that is really where the additional growth will come from.”

Roche reported CHF 28 million ($30.7 million) in Columvi sales last year. Genmab reported $64 million for its rival AbbVie-partnerd T-cell engager Epkinly. Columvi and Epkinly won their respective accelerated approvals on the strength of Phase I/II results and their developers are running confirmatory studies that could move their therapies into earlier lines of treatment. AbbVie and its partner Genmab began a Phase III DLBCL study one month before Roche started its confirmatory trial.

https://www.biospace.com/article/roche-bispecific-t-cell-engager-improves-survival-in-lymphoma-teeing-up-label-expansion/

Marinus Update on the Phase 3 RAISE Trial and Reports Preliminary First Quarter

 rial did not meet pre-defined stopping criteria at the interim analysis; Marinus has completed RAISE enrollment at approximately 100 patients with topline results expected summer 2024

Future development of IV ganaxolone in refractory status epilepticus to be assessed following review of the final RAISE results

Enrollment in the TrustTSC trial expected to complete mid-May with topline data on track for the first half of Q4 2024

Cost reduction activities to extend cash runway are under review and expected to be implemented Q2 2024

ZTALMY® (ganaxolone) Q1 2024 preliminary net product revenue of between $7.4 and $7.6 million; preliminary unaudited cash, cash equivalents and short-term investments of $113.3 million as of March 31, 2024

https://www.businesswire.com/news/home/20240415026329/en/

Soligenix: Orphan Status for PrePrep for Marburgvirus Infection

 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in MarVax™, the subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for "the prevention and post-exposure prophylaxis against MARV infection." 

https://www.prnewswire.com/news-releases/fda-grants-soligenix-orphan-drug-designation-for-the-prevention-and-post-exposure-prophylaxis-against-marburg-marburgvirus-infection-302115205.html

Longeveron Phase 2 in Mild Alzheimer’s Featured Research at the 2024 Alzheimer’s Association

  Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that it has been accepted for a Featured Research Oral Presentation to present the Company’s CLEAR MIND Phase 2a study results. CLEAR-MIND is a Phase 2a randomized clinical trial evaluating Lomecel-BTM in mild Alzheimer’s Disease. In addition to the clinical study results, the Company has been accepted for a poster presentation at the 2024 Alzheimer’s Association International Conference (AAIC), to be held July 28 – August 1, 2024 in Philadelphia, PA, USA and online.

https://www.globenewswire.com/news-release/2024/04/15/2862761/0/en/Longeveron-s-CLEAR-MIND-Randomized-Phase-2a-Clinical-Trial-Evaluating-Lomecel-B-in-Mild-Alzheimer-s-Disease-Accepted-for-Featured-Research-Session-Oral-Presentation-at-the-2024-Alz.html

Reviva: FDA Alignment on Brilaroxazine Clinical Trials for NDA in Schizophrenia

  FDA acceptance of 4-week global registrational Phase 3 RECOVER-2 study -

- Two positive 4-week studies plus a 12-month long-term safety study have potential to support a New Drug Application (NDA) for brilaroxazine in schizophrenia –

- Topline data from 1-year open-label extension (OLE) long-term safety trial expected in Q4 2024 -

https://www.globenewswire.com/news-release/2024/04/15/2862775/0/en/Reviva-Announces-FDA-Alignment-on-Brilaroxazine-Clinical-Trials-for-NDA-in-Schizophrenia.html

FDA places clinical hold on Neumora's schizophrenia drug study

 Neumora Therapeutics said on Monday the U.S. Food and Drug Administration had placed a clinical hold on early-stage study of its experimental schizophrenia drug. 

https://finance.yahoo.com/news/u-fda-places-clinical-hold-103634662.html