On October 4, 2024 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of potentially best-in-class IL-2 therapeutics, reported the presentation of continued promising safety and efficacy data from Phase 2 dose expansion cohorts in the Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic solid tumor cancers (Press release, Aulos Bioscience, OCT 4, 2024, View Source [SID1234647023]). The new data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, being held virtually and in Houston, Texas, from November 6-10, 2024.

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"The Phase 2 dose expansion data for our monoclonal antibody, AU-007, continue to build upon the positive clinical data presented at ASCO (Free ASCO Whitepaper) and we look forward to presenting further details, particularly early Phase 2 data in melanoma and renal cell carcinoma, at the SITC (Free SITC Whitepaper) Annual Meeting," said Aron Knickerbocker, Aulos Bioscience’s president and chief executive officer.

Details of the poster presentation are as follows:

Poster Title: A phase 1/2 dose escalation and cohort expansion study of AU-007, a human monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, plus low-dose aldesleukin in advanced solid tumors
Abstract: 685
Date and Time: Friday, November 8, 2024, 9:00 a.m.-7:00 p.m. CST

The poster will be presented in Exhibit Halls AB at the George R. Brown Convention Center. An electronic version will also be available on the SITC (Free SITC Whitepaper) 2024 virtual meeting platform.

About AU-007
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the AU-007 Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

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.

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 3, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported to gather clinical evidence for the steady improvement of its AI-Immunology platform (Press release, Evaxion Biotech, OCT 3, 2024, View Source [SID1234647026]).

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The platform’s precision has significantly improved between the two clinical trials with Evaxion’s personalized cancer vaccine EVX-01. In the ongoing phase 2 trial, 81 out of 103 (79%) vaccine targets assessed to date triggered a tumor-specific immune response, a notable increase from the 58% observed in the phase 1 trial completed last year.

The high number of immune-active vaccine targets is observed across all patients. The ability to trigger a broad and consistent tumor-specific immune response is pivotal for a vaccine’s clinical efficacy and, thereby, critical for the vaccine’s commercial potential and ability to address unmet medical needs.

"As a truly AI-first TechBio company, Evaxion rests on our leading AI-Immunology platform and its continued improvement remains a top priority for us. It is, of course, very pleasing to see that we are successful in that work, reaching 79% of identified vaccine targets triggering an immune response in the ongoing EVX-01 phase 2 trial. This compares very favorably to data reported from other personalized cancer neoantigen trials. We are further pleased that the clinical outcome data are also very strong, providing us with a compelling AI-Immunology derived investigational vaccine candidate." says Christian Kanstrup, CEO of Evaxion.

The improvement of the AI-Immunology platform’s predictive capabilities results from iterative learning loops, optimization based on clinical data and the integration of novel bioinformatic and machine learning methodologies.

About AI-Immunology
AI-Immunology is a scalable and adaptable artificial intelligence technology platform at the forefront of vaccine discovery for infectious diseases and cancers. By integrating the collective power of proprietary AI models PIONEER, EDEN, RAVEN, and ObsERV, the platform can model the complexity of the patient’s immune system. AI-Immunology advanced computational modeling swiftly and uniquely identifies, predicts, and designs vaccine candidates, revolutionizing the landscape of immunotherapy by offering a holistic and personalized approach to combat fast-evolving pathogens and malignant cells.

On October 3, 2024 OS Therapies (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, reported that the last patient (Patient #41) enrolled in the AOST-2121 clinical trial (NCT04974008) of OST-HER2 in recurred, resected Osteosarcoma (OS) has completed their final radiographical evaluation at 52 weeks and the treatment period for the clinical trial has now ended (Press release, OS Therapies, OCT 3, 2024, View Source [SID1234647022]). The Company is preparing to request a Type C Meeting with the U.S. Food & Drug Administration (FDA) and to make any protocol adjustments based on FDA’s recommendations. Following those adjustments, the Company will lock the clinical trial database in preparation for data analysis and topline data readout, expected to be announced in the fourth quarter of 2024.

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Concurrent with this announcement the Company announces that it will be ringing the closing bell at the New York Stock Exchange today. Company President and CEO Paul Romness is scheduled to give two interviews live on national television networks:

"B" Block in Market Movers on Fintech.TV at 9:10am on Thursday, October 3, 2024
Trading 360 on the Schwab Network at 11:30am on Thursday, October 3, 2024
OST-HER2, a biologic therapeutic candidate, is a Lm (Listeria monocytogenes) vector-based off-the-shelf immunotherapeutic vaccine designed to prevent metastasis, delay recurrence, and increase overall survival in patients with Osteosarcoma. The AOST-2121 Phase 2b clinical trial of 41 patients treated with OST-HER2 at 21 clinical trial sites across the United States is designed to demonstrate efficacy in patients who have already had recurrent metastatic disease to the lungs and are highly likely to continue to recur. A total of 16 OST-HER2 doses were administered once every three weeks, with a follow-up approximately four weeks after the final dose was administered, for a total of 52 weeks on study. Radiographic evaluation of recurrence occurred throughout the treatment period. The primary endpoints for the AOST-2121 study are Event Free Survival ("EFS"), defined as absence of recurrence of primary tumor or metastasis) at 12 months and Overall Survival (OS) at 36 months, with interim OS endpoints at 12 months, 18 months and 24 months. Topline EFS data, interim OS data, as well as additional secondary data analyses are expected to be reported in the fourth quarter of 2024.

The proposed OST-HER2 mechanism of action is based on innate and adaptive immune stimulating responses activated by the Lm vector. This treatment generates T-cells that can eliminate or slow potential micro-metastases that can grow into recurrent Osteosarcoma. T-cell responses target HER2 expressed by the tumor and then kill the cell, releasing additional tumor targets. There are currently no approved adjuvant treatments for recurrent Osteosarcoma in the United States. There have not been any novel therapeutic interventions approved by the FDA in over 40 years.