On April 10, 2024 Tallac Therapeutics, Inc., a privately held clinical stage biopharmaceutical company pioneering the discovery and development of novel antibody-oligonucleotide conjugates, reported the presentation of preclinical data demonstrating TAC-001 potentiates cancer vaccine efficacy and rejuvenates vaccine responses (Press release, Tallac Therapeutics, APR 10, 2024, View Source [SID1234641989]). TAC-001 is an investigational, systemically delivered, Toll-like Receptor Agonist Antibody Conjugate (TRAAC) molecule, designed to selectively activate B cells to drive an anti-tumor immune response. The data will be presented today as part of the Vaccines, Antigens, and Antigen Presentation 2 session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2024 Annual Meeting taking place in San Diego, April 5-10, 2024.

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The findings presented in the poster "A B cell targeted TLR9 Agonist Antibody Conjugate Potentiates Cancer Vaccine Efficacy and Rejuvenates Vaccine Responses in the Elderly" demonstrate that in combination with cancer vaccines, TAC-001 promotes robust and durable vaccine specific IgG titers, skews humoral response to Th1 phenotype, and rejuvenates vaccine responses. Moreover, TAC-001 enhances vaccine specific T cell activation and cytotoxic activity. As a result, anti-tumor vaccine efficacy is greatly improved by the combination with TAC-001. "The emerging data on TAC-001 in combination with cancer vaccines enhances our understanding of TAC-001 mechanisms in eliciting humoral and cellular anti-tumor immunity and provide a compelling rationale for combining TAC-001 with cancer vaccines in the clinic. This preclinical proof of concept expands the prospective therapeutic application of TAC-001 in oncology and other disease indications" said Dr. Hong I. Wan, president, CEO, and co-founder of Tallac Therapeutics.

AACR Poster Presentation Details:

Title: "A B cell targeted TLR9 Agonist Antibody Conjugate Potentiates Cancer Vaccine Efficacy and Rejuvenates Vaccine Responses in the Elderly."
Session Type: Poster Session
Session Category: Immunology
Session Title: Vaccines, Antigens, and Antigen Presentation 2
Abstract Number: 6746
Section 4, April 10, 9:00AM-12:30PM
About TAC-001 (CD22 TRAAC)

TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC) comprised of a potent toll-like receptor 9 agonist (T-CpG) conjugated to an antibody against CD22, a receptor restricted to B cells, including tumor-infiltrating B cells. TAC-001 is designed to systemically deliver T-CpG to B cells by binding to CD22, leading to internalization of TAC-001, TLR9 signaling, B cell activation and a cascade of immune reactions. Preclinical studies demonstrate that the innate and adaptive immune responses triggered by TAC-001 lead to potent anti-tumor activity. TAC-001 is being developed for the treatment of solid tumors and is currently in a Phase 1/2 Study in cancer patients (NCT05399654). Emerging clinical data demonstrating tolerability, pharmacodynamic activity and preliminary clinical activity of single agent TAC-001 were observed (SITC 2023).

On April 10, 2024 Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Michael A. Metzger, Chief Executive Officer of Syndax, will participate in a fireside chat at the at Stifel 2024 Virtual Targeted Oncology Forum on Wednesday, April 17, 2024, at 11:00 a.m. ET (Press release, Syndax, APR 10, 2024, View Source [SID1234641988]).

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A live webcast of the fireside chat can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.

On April 10, 2024 Stamford Pharmaceuticals Inc, a clinical-stage biotechnology company developing science-driven immune therapies, reported initiation of its locally advanced basal cell carcinoma (laBCC) trial (NCT06344052) (Press release, Stamford Pharmaceuticals, APR 10, 2024, View Source [SID1234641987]). The study will evaluate SP-002, an adenoviral-based immunotherapy, in combination with Roche’s vismodegib (Erivedge), a Hedgehog Pathway inhibitor (HHPI), approved for the treatment of adult patients presenting with locally advanced and metastatic basal cell carcinoma. The phase 2 clinical study is funded with proceeds from a Series A led by Tenmile Ventures, Prevail Partners and other syndicate parties completed in October 2023.

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"We are excited to progress SP-002 in combination with HHPI into this subset of locally advanced BCC patients. This study was motivated by encouraging results observed in clinical studies evaluating SP-002 as a monotherapy or in combination with HHPI in other BCC settings. We believe there is an opportunity to further improve patient benefit in locally advanced BCC patients based on the current standard of care." said Clement Leong, PhD., CEO of Stamford Pharmaceuticals.

On April 10, 2024 OncoNano Medicine, Inc. reported a late-breaking poster detailing the preclinical efficacy and safety of muONM-412, an ON-BOARD nanoparticle-encapsulated murine interleukin-12 fusion protein (IL-12Fc), and in vitro characterization of ONM-412, encapsulating human IL-12Fc, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 in San Diego, California (Press release, OncoNano Medicine, APR 10, 2024, View Source [SID1234641985]).

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Despite its potent pleiotropic and well-established anti-cancer effects, the clinical application of IL-12 has been hindered by significant adverse toxicities. OncoNano developed ON-BOARD, an ultra-pH sensitive nanoparticle platform, to shield payloads from systemic exposure and target solid tumors by responding to the highly acidic tumor microenvironment. Encapsulation of payloads like IL-12 by ON-BOARD may provide the opportunity to improve the therapeutic index of a variety of anti-cancer therapies.

"As part of the study presented at AACR (Free AACR Whitepaper), the preclinical safety and activity of muONM-412 were evaluated with the data demonstrating it significantly improved tolerability over unencapsulated IL-12Fc while showing potent antitumor efficacy in mice. Findings also reveal that ONM-412 illustrates favorable stability and pH-responsive IL-12 bioactivity in vitro," said Tian Zhao, Ph.D., Vice President of Research and Development for OncoNano Medicine. "We believe our ON-BOARD ultra-pH sensitive micelle technology can transform the targeted delivery of oncology therapeutics and look forward to continuing the development of new treatments for patients with cancer."

muONM-412 key findings:

Exhibited improved tolerability in vivo compared to unencapsulated IL-12Fc through the observation of reduced body weight loss, absence of liver toxicity and lower plasma IFNy levels.
Induced tumor immune remodeling, with increased infiltration by IFNγ+ and GzmB+ CD8 T and NK cells.
Strong dose-responsive anti-tumor efficacy shown in MC38 tumor-bearing animals.
ONM-412 key findings:

Demonstrated high encapsulation efficiency (>85%) in uniformly distributed particles (Dh<50nm) with 12-month on-going shelf-life stability.
Rapid and complete recovery of IL-12 bioactivity shown <10 minutes after acid-activation.
Confirmed pH-specific release in vitro with a >100-fold activation window between the acid-activated and intact formulations by a HEK reporter assay and an IFNγ induction assay.
Presentation Overview:

TITLE: Preclinical characterization of ONM-412, an ultra-pH sensitive nanoparticle encapsulated IL-12 fusion protein
PRESENTER: Jason Miller, Ph.D., Associate Director, Research Pipeline Development, OncoNano Medicine

Link to the poster may be found on the OncoNano Medicine website at: News – OncoNano Medicine.

On April 10, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, reported that its Phase 1 dosimetry clinical trial for its novel radiopharmaceutical imaging agent MNPR-101-Zr (MNPR-101 conjugated to zirconium-89) is now active and recruiting patients with advanced cancers (Press release, Monopar Therapeutics, APR 10, 2024, View Source [SID1234641984]). The antibody MNPR-101 targets the urokinase plasminogen activator receptor (uPAR), which is expressed on numerous tumor types including pancreatic, breast, colorectal, and bladder.

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The study is now open for enrollment at the Melbourne Theranostic Innovation Centre (MTIC) in Australia, and is being led by Professor Rodney Hicks, an internationally recognized physician and pioneer in the radiopharma space. MTIC will use one of the world’s most sensitive, state-of-the-art, clinical total-body PET/CT (positron emission tomography–computed tomography) scanners, the Siemens Biograph Vision Quadra, to image the tumor targeting ability of MNPR-101-Zr in advanced cancer patients.

The Phase 1 dosimetry trial is evaluating the safety and dosimetry of MNPR-101-Zr in up to 12 patients with advanced cancer. Preclinical data to date have shown highly specific and durable tumor uptake of MNPR-101-Zr in human cancer xenograft models. Moreover, Monopar recently shared positive preclinical efficacy data showing potent and durable anti-tumor activity of MNPR-101 bound to therapeutic radioisotopes. If the tumor uptake, biodistribution, and safety look encouraging in this Phase 1 clinical trial for MNPR-101-Zr, the Company plans to expand the study or initiate a new study to test the potential efficacy of MNPR-101 bound to a therapeutic radioisotope such as Ac-225 in patients with advanced cancers.

"The Monopar team is quite excited about this trial initiation," said Chandler Robinson, MD, Monopar’s Chief Executive Officer. "The preclinical results to date in hard-to-treat cancers such as pancreatic and triple negative breast have impressed us, with our radiopharma program demonstrating a promising ability to selectively target and destroy uPAR expressing tumors. We are very much looking forward to seeing the biodistribution and dosimetry data from this first-in-human study in advanced cancer patients."

Further information about the MNPR-101-Zr trial is available at www.ClinicalTrials.gov under study identifier NCT06337084.