On January 25, 2024 Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, reported that the interim analysis data from the Phase II clinical trial of oral APL-1202 in combination with PD-1 inhibitor tislelizumab as neoadjuvant therapy for muscular invasive bladder cancer (MIBC) will be presented for the first time in the form of a rapid oral presentation abstract (Abstract No. 632) at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) (Press release, Asieris Pharmaceuticals, JAN 25, 2024, View Source [SID1234639486]).

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Dr. Matt D. Galsky, MD, FASCO, from the Tisch Cancer Institute, Division of Hematology and Medical Oncology, at the Icahn School of Medicine at Mount Sinai, will be the speaker.

On January 25, 2024 Aim Immunotech presented its corporate presentation (Presentation, AIM ImmunoTech, JAN 25, 2024, View Source [SID1234639470]).

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On January 25, 2024 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten (formerly EPI-7386) in combination with enzalutamide at the 2024 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium, taking place January 25 – 27, 2024, in San Francisco, CA (Press release, ESSA, JAN 25, 2024, View Source [SID1234639487]). Masofaniten is a first-in-class N-terminal domain androgen receptor ("AR") inhibitor that suppresses androgen activity through a novel mechanism of action and is being developed for the treatment of prostate cancer. The poster presentation is available on the "Publications" section of the Company’s website at www.essapharma.com.

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"The maturing data from the Phase 1 dose escalation study evaluating masofaniten in combination with enzalutamide continue to demonstrate that the combination is well tolerated, accompanied by deep and durable reductions in circulating prostate-specific antigen ("PSA") levels. While the data are still immature, the durability of the PSA responses is encouraging with a median time to PSA progression currently at 16.6 months. The Phase 2 dose expansion head-to-head portion of the study is underway and is designed to evaluate the proportion of patients with a PSA decline on combination therapy compared to single agent enzalutamide," said David Parkinson, MD, President and CEO of ESSA. "We look forward to evaluating the potential long-term benefits of masofaniten in patients with metastatic castration-resistant prostate cancer ("mCRPC") and to providing future updates."

Poster presentation details:

Title: Phase 1/2 trial of oral EPI-7386 (masofaniten) in combination with enzalutamide (Enz) compared to Enz alone in patients with metastatic castration-resistant prostate cancer (mCRPC): Phase 1 (P1) results and phase 2 (P2) design.
Presenting Author: Christos Kyriakopoulos, MD, University of Wisconsin-Madison Carbone Cancer Center
Abstract #: 141
Date and time: Thursday, January 25, 2024; 11:30-1:00 p.m. PT

Data summary: This Phase 1/2 multicenter, open-label clinical trial enrolled patients with mCRPC who have received androgen deprivation therapy and who are naïve to second-generation antiandrogens but may have been treated previously with one line of prior chemotherapy in the metastatic hormone-sensitive prostate cancer setting. The data presented today include 18 patients across four cohorts in the Phase 1 dose escalation portion of the study. Masofaniten has no effect on enzalutamide exposure, thus allowing the use of full dose per label (160mg) of enzalutamide in combination. Enzalutamide reduces masofaniten exposure but twice daily dosing of masofaniten appears to mitigate the reduction and maintains clinically relevant drug exposures.

In patients evaluable for safety (n=18), masofaniten combined with enzalutamide, continues to be well-tolerated at the dose levels tested through 25 cycles of dosing in some patients. Most frequent adverse events were Grades 1 and 2, related to either AR inhibition or gastrointestinal tract irritation. In Cohort 4, one patient experienced a Grade 3 rash, which was observed immediately following administration of masofaniten combined with enzalutamide and deemed probably related, resulting in the expansion of the cohort from four to seven patients. No additional dose-limiting toxicities (DLTs) were observed, therefore the maximum tolerated dose (MTD) was not reached. The recommended Phase 2 combination doses (RP2CDs) were identified as masofaniten 600 mg twice daily (BID) in combination with enzalutamide 160 mg once daily (QD).

In the patients evaluable for efficacy (n=16), rapid, deep and durable reductions in PSA were observed, regardless of previous chemotherapy status, including in patients who received lower than the full dose of enzalutamide (120 mg). Across all dose cohorts, 88% of patients (14 of 16) achieved PSA50, 81% of patients (13 of 16) achieved PSA90, 69% of patients (11 of 16) achieved PSA90 in less than 90 days, and 63% of patients (10 of 16) achieved PSA <0.2ng/mL. While the data for disease PSA progression are still maturing with a current median follow up of 11.1 months, the median time to PSA progression is at 16.6 months.

The randomized, open-label, two arm, Phase 2 dose expansion portion of the study is underway and is designed to evaluate the combination of masofaniten and enzalutamide versus single agent enzalutamide in patients with mCRPC naïve to second generation anti-androgens. The study is currently enrolling at approximately 25 sites in the USA, Canada and Australia. Expansion to European sites is in progress.

About Masofaniten
Masofaniten (formerly known as EPI-7386) is a first-in-class investigational, highly selective, oral, small molecule inhibitor of the N-terminal domain ("NTD") of the androgen receptor ("AR"). Masofaniten’s unique mechanism of action disrupts the AR signaling pathway, the primary pathway that drives prostate cancer growth, by selectively binding to the NTD, a region of the AR that is not currently targeted by other therapies. Masofaniten is currently being studied in an open-label, randomized Phase 2 clinical trial (NCT05075577) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) naïve to second-generation antiandrogens. ESSA is also conducting a Phase 1 monotherapy study (NCT04421222) in patients with mCRPC whose tumors have progressed on standard-of-care therapies. The U.S. Food and Drug Administration has granted Fast Track designation to masofaniten for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to masofaniten worldwide.

On January 25, 2024 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of best-in-class IL-2 therapeutics, reported dosing of the first patient in the initial Phase 2 expansion cohorts of its Phase 1/2 clinical trial evaluating AU-007 for treatment of unresectable locally advanced or metastatic cancers (Press release, Aulos Bioscience, JAN 25, 2024, View Source [SID1234639471]). AU-007 is a human IgG1 monoclonal antibody designed to harness the power of interleukin-2 (IL-2) to eradicate solid tumors, and the first AI-designed human monoclonal antibody to be tested in a clinical trial. Phase 1 data demonstrate that AU-007 is currently the only IL-2 agent that can reduce regulatory T cells (Tregs), which suppress the immune system.

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"Dosing of the first patient in the Phase 2 portion of our AU-007 Phase 1/2 study marks a significant milestone as we advance development of this promising, novel IL-2 therapeutic for the treatment of solid tumor cancers," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "AU-007 was created to solve pressing safety and efficacy challenges associated with IL-2 therapeutics, and we are encouraged by ongoing new Phase 1 data that indicate clinical activity in several heavily pre-treated patients whose tumors progressed through checkpoint inhibitors. We are grateful to the participating patients and investigators in this clinical trial, and look forward to enrolling additional patients and presenting clinical data from the Phase 2 expansion cohorts later this year."

Aulos’ Phase 1/2 clinical trial is a two-part, open label, first-in-human study evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. The initial Phase 2 expansion cohorts focus on melanoma and renal cell carcinoma (RCC), with AU-007 administered every two weeks in combination with a single loading dose of low-dose, subcutaneous Proleukin (aldesleukin; recombinant human IL-2), or with AU-007 and low-dose, subcutaneous Proleukin, both administered every two weeks.

Created by Biolojic Design, AU-007’s unique computational design allows it to bind precisely to the portion of IL-2 that binds to CD25, which prevents IL-2 from binding to high-affinity IL-2 receptors on Tregs, vasculature, pulmonary tissue and eosinophils. This redirects IL-2 to medium-affinity receptors on effector T cells (Teffs) and natural killer (NK) cells, which expand and kill tumor cells. Phase 1 dose escalation cohort data presented at two separate medical meetings last fall demonstrate that when AU-007 is administered to patients as monotherapy or in combination with low doses of Proleukin, the number of immunosuppressive Tregs decreases and the numbers of Teffs and NK cells increase. Additionally, data indicate that AU-007 is well tolerated and tumor shrinkage was observed in patients with melanoma, bladder, kidney, head and neck, and lung cancers.

To learn more about the AU-007 clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626). For patients and providers in the U.S., please visit www.solidtumorstudy.com. For patients and health professionals in Australia, please visit www.solidtumourstudy.com.

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.

On January 25, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported the closing of its previously announced underwritten public offering of 32,379,667 shares of its common stock, which includes 5,325,000 shares sold and issued upon the exercise in full by the underwriters of their option to purchase additional shares of common stock, and, in lieu of common stock to certain investors, pre-funded warrants to purchase 8,445,333 shares of common stock (Press release, Adicet Bio, JAN 25, 2024, View Source [SID1234639488]). The shares of common stock were sold at a public offering price of $2.40 per share and the pre-funded warrants were sold at a public offering price of $2.3999 per pre-funded warrant, which represents the per share public offering price of each share of common stock minus the $0.0001 per share exercise price for each pre-funded warrant. The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $98.0 million. All of the securities in the offering were sold by Adicet.

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Jefferies and Guggenheim Securities acted as joint book-running managers for the offering. Truist Securities also acted as a joint bookrunner. Wedbush PacGrow and JMP Securities, A Citizens Company acted as co-managers.

The securities described above were offered by Adicet pursuant to a shelf registration statement that was previously filed with, and subsequently declared effective on May 9, 2022 by, the U.S. Securities and Exchange Commission ("SEC"). A final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on January 24, 2024. Copies of the final prospectus supplement and the accompanying prospectus relating to the offered securities may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected] or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.