1stOncology™: Cancer Intelligence Service – Page 5704 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Janux Therapeutics Announces Submission of Investigational New Drug Application for JANX008, an EGFR-TRACTr for Solid Tumors

On December 27, 2022 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported that the Company has submitted the investigational new drug (IND) application for JANX008 to the U.S. Food and Drug Administration, an EGFR-TRACTr in development for the treatment of EGFR-expressing solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), renal cell carcinoma (RCC), and squamous cell carcinoma of the head and neck (SCCHN) (Press release, Janux Therapeutics, DEC 27, 2022, View Source [SID1234625626]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"We are proud to announce today the submission of Janux’s second IND – a critical milestone for our TRACTr platform as we advance our broad pipeline of next generation immunotherapies," said David Campbell, Ph.D., President and CEO of Janux. "JANX008 is uniquely designed to overcome cytokine release syndrome and known on-target EGFR healthy tissue toxicities, potentially allowing a breadth of opportunities in EGFR-expressing cancers."

JANX008 is a double-masked TRACTr in which the EGFR-binding domain and the T cell-specific binding domain (CD3) is masked. In preclinical studies, JANX008 was well tolerated in non-human primates with limited healthy tissue toxicities and cytokine release syndrome and exhibited enhanced safety and PK properties relative to unmasked TCEs. These data along with the superior manufacturability properties of JANX008 support its further development as an attractive solid tumor therapeutic.

ImmunoGen Announces Webcast of Presentation and Q&A at the 41st Annual J.P. Morgan Healthcare Conference

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.

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.

Novocure to Participate in 41st Annual J.P. Morgan Healthcare Conference

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.

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.

CG Oncology to Present at the 41st Annual J.P. Morgan Healthcare Conference

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.

InnoCare Announces Approval of Tafasitamab in Combination With Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Hong Kong

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]).

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.