On December 27, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Mark Enyedy, President and CEO, will present at the upcoming 41st Annual J.P. Morgan Healthcare Conference in San Francisco, CA (Press release, ImmunoGen, DEC 27, 2022, View Source [SID1234625625]). The presentation is scheduled for 3:45pm PT (6:45pm ET) on January 10, 2023.

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Following the presentation, Mr. Enyedy will be joined by other members of ImmunoGen’s management team for a question-and-answer session at 4:05pm PT (7:05pm ET).

A webcast of the presentation and question-and-answer session will be accessible live through the "Investors & Media" section of the Company’s website, www.immunogen.com; a replay will be available in the same location.

On December 27, 2022 Novocure (NASDAQ: NVCR) reported that it will participate in the 41st Annual J. P. Morgan Healthcare Conference on January 10-11, 2023. William Doyle, Novocure’s Executive Chairman, will speak on behalf of the company and address questions from analysts at 7:30 a.m. PST on January 10, 2023 (Press release, NovoCure, DEC 27, 2022, View Source [SID1234625624]). Mr. Doyle and Ashley Cordova, Novocure’s Chief Financial Officer, will also participate in one-on-one meetings with investors throughout the event.

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A live audio webcast of the presentation and all presentation materials can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the event. Novocure has used, and intends to continue to use, its Investor Relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On December 27, 2022 CG Oncology, Inc., an oncolytic immunotherapy company focused on developing novel therapeutics for patients with urologic cancers, reported that Arthur Kuan, Chief Executive Officer, will present at the 41st Annual J.P. Morgan Healthcare Conference in San Francisco, California on Wednesday, January 11, 2023 at 4pm Pacific Standard Time (Press release, CG Oncology, DEC 27, 2022, View Source [SID1234625623]). The presentation will be webcast live and available for replay from the news section of CG Oncology’s website at www.cgoncology.com.

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On December 27, 2022 InnoCare Pharma (HKEX: 09969; SSE: 688428) reported the approval of tafasitamab in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT) by the Department of Health, the Hong Kong Special Administrative Region, China (Press release, InnoCare Pharma, DEC 27, 2022, View Source [SID1234625622]).

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Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "The Hong Kong approval of tafasitamab and lenalidomide will not only provide access to eligible DLBCL patients in the region, but may also help patient access in the Greater Bay Area soon. Moving forward, we will accelerate the clinical trials of tafasitamab in China in the hopes of meeting more unmet medical needs."

Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, is not approved by the National Medical Products Administration (NMPA) for any indication in China, except that tafasitamab in combination with lenalidomide has been approved by the Health Commission and Medical Products Administration of Hainan Province for the treatment of eligible DLBCL patients, under the early access program in Boao Lecheng International Medical Tourism Pilot Zone. As part of this early access program, the first prescription of tafasitamab in combination with lenalidomide was filed in July at the Ruijin Hainan Hospital for an eligible DLBCL patient.

Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in combination with lenalidomide for the treatment of relapsed or refractory DLBCL patients who are not eligible for autologous stem cell transplantation (ASCT).

About Tafasitamab

Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy.

In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Monjuvi and Minjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name MONJUVI in the U.S., and marketed by Incyte under the brand name Minjuvi in Europe and Canada. As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitamab outside the United States, and in August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China.

On December 27, 2022 ZielBio, Inc., a clinical-stage biotechnology company discovering new treatments for cancer and other serious diseases through its innovative drug discovery platform, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead program, ZB131, for the treatment of treatment of pancreatic cancer, a rare solid-tumor cancer originating from the pancreas (Press release, ZielBio, DEC 27, 2022, View Source [SID1234625621]). ZB131 is a proprietary monoclonal antibody with a high affinity and specificity for cancer-specific plectin (CSP), a cell surface protein identified in a wide range of cancers that correlates with poor prognosis and aggressive tumors, including pancreatic cancer. ZielBio previously received Orphan Drug Designation for ZB131 for the treatment of cholangiocarcinoma (bile duct cancer).

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"More than 62,000 people in the United States are diagnosed with pancreatic cancer each year and the five-year survival rate is only 11%," said Kimberly Kelly, Ph.D., founder and president of ZielBio. "We appreciate the special status that the FDA has granted ZB131 with this Orphan Drug Designation for pancreatic cancer, which is typically diagnosed at an advanced stage with few effective treatment options."

ZielBio developed ZB131 to target CSP after discovering that, unlike in healthy cells where plectin exists in the cytoplasm, plectin presents on the surface of cancer cells, where it functions as a driver of tumor growth and metastasis. In preclinical studies, ZB131 demonstrated high specific binding to CSP and strong anti-cancer activity. A Phase 1/2 trial is underway to study the safety, tolerability, and efficacy of ZB131 in patients with solid tumors, including cholangiocarcinoma, pancreatic, and ovarian cancers. Additional study details are available at clinicaltrials.gov with the trial identifier NCT05074472.

FDA Orphan Drug Designation may be granted to investigational drugs or biological products which show promise in treating rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Certain benefits associated with Orphan Drug Designation encourage the continued development of medicines that bring novel solutions to underserved patients. Roughly 32,970 men and 29,240 women in the United States are diagnosed each year with pancreatic cancer.