On September 7, 2023 Intensity Therapeutics, Inc. ("Intensity" or the "Company") (Nasdaq: INTS), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that the US Food and Drug Administration’s Office of Orphan Products Development has granted orphan-drug designation for the treatment of soft tissue sarcoma (STS) to the three active moieties comprising INT230-6, cisplatin, vinblastine sulfate, and the diffusion enhancer SHAO-FA (8-((2-hydroxybenzoyl) amino)octanoate) (Press release, Intensity Therapeutics, SEP 7, 2023, View Source [SID1234635005]). INT230-6 is the Company’s lead product candidate.

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"The designation of cisplatin, vinblastine and our diffusion enhancer, SHAO for orphan status for STS is quite important," said Lewis H. Bender President and CEO. "The Orphan Drug Designation qualifies us for incentives including tax credits for qualified clinical trials, exemption from user fees and potentially seven years of marketing exclusivity for products containing these three key components should the Company gain approval of INT230-6 for treatment of STS."

An FDA condition to obtain orphan drug designation was for the Company to provide a scientific rationale in its application with sufficient data to establish a medically plausible basis for expecting the drug to be effective in STS. The Company submitted clinical data including immune activation results in sarcoma patients.

At ASCO (Free ASCO Whitepaper) in June 2023 Assistant Professor of Oncology at the Sidney Kimmel Cancer Center at Johns Hopkins University Christian Frederick Meyer, M.D., Ph.D., M.S., an investigator involved in Intensity’s Phase 1/2 clinical study, reported that compared to synthetic controls, median overall survival using INT230-6 alone in refractory soft tissue sarcoma subjects was prolonged by nearly 450 days with favorable safety over what would have been expected for the patient population. Data also reported at ASCO (Free ASCO Whitepaper) showed that INT230-6 when delivered locally led to a systemic immune response in several sarcoma subtypes that are considered to be non-immunogenic cancers. Intensity is planning a phase 3 registration study in STS.

About Soft Tissue Sarcoma
Soft tissue sarcoma is a broad term for cancers that start in soft tissues (muscle, tendons, fat, lymph and blood vessels, and nerves). These cancers can develop anywhere in the body but are found mostly in the arms, legs, chest, and abdomen. There are many types of sarcoma; however, the four most common are bone sarcoma (referred to as osteosarcoma), leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS) and liposarcoma. When sarcoma is metastatic prognosis is poor; even with chemotherapy, half of people diagnosed with metastatic disease die within 15 months. Each year, 12,000 people in the U.S. and 1,150 in Canada are diagnosed with soft tissue sarcomas. About 3,000 patients have bone sarcomas.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor resulting in a favorable safety profile. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient’s malignancy, leading to engagement of the immune system and systemic anti-tumor effects.

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.