On February 1, 2023 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that patient dosing is underway in the expansion portion of its UPGRADE-A clinical trial of UpRi in combination with carboplatin in platinum-sensitive ovarian cancer (Press release, Mersana Therapeutics, FEB 1, 2023, View Source [SID1234626712]). UpRi is Mersana’s first-in-class NaPi2b-targeting ADC with a novel scaffold-linker-payload designed to enable a high drug-to-antibody ratio and controlled bystander effect.

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"While the combination of carboplatin and paclitaxel has historically served as the standard of care in early lines of therapy for platinum-sensitive ovarian cancer, it is limited by distinct tolerability and side effect challenges that can include severe neutropenia, peripheral neuropathy and alopecia," said Dr. Arvin Yang, Senior Vice President and Chief Medical Officer of Mersana Therapeutics. "With UPGRADE-A, we are investigating the potential benefits of replacing paclitaxel with UpRi in the induction phase of treatment and then continuing UpRi as maintenance monotherapy. We are pleased to enter this exciting new phase of the trial."

UPGRADE-A is a Phase 1 open-label trial evaluating the combination of UpRi and carboplatin in patients with platinum-sensitive high-grade serous ovarian cancer following one to three prior lines of treatment. Patients in the trial receive combination treatment every four weeks for six cycles followed by UpRi as a single-agent maintenance therapy. While patients in the trial are not preselected for NaPi2b-positive status, archival or fresh tissue is required for retrospective assessment of expression.

The escalation portion of the trial investigated carboplatin combined with UpRi doses up to 36 mg/m2. There were no dose-limiting toxicities at this dose level. Consistent with Mersana’s UP-NEXT Phase 3 clinical trial, a 30mg/m2 dose of UpRi has been chosen for the dose expansion portion of UPGRADE-A. Mersana expects to report interim data from UPGRADE-A in the second half of 2023.

On February 1, 2023 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the following presentations by Company management at upcoming investor conferences will be webcast (Press release, ImmunoGen, FEB 1, 2023, View Source [SID1234626710]).

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Guggenheim Healthcare Talks 2023 Oncology Conference
February 9 at 3:20pm ET

SVB Securities Global Biopharma Conference
February 15 at 10:00am ET

A webcast of each presentation will be accessible through the "Investors and Media" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay will be available at the same location.

On February 1, 2023 Immunocore Holdings Plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune, and infectious diseases, reported that management will present at the following investor conferences in February (Press release, Immunocore, FEB 1, 2023, View Source [SID1234626709]).

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Guggenheim Oncology Conference
Fireside Chat: Wednesday, February 8, 2023, at 11:20 a.m. ET
SVB Securities Global Biopharma Conference
Fireside Chat: Thursday, February 16, 2023, at 2:20 p.m. ET
Citi’s 2023 Virtual Oncology Leadership Summit
Fireside Chat: Wednesday, February 22, 2023, at 12:00 p.m. ET
The presentations will be webcast live and will be available in the ‘Investors’ section of Immunocore’s website at www.immunocore.com. A replay of the presentations will be made available for a limited time.

On February 1, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will report financial results for the fourth quarter and full year 2022 after market close on Thursday, February 23, 2023 (Press release, Guardant Health, FEB 1, 2023, View Source [SID1234626708]). Company management will be webcasting a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.

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Live audio of the webcast will be available on the "Investors" section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event.

On February 1, 2023 Genoscience Pharma, a clinical-stage biotech company developing unique lysosomotropic drug candidates for the treatment of cancer, fibrosis and auto-immune diseases through autophagy modulation, reported that its lead candidate, ezurpimtrostat, a PPT-1 (Palmitoyl Protein Thioesterase-1) inhibitor, has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of HepatoCellular Carcinoma (HCC) (Press release, GenoScience, FEB 1, 2023, View Source [SID1234626707]). This is an important milestone in the development of ezurpimtrostat, as well as for patients. ODD qualifies ezurpimtrostat for a potential seven years of market exclusivity after approval.

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The FDA’s ODD program provides orphan status to drugs and biologics intended for the treatment, prevention or diagnosis of a rare disease or condition; those affecting less than 200,000 people in the US. 35,563 new cases of primary liver cancer were reported in 2019 and 27,958 people died. Liver cancer is the sixth most common cancer worldwide and the third leading cause of cancer-related death. 1

Without treatment, HCC is rapidly fatal. In the disease’s untreated progression, the median survival time for patients with advanced HCC ranges from four to eight months. The approved combination of atezolizumab and bevacizumab has more than doubled this life expectancy and improved the patient-reported outcome. However, progression-free survival remains short and new treatment options are needed.

Ezurpimtrostat (GNS561) is a first-in-class, first-in-human autophagy inhibitor whose anticancer activity is linked to PPT-1 inhibition. It displayed high liver tropism and potent anti-tumor activity against a panel of human cancer cell lines and in HCC in vivo models – alone and in combination with immune checkpoint inhibitors. Recent investigations show that autophagy inhibitors in combination with immune checkpoint inhibitors provide opportunities for enhancing anti-tumor activity. Preliminary data from a phase 1b trial on primary and secondary liver tumors has confirmed that administration of ezurpimtrostat as a monotherapy is both feasible and well tolerated.

The drug candidate is currently being trialed, as a first-line treatment in combination with an anti-PDL1 and an anti-angiogenic, in ABE-Liver, a phase 2b clinical trial sponsored by Grenoble University Hospital (France), which will enroll up to 196 patients.

"FDA Orphan Drug Designation is a significant milestone for both Genoscience and for our product, ezurpimtrostat. It recognizes that our treatment has the potential to improve the lives of individuals living with HCC," said Professor Philippe Halfon, CEO of Genoscience Pharma. "We have recently launched our phase 2b clinical trial using ezurpimtrostat in conjunction with the standard atezolizumab/bevacizumab treatment. We are looking forward to sharing the intermediate results in 2024."

About Orphan Drug Designation The FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics intended for the treatment, prevention or diagnosis of a rare disease or condition; those that affect less than 200,000 people in the US or meet the cost recovery provisions of the act. Orphan designation qualifies the sponsor of the drug for the various development incentives in the Orphan Drug Act, including tax credits for qualified clinical testing. In addition, it provides seven years of marketing exclusivity upon regulatory approval of the drug in the orphan designation indication.