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.

On April 3, 2023 Addex Therapeutics Ltd (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported that it has entered into a definitive agreement with a leading institutional healthcare investor (the "Investor") to sell 7,999,998 shares in the form of 1,333,333 American Depositary Shares ("ADSs") at a gross purchase price of $0.95 per ADS (Press release, Addex Therapeutics, APR 3, 2023, View Source [SID1234629728]). Each ADS represents six shares. Additionally, Addex has agreed to issue unregistered pre-funded warrants to purchase 3,929,825 ADSs (the "Unregistered Pre-Funded Warrants") at a funded amount of $0.94 with $0.01 payable on exercise as well as unregistered warrants to purchase up 5,263,158 ADSs (the "Unregistered Warrants" and together with the "Unregistered Pre-Funded Warrants", the "Warrants") in a concurrent private placement. The Unregistered Warrants have an exercise price of $1 per ADS, will become exercisable in 90 days after their date of issuance and will expire five years from their date of issuance. Each ADS represents 6 ordinary shares.

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The gross proceeds to Addex, before deducting offering expenses, will be $5.0 million. Addex intends to use the net proceeds from this offering to advance its portfolio of drug candidates and for general corporate purposes.

The closing of the offering is expected to occur on or about April 5, 2023, subject to the satisfaction of customary closing conditions.

Addex also entered into warrant repricing transactions with the Investor to amend previously issued warrants to reduce the exercise price of such warrants, as well as to amend certain other terms. The warrants to be amended were originally issued in private placements that closed on December 21, 2021 ("Original 2021 Warrants") and July 26, 2022 ("Original 2022 Warrants"). The Original 2021 Warrants are currently exercisable at $6.50 per ADS to purchase an aggregate of up to 1,538,462 ADSs. The Original 2022 Warrants are currently exercisable at $1.90 per ADS to purchase an aggregate of up to 2,500,000 ADSs.

By letter agreement, dated April 3, 2023, Addex and the Investor agreed to amend the Original 2021 Warrants and Original 2022 Warrants to reduce their exercise price to $1 per ADS ("Reduced Exercise Price") and certain other amendments (the "Amended Warrants"). The Amended Warrants will not be exercisable until July 5, 2023.

The ADSs (but not the Warrants or the shares underlying the Warrants) are being offered by Addex pursuant to a "shelf" registration statement on Form F-3 that was originally filed on April 7, 2021 and declared effective by the Securities and Exchange Commission ("SEC") on April 13, 2021 and the base prospectus contained therein (File No. 333-255089). The offering of the shares is being made only by means of a prospectus supplement that forms a part of the registration statement. Electronic copies of the prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at View Source

The Warrants, the shares underlying the Warrants and the Amended Warrants are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares underlying the Warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the Warrants, the Amended Warrants and underlying shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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

On April 3, 2023 Jounce Therapeutics, Inc. ("Jounce" or the "Company") and Redx Pharma plc ("Redx") reported to have agreed to terminate their proposed business combination following the decision by Jounce’s Board of Directors to withdraw the recommendation for the all-share merger transaction with Redx (the "Redx Business Combination") (Press release, Jounce Therapeutics, APR 3, 2023, View Source [SID1234629726]).

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Jounce’s decision was based upon the receipt of an unsolicited proposal from Concentra Biosciences, LLC ("Concentra"), which led to Jounce entering into a merger agreement whereby Concentra will acquire Jounce through a cash tender offer for all of Jounce’s outstanding shares for $1.85 in cash per share plus a non-tradeable contingent value right (the "CVR"). The $1.85 per share upfront consideration represents a premium of approximately 75% to Jounce’s closing share price immediately prior to the March 14, 2023, public disclosure of Concentra’s acquisition proposal.

Jounce conducted a thorough review of both the proposed transaction with Concentra and the proposed Redx Business Combination, with the assistance of its legal and financial advisers, and Jounce’s Board of Directors ultimately concluded that the proposed transaction with Concentra is in the best interest of Jounce stockholders, and therefore, unanimously approved the merger agreement with Concentra and withdrew its recommendation of the Redx Business Combination. On March 27, 2023, Jounce notified Redx of the withdrawal of its recommendation in favor of the Redx Business Combination and termination of the co-operation agreement dated February 23, 2023 between Jounce and Redx.

Given that Jounce’s Board of Directors has withdrawn its recommendation to proceed with the Redx Business Combination, Jounce believes it is unlikely that Jounce stockholders would support the Redx Business Combination, which is a condition to closing the transaction. Accordingly, Jounce and Redx have agreed not to proceed with the proposed scheme of arrangement. In addition, Jounce has confirmed that it does not wish to switch to a contractual takeover offer. As a result, the U.K. Takeover Panel has confirmed that upon Redx announcing:

its withdrawal of its recommendation;
that it will not proceed with the scheme of arrangement; and
it has agreed to the release of Jounce from its obligation to proceed with the offer,
the offer period in respect of the Redx Business Combination will end with effect from the publication of Redx’s announcement, and the transaction will lapse.

As a result, Jounce will not be convening a Jounce meeting of stockholders to consider the Redx Business Combination. Under the U.K. Takeover Code, except with consent of the U.K. Takeover Panel, Jounce must not, among other things, announce a further offer for Redx within 12 months from the date of this announcement.