On May 2, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Cancer Research reported the acceptance of an abstract for a poster presentation at the upcoming European Society for Medical Oncology Breast Cancer Meeting, which is taking place both online and in-person at hub27 – Messe Berlin in Berlin, Germany from May 3-5, 2022 (Press release, Oncolytics Biotech, MAY 2, 2022, View Source [SID1234613308]).

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The accepted abstract (#364) is available on the ESMO (Free ESMO Whitepaper) Breast Cancer Meeting website. Included in the abstract are new results from cohort 1 and cohort 2 of the AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, each of which enrolled ten HR+/HER2- early-stage breast cancer patients. These patients were treated with pelareorep and the aromatase inhibitor letrozole without (cohort 1) or with (cohort 2) the PD-L1 checkpoint inhibitor atezolizumab. Evaluation of these cohorts was the primary focus of AWARE-1 as HR+/HER2- is the breast cancer subtype Oncolytics intends to investigate in a future registrational study.

Results of this exploratory study described in the abstract show pelareorep’s potential to induce an inflamed tumor phenotype and its synergy with atezolizumab. They also support pelareorep’s immune-based mechanism of action and suggest that the combination of pelareorep and atezolizumab may improve outcomes in breast cancer. Additional details on analyses and results described in the abstract will be provided following the publication of its corresponding poster, in accordance with the ESMO (Free ESMO Whitepaper) Breast Cancer Meeting’s embargo policies.

Details on the abstract and upcoming poster presentation are shown below.

Title: The oncolytic virus pelareorep primes the tumor microenvironment for checkpoint blockade therapy in early breast cancer patients – results from AWARE-1 study

Category: Biomarkers and translational research and precision medicine

Abstract Number: 364

Presentation Date: May 4, 2022

Presentation Time: 12:15 p.m. CET

About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers.

On May 2, 2022 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported topline results from the six-week, Phase 2a, open-label, single-arm AESOP trial of avasopasem evaluating its ability to reduce the incidence of severe acute radiation-induced esophagitis in patients with lung cancer receiving concurrent chemoradiotherapy (Press release, Galera Therapeutics, MAY 2, 2022, View Source [SID1234613307]).

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The multicenter Phase 2a trial enrolled 39 patients (62 screened) with unresectable Stage 3A/3B or post-operative Stage 2B non-small cell (NSCLC) or limited-stage small cell (SCLC) lung cancers. Thirty-five patients completed treatment with 60 gray of intensity-modulated radiation therapy (IMRT) plus chemotherapy over six weeks. Of these 35 patients, 29 received at least five weeks of 90 mg of avasopasem on the days they underwent IMRT. These 29 patients were evaluated as the pre-specified per protocol population. Patients enrolled in this trial were considered at high risk for developing esophagitis due to the amount of radiation planned to be delivered to the esophagus.1 Patients were assessed and classified according to NCI-CTCAE criteria.2

Incidence of esophagitis by grade and timepoint in the AESOP trial (per protocol, n=29):

Grading Scale for Esophagitis per NCI Criteria
Grade 1 Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2 Symptomatic; altered eating/swallowing; oral supplements indicated
Grade 3 Severely altered eating/swallowing; tube feeding, TPN, or hospitalization indicated
Grade 4 Life-threatening consequences; urgent operative intervention indicated
Grade 5 Death
Only two of the 29 patients (7%) experienced Grade 3 esophagitis at any time, with neither patient experiencing Grade 3 for more than one week. No patients experienced Grade 4 or 5 esophagitis at any point during the trial. These data compare favorably to the literature in which approximately 20-30 percent of these patients experienced Grade 3 or 4 esophagitis.3 Avasopasem was generally well tolerated. The adverse events experienced are comparable to those expected with chemoradiotherapy.

"These encouraging results demonstrate avasopasem’s potential to meaningfully reduce radiotherapy-induced Grade 3 or worse esophagitis," said Mel Sorensen, M.D., Galera’s President and CEO. "Patients with lung cancer undergoing chemoradiotherapy are at high risk of severe and potentially life-threatening esophagitis, including an inability to eat or swallow, severe pain, ulceration, infection, bleeding and weight loss, and there are no established drug therapies. Following the positive Phase 3 results of avasopasem in radiotherapy-induced severe oral mucositis (SOM), we believe these results in esophagitis support the safety and efficacy of avasopasem as a potential therapy to prevent the most severe forms of radiotherapy-induced toxicities."

Approximately 50,000 lung cancer patients undergo standard-of-care chemoradiotherapy every year in the U.S. and are at risk of developing esophagitis.

About Radiotherapy-Induced Esophagitis
Radiotherapy-induced esophagitis is a common and debilitating adverse effect that develops in patients receiving radiotherapy, most commonly for lung, esophageal, breast or head and neck cancers or for lymphoma. Radiotherapy-induced esophagitis is inflammation, edema, erythema, and erosion of the mucosal surface of the esophagus caused by radiotherapy. Esophagitis can be life-threatening, and symptoms include an inability to swallow, severe pain, ulceration, infection, bleeding and weight loss and may require hospitalization. There are currently no FDA-approved drugs and no established guidelines for the treatment of radiotherapy-induced esophagitis.

About Avasopasem
Avasopasem manganese (avasopasem, or GC4419) is a selective small molecule dismutase mimetic in development for the reduction of radiation-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) and for the reduction of radiation-induced esophagitis in patients with lung cancer. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy.

About the Phase 2a AESOP Trial
The AESOP trial is an open-label, multicenter trial designed to evaluate the ability of avasopasem to reduce the incidence of radiotherapy-induced esophagitis in patients receiving chemoradiotherapy for unresectable Stage 3A/3B or post-operative Stage 2B non-small cell lung cancer, or small cell lung cancer treatable with chemoradiotherapy. For more information, please visit View Source

On May 2, 2022 Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", "Junshi", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) reported that the U.S. Food and Drug Administration ("FDA", "the Agency") has issued a complete response letter ("CRL") for the Biologics License Application ("BLA") for toripalimab in combination with gemcitabine and cisplatin in the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma ("NPC") and for toripalimab monotherapy in the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy (Press release, Coherus Biosciences, MAY 2, 2022, View Source [SID1234613306]).

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The CRL requests a quality process change that Coherus and Junshi Biosciences believe is readily addressable. Coherus and Junshi Biosciences plan to meet with the FDA directly and expect to resubmit the BLA by mid-summer 2022. The Agency also communicated in the CRL that the review timeline for the BLA resubmission would be six months, as required onsite inspections have been hindered by travel restrictions related to the COVID-19 pandemic in China.

"We will continue to work closely with our partner, Junshi Biosciences, to facilitate the completion of the FDA’s review of the toripalimab BLA. In late April, we responded quickly to an FDA request for a quality process change and implemented required actions," said Denny Lanfear, CEO of Coherus. "We plan to first meet with the FDA and directly thereafter to resubmit the BLA. The FDA has indicated that the existing toripalimab clinical data are supportive of the BLA submission, and we eagerly await scheduling and completion of the required inspections in China that have been impeded to date by COVID-related travel restrictions. We believe toripalimab addresses an important unmet need for patients with NPC for whom there are currently no approved immunotherapies in the United States, and the FDA has stated that this indication warrants regulatory flexibility with respect to the sufficiency of single country clinical data."

"Junshi Biosciences is dedicated to the discovery, development and commercialization of innovative new drugs on a global scale," said Dr. Ning Li, CEO of Junshi Biosciences. "Toripalimab, our PD-1 inhibitor, has demonstrated a compelling clinical profile in studies across multiple tumor types and is currently approved in China for four indications. We fully support our partner, Coherus, in its efforts to seek toripalimab approval in the United States for advanced nasopharyngeal carcinoma, as well as in the subsequent commercial launch, if approved. Our respective teams are working diligently together in a well coordinated effort to achieve these goals as partners."

About Nasopharyngeal Carcinoma (NPC)

NPC is a type of aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of skull. Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with radiation and chemotherapy. In the United States, there are presently no immunotherapies approved for the treatment of NPC.

About toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.

More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). Currently, there are four approved indications for toripalimab in China:

unresectable or metastatic melanoma after failure of standard systemic therapy;
recurrent or metastatic nasopharyngeal carcinoma NPC after failure of at least two lines of prior systemic therapy;
locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC.
The first three indications have been included in the National Reimbursement Drug List ("NRDL") (2021 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for melanoma and NPC.

In addition, two supplemental New Drug Applications ("NDAs") for toripalimab are currently under review by the National Medical Products Administration ("NMPA") in China:

in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic ESCC.
in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic NSCLC without EGFR or ALK mutations.
In the United States, the FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Coherus and Junshi Biosciences plan to resubmit a BLA for toripalimab for advanced NPC by mid-summer 2022. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug Designation for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and SCLC. In 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next several years for multiple other cancer types.

On May 2, 2022 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported that it will publish financial results for the first quarter 2022 and provide a business update on May 9, 2022 (Press release, Precision Biosciences, MAY 2, 2022, View Source [SID1234613305]). Precision BioSciences also announced that Michael Amoroso, Chief Executive Officer will participate in the H.C. Wainwright Global Investment Conference on May 24, 2022.

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Details for the virtual presentation are below:

H.C. Wainwright Global Investment Conference
Date: Tuesday, May 24, 2022
Time: On-demand session available at 7:00 AM ET

A live webcast of the presentation will be accessible on the Company’s website in the Investors section under Events & Presentations: View Source An archived replay of the webcast will be available for approximately 30 days.

On May 2, 2022 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will release its first quarter 2022 financial results on Monday, May 9, after the close of the U.S. financial markets (Press release, Syndax, MAY 2, 2022, View Source [SID1234613304]).

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In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET on Monday, May 9, to discuss the Company’s financial results and provide a general business update.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website, www.syndax.com.