On April 3, 2023 Ashvattha Therapeutics ("Ashvattha"), a clinical-stage company developing a new class of nanomedicines, reported that the company will present preclinical data at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) and the Association for Research in Vision and Ophthalmology (ARVO) 2023 annual meetings (Press release, Ashvattha Therapeutics, APR 3, 2023, View Source [SID1234629734]). The presentations will showcase the potential of Ashvattha’s pipeline of nanomedicines to transverse tissue barriers to selectively target activated cells in regions of inflammation. The poster presented at AACR (Free AACR Whitepaper) will be published in an online-only Proceedings supplement to the AACR (Free AACR Whitepaper) journal Cancer Research on Friday, April 14.

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Details for the presentations are as follows:

AACR Annual Meeting 2023
April 14 – 19, 2023
Orange County Convention Center, Orlando, Florida

Poster Title: A potent macrophage switching drug D-4559 reduces tumor growth in a hepatocellular carcinoma mouse model
Session Title: Late-Breaking Research: Immunology 2
Abstract Presentation Number: LB208
Presenter: Naze Avci, Ph.D., Ashvattha Therapeutics
Date/Time: Tuesday, April 18, 2023, 9:00 a.m. – 12:30 p.m. ET
Location: Poster Section 36

ARVO 2023 Annual Meeting
April 23 – 27, 2023
The New Orleans Ernest N. Morial Convention Center, New Orleans, Louisiana

Title: Oral Formulation Development of the Anti-Angiogenesis Drug D-4517.2 to Treat Age-related Macular Degeneration (wet-AMD) and Diabetic Macular Edema (DME)
Session Title: AMD: New drugs, delivery systems and mechanisms of action 2
Presenter: Natacha Le Moan, Ph.D., Ashvattha Therapeutics
Session Number: 204
Date/Time: Monday, April 24, 2023, 12:45 p.m. – 1:00 p.m. CT
Location: Room R01

Title: Suppression of subretinal neovascularization in Vldlr knockout mice by systemic administration of a targeted VEGF-receptor inhibitor
Session Title: Cellular pathways underlying retinal degeneration
Presenter: Elia Duh, M.D., Johns Hopkins University School of Medicine
Session Number: 415
Poster Presentation Number: 3900-B0180
Date/Time: Wednesday, April 26, 2023, 10:30 a.m. – 12:30 p.m. CT
Location: Exhibit Hall – B

On April 3, 2023 Ascendis Pharma A/S (Nasdaq: ASND) reported that initial dose escalation data from the Company’s ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β/γ alone or in combination with pembrolizumab has been accepted for online publication at ASCO (Free ASCO Whitepaper) 2023, the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held June 2-6 in Chicago (Press release, Ascendis Pharma, APR 3, 2023, View Source [SID1234629733]). TransCon IL-2 β/γ is an investigational novel long-acting prodrug with sustained release of an IL-2Rβ/γ-selective analog (IL-2β/γ) designed to address the drawbacks of interleukin-2 (IL-2) cancer immunotherapy through prolonged activation of IL-2Rβ/γ with low Cmax.

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"We look forward to sharing this initial dose escalation data, which will guide our selection of the recommended Phase 2 dose of monotherapy TransCon IL-2 β/γ in this ongoing Phase 1/2 trial," said Stina Singel, Executive Vice President, Head of Clinical Development, Oncology at Ascendis Pharma. "Our goal is to address the known shortcomings of current IL-2 immunotherapy, such as short half-life and high Cmax. We believe that our novel approach to achieving sustained activation and expansion of the cytotoxic immune cell types while avoiding upregulation of immunosuppressive cells could, if successful, lead to a potentially best-in-class cancer immunotherapy product."

The primary objectives of the Phase 1 portion of the ongoing Phase 1/2 IL-Believe Trial are to evaluate the safety and tolerability and to define the maximum tolerated dose and recommended Phase 2 dose of TransCon IL-2 β/γ alone or in combination with pembrolizumab in adults with locally advanced or metastatic solid tumors.

About TransCon IL-2 β/γ1
Recombinant interleukin-2 (IL-2, aldesleukin) is an approved cancer immunotherapy but may cause severe side effects including cytokine release syndrome (CRS) and vascular leak syndrome (VLS). This is believed to be due to activation of IL-2Rα+ endothelial cells and inflammatory eosinophils as well as high Cmax due to the short half-life requiring frequent high-dose administrations. Potent activation of immunosuppressive IL-2Rα+ regulatory T cells (Tregs) may also limit IL-2’s efficacy. TransCon IL-2 β/γ is a novel long-acting prodrug with sustained release of an IL-2Rβ/γ-selective IL-2 analog designed to address these shortcomings. In pre-clinical studies, TransCon IL-2 β/γ has demonstrated improved pharmacokinetics and profound expansion of cytotoxic immune cells in animal models.

On April 3, 2023 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that its first patient with advanced inoperable pancreatic cancer has been treated in a feasibility and safety study of Alpha DaRT at the Jewish General Hospital ("JGH") in Montreal, Canada, which is an affiliated teaching hospital of McGill University, Faculty of Medicine (Press release, Alpha Tau Medical, APR 3, 2023, View Source [SID1234629731]).

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The trial seeks to recruit 30 participants who have Stage II, III, or IV pancreatic cancer and who have a pancreatic tumor which is deemed inoperable due to non-resectability, metastasis, or lack of fitness for surgery. The study will primarily examine the safety and feasibility of placing the Alpha DaRT sources in the tumor utilizing endoscopic ultrasound, and the overall safety of the procedure by measuring adverse events. In addition, the study will examine the efficacy of Alpha DaRT in terms of metrics such as overall response rate, overall survival and change in blood levels of CA19-9 (a blood-based biomarker often correlated with metrics such as disease progression). Additional information about the trial can be found at View Source

Alpha Tau CEO Uzi Sofer commented, "Getting this trial underway is another huge milestone for the Company, as we continue to focus on treating tumors in internal organs. We would like to thank Dr. Corey Miller of the JGH for enrolling and treating the first patient in this very important feasibility and safety trial." Mr. Sofer added, "This trial is a cornerstone of our overall strategy to broaden the use of the Alpha DaRT in other hard-to-treat indications such as cancers of the brain, lung, vulva and breast. We look forward to the preliminary results of this trial, which we hope will further our goal of advancing the use of Alpha DaRT across a range of indications and helping patients worldwide."

Corey Miller, MD, CM, FRCPC, Director of Therapeutic Endoscopy of the Division of Gastroenterology of the JGH, Assistant Professor of Medicine at McGill University, Associate Researcher at the Lady Davis Institute, and the principal investigator of the trial, commented "The treatment of this first patient represents a major milestone of an on-going partnership between the departments of Gastroenterology and Radiation Oncology of the JGH, the McGill Centre for Translational Research in Cancer (MCTRC) of the Lady Davis Institute, MEDTEQ+ (the pan-Canadian consortium for research and innovation in medical technologies) and the Institute TransMedTech." Dr. Miller continued "Patients with stage II, III, or IV of pancreatic cancer have limited and, often, ineffective treatment options. With the Alpha DaRT technology and our expertise in developing novel advanced endoscopic techniques, we are thrilled to offer patients with inoperable advanced pancreatic cancer an innovative therapeutic option. We hope that the Alpha DaRT treatment will offer better outcomes to these patients with such a challenging disease. We appreciate the unconditional support from Alpha Tau and the MCTRC who worked together to eliminate any barriers for opening this trial at our hospital and for securing a straightforward procedure for Alpha DaRT insertion into the pancreatic tumor."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On April 3, 2023 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application, allowing the company to initiate the OPTIMIZE-2 Phase 2 trial evaluating its lead asset mitazalimab in urothelial carcinoma (Press release, Alligator Bioscience, APR 3, 2023, View Source [SID1234629730]).

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Urothelial carcinoma accounts for approximately 90 percent of bladder cancers, which is the most common malignancy involving the urinary system[1], with 83,000 new patients and 16,700 deaths each year in the U.S.[2]

This open-label, multi-center study aims to assess the safety and efficacy of an immunotherapeutic combination of mitazalimab (CD40 mAb) and a PD-1 inhibitor, in adult patients with histologically confirmed urothelial carcinoma, and who have progressed following prior treatment with PD-(L)1 therapy. The study will take place in approximately 15 to 20 clinical sites across the U.S. and Europe.

"This IND approval allows us to advance our lead asset mitazalimab into clinical development in a new indication, urothelial carcinoma, the most common type of bladder cancer," said Søren Bregenholt, CEO of Alligator Bioscience. "We have demonstrated the clinical activity of mitazalimab in combination with chemotherapy in an interim analysis of OPTIMIZE-1, showing its potential to provide significant clinical benefit over standard of care. The experiences and data from the mitazalimab program thus far was used to de-risk and enhance the design of OPTIMIZE-2, and we strongly believe in mitazalimab’s potential to benefit patients with urothelial carcinoma that has become refractory to prior checkpoint inhibitor-therapy."
OPTIMIZE-2 will consist of a dose-finding phase with two mitazalimab dose levels in combination with a PD-1 inhibitor to select a recommended Phase 2 dose (RP2D). Thereafter, patient enrolment will be expanded at the RP2D, enabling primary analysis. Objective response rate as per RECIST 1.1 criteria will be the primary efficacy endpoint of the study.

Alligator Bioscience expects the OPTIMIZE-2 study to begin in H1 2024, or earlier, subject to operational feasibility.

Mitazalimab is currently being evaluated in OPTIMIZE-1, a Phase 1b/2 study assessing its safety and efficacy in combination with mFOLFIRINOX in patients with previously untreated metastatic pancreatic cancer. Interim efficacy results from the Phase 2 part of the trial announced in January demonstrated a 52% objective response rate. Top-line data from this trial are expected in Q1 2024.

On April 3, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, reported its financial results for the fourth quarter and full year 2022 and provided a business update (Press release, AIM ImmunoTech, APR 3, 2023, View Source [SID1234629729]). As previously announced, the Company will host its inaugural conference call and audio webcast, today, Monday, April 3, 2023, at 8:30 AM ET (details below).

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"2022 was a year marked by continued successful operational, clinical and regulatory execution across our development pipeline. We made significant progress building upon our solid foundation of pre-clinical and clinical work to advance Ampligen. Our team is committed to the development of Ampligen for unmet medical needs in cancers, immune disorders and viral diseases. Further, we have launched a new corporate website to better communicate our plans and progress. AIM’s goal is to generate near- and long-term value for all stockholders," commented Thomas K. Equels, Chief Executive Officer of AIM.

Recent Highlights

Launched new corporate website to align with the Company’s mission and vision going forward: advancing immunology solutions for a better future.
Nancy K. Bryan, pharmaceutical industry veteran, appointed to Board of Directors.
Announced the publication of a new analysis of the ability of Ampligen (rintatolimod) to inhibit the spread and replication of Ebola virus disease, which adds to the body of evidence supporting Ampligen’s potential as an early-onset prophylactic therapy against human Ebola outbreak. Additionally, the data from the analysis was presented in a late-breaking presentation at the 36th International Conference on Antiviral Research (ICAR).
Commenced its Phase 2 study of Ampligen for the treatment of pancreatic cancer and began recruiting patients.
Entered into an external sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca to evaluate the potential of AIM’s Ampligen in combination with AstraZeneca’s Imfinzi (durvalumab) for the treatment of pancreatic cancer.
Broadened patent portfolio with new Netherlands utility patent covering Ampligen and other AIM-developed dsRNA products to include rugged dsRNA for use in COVID-19 treatment or prevention.
Appointed Christopher McAleer, Ph.D. as Scientific Officer.
Presented positive safety, tolerability and biological activity data for intranasal Ampligen in healthy subjects at the British Society for Immunology Congress 2022.
Expected Upcoming Pipeline Milestones

Q2 2023

Locally Advanced Pancreatic Cancer: Enroll first patient in Phase 2 study
Locally Advanced Pancreatic Cancer: Dose first patient in Phase 2 study
Post-COVID Conditions: IRB approval to commence Phase 2 study
Post-COVID Conditions: Enroll and dose first patient in Phase 2 study
Q3 2023

Advanced Recurrent Ovarian Cancer: Announce formal interim results
Q4 2023

Metastatic Pancreatic Cancer: Begin clinical trial
Post-COVID Conditions: Enroll last patient in Phase 2 study
Summary of Financial Highlights for Fiscal Year 2022

As of December 31, 2022, AIM reported cash and cash equivalents of $34.2 million, compared to $48.3 million as of December 31, 2021.
Research and development expenses for the year ended December 31, 2022 were $7.0 million, compared to $7.7 million for the year ended December 31, 2021.
General and administrative expenses were $13.1 million for the year ended December 31, 2022 compared to $8.7 million for the year ended December 31, 2021.
Please refer to the full 10-K for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host its inaugural quarterly conference call and live audio webcast to discuss the operational and financial results on today, April 3, 2023, at 8:30 AM ET.

The call will be hosted by members of AIM’s leadership team, Thomas K. Equels, Chief Executive Officer and Christopher McAleer, PhD, Scientific Officer. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The live webcast will be accessible on the Events and Presentations page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.