July 2, 2024 - 🧬 [nGram] Today’s Oncology Scoop: Allogene's Phase 2 Trial, Ipsen's Cabometyx Expansion, Orion & MSD's Opevesostat Deal

  1. 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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  2. 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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  3. 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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  4. 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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  5. 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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  6. 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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  7. 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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