On October 4, 2024 Beijing Avistone Biotechnology Co., Ltd (also referred to as "Avistone Biotechnology" or "Avistone"), an innovative biotechnology company focused on precision oncology therapeutics, reported that the Phase I dose escalation study evaluating ANS014004 ("ANS01"), a novel small-molecule type II c-Met tyrosine kinase inhibitor (TKI) was recently cleared to proceed with enrollment of patients in Canada by Health Canada (Press release, Avistone Pharmaceuticals, OCT 4, 2024, View Source [SID1234647048]). The U.S. Food and Drug Administration (FDA) cleared ANS01’s Investigational New Drug (IND) Application last year and the trial is currently enrolling US patients in the dose escalation portion of the phase 1 study. Detailed information on the trial can be found at View Source

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There is also a concurrent, ongoing Phase I study operating in China and detailed information on this study can be found at: View Source

Both Phase I studies are enrolling patients diagnosed with locally advanced or metastatic solid tumors harboring a pathogenetic MET alteration (including MET mutation, MET amplification, MET overexpression, or MET fusion) and the primary objectives are (1) to evaluate the tolerability and safety of ANS014004 and (2) to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ANS014004.

Mesenchymal epithelial transition (MET) proto-oncogene receptor tyrosine kinase (RTK) is a cell surface receptor selective for hepatocyte growth factor (HGF), and is involved in embryogenesis regulation, wound healing, organ regeneration, angiogenesis, and immunomodulation. Aberrant MET oncogenic alterations include MET exon 14 skipping (MET∆ex14) mutations; activating mutations in the kinase domain; MET gene amplification; MET fusions; and MET protein overexpression. These oncogenic alterations occur in a wide range of human solid cancers.

Presently, type I c-Met inhibitors are used as monotherapies in patients with locally advanced or metastatic NSCLC with MET∆ex14 mutations. However, development of post-treatment resistance to type I c-Met inhibitors occurs clinically, including through acquired mutations in codons D1228 and Y1230. No drugs have been approved globally for MET alteration indications other than MET∆ex14 mutations. Next generation MET inhibitors are thus needed to treat patients harboring various MET oncogenic alterations beyond MET∆ex14, including post-treatment acquired mutations.

On October 4, 2024 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vector-based cancer vaccines targeting neoantigens, reported that updated safety data, as well as compelling immunogenicity and durability of T cell response from its Phase 1b/2 study evaluating NOUS-209 in Lynch Syndrome carriers will be presented at the 39th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 annual meeting (6th – 10th November 2024, Houston, TX, USA) (Press release, NousCom, OCT 4, 2024, View Source;utm_medium=rss&utm_campaign=nouscom-to-present-updated-positive-data-on-nous-209s-potential-to-intercept-cancer-in-lynch-syndrome-carriers-at-sitc-2024 [SID1234647033]).

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NOUS-209 is an innovative and unique off-the-shelf vaccine encoding 209 neoantigens that are shared across sporadic and hereditary Microsatellite Instable (MSI) tumors. Lynch Syndrome (LS) is one of the most prevalent hereditary cancer syndromes affecting approximately one in 300 people. LS carriers have a high-risk predisposition to developing MSI tumors with an up to 80% lifetime risk of developing colorectal cancer (CRC). Currently, there are no treatment options for LS carriers, other than active surveillance and / or prophylactic surgery. NOUS-209 monotherapy has the potential to ‘intercept’ cancer before it occurs in these individuals.

Interim results in the first ten LS participants from a Phase 1b/2 study (NCT05078866) were reported in a late-breaking abstract and presented at the SITC (Free SITC Whitepaper) 2023 demonstrating good safety and robust and broad CD4 and CD8 T cell immunity of NOUS-209 monotherapy (D’Alise et al.1).

Abstract details are as follows:

Abstract Title: Nous-209 vaccine induces shared neoantigen immunogenicity for cancer interception in healthy Lynch Syndrome carriers: results from Phase Ib/II trial
Abstract Number: 638
Presenter: Dr Eduardo Vilar

NOUS-209 is also being evaluated in a randomized, global multicenter Phase 2 trial for the treatment of deficient mismatch repair (dMMR)/MSI-High tumor patients with unresectable or metastatic CRC in combination with pembrolizumab (NCT04041310).

On October 4, 2024 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that the Company will introduce proof-of-concept data for its new CD3 Switch-DARPin designed to overcome current T cell engager challenges in solid tumors, as well as present additional analyses from its Phase 1 study of MP0317 in patients with advanced solid tumors, at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held November 8-10 in Houston, TX (Press release, Molecular Partners, OCT 4, 2024, View Source [SID1234647017]).

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The poster presentation details are as follows:

Title: Unlocking precision: a next generation multi-specific CD3 Switch-DARPin with enhanced function to tackle the current limitations of T cell engagers in ovarian cancer
Abstract & Poster Number: 842

Title: Comprehensive biomarker analyses from a Phase 1 study reveals marked tumor microenvironment modulation in patients with advanced solid tumors treated with MP0317, a FAP-localized CD40 agonistic DARPin
Abstract & Poster Number: 612

Timing & Location: November 9, 2024 at 9 am – 8:30 pm CT; Exhibit Halls AB

The posters will be made available on Molecular Partners’ website after the conference.

On October 4, 2024 Onchilles Pharma, a private biotech company developing pan-cancer therapeutics that leverage the ELANE pathway, a novel innate immune mechanism of action for potent and selective cancer killing, reported that it will present new preclinical data for its NEU-002 program for systemic delivery at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Onchilles Pharma, OCT 4, 2024, View Source [SID1234647034]). The meeting will be held both virtually and at the George R. Brown Convention Center in Houston from November 8-10, 2024.

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Presentation Details

Poster Title: NEU-002 leverages a cancer-specific innate immune pathway to induce immunogenic cell death and stimulate anti-tumor immunity

Abstract Number: 1297

Date and Time: Friday, November 8, 2024, 9:00 a.m. to 7:00 p.m. CST

Location: George R. Brown Convention Center, Level 1, Exhibit Halls AB or at View Source

About the NEU-002 Program and the ELANE Pathway

Onchilles’ scientific founder, Dr. Lev Becker, discovered that human neutrophils release neutrophil elastase (ELANE), which selectively and potently kills cancer cells while sparing healthy cells. This novel innate mechanism of action, known as the ELANE pathway, was published in the journal Cell in 2021. Targeting the ELANE pathway enables the eradication of cancer cells regardless of their genetic makeup, anatomical origin, or immune status. Building on these findings, Onchilles has developed NEU-001 (N17350) for intratumoral delivery and NEU-002 for intravenous delivery and has generated an extensive preclinical dataset showing strong monotherapy efficacy across many tumor types. This efficacy is mediated by immunogenic cancer cell death and mobilization of the immune system, leading to durable responses in preclinical mouse models.

On October 4, 2024 ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, reported that it has entered into a clinical trial collaboration and supply agreement with MSD (a subsidiary of Merck & Co., Inc., Rahway, NJ, USA), to evaluate ABL103 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced or metastatic solid tumors (Press release, ABL Bio, OCT 4, 2024, View Source [SID1234647018]).

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Under the terms of the agreement, ABL Bio will conduct a phase 1b/2 clinical trial to evaluate the safety and efficacy of ABL103 in combination with KEYTRUDA. In this combination study, MSD will supply KEYTRUDA.

ABL103 is bispecific antibody that simultaneously targets B7-H4 and 4-1BB. ABL103 is one of the pipeline programs in which ABL Bio’s 4-1BB based bispecific antibody platform ‘Grabody-T’ has been applied. Grabody-T is designed to activate T cells only in the tumor microenvironment, reducing the liver toxicity of conventional 4-1BB monoclonal antibody and enhancing the antitumor activity.

ABL103 also has mechanism to activate the 4-1BB signaling pathways in the tumor microenvironments where the B7-H4 antigens exist, allowing T cells to selectively attack tumor cells while sparing normal cells. Currently, the dose escalation part of the phase 1 clinical trial for ABL103 is ongoing in South Korea.

Sang Hoon Lee, CEO of ABL Bio said "we are pleased to enter into this clinical collaboration agreement with MSD. With this agreement, we are ready to move on to the next stage of ABL103 clinical development. We hope that the combination of ABL103 and KEYTRUDA contributes to a better life for patients with advanced or metastatic solid tumors. To date, the phase 1 study for ABL103 monotherapy is progressing smoothly, and we will do our best in clinical development to achieve meaningful results from ABL103."

Meanwhile, ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. More than 15 clinical projects for more than 7 assets, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In the case of ABL001, the U.S. Food and Drug Administration (FDA) recently granted Fast Track designation to support the rapid development of this new drug candidate. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.