RE:RE:RE:RE:RE:RE:Pelareorep in 3rd line HR+/HER2 negative breast cancer
September 30, 2024 - Roche/Genentech announced an US$850 Million up-front cash payment (with future follow-on development milestone payments) for the acquisition of Regor Therapeutics single indication small molecule breast cancer product that is in early stage development.
Furthermore, Roche/Genetech's acquisition of Rigor's RGT-419B CDK 4 inhibitor is on the basis of only one Phase 1 clinical trial involving 12 patients.
Regor reported first-in-human data with RGT-419B at last year’s SABCS, from 12 patients, all of whom had also received CDK4/6 inhibitors. Here there were three confirmed responses (one of which relapsed at 32 days), plus one unconfirmed response that was still ongoing at the 26 September 2023 data cutoff.
Yet Roche was willing to acquire RGT-419B for an up-front cash payment of US$850 Million PLUS further milestone payments on future clinical development outcomes.
ONCY, on the other-hand is a late-stage clinical develoment company, which has the the biologic drug pelareorep in clinical trials in 4 unmet need, orhan, or rare disease indications that are in mid to late-stage development, with the added potential of being ggranted expedited market approvals through the FDA's Accelerated Approval program.
Roche/Genentech's recent US$850 Million up-front payment is for a single indication, with a small molecule drug that is a continuation of CDK inhibitors already on the market, which already address the front-end need (1L) of the HR+/HER2- breast cancer market.
Roche/Genentech's decision to acquire a CDK inhibitor demonstrates the need for Big Pharma to begin filling its oncology product pipeline. This is particularly palpable given the forseen limited effectiveness of ADCs and Big Pharma's unquestionable challenge of an advancing patent cliff on blockbuster products. An added issue for Big Pharma is that small molecules are only being given 9 years of FDA market exclusivity upon approval, while biologics like pelareorep will be entitled to 13 years of market exclusivity.
Regor reported first-in-human data with RGT-419B at last year’s SABCS, from 12 patients, all of whom had also received CDK4/6 inhibitors. Here there were three confirmed responses (one of which relapsed at 32 days), plus one unconfirmed response that was still ongoing at the 26 September 2023 data cutoff.