On May 23, 2023 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company utilizing a proprietary human memory B cell platform to discover and develop antibody therapeutics to improve patient care, reported the publication of data highlighting efficacy of its preclinical IL-38 blocking antibody, titled "IL-38 blockade induces anti-tumor immunity by abrogating tumor-mediated suppression of early immune activation," in the peer-reviewed journal mAbs (Press release, Immunome, MAY 23, 2023, View Source [SID1234631981]). The data in the article demonstrates that antibody-based targeting of IL-38 reactivates the immunostimulatory anti-tumor mechanisms within the tumor microenvironment in preclinical testing.

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"Although immune checkpoint inhibitors have transformed how we treat cancer, these therapies are only effective in a small subset of patients. This highlights a significant need for continued innovation in this space," said Matthew Robinson, Ph.D., Chief Technology Officer of Immunome. "Our Discovery Engine identified IL-38 as a potentially interesting immuno-oncology target. Based on our work highlighting the antitumor activity associated with targeting this novel cytokine and its marked expression across a range of cancers, including head and neck, lung, gastroesophageal, and others, we believe targeting IL-38 could benefit a number of patients."

Key highlights from the study are:

IL-38 is expressed across all stages of disease in a range of tumors of high unmet medical need
An anti-IL-38 antibody, identified by Immunome, inhibits tumor growth in two in-vivo preclinical cancer models
Treatment in these models with the IL-38 blocking antibody resulted in increased levels of intra-tumoral chemokines
Animals whose tumors fully resolved, when rechallenged, are resistant to tumor growth, suggesting the induction of immunological memory

Purnanand Sarma, Ph.D., President and Chief Executive Officer of Immunome, added, "These initial preclinical results support both the continued development and the approach we have taken in our patent filings for our anti-IL-38 program. We remain committed to leveraging the full power of our technology platform to continue advancing new and potentially transformative options for cancer patients."

On May 23, 2023 Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Limited, committed to cutting-edge antibody technology innovation and provider of integrated solutions from "Idea to IND" (I to ITM), reported that it has entered into an agreement with ModeX Therapeutics, an OPKO Health company, for the use of Nona’s platforms to support ModeX’s development of multispecific antibody therapeutics (Press release, ModeX Therapeutics, MAY 23, 2023, View Source [SID1234631980]).

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Under the terms of the agreement, ModeX will have access to Nona Bioscience’s fully human Harbour Mice platforms to accelerate discovery of monoclonal antibodies to be integrated into ModeX’s MSTAR platform. This is intended to significantly reduce an often time-consuming step of the preclinical development process. The MSTAR platform is designed to layer multispecific functionality onto industry standard antibody designs to enable a much wider range of functionality and disease applicability. The collaboration aims to leverage each company’s unique strengths to drive forward the discovery of cutting edge treatments.

"We are delighted to enter into this collaboration with ModeX Therapeutics," Jingsong Wang, M.D., Ph.D., Chairman of Nona Biosciences, said, "We believe that our discovery platforms are highly complementary to ModeX’s approach and are pleased to be able to offer a solution with the potential to speed the discovery of antibodies that ModeX can leverage in multispecific research and development."

"We look forward to partnering with Nona Biosciences to accelerate and enhance our discovery of novel multispecific antibody constructs that our team can advance into clinical development," said John Mascola, M.D., Chief Scientific Officer at ModeX.

On May 23, 2023 ImmPACT Bio USA, Inc. ("ImmPACT BIO"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, reported that it will participate at the 2023 Jefferies Healthcare Conference, to be held from June 7-9, 2023, in New York, NY (Press release, ImmPACT-Bio, MAY 23, 2023, View Source [SID1234631979]).

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Sumant Ramachandra, M.D., Ph.D., ImmPACT Bio’s president and chief executive officer, will provide a corporate update and participate in a live Q&A session on Wednesday, June 7, 2023, at 2:00 PM ET. A live webcast of the presentation can be accessed at https://bit.ly/3Mhkkdv.

On May 23, 2023 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage mRNA-immunotherapy company, reported that it will participate in the SVB Securities Biopharma Company Connect event, taking place virtually May 24th- 25th, 2023 (Press release, Myeloid Therapeutics, MAY 23, 2023, View Source [SID1234631978]).

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Myeloid management will participate in virtual one-on-one meetings with investors during the event.

On May 23, 2023 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading commercial-stage innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, reported that ATG-022, a Claudin 18.2 antibody drug conjugate (ADC) in-house discovered and developed by Antengene, has been granted two Orphan Drug Designations (ODD) consecutively by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer (Press release, Antengene, MAY 23, 2023, View Source [SID1234631977]). To date, Antengene has received 3 ODDs from the FDA for two of its in-house products.

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Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. Orphan Drug Designations by the U.S. FDA are meant to support the development of drug candidates that could potentially bring substantial therapeutic benefits to patients with rare diseases (a condition with a prevalence of less than 200,000 in the U.S.), and to provide incentives to the subsequent development, registration and commercialization to designated drugs. Those incentives include tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, and 7-year market exclusivity in the U.S. regardless of the patent status of the designated drug.

ATG-022 is an antibody-drug-conjugate targeting Claudin 18.2. Claudins are cell adhesion molecules normally expressed within the tight junctions between cells to form a barrier that regulates cell permeability. In cancer, Claudins are expressed at the cell surface due to changes in cell polarity. The Claudin 18.2 isoform is overexpressed in various primary malignant tumors including gastric, esophageal and pancreatic cancers. The Phase I CLINCH study of ATG-022 in patients with advanced or metastatic solid tumors, already approved by the China National Medical Products Administration (NMPA) and Bellberry Human Research Ethics Committee (HREC) in Australia, is currently ongoing in China and Australia.

"We believe the that Orphan Drug Designation represents an important regulatory milestone for ATG-022, recognizing the significant and urgent unmet need for new treatments to help patients who are fighting difficult to treat and devastating diseases such as pancreatic and gastric cancers," said Dr. Amily Zhang, Antengene’s Chief Medical Officer. "We are enthusiastic about the potential for ATG-022 to treat gastric and pancreatic cancers. Moving forward, Antengene will work closely with regulators and clinical investigators to advance the CLINCH trial and fully assess ATG-022’s therapeutic potential for solid tumors."

About Gastric cancer

Gastric cancer is malignancy arises in the gastric epithelium. According to the statistic for 2019 of the World Health Organization’s (WHO), gastric cancer was ranked the ninth by mortality among all cancers. In 2022, there were an estimated 26,000 gastric cancer diagnoses and 11,000 gastric cancer-related death in the U.S. The current 5-year survival of patients with metastasized and local gastric cancers are 70% and 32%, respectively[1].

About Pancreatic cancer

Pancreatic cancer is a highly malignant type of gastrointestinal cancer. According to the statistics of the World Health Organization (WHO), pancreatic cancer was ranked 13th and 7th globally by its incidence rate and mortality rates in 2012. In 2018, the U.S. reported over 55,000 newly- diagnosed pancreatic cancer cases and 44,330 related deaths. Whereas pancreatic cancer is still defined as an orphan disease currently, it is projected that by 2030, pancreatic cancer will become the second most common cause of cancer-related deaths.

About ATG-022

ATG-022 is an antibody-drug-conjugate targeting Claudin 18.2. Claudins are cell adhesion molecules normally expressed within the tight junctions between cells to form a barrier that regulates cell permeability. In cancer, Claudins are expressed at the cell surface due to changes in cell polarity. The Claudin 18.2 isoform is overexpressed in various primary malignant tumors including gastric, esophageal and pancreatic cancers.

Data from preclinical studies, including results from gastric cancer-patient derived xenograft models presented at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2022), showed that ATG-022 binds to Claudin 18.2 with low nanomolar affinity and demonstrated potent in vitro and in vivo antitumor effects, including in vivo efficacy demonstrated in Claudin 18.2 low expression models. This could pave the way for broad clinical utility of ATG-022 in gastric cancer patients with a wide range of Claudin 18.2 expression levels. ATG-022 demonstrated an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies.