On November 1, 2021 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that it will release third quarter 2021 financial results after the market closes on Monday, November 8, 2021 (Press release, Xencor, NOV 1, 2021, View Source [SID1234594045]).

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Xencor management will host a webcast and conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers and referencing conference ID number 5536153. A live webcast of the conference call will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. The webcast will be archived on the company website for 30 days.

On November 1, 2021 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, reported that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) target date for ciltacabtagene autoleucel (cilta-cel) to February 28, 2022 (Press release, Legend Biotech, NOV 1, 2021, View Source [SID1234594044]). Cilta-cel is a BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy being investigated for the treatment of adults with relapsed and/or refractory multiple myeloma. The Biologics License Application (BLA) was submitted by Legend Biotech’s collaboration partner Janssen Biotech, Inc. (Janssen).

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"We are working closely with Janssen and the FDA to facilitate an efficient and thorough review of the BLA for cilta-cel," said Ying Huang, Ph.D., Chief Executive Officer and Chief Financial Officer at Legend Biotech. "We remain confident that cilta-cel has shown great promise in patients with relapsed and refractory multiple myeloma, and we are focused on making this therapy available to them in the US as soon as possible."

The FDA notified Janssen on October 28, 2021 of the extension of the PDUFA date to allow sufficient time to review information recently submitted pertaining to an updated analytical method following an FDA information request. Legend and Janssen met with the FDA on November 1. No additional clinical data have been requested.

About Cilta-cel
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the U.S. and Europe and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies.

In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel. In December 2020, Legend announced initiation of rolling submission of Biologics License Application to the FDA seeking approval of cilta-cel for the treatment of relapsed and/or refractory multiple Myeloma, which was accepted under Priority Review in May 2021. Cilta-cel was previously granted Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, and Orphan Drug Designation in February 2019.

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.1 Although treatment may result in remission, unfortunately, patients will most likely relapse.2 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.3 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.4,5 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.6 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses

On November 1, 2021 Imugene Ltd ("Imugene") (ASX: IMU), a clinical stage immuno-oncology company, and Eureka Therapeutics, Inc. ("Eureka"), a clinical-stage biotechnology company developing novel T-cell therapies to treat solid tumours, reported a strategic collaboration to evaluate Imugene’s CD19 oncolytic virus onCARlytics technology in combination with Eureka’s anti-CD19 ARTEMIS T-cell therapy for the treatment of solid tumours (Press release, Imugene, NOV 1, 2021, View Source [SID1234594043]).

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Oncolytic viruses in combination with T-cell therapies represent a novel and promising approach to treat solid tumours. In preclinical studies conducted by the City of Hope Comprehensive Cancer Center, scientists combined CAR-T therapy with an oncolytic virus to eliminate solid tumours in mice. The virus enters the tumour cells and forces them to express the CD19 protein on the cell surface, presenting a target for anti-CD19 T-cells to pursue and kill. Imugene licensed the patents covering City of Hope’s oncolytic virus technology in May 2021.

"By combining oncolytic virus and CAR T-cell therapies, we have developed a ‘mark and kill’ approach to treating solid tumours with T-cell therapies," said Saul Priceman, Ph.D., Assistant Professor in the Department of Hematology and Hematopoietic Cell Transplantation at City of Hope and co-inventor of the platform. "In our animal studies, we were able to express CD19 in triple-negative breast, pancreatic, prostate, ovarian, and head and neck cancer, as well as brain tumours."

"T-cell and CAR-T therapies have not achieved much success in solid tumours in part because of a lack of tumour-specific targets. By using our proprietary oncolytic technology to force the tumour to express the CD19 target, we now have the ability to address this shortcoming. We believe the synergy between our onCARlytics platform and Eureka’s anti-CD19 ARTEMIS T-cells has the potential to shift the cellular medicine paradigm in treating solid tumours," said Leslie Chong, Managing Director & Chief Executive Officer of Imugene.

"We are delighted to be working with Imugene on tackling solid tumours using this innovative approach," said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. "We believe our ARTEMIS T-cell platform to be the ideal one to evaluate this combination. In head-to-head pre-clinical studies against CAR-T cells, our ARTEMIS T-cells demonstrated superior efficacy, enhanced tumour infiltration, and less T-cell exhaustion. In the clinical context, our ARTEMIS T-cells have demonstrated reduced cytokine release syndrome (CRS) and other cytokine-related toxicities compared to CAR-T cells, potentially improving the efficacy and safety of a combination approach."

On November 1, 2021 Epizyme reported the launch of In My Blood, an online resource designed to empower people living with follicular lymphoma to partner with their healthcare providers and play a proactive role in treatment decision-making based on where they are in their follicular lymphoma journey (Press release, Epizyme, NOV 1, 2021, View Source [SID1234594042]).

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In My Blood offers follicular lymphoma patients, and their care partners, unique resources to aid them in taking a proactive role in their care as they navigate life with this typically incurable blood cancer. A central feature is My Follicular Lymphoma Coach, a first-of-its-kind quiz for follicular lymphoma patients. This brief questionnaire takes key information into consideration, including stage of disease, current symptoms, and lifestyle. Patients are then provided with a customized, downloadable guide to support them in having proactive, informed discussions with their healthcare providers. The personalized guide is designed for patients at any stage of their experience with follicular lymphoma and provides tools for them to engage proactively in their health, during both periods of treatment and remission.

"Over the years, through continued partnership with healthcare providers and patient advocates in the follicular lymphoma community, we’ve seen firsthand the importance of the healthcare provider-patient relationship when dealing with the complexities of navigating this typically incurable blood cancer over many years, sometimes even decades," said Cheya Pope, Vice President, Corporate Affairs at Epizyme. "Knowing this relationship is paramount, we created In My Blood and My Follicular Lymphoma Coach, with input from the follicular lymphoma advocacy community, to fulfill a need for patients. We hope the resources provided will enable meaningful conversations between patients and healthcare providers to ultimately improve care."

As clear and proactive communication with healthcare providers is essential in order to detect signs of a potential relapse in follicular lymphoma, In My Blood also offers downloadable daily and weekly symptom trackers to support patients and care partners with disease monitoring. It also features stories and insights from individuals living with follicular lymphoma, which highlight how they have been able to proactively manage their disease and celebrates how they continue living life to the fullest. Additional resources, background information and links to related advocacy organization resources are also available.

"Upon learning you have follicular lymphoma the sheer volume of information, choices, and decisions you have to make can feel overwhelming. When I was newly diagnosed, I knew that I would need to advocate for myself to ensure that I received the best care and treatment based on my diagnosis and individual needs," said Kendra Munger, In My Blood patient ambassador. "Now with In My Blood and My Follicular Lymphoma Coach, patients like me who are navigating life with follicular lymphoma can create a personalized guide with relevant information for where they are in their follicular lymphoma journey, along with important questions to ask their doctors as they work together to determine the best path forward."

For more information on In My Blood and to access My Follicular Lymphoma Coach, visit FollicularLymphoma.com.

About Follicular Lymphoma

Follicular lymphoma is a type of cancer that starts in the lymphatic system, a system of lymph nodes found throughout the body.i Of the estimated 74,000 individuals diagnosed with non-Hodgkin’s lymphoma in the United States each year, follicular lymphoma accounts for approximately 20% of all cases, or about 14,800 individuals.ii People with follicular lymphoma often experience periods of remission before the disease returns (relapse), and they typically undergo treatment with numerous therapies during their disease journey. In addition, many patients find their cancer has become resistant to treatments they’ve received before, leaving them with fewer options when their cancer returns. To learn more about follicular lymphoma and In My Blood, visit FollicularLymphoma.com.

On November 1, 2021 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates, reported that data from the Phase 2 clinical trial of PEN-221 will be presented at the North American Neuroendocrine Tumor Society (NANETS) 2021 Multidisciplinary NET Medical Virtual Symposium occurring November 3-6, 2021 (Press release, Tarveda Therapeutics, NOV 1, 2021, View Source [SID1234594041]).

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The presentation details are as follows:

Date: Saturday, November 6, 2021
Time: 1:25pm Eastern Time
Title: The safety and efficacy of PEN-221 somatostatin analog (SSA)-DM1 conjugate in patients (PTS) with advanced GI mid-gut neuroendocrine tumor (NET): Phase 2 Results
Location: Virtual – Register to attend