On October 15, 2021 Antengene reported that The 36th Annual Meeting of the Society for Immunotherapy for Cancer (SITC 2021) will take place in Washington, D.C., United States, on November 10-14, 2021 (Press release, Antengene, OCT 15, 2021, View Source [SID1234591309]). The SITC (Free SITC Whitepaper)’s annual meeting is the world’s largest gathering in the field of immuno-oncology. The event is dedicated to promoting exchanges and collaborations in the field in order to improve treatment outcomes for cancer patients. At this year’s event, Antengene will release data of its PD-L1/4-1BB bispecific antibody, ATG-101, and its ERK1/2 inhibitor, ATG-017, in poster presentations both online and offline.

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Details of those poster presentations are as follows:

Abstract Number: 227
Title: A computational semi-mechanistic pharmacology model of ATG-101, a PD-L1/4-1BB bispecific antibody for treatment of solid tumors and NHL
Time: 7:00-17:00 EST, November 12-14, 2021
Presenter: Dr. David C. Flowers, Applied BioMath, LLC
First Author: Dr. David C. Flowers, Applied BioMath, LLC

Abstract Number: 608
Title: Synergistic effect of the combination of ATG-017, an ERK1/2 inhibitor, and immune checkpoint inhibitor in preclinical cancer models
Time: 7:00-17:00 EST, November 12-14, 2021
Presenter: Dr. Bing Hou, Antengene Corporation Limited
First Author: Dr. Peng Chen, Antengene Corporation Limited

Abstract Number: 893
Title: ATG-101, a novel PD-L1/4-1BB bispecific antibody, augments anti-tumor immunity through immune checkpoint inhibition and PDL1-directed 4-1BB activation
Time: 7:00-17:00 EST, November 12-14, 2021
Presenter: Dr. Bing Hou, Antengene Corporation Limited
First Author: Dr. Hui Yuwen, Antengene Corporation Limited

About ATG-101

ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of multiple kinds of cancer. ATG-101 can activate anti-tumor immune effectors by simultaneously blocking the binding of PD-L1/PD-1 and inducing 4-1BB stimulation. In PD-L1 over-expressed cancer cells, ATG-101 has shown potent PD-L1 crosslinking-dependent 4-1BB agonist activity, thus potentially enhancing therapeutic efficacy, whilst mitigating risk of hepatoxicity. Antengene is currently conducting a Phase I study of ATG-101 in Australia for the treatment of patients with metastatic/advanced solid tumors and non-Hodgkin lymphoma.

About ATG-017

ATG-017 (AZD0364) is a potent and selective small molecule extracellular signal-regulated kinases 1 and 2 (ERK1/2) inhibitor. ERK1/2 are related protein-serine/threonine kinases that function as terminal kinases in the RAS-MAPK signal transduction cascade. This cascade regulates a large variety of cellular processes, including proliferation. The RAS-MAPK pathway is dysregulated in more than 30% of human cancers with the most frequent alterations being observed in RAS or BRAF genes across multiple tumor types. An ERK inhibitor enables the targeting of both RAS and BRAF mutant diseases. In nonclinical pharmacology studies, ATG-017 has demonstrated potent inhibition of ERK1/2 enzyme activity and tumor growth in vitro and in vivo. At present, Antengene is conducting a Phase I study of ATG-017 in Australia for the treatment of patients with advanced solid tumors and hematologic malignancies.

On October 15, 2021 Genmab A/S (Nasdaq: GMAB) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended the granting of a conditional marketing authorization in Europe for Janssen’s amivantamab, a fully human bispecific antibody, for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy (Press release, Genmab, OCT 15, 2021, View Source [SID1234591282]). In July 2012, Genmab entered into a collaboration with Janssen Biotech, Inc. to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. This is the first CHMP opinion for a product that was created using Genmab’s proprietary DuoBody technology platform.

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"Following the U.S. FDA approval of RYBREVANT earlier this year, we are extremely pleased that the CHMP has granted Janssen a positive opinion for amivantamab, the first such opinion for a product created using Genmab’s DuoBody technology platform. We are hopeful that this opinion will lead to an approval and to the first treatment option for European patients with advanced NSCLC with activating EGFR exon 20 insertion mutations," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

For more information related to Janssen’s CHMP opinion for amivantamab, click here.

On October 15, 2021 Geron Corporation (Nasdaq: GERN) reported that it will host a virtual investor event on November 9 at 4:00 p.m. ET. Topics to be covered at the event, include (Press release, Geron, OCT 15, 2021, View Source [SID1234591283]):

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The unmet medical needs in lower risk myelodysplastic syndromes and refractory myelofibrosis and the disease modification potential of imetelstat, Geron’s first-in-class telomerase inhibitor.
Expansion opportunities for imetelstat into new indications and in combination with other drugs.
A live physician panel discussion and question-and-answer session with:
Dr. Swaminathan Iyer, Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
Dr. John Mascarenhas, Associate Professor of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York
Prof. Uwe Platzbecker, Director, Clinic and Policlinic for Hematology, Cell Therapy and Hemostaseology, University Hospital, Leipzig, Germany
A live webcast of the presentation will be available through the Investor Relations section of Geron’s website under Events. Following the presentation, the webcast will be archived and available for replay for a period of 30 days.

On October 15, 2021 Hervolution Therapeutics reported that Hervolution is one of just 65 European companies to receive funding through the European Innovation Council Accelerator of 2.5M EUR (Press release, Hervolution Therapeutics, OCT 15, 2021, View Source [SID1234637208]).

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On October 15, 2021 I-Mab (the "Company") (NASDAQ: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that it has completed the patient enrollment of the phase 3 clinical trial of human CD38 antibody felzartamab (also known as TJ202) in combination with lenalidomide as a second-line therapy in patients with multiple myeloma (MM) (Press release, I-Mab Biopharma, OCT 15, 2021, View Source [SID1234591284]).

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The phase 3 trial (NCT03952091) is a randomized, open-label, parallel-controlled, multi-center study to evaluate the efficacy and safety of the combination of felzartamab, lenalidomide (LEN) and dexamethasone (DEX) versus the combination of LEN and DEX in patients with relapsed or refractory MM who received at least one prior line of treatment. The primary endpoint of the study is to evaluate the progression-free survival (PFS) comparing the efficacy of felzartamab plus LEN/DEX versus LEN/DEX. Data from this study are expected to be the major package supporting Biologics License Application (BLA) submission for second-line treatment of MM in China.

"We are delighted to have completed the patient enrollment as planned under very challenging circumstances. The results will further support the clinical program towards registration to treat patients with multiple myeloma in China," said Dr. Joan Shen, CEO of I-Mab.

I-Mab has completed the single-arm registrational trial with felzartamab and DEX as a third-line therapy for MM patients in Greater China (NCT03860038). Topline data from the study has met the primary and secondary endpoints and confirmed its clinical advantages as estimated. BLA submission is on track in Q4 2021. Further, a new IND application is planned in Q4 2021 to initiate a clinical trial for combination of felzartamab with another I-Mab clinical asset as a potential first-line treatment for MM.

About Felzartamab

Felzartamab (TJ202/MOR202) is an investigational human monoclonal antibody derived from MorphoSys’ HuCAL antibody technology. The antibody is directed against CD38 on the surface of multiple myeloma cells, which has been characterized as one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells. According to its suggested mode of action, the antibody recruits cells of the body’s immune system to kill the tumor through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). The antibody does not involve complement dependent cytotoxicity, or CDC, an additional immune mechanism involved in tumor cell killing. Scientific research suggests that an anti-CD38 antibody may have therapeutic potential also in other cancers as well as autoimmune diseases. Based on a licensing agreement between MorphoSys and I-Mab signed in November 2017, I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao.