On October 4, 2024 AbCellera (Nasdaq: ABCL) reported an upcoming poster presentation on its T-cell engager platform at the SITC (Free SITC Whitepaper) 39th Annual Meeting, to be held November 6 to 10 at the George R. Brown Convention Center in Houston, Texas (Press release, AbCellera, OCT 4, 2024, View Source [SID1234647047]).

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Details on AbCellera’s poster presentation at SITC (Free SITC Whitepaper) are as follows:

Title: Profiling bispecific T-cell engagers: Strategies for enhancing potency while minimizing cytokine release
Abstract Number: 1291
Date and Time: Friday, November 8 from 9:00 a.m. to 7:00 p.m. CST
Location: Exhibit Halls A B George R. Brown Convention Center or online at View Source

About AbCellera’s T-Cell Engager Platform

CD3 T-cell engagers have the potential to be a cornerstone of cancer treatment. They guide the immune system to find and eliminate cancer cells by binding tumor targets and the CD3 protein on cancer-killing T cells at the same time. However, the development of T-cell engagers has been limited due to challenges with efficacy and safety. To address these challenges, AbCellera developed a T-cell engager platform that includes novel CD3-binding antibodies to expand the therapeutic window for this modality, costimulatory building blocks to enhance efficacy for difficult-to-treat cancers, and discovery capabilities to broaden the range of T-cell engagers to complex peptide-MHC tumor targets. AbCellera is leveraging its platform to unlock the full potential of this modality and bring potential new cancer medicines to patients.

On October 4, 2024 Biodexa Pharmaceuticals PLC ("Biodexa" or "the Company"), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs reported an update in respect of its open label Phase 1 study of MTX110 in recurrent glioblastoma (Press release, Biodexa Pharmaceuticals, OCT 4, 2024, View Source [SID1234647032]).

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In October 2023, the Company announced completed recruitment of four patients into cohort A of its Phase 1 study of MTX110 (also known as MAGIC-G1 study)(NCT 05324501) in patients with recurrent glioblastoma (rGBM).

MAGIC-G1 is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter. Patients received MTX110 via intermittent repeated CED infusions. As of today, the status of patients in Cohort A is as follows:

Patients #1 and #2 have deceased with overall survival (OS) since start of treatment of 12 months and 13 months, respectively.

Patients #3 and #4 remain in post-study follow-up. Patient #3 had progression free survival (PFS) of six months and OS thus far of 13 months since start of treatment. Patient #4 has not yet had confirmed progression and, as of today, has PFS and OS of 12 months since start of treatment.

Glioblastoma (GBM) is the most aggressive central nervous system (CNS) primary malignancy in adults with an annual incidence is approximately 3 per 100,000 population. The standard of care in newly diagnosed GBM includes maximal safe surgical resection, followed by concurrent radiotherapy and temozolomide (TMZ). GBM virtually always recurs with median PFS of 1.5–6.0 months and median OS of 2.0–9.0 months (source: Birzu et al. View Source).

These interim data in rGBM build on the data announced by the Company on July 2, 2024, and presented at the recent 21st International Symposium on Paediatric Neuro-Oncology (ISPNO 2024) of a Phase 1 study of MTX110 in nine patients with Diffuse Midline Glioma ("DMG") which showed, after only two infusions and a single patient at optimum dose, median OS of 16.5 months. In an earlier Phase 1 study conducted by the University of California San Francisco of MTX110 in seven patients with DMG which showed median OS of 26.1 months. These data compare favorably with median OS in a cohort of 316 cases of 10.0 months (source: Jansen et al, 2015. Neuro-Oncology 17(1):160-166).

About MTX110
MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-β-cyclodextrin (HPBCD), that enables convection-enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumor. Panobinostat is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak) is not suitable for treatment of brain cancers owing to poor blood-brain barrier penetration and inadequate brain drug concentrations. Based on favourable translational science data, MTX110 is being evaluated clinically as a treatment for recurrent glioblastoma (NCT05324501) and recurrent medulloblastoma (NCT04315064). MTX110 is delivered directly into and around the patient’s tumor via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumor to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG (DMG) and GBM tumor cells in in vitro and in vivo models, and in a key study it was the most promising of 83 anticancer agents tested in 14 patient-derived DIPG (DMG) cell lines (Grasso et al, 2015. Nature Medicine 21(6), 555-559).

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.