Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced positive initial data from a mid-stage study on investigational candidate linvoseltamab (formerly REGN5458) at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition.
The ongoing, open-label, multicenter phase I/II dose-escalation and dose-expansion trial is investigating linvoseltamab in patients with relapsed/refractory (R/R) multiple myeloma. Data from the expansion cohort evaluating investigational linvoseltamab at the 200 mg dose recommended for further development in patients with heavily pre-treated R/R multiple myeloma. Data represent initial efficacy results from first 58 patients in ongoing phase II study.
Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.
81% of patients of the total 252 treated were triple-refractory to existing therapeutic options, including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody. In addition, 37% had bone marrow plasma cells ≥50%, and the median soluble BCMA was 0.43 mg/L, representing a patient population with a higher disease burden than those enrolled in similar trials. Of the 87 patients in the 200 mg cohort, 58 were evaluated for efficacy.
Recommended 200 mg dose of linvoseltamab demonstrated a 64% response rate, with 45% of responders achieving a very good partial response or better. The company expects that responses may further improve with longer follow-up. Per Kaplan-Meier estimates, 79% probability of maintaining a response at 6 months.
The phase I dose-escalation portion of the study primarily assessed safety, tolerability and dose-limiting toxicities of linvoseltamab and was comprised of 9 dose-levels. The fully-enrolled phase II dose expansion portion of the trial is further assessing the safety and anti-tumor activity of linvoseltamab, with a primary objective of objective response rate.
Concurrently, the company announced positive first data from a cohort of phase II study evaluating investigational odronextamab in patients with heavily pre-treated, relapsed/refractory (R/R) follicular lymphoma (FL) grades 1 to 3a.
Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.
Data showed an 82% response rate in patients with grades 1 to 3a disease, with 75% of the overall population achieving a complete response. The results will form the basis of planned submissions to regulatory authorities in 2023. The candidate has been granted Fast Track Designation for FL by the FDA. It also enjoys Orphan Drug Designation for FL in the EU.
Shares of Regeneron have gained 17.5% in the year so far against the industry’s decline of 18.5%.
Growth in ophthalmology drug Eylea (aflibercept) and its share of profits/losses in connection with global sales of Dupixent have maintained momentum for Regeneron.
However, stiff competition from the potential entry of generics and new treatment options weigh on Eylea which has been jointly developed with Bayer AG (BAYRY - Free Report) . While REGN records net product sales of Eylea in the United States, Bayer records net product sales of the drug outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.
Roche’s (RHHBY - Free Report) Vabysmo has also been approved for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).
Regeneron is also looking to diversify in the lucrative oncology space with Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced NSCLC.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced positive initial data from a mid-stage study on investigational candidate linvoseltamab (formerly REGN5458) at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition.
The ongoing, open-label, multicenter phase I/II dose-escalation and dose-expansion trial is investigating linvoseltamab in patients with relapsed/refractory (R/R) multiple myeloma. Data from the expansion cohort evaluating investigational linvoseltamab at the 200 mg dose recommended for further development in patients with heavily pre-treated R/R multiple myeloma. Data represent initial efficacy results from first 58 patients in ongoing phase II study.
Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.
81% of patients of the total 252 treated were triple-refractory to existing therapeutic options, including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody. In addition, 37% had bone marrow plasma cells ≥50%, and the median soluble BCMA was 0.43 mg/L, representing a patient population with a higher disease burden than those enrolled in similar trials. Of the 87 patients in the 200 mg cohort, 58 were evaluated for efficacy.
Recommended 200 mg dose of linvoseltamab demonstrated a 64% response rate, with 45% of responders achieving a very good partial response or better. The company expects that responses may further improve with longer follow-up. Per Kaplan-Meier estimates, 79% probability of maintaining a response at 6 months.
The phase I dose-escalation portion of the study primarily assessed safety, tolerability and dose-limiting toxicities of linvoseltamab and was comprised of 9 dose-levels. The fully-enrolled phase II dose expansion portion of the trial is further assessing the safety and anti-tumor activity of linvoseltamab, with a primary objective of objective response rate.
Concurrently, the company announced positive first data from a cohort of phase II study evaluating investigational odronextamab in patients with heavily pre-treated, relapsed/refractory (R/R) follicular lymphoma (FL) grades 1 to 3a.
Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.
Data showed an 82% response rate in patients with grades 1 to 3a disease, with 75% of the overall population achieving a complete response. The results will form the basis of planned submissions to regulatory authorities in 2023. The candidate has been granted Fast Track Designation for FL by the FDA. It also enjoys Orphan Drug Designation for FL in the EU.
Shares of Regeneron have gained 17.5% in the year so far against the industry’s decline of 18.5%.
Growth in ophthalmology drug Eylea (aflibercept) and its share of profits/losses in connection with global sales of Dupixent have maintained momentum for Regeneron.
However, stiff competition from the potential entry of generics and new treatment options weigh on Eylea which has been jointly developed with Bayer AG (BAYRY - Free Report) . While REGN records net product sales of Eylea in the United States, Bayer records net product sales of the drug outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.
Roche’s (RHHBY - Free Report) Vabysmo has also been approved for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).
Regeneron is also looking to diversify in the lucrative oncology space with Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced NSCLC.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Globally, electric car sales continue their remarkable growth even after breaking records in 2021. High gas prices have fueled his demand, but so has evolving EV comfort, features and technology. So, the fervor for EVs will be around long after gas prices normalize. Not only are manufacturers seeing record-high profits, but producers of EV-related technology are raking in the dough as well. Do you know how to cash in? If not, we have the perfect report for you – and it’s FREE! Today, don't miss your chance to download Zacks' top 5 stocks for the electric vehicle revolution at no cost and with no obligation.
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