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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

On April 10, 2024 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported positive preclinical data regarding the Company’s next-generation anthracycline, Annamycin, was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 5-10, 2024 in San Diego, CA (Press release, Moleculin, APR 10, 2024, View Source [SID1234641983]).

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The poster titled, Non-cardiotoxic Properties of Annamycin, a Clinically Evaluated Anthracycline and Potent Topoisomerase 2β Poison, was presented in the "Late-Breaking Research: Experimental and Molecular Therapeutics 2" session held on Monday, April 8th. The presented poster outlined results from the assessment and comparison of the potency of doxorubicin (a commonly prescribed anthracycline) and Annamycin, Moleculin’s next-generation anthracycline, against topoisomerase II-alpha and II-beta and determine their impact on physiology of human cardiomyocytes demonstrating no pathologic changes in mice hearts following chronic in vivo exposure.

"Cardiotoxicity continues to be a significant side effect limiting the clinical use of anthracyclines, despite anthracyclines representing some of the most important treatments available for AML and Advanced STS. These data, documenting lack of cardiotoxicity of Annamycin and aligned with the data demonstrated to date in our ongoing clinical trials, bolster our confidence in Annamycin potential to offer patients a safe and effective treatment option. Interestingly, the presented data demonstrates that Annamycin appears to be a significantly more potent inhibitor of topoisomerase II-beta than doxorubicin providing validation for additional studies to reevaluate the role of topoisomerase II-beta in anthracycline induced cardiotoxicity," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.

"Additionally, with our recently issued patent, which covers composition of matter protection across all indications, we have the potential to expand the development of Annamycin into greater patient populations in indications where cardiotoxicity remains a significant unmet need. We remain highly encouraged by Annamycin and committed to advancing its development," concluded Mr. Klemp.

As part of the presented data, the potency of Annamycin and doxorubicin to inhibit topoisomerase II was tested in DNA relaxation assays using recombinant topoisomerase II-alpha and II-beta with kinetoplast as the DNA substrate. Annamycin and doxorubicin cytotoxicity was assessed in a panel of cancer cell lines cardiomyocytes (murine and human). In addition, the effects on cardiomyocyte physiology (beating rate, contraction, electric potential,) were assessed in human cardiomyocytes using the xCELLigence RTCA CardioECR. The pathophysiology of the heart after chronic exposure to the drugs was also evaluated in mice models.

Key Data Highlights:

Annamycin demonstrated to be a more potent topoisomerase II-alpha and II-beta poison than doxorubicin.
In contrast to doxorubicin:
Annamycin does not affect viability of established culture of human iPSCc cardiomyocytes (tested up to 1.5 μM)
Annamycin does not affect contractility or the electric potential of the cardiomyocytes
Rat cardiomyocytes (H9c2) appear to be resistant to ANN while sensitive to DOX
Annamycin is well tolerated by the animals even at schedules exceeding the therapeutic dosage while ex vivo pathology examination of the mice confirmed no toxicity to the heart/myocardium.
These data are clearly aligned with the lack of drug-related cardiotoxic events in Annamycin-treated patients in ongoing clinical trials
The role of topoisomerase II-beta in cardiotoxicity of anthracyclines should be further investigated
A video on the comparison of cardiotoxic effects of Annamycin and doxorubicin on human cardiomyocytes can be accessed here
The Company also announced that the United States Patent and Trademark Office (USPTO) formally issued U.S. Patent number 11,951,118 titled, "Preparation of Preliposomal Annamycin Lyophilizate" (the ‘118 patent’) to Moleculin and The University of Texas System Board of Regents.

Annamycin is currently being evaluated in ongoing clinical trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. For more information about the ongoing trials, please visit clinicaltrialsregister.eu: EudraCT 2020-005493-10 or clinicaltrials.gov: NCT05319587; and clinicaltrials.gov: NCT04887298, respectively.