On April 23, 2021 Purple Biotech (Nasdaq/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, reported that the first patient has been dosed in a Phase 1b/2 clinical trial of CM24, a monoclonal antibody blocking CEACAM1, for the first time in combination with nivolumab (Opdivo), a PD-1 inhibitor, in advanced cancer patients, with expansion cohorts in subjects with non-small cell lung cancer (NSCLC) and pancreatic cancer (Press release, Purple Biotech, APR 23, 2021, View Source [SID1234578433]).

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"The dosing of the first patient in this study, which is being conducted in clinical collaboration with Bristol Myers Squibb, is a critical achievement for the development of CM24," said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Purple Biotech. "Targeting CEACAM1 is a cutting-edge approach utilizing the most current knowledge of the interface of the myeloid and T-cell systems in the neoplastic phenotype. We look forward to the availability of preliminary data from the first part of this study which we expect to receive during the second half of this year."

The study is a Phase 1b/2 clinical trial with expansion cohorts in subjects with NSCLC and pancreatic cancer. CM24 will be dose escalated from 10mg/kg, targeting a 20mg/kg dose, in combination with nivolumab in Phase 1b, in patients with NSCLC, pancreatic cancer, ovarian carcinoma, colorectal adenocarcinoma, melanoma or thyroid carcinoma, with the primary objective of evaluating safety, PK and determining the recommended Phase 2 dose. In the Phase 2 component, patients with NSCLC will be treated with CM24 and nivolumab after first-line immuno-oncology failure, and patients with metastatic pancreatic adenocarcinoma will be treated with CM24, nivolumab and nab-paclitaxel (ABRAXANE) after first-line therapy failure, with study endpoints being safety and preliminary efficacy. CEACAM1 level of expression, as well as a number of other immune and adhesion-related molecules, will be evaluated as potential biomarkers in the study.

The Phase 1b/2 study will be conducted in multiple countries, with sites anticipated in the U.S., E.U. and Israel. Additional information about the trial can be found at www.clinicaltrials.gov, NCT Identifier NCT04731467.

On April 23, 2021 Coherus BioSciences, Inc. (Nasdaq: CHRS) reported that it has received notice from immuno-oncology partner Junshi Biosciences that the Independent Data Monitoring Committee of the JUPITER-06 clinical trial has determined that toripalimab, an anti-PD-1 monoclonal antibody, in combination with paclitaxel/cisplatin as first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC), has achieved the pre-specified primary endpoints of progression free survival (PFS) and overall survival (OS) at the interim analysis. JUPITER-06 is a randomized, double-blind, placebo-controlled, multi-center, phase 3 clinical trial initiated in 2019 with 514 patients enrolled (Press release, Coherus Biosciences, APR 23, 2021, View Source [SID1234578430]).

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The interim analysis showed that toripalimab, in combination with paclitaxel/cisplatin, significantly prolonged the PFS and OS of patients with advanced ESCC, compared with paclitaxel/cisplatin chemotherapy alone. Data from the study are expected later this year.

Earlier in 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. More than 2,100 patients have received toripalimab treatment in clinical trials, and pivotal clinical trials are ongoing or completed evaluating toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin. In the U.S., a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted toripalimab Breakthrough Therapy Designation for this indication. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

About Esophageal Squamous Cell Carcinoma (ESCC)
Esophageal cancer is a primary malignant tumor of the esophageal mucosa epithelium. ESCC and adenocarcinoma are the two main histological subtypes of esophageal cancer. Approximately 6,000 patients in the United States are diagnosed annually with esophageal squamous cell carcinoma. The current standard first-line treatment is platinum-based chemotherapy. The prognosis of patients with advanced ESCC is poor with five-year survival rates of less than 20%.

About JUPITER-06 Study
JUPITER-06 is a randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial evaluating the efficacy and safety of toripalimab combined with paclitaxel/cisplatin versus placebo combined with paclitaxel/cisplatin as first-line treatments for advanced esophageal squamous cell carcinoma. The JUPITER-06 Clinicaltrials.gov identifier is NCT03829969. Professor Ruihua Xu from the Sun Yat-sen University Cancer Hospital is the principal investigator of the JUPITER-06 study. A total of 514 patients were enrolled in the study. The primary endpoints are PFS as assessed by the Blinded Independent Review Committee and OS. Secondary endpoints include the PFS assessed by investigator, objective response rate, disease control rate and duration of response.

On April 23, 2021 Shanghai Junshi Biosciences reported that it stopped the Phase III trial of its anti-PD-1 candidate early because toripalimab met its survival endpoints at an interim review (Press release, Shanghai Junshi Bioscience, APR 23, 2021, View Source [SID1234578428]). Toripalimab was administered together with paclitaxel/cisplatin as a first-line treatment for patients with advanced esophageal squamous cell carcinoma. The combination met the pre-specified primary endpoints of Progression Free Survival and Overall Survival in a double-blind Phase III trial. Toripalimab is already approved for three other indications in China.

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On April 23, 2021 GW Pharmaceuticals plc (Nasdaq: GWPH) (GW) and Jazz Pharmaceuticals plc (Nasdaq: JAZZ) (Jazz) reported that GW’s shareholders voted to approve the acquisition of GW by a subsidiary of Jazz (or its nominee(s)) at the GW shareholder meetings held today (Press release, Jazz Pharmaceuticals, APR 23, 2021, View Source [SID1234578427]). The proposals required to be approved by GW’s shareholders in order to complete the acquisition were each approved. In addition, the non-binding, advisory proposal to approve certain compensation arrangements for GW’s named executive officers was approved. Detailed information regarding the results will be made available by GW in a filing with the U.S. Securities and Exchange Commission (SEC).

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All shareholder and regulatory approvals required for the acquisition have now been obtained. Completion of the acquisition remains subject to the sanction by the High Court of Justice of England and Wales (Court) and other customary closing conditions. The Court hearing to sanction the acquisition is currently scheduled for May 5, 2021, and the completion of the acquisition is expected to occur shortly thereafter.

On April 23, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, APR 23, 2021, View Source [SID1234578426]):

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Bank of America Securities Virtual Health Care Conference at 1:15 p.m. ET on Tuesday, May 11, 2021

RBC Capital Markets Virtual Global Healthcare Conference at 8:00 a.m. ET on Tuesday, May 18, 2021
The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the webcasts will be archived on the Company’s website for at least 30 days.