On September 7, 2023 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported updated survival data from its Phase 1b trial evaluating Actimab-A in combination with the salvage chemotherapy CLAG-M in patients with high-risk relapsed or refractory acute myeloid leukemia (r/r AML) and new preclinical data with Actimab-A in combination with FLT3 inhibitors at the Society of Hematologic Oncology (SOHO) 2023 Annual Meeting (Press release, Actinium Pharmaceuticals, SEP 7, 2023, View Source;clag-m-trial-and-preclinical-data-supporting-program-expansion-with-flt3-inhibitor-combinations-at-soho-301920692.html [SID1234635004]). In addition, results of the completed and positive Phase 3 SIERRA trial of Iomab-B were presented.

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SOHO Data Highlights:

Updated Actimab-A + CLAG-M Phase 1b Study Results:

– 30-month median Overall Survival (OS) in patients with prior venetoclax treatment who proceeded to bone marrow transplant (BMT) following Actimab-A + CLAG-M
– 24-month median OS in all patients who proceeded to BMT following Actimab-A + CLAG-M
– 100% measurable residual disease (MRD) negativity in patients with prior venetoclax treatment and 75% MRD negativity in all patients
– 83% of patients (19/23) had high-risk r/r AML; 57% of patients (13/23) received prior treatment with venetoclax
– Patients who relapse after venetoclax treatment have poor survival outcomes with a limited percentage of patients proceeding to BMT

Poster Title: Sequential Salvage Chemotherapy and Lintuzumab-Ac225 in Relapsed/Refractory AML Results in Deep Responses and Prolonged Survival in Adverse Risk Acute Myeloid Leukemia (AML) and in AML Patients that Received Prior Venetoclax Therapy

"These data continue to demonstrate the broad potential and applicability of targeted radiotherapeutics as well as Actinium’s leadership position in their development for r/r AML and other blood cancers," said Sandesh Seth, Actinium Chairman and CEO. "As we progress Actimab-A + CLAG-M to a pivotal trial, we are highly encouraged by this new follow-up data showing 100% MRD negativity and median survival of 30 months in patients proceeding to transplant who had prior venetoclax treatment. Given the significant number of patients with AML who receive venetoclax treatment and, unfortunately, have disease relapse, better therapeutic options are needed for this growing patient segment. We are excited by the potential of Actimab-A to meet this high unmet need given its differentiated mechanism of action and clinical profile thus far."

Actimab-A Program Expansion into FLT3 Mutant AML:

– Actimab-A shown to have single-agent cytotoxic activity against FLT3 mutant AML cell lines
– The addition of Actimab-A enhances the anti-leukemic activity of FLT3 inhibition of approved FLT3 inhibitors gilteritinib (Xospata, Astellas) and midostaurin (Rydapt, Novartis) in vitro
– FLT3 mutations are associated with aggressive disease with poor outcomes and occur in approximately 30% of patients, making it one of the most commonly mutated genes in AML
– Combinations of Actimab-A with FLT3 inhibitors can potentially be explored under Actinium’s CRADA with the NCI

Poster Title: Antileukemic Activity of Lintuzumab-Ac225 in Preclinical Model of FLT3 Mutant AML

Mr. Seth added, "The mutation agnostic mechanism of action, potent cell killing ability and synergistic potential of Actimab-A provides multiple avenues for development as evidenced by this new preclinical data supporting combinations with FLT3 inhibitors. With FLT3 gene mutations being the most common in AML, we are excited to further Actimab-A’s backbone potential by continuing to explore this novel combination that could address approximately 30% of the AML patient population."

On September 7, 2023 Strata Oncology, Inc. ("Strata"), a next-generation precision oncology company enabling smarter and earlier cancer treatment, reported new data showing its proprietary biomarker algorithm, Immunotherapy Response Score (IRS), supports informed clinical decisions for first-line treatment of patients with non-small cell lung cancer (NSCLC) beyond the standard of care biomarker PD-L1 immunohistochemistry (IHC) (Press release, Strata Oncology, SEP 7, 2023, View Source [SID1234635003]).

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The data from Kaiser Permanente Northern California — the first of its kind for first-line treatment of patients with NSCLC — will be presented at the 2023 World Conference on Lung Cancer in Singapore on Sunday, September 10, 2023 in the Pathology and Biomarkers – Biomarkers for Immuno-Oncology poster session from 5:30 PM to 7:30 PM SGT.

A pre-specified blinded analysis of more than 200 NSCLC patients initially treated with pembrolizumab either alone or in combination with chemotherapy, showed that IRS was significantly associated with time-to-next-treatment (TTNT) independent of therapy type and PD-L1 IHC by tumor proportion score (TPS). Subgroup analysis demonstrated that among patients with PD-L1 High (TPS>=50%), IRS High patients had significantly longer single-agent pembrolizumab TTNT than IRS Low patients, illustrating the opportunity to fill a clear unmet need.

"In NSCLC with PD-L1 TPS>=50%, guidelines recommend either pembrolizumab alone or in combination with chemotherapy. IRS can potentially guide treatment selection in this important and frequent clinical scenario," said Kat Kwiatkowski, Ph.D., Strata Oncology SVP, Clinical Development. "Given the significant difference between IRS groups, IRS High status would favor treatment with pembrolizumab alone, whereas IRS Low status would favor combination therapy."

IRS has been validated as a pan-solid tumor predictive biomarker for anti-PD-1/PD-L1 checkpoint inhibitor monotherapy benefit in multiple studies, most recently in a publication in Cancer Research Communications, where the clinical utility of IRS beyond standard biomarkers used to guide anti-PD-1/PD-L1 therapy, including tumor mutation burden (TMB), microsatellite instability (MSI) and PD-L1 IHC was shown. This study also demonstrated the clinical utility of IRS as a useful tool to help guide the choice between chemotherapy alone, anti-PD-1/PD-L1 monotherapy, or anti-PD-1/PD-L1 in combination with chemotherapy, across five tumor types where this is a critical treatment decision.

"Our Immunotherapy Response Score meets a significant unmet medical need for an integrative diagnostic test that can predict benefit across tumor types, and in this case, specifically help clinicians make informed decisions for first-line treatment of patients with NSCLC," said Scott Tomlins, M.D., Ph.D., Strata Oncology co-founder and Chief Medical Officer. "This new data marks significant progress in the effort to provide clinicians with the ability to make accurate and precise treatment recommendations that patients with NSCLC require."

Immunotherapy Response Score is available clinically as part of the Strata SelectTM test, which is covered for Medicare beneficiaries with advanced solid tumors seeking additional treatment. Learn more at View Source

On September 7, 2023 Oncolytics Biotech Inc. ("Oncolytics" or the "Company") (NASDAQ: ONCY) (TSX: ONC) reported that in connection with the previously announced underwritten public offering of US$15,000,750 (the "Offering") and the underwriting agreement dated August 1, 2023 (the "Underwriting Agreement"), Leede Jones Gable Inc. (the "Underwriter") has exercised their option (the "Over-Allotment Option"), in full, to purchase 1,000,050 units (the "Optioned Units") at US$2.25 for aggregate gross proceeds of US$2,250,112 (Press release, Oncolytics Biotech, SEP 7, 2023, View Source [SID1234635002]). The Company intends to use the proceeds from the Offering to continue the advancement of its pelareorep clinical programs in metastatic breast and pancreatic cancers, as well as general corporate and working capital purposes.

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Each Optioned Unit consists of one common share of the Company (each a "Common Share") and one Common Share purchase warrant (each a "Warrant"). Each Warrant entitles the holder thereof to purchase one Common Share at an exercise price of US$2.81 at any time up to 60 months following the Closing, subject to acceleration in certain circumstances. Pursuant to the Underwriting Agreement, in consideration for the services rendered by the Underwriter in connection with the Offering, the Company paid to the Underwriter a cash commission equal to 7.0% of the aggregate gross proceeds raised from the Offering and issued to the Underwriter such number of compensation warrants (the "Compensation Warrants") as is equal to 7.0% of the aggregate number of Optioned Units sold in the Offering. Each Compensation Warrant is exercisable into one Common Share (an "Underwriter’s Warrant Share") at an exercise price of US$2.25 per Underwriter’s Warrant Share at any time up to 60 months following the Closing.

The Offering is being made by way of a prospectus supplement to the Company’s short form base shelf prospectus filed on August 1, 2023 in each of the provinces and territories of Canada, except Quebec, pursuant to National Instrument 44-101 – Short Form Prospectus Distributions and National Instrument 44-102 – Shelf Distributions.

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This press release does not constitute an offer for sale of securities, nor a solicitation for offers to buy any securities in the United States, nor in any other jurisdiction in which such offer, solicitation or sale would be unlawful. Any public offering of securities in the United States must be made by means of a prospectus containing detailed information about the company and management, as well as financial statements.

On September 7, 2023 Mustang Bio, Inc. ("Mustang") (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, reported that Manuel Litchman, M.D., President and Chief Executive Officer, will participate in two upcoming investor conferences in New York City (Press release, Mustang Bio, SEP 7, 2023, View Source [SID1234635001]).

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Details of the events are as follows:

H.C. Wainwright 25th Annual Global Investment Conference: The company will present a corporate update on Monday, September 11, 2023, at 3:30 p.m. ET and will participate in one-on-one meetings during the conference.

2023 Cantor Fitzgerald Global Healthcare Conference: The company will participate in a panel presentation on Wednesday, September 27, 2023, at 8:35 a.m. ET and will participate in one-on-one meetings during the conference.

A webcast and subsequent archived replay of each of the company’s presentations will be available on the News & Events page of the Investor Relations section of Mustang’s website, www.mustangbio.com, for approximately 30 days after each meeting.

On September 7, 2023 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a commercial-stage biopharmaceutical company, reported the company changed its name to DMK Pharmaceuticals Corporation in order to better reflect its new strategic focus on advancing small molecules for the treatment of substance use disorders (Press release, Adamis Pharmaceuticals, SEP 7, 2023, View Source [SID1234635000]). In conjunction with the name change, the company’s common stock is expected to trade under the new Nasdaq ticker symbol "DMK" on or about September 8, 2023. The CUSIP number for the common stock, 00547W307, will remain unchanged.

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"The new DMK Pharmaceuticals is committed to developing groundbreaking and innovative therapies to establish itself as a leader in the treatment of substance abuse including opioid and alcohol use disorders," said Eboo Versi, MD, PhD, CEO of Adamis, "Rebranding the company signifies our new strategic vision and reinforces our commitment to a renewed corporate strategy. Along with our flagship approved treatment for emergency treatment of opioid overdose, ZIMHI, our lead clinical stage compound, DPI-125 will be our core focus. DPI-125 is a novel molecule for the treatment of opioid use disorder. Currently approved therapies are old and the vast majority of sufferers are not getting this medical treatment. I believe this is because they have unfavorable drug scheduling resulting in limited access, and in many cases, patients have to undergo opioid withdrawal symptoms prior to starting treatment. It is my belief that DPI-125, if successfully developed, will receive a more favorable drug scheduling and be a more ‘patient friendly’ treatment. DPI-125 is also being developed for the treatment of moderate to severe pain. If clinical studies confirm what we suspect from animal studies, this drug will not be addictive and as such could even help to reduce the incidence of opioid use disorder."

DMK expects several potential significant milestones for DPI-125 by the end of 2024 including: manufacture of a transdermal delivery system; results of a respiratory depression safety study compared to fentanyl; results of a pharmacokinetic study in humans; and results of an abuse liability study compared to current treatments for OUD and pain relief, in each case assuming the availability of adequate funding and no unexpected developments or delays. There can be no assurances that any of these milestones will be achieved or will be achieved within the anticipated time periods.