Regeneron Pharmaceuticals

November's dermatology highlights include FDA approval of bimekizumab for HS, resubmissions for dupilumab and pz-cel, obesity's link to psoriasis, JNJ-2113's efficacy in psoriasis, stress's impact on skin aging, and factors affecting HS diagnostic wandering.

Huntington’s disease, caused by a defective gene, leads to protein clumps damaging brain cells. A new trial tests ALN-HTT02, an RNAi therapeutic, aiming to reduce the damaging protein. Up to 54 participants will receive either the drug or a placebo, with the option to switch. The trial, led by Professor Sarah Tabrizi, seeks to slow disease progression and improve patient outcomes.

MAIA Biotechnology amends 2021 clinical supply agreement with Regeneron for THIO-101 Phase 2 trial expansion, aiming to assess THIO's efficacy in third-line non-small cell lung cancer patients resistant to previous treatments. New patient enrollment expected soon.

MAIA Biotechnology expands Phase 2 trial of THIO-101 to evaluate THIO in combination with Regeneron's Libtayo® for third-line NSCLC patients resistant to prior therapies. The trial aims to assess safety, tolerability, and efficacy, with interim results showing favorable survival rates and response rates. MAIA maintains strong liquidity and considers an accelerated approval pathway.

MAIA Biotechnology amended its 2021 clinical supply agreement with Regeneron to expand the THIO-101 Phase 2 trial, assessing THIO with Libtayo for advanced NSCLC patients resistant to previous treatments. MAIA sponsors the trial, with Regeneron providing Libtayo, and expects to start enrolling new patients soon, potentially aiming for accelerated U.S. approval.

T.C. has consulted/advised/spoken for ASCO Post, AstraZeneca, Bio Ascend, Bristol Myers Squibb, Clinical Care Options, Daiichi Sankyo, Genentech, IDEOlogy Health, Medical Educator Consortium, Medscape, Merck, OncLive, oNKo-innate, PEAK Medicals, PeerView, Pfizer, Physicians’ Education Resource, RAPT Therapeutics, Regeneron, Targeted Oncology. W.N.W.Jr. has consulted/advised/spoken for Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Daiichi-Sankyo, Eli Lilly, Genentech/Roche, Ipsen, Janssen, Merck, MSD, Novartis, Pfizer, Sanofi-Aventis, Takeda, United Medical.

MAIA Biotechnology amended its 2021 clinical supply agreement with Regeneron to expand the THIO-101 trial, assessing THIO sequenced with Libtayo® for advanced NSCLC patients resistant to previous checkpoint inhibitors and chemotherapy. MAIA sponsors the trial, with Regeneron providing Libtayo® for all patients, including the expansion. MAIA holds an exclusive worldwide patent license for THIO and plans to enroll new patients soon, evaluating a potential accelerated approval in the U.S.