Coherus Oncology, Inc. reports commercial-stage oncology developments centered on LOQTORZI® (toripalimab-tpzi), an approved next-generation PD-1 inhibitor for recurrent or metastatic nasopharyngeal carcinoma. Company updates also cover its antibody immunotherapy pipeline, including tagmokitug, an anti-CCR8 cytolytic antibody, and casdozokitug, an IL-27 antagonistic antibody, across solid-tumor programs such as liver, prostate, head and neck, colorectal, gastric and esophageal cancers.
Recurring news includes financial results, LOQTORZI revenue commentary, clinical-development updates, strategic partnerships, investor-conference presentations, public common-stock offerings, debt reduction and other capital-structure actions tied to the company's transition from biosimilars to innovative oncology.
Coherus BioSciences, Inc. (Nasdaq: CHRS) announced on Sept. 24, 2021, that it granted options to purchase 229,500 shares of common stock to newly hired employees, effective Sept. 22, 2021. The options have an exercise price of $17.06, matching the closing trading price on the grant date. Among the recipients, a new Senior Vice President received options for 100,000 shares. These grants were made under the Coherus BioSciences 2016 Employment Commencement Incentive Plan, approved to attract new talent.
Coherus BioSciences (CHRS) and Junshi Biosciences announced positive interim results from the Phase 3 JUPITER-06 trial on toripalimab combined with chemotherapy for advanced esophageal squamous cell carcinoma (ESCC). The study demonstrated statistically significant improvements in both progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone, meeting co-primary endpoints. The companies plan to submit a Biologics License Application (BLA) supplement in 2022 to expedite toripalimab's availability for ESCC patients in the U.S. Full data will be presented at the ESMO Congress on September 17, 2021.
Coherus BioSciences (Nasdaq: CHRS) and Shanghai Junshi Biosciences announced significant findings from the JUPITER-02 clinical trial, published in Nature Medicine. The Phase 3 trial demonstrated that toripalimab combined with standard chemotherapy improved progression-free survival (PFS) in patients with advanced nasopharyngeal carcinoma (NPC), showing a median PFS of 11.7 months versus 8.0 months with chemotherapy alone. While overall survival data is not yet mature, a 40% reduction in death risk was noted. A biologics license application has been submitted to the FDA for approval.
Coherus Biosciences (CHRS) and Junshi Biosciences have announced positive interim results from the Phase 3 clinical trial CHOICE-01, assessing toripalimab plus chemotherapy for advanced non-small cell lung cancer (NSCLC). The interim analysis showed significant improvement in progression-free survival (PFS) compared to chemotherapy alone. The data was presented at the World Conference on Lung Cancer. Further analyses are anticipated later this year, with plans for FDA discussions for a biologics license application for toripalimab in the U.S.
Coherus BioSciences, Nasdaq: CHRS, has announced that its senior management will present at the 23rd Annual H.C. Wainwright Global Investment Conference on September 14, 2021, at 7 a.m. ET. The presentation will be accessible via the investors’ page on Coherus’ website. The company focuses on providing cost-effective medicines and aims to enhance its immuno-oncology franchise, leveraging revenue from its commercial biosimilars. For more details, visit www.coherus.com.
Coherus BioSciences (Nasdaq: CHRS) announced key presentations at upcoming medical conferences. Toripalimab clinical data will be shared on September 13 at the IASLC 2021 World Conference on Lung Cancer and on September 17 at the ESMO Congress 2021. Additionally, a study on pegfilgrastim will be presented at the ASCO Quality Care Symposium on September 25, and clinical data from the CHS-201 program will be highlighted on October 1 at the Retina Society's Annual Meeting. These events showcase Coherus’ commitment to advancing cancer treatment options.
Coherus (Nasdaq: CHRS) and Junshi Biosciences have completed the rolling submission of a Biologics License Application (BLA) to the FDA for toripalimab in combination with chemotherapy and as a monotherapy for nasopharyngeal carcinoma (NPC). The FDA granted Breakthrough Therapy Designation for both treatment options, intended to expedite drug development for severe diseases. Toripalimab has shown significant efficacy in clinical studies and received early approval in China. Coherus plans to file additional BLAs for toripalimab over the next three years.
On August 27, 2021, Coherus BioSciences (Nasdaq: CHRS) announced the grant of stock options totaling 278,000 shares to newly hired employees, effective as of August 26, 2021. The options have an exercise price of $15.82 per share, matching the closing price on the grant date. Among the recipients, two Vice Presidents received options for 45,000 shares each, while an additional 188,000 shares were granted to fifteen non-officer employees. This grant is part of the 2016 Employment Commencement Incentive Plan approved by the board to attract new talent.
Coherus BioSciences (Nasdaq: CHRS) and Junshi Biosciences announced positive interim results from the CHOICE-01 Phase 3 trial evaluating toripalimab plus chemotherapy for advanced non-small cell lung cancer (NSCLC). The interim analysis met its primary endpoint, showing a significant improvement in progression-free survival (PFS) of 8.3 months versus 5.6 months with chemotherapy alone (HR=0.58, p=0.0001). Both squamous and non-squamous NSCLC patients benefited, leading to plans for potential regulatory submissions in the US and China.
Coherus BioSciences (Nasdaq: CHRS) and Junshi Biosciences announced that the FDA granted Breakthrough Therapy Designation for toripalimab combined with chemotherapy for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC).
The designation will expedite the review process, providing closer guidance from the FDA. A biologics license application (BLA) for this combination and for toripalimab monotherapy for second/third line NPC is expected this quarter.
The designation is backed by positive results from the JUPITER-02 trial, showing significant progression-free survival improvements.