Allogene Therapeutics activates three community cancer centers for pivotal phase 2 ALPHA3 trial
- Allogene Therapeutics has initiated the pivotal Phase 2 ALPHA3 trial at three community cancer centers.
- The trial evaluates cemacabtagene ansegedleucel (cema-cel) as a first-line consolidation treatment for large B-cell lymphoma (LBCL).
- Patient screening is underway at Rocky Mountain Cancer Centers, Astera Cancer Care, and Norton Cancer Institute.
- ALPHA3 is the first trial to offer CAR T therapy as part of first-line treatment at community cancer centers.
- The trial aims to complete enrollment in the first half of 2026, with a potential BLA submission in 2027.
- Cema-cel is designed to improve cure rates for LBCL patients likely to relapse after initial treatment.
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Ipsen expands collaboration and license agreement for development of Cabometyx in advanced neuroendocrine tumors based on positive CABINET Phase III trial
- Ipsen expands its collaboration with Exelixis to develop Cabometyx for advanced pancreatic and extra-pancreatic neuroendocrine tumors.
- The decision is based on positive results from the CABINET Phase III trial, which showed improvements in progression-free survival (PFS) for Cabometyx versus placebo.
- Ipsen will seek marketing authorizations for Cabometyx in these indications outside the U.S. and Japan.
- The CABINET Phase III trial, led by the Alliance for Clinical Trials in Oncology, demonstrated significant PFS benefits in both pNET and epNET cohorts.
- Ipsen plans to submit a regulatory filing in the European Union based on these data.
- Next steps include engaging with regulatory authorities to discuss the clinical findings and potential approvals.
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Orion and MSD announce exclusive rights agreement for opevesostat
- Orion and MSD have converted their co-development agreement for opevesostat into an exclusive global license for MSD.
- Opevesostat is an investigational CYP11A1 inhibitor for treating metastatic castration-resistant prostate cancer (mCRPC).
- MSD will now have global exclusive rights to develop and commercialize opevesostat and other CYP11A1-targeting candidates.
- Orion is eligible for up to USD 1.63 billion in milestone payments and tiered royalties on net sales.
- MSD will assume all past and future development and commercialization expenses.
- The agreement is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and is expected to become effective in Q3 2024.
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Merck and Orion announce mutual exercise of option for global exclusive rights to opevesostat
- Merck and Orion have converted their co-development and co-commercialization agreement for opevesostat into an exclusive global license for Merck.
- Opevesostat is an investigational CYP11A1 inhibitor for treating metastatic castration-resistant prostate cancer (mCRPC).
- Orion is eligible to receive up to $30 million in development milestone payments, $625 million in regulatory milestone payments, and $975 million in sales-based milestone payments.
- Merck will assume full responsibility for all past and future development and commercialization expenses associated with the candidates covered by the agreement.
- The exclusive global license is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and is expected to become effective in Q3 2024.
- Two pivotal Phase 3 trials, OMAHA1 and OMAHA2a, are currently evaluating opevesostat in combination with hormone replacement therapy for treating mCRPC.
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Radionetics oncology enters into strategic agreement with Lilly
- Radionetics Oncology has formed a strategic relationship with Eli Lilly and Company.
- Radionetics received a $140 million upfront cash payment from Lilly.
- Lilly obtained the exclusive right to acquire Radionetics for $1 billion after an exercise period.
- During the exercise period, Radionetics will continue to develop its proprietary pipeline of GPCR-targeting radiopharmaceuticals.
- The collaboration leverages Radionetics' discovery platform and intellectual property to advance novel radioligand therapeutics.
- Legal advisors for the deal are Cooley LLP for Radionetics and Ropes & Gray LLP for Lilly.
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Syncromune granted FDA fast-track designation for SYNC-T SV-102 for the treatment of metastatic castrate-resistant prostate cancer
- The FDA has granted Fast Track designation to Syncromune's SYNC-T SV-102 therapy for metastatic castrate-resistant prostate cancer (mCRPC).
- SYNC-T SV-102 is part of Syncromune's SYNC-T platform, which uses a combination multi-target approach to cancer treatment.
- The Fast Track designation aims to expedite the development and review of therapies addressing serious conditions with unmet medical needs.
- Benefits of the Fast Track designation include more frequent FDA interactions, eligibility for accelerated approval, and priority review.
- Interim data from a Phase 1 study showed an 85% overall response rate for SYNC-T SV-102 with a favorable safety profile.
- Syncromune plans to initiate trials at multiple US sites later this year.
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Signet Therapeutics announces IND approval by the FDA for world’s first targeted therapy for diffuse gastric cancer
- Signet Therapeutics received FDA IND approval for sigx1094, the first targeted drug candidate for diffuse gastric cancer (DGC).
- The company will commence a Phase I clinical trial to assess the safety and efficacy of sigx1094 in patients with DGC and other advanced solid tumors.
- Sigx1094 was developed using Signet's proprietary organoid disease model platform and AI, in collaboration with XtalPi.
- The drug candidate has shown promise in preclinical studies for treating various cancers, including ovarian, triple-negative breast, and pancreatic cancers.
- Signet Therapeutics aims to revolutionize drug discovery by combining organoid disease models and AI, increasing the likelihood of clinical trial success.
- The company has secured nearly $22 million in funding and was recognized by Forbes Asia 100 to Watch list in 2023.
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