On March 11, 2024 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. reported that the Phase Ib/II clinical study of the company developed bispecific antibody-receptor recombinant protein drug targeting both CD47 and CD20 (Project No.: IMM0306) in combination with lenalidomide (Study No.: IMM0306-003) for the treatment of advanced relapsed/refractory follicular lymphoma (FL) was discussed at the SRC meeting and the Phase II recommended dose was determined, So the project entered Phase II clinical trial officially (Press release, ImmuneOnco Biopharma, MAR 11, 2024, View Source [SID1234655697]). This is another milestone achievement in the rapid development of ImmuneOnco.

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Previously, IMM0306 obtained permission from China’s NMPA and the US FDA to conduct clinical trials, and obtained patent authorization in China, the United States, Japan and Europe, consolidating ImmuneOnco’s leading position in the research echelon of CD47 target drug development and bispecific antibodies. Recently, the Safety Review Committee (SRC) unanimously approved 1.6mg/kg QW as the RP2D dose of IMM0306 in combination with lenalidomide for the treatment of advanced relapsed/refractory follicular lymphoma (FL) to enter Phase II for further development. In the phase I clinical study in relapsed or refractory B-cell lymphoma, IMM0306 monotherapy showed encouraging efficacy and a favorable safety profile, with no DLTs observed in any of the eight dose groups. Five cases of CR and five cases of PR were observed in four dose groups, starting from 0.8 mg/kg to 2.0 mg/kg, and the ORR of relapsed and refractory FL reached 41%. At the same time, all patients did not have significant cytokine storm toxicity.

Dr. Tian, Wenzhi, founder and chairman of ImmuneOnco, said:

"We are very pleased to see that our IMM0306 in combination with lenalidomide in patients with advanced relapsed/refractory follicular lymphoma (FL) has determined the recommended Phase II dose. Data from the Phase I clinical study showed a favorable safety and clinical efficacy of monotherapy, especially in the combination escalation study of lenalidomide, in which 11 patients with FL/MZL who failed at least one prior line of therapy were enrolled, and ORR of 75% was observed (2 patients with CR and 4 patients with PR). We firmly believe that the development of second-line follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) will be extremely competitive in the market. We will continue to promote the research of IMM0306 projects and strive to bring good news to cancer patients as soon as possible. "

Dr. Lu, Qiying, Chief Medical Officer/Senior Vice President of ImmuneOnco, said:

"Today, it is important for our company to determine the recommended dose in a Phase II clinical study of IMM0306, one of our main products, in combination with lenalidomide in patients with advanced relapsed/refractory follicular lymphoma (FL). At present, outstanding efficacy has been observed in multiple indications (including indolent lymphoma dominated by FL and MZL and DLBCL, the most common aggressive lymphoma in clinical practice), indicating that the product has broad clinical development prospects. IMM0306 Phase I data was postered at ASCO (Free ASCO Whitepaper) 2023 conference attracted the attention of many global researchers. At present, we have carried out a comprehensive layout of this product, not just a single-agent clinical development project, but also a combined LEN project to fully develop NHL indications, not only for FL, MZL, DLBCL and other indications. In the current combination escalation study with lenalidomide, in FL/MZL patients who have failed at least first-line therapy, 75% ORR was observed (2 CR patients, 4 PR patients), and the company will accelerate the clinical development of this product. We look forward to bringing new treatment options to cancer patients."

On March 11, 2024 GenScript reported its 2023 Annual Results Presentation (Presentation, GenScript, MAR 11, 2024, https://www.genscript.com/gsfiles/IPO/2023%20Annual%20Results.pdf?1153641870 [SID1234644733]).

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On March 11, 2024 Modulus Discovery, Inc (Headquartered in Chiyoda-ku, Tokyo; CEO S. Roy Kimura) reported that, effective March 11, 2024, the Company has changed its name to Alivexis, Inc (Press release, Modulus Discovery, MAR 11, 2024, View Source,Modulus%20Discovery%2C%20Inc.%20to%20Change%20Its%20Name%20to%20Alivexis%2C,its%20name%20to%20Alivexis%2C%20Inc. [SID1234644086]).

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Details】
●　New company name: Alivexis, Inc.（URL：View Source;
●　Date of change: March 11, 2024
*Please note that this change is limited to the company name; there will be no changes to the address or representatives.
*Concurrent with this name change, our subsidiary, Modulus Discovery, Inc. (Headquarters: 1 Broadway, 14th Floor, Cambridge, MA 02142; CEO S. Roy Kimura), will also be changing its name to Alivexis, Inc.

【Purpose of the Company Name Change】
Since its establishment in August 2016, we have committed to delivering groundbreaking pharmaceuticals efficiently to patients suffering from cancer, chronic immune and inflammatory diseases, and rare diseases, along with their families. Our mission has been to integrate insights into core biology, cutting-edge drug discovery platforms, and a global network-based research system to advance our unique portfolio of small molecule drug discovery projects and various research and development collaborations. Aiming to fulfill this social mission, we have been operating as a network-based drug discovery company, led by a team with extensive experience in drug discovery and computational science research within pharmaceutical and biotechnology companies, with bases in Tokyo and Boston.

As of March 2024, our strengths – (1) insights into core biology crucial to life and diseases, (2) a unique drug discovery platform, and (3) an attractive drug research pipeline – have been crystalized as clinical development candidates in three lead projects, with several more projects making significant progress into late-stage of lead optimization. Considering the substantial changes in the internal and external business environment since the company’s inception, we have changed the name of our company and its subsidiaries to "Alivexis" with the aim of further clarifying our social mission and focus areas for future business development.

【Origin of the new Company Name】
The new name "Alivexis" is a blend of "alive," signifying "life, living," "synthesis," representing "the combination of various elements to form a larger entity or concept," and "exis," meaning "to arise, to emerge." It was selected to reflect our hope that vibrant, healthy, and happy lives will emerge from our drug discovery platform and research and development activities.

【Our Mission Reinforced by Our New Identity】
Alivexis is dedicated to fostering healthier and more fulfilling lives by integrating cutting-edge drug discovery platforms, profound understanding of disease biology, and agile global business operations.

【CEO S. Roy Kimura’s Comments】
"I am thrilled to announce our new corporate name, Alivexis, which signifies the vitality of life emerging from our deep commitment and passion to deliver much needed medicines for patients and their families afflicted by various diseases. Over the last 6 years I have had the pleasure to be part of an exceptionally hard-working and talented team to accomplish what some initially thought impossible — rapidly discovering multiple novel high-value drug candidates starting from zero resources by leveraging our cutting-edge drug discovery platform. Our new name marks the beginning of the next stage in our evolution, growing from a platform-based drug discovery firm to a therapeutics driven company with a powerful platform and multiple programs nearing clinical trials. We continue to be excited about our mission to discover and deliver new medicines for patients in need around the globe.

On March 11, 2024 Assertio Holdings, a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, today reported financial results for the fourth quarter and full year ended December 31, 2023 (Press release, Assertio Holdings, MAR 11, 2024, View Source [SID1234643722]).

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On March 11, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported that Chen Schor, President and Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 2nd Annual Cell Therapy Virtual Conference being held March 26, 2024 (Press release, Adicet Bio, MAR 11, 2024, View Source [SID1234641042]).

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Details of the event are as follows:

Date: Tuesday, March 26, 2024
Time: 10:30 a.m. ET

The live audio webcast of the presentation can be accessed on the Investors section of Adicet Bio’s website at View Source An archived replay will be available for 30 days following the presentation.