On July 12, 2024 Phio Pharmaceuticals Corp., a Delaware corporation (the "Company") reported the company entered into inducement letter agreements (the "Inducement Letter Agreements") with certain holders (the "Holders") of certain of its existing warrants to purchase up to an aggregate of 545,286 shares of the Company’s common stock, $0.0001 par value (the "Common Stock"), originally issued to the Holders in February 2020 through December 2023, having exercise prices between $324.00 and $9.72 per share (the "Existing Warrants") (Filing, Phio Pharmaceuticals, JUL 12, 2024, View Source [SID1234644805]).

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The shares of Common Stock issuable upon exercise of the Existing Warrants are registered pursuant to effective registration statements on Form S-1 (Nos. 333-239779, 333-234032, 333-238204, 333-271521, 333-272526 and 333-276146) and Form S-3 (No. 333-252588).

Pursuant to the Inducement Letter Agreements, the Holders agreed to exercise for cash the Existing Warrants at a reduced exercise price of $5.45 per share in consideration of the Company’s agreement to issue new unregistered Series C Warrants (the "Series C Warrants") to purchase up to 583,098 shares of Common Stock and new unregistered Series D Warrants (the "Series D Warrants" and, together with the Series C Warrants, the "New Warrants") to purchase up to 507,474 shares of Common Stock (collectively, the "New Warrant Shares"), issued and sold at a price of $0.125 per New Warrant. The Series C Warrants will have an exercise price of $5.45 per share, will be exercisable immediately upon issuance and have a term equal to five and one-half years from the date of issuance. The Series D Warrants will have an exercise price of $5.45 per share, will be exercisable immediately upon issuance and have a term equal to eighteen months from the date of issuance.

The Company has agreed to file a registration statement providing for the resale of the New Warrant Shares issuable upon the exercise of the New Warrants (the "Resale Registration Statement"), within 20 calendar days from the date of the Inducement Letter Agreements. Pursuant to the Inducement Letter Agreements, the Company agreed not to issue, enter into any agreement to issue or announce the issuance or proposed issuance of any Common Stock or Common Stock equivalents or file any registration statement or any amendment or supplement to any existing registration statement (other than the Resale Registration Statement contemplated by the Inducement Letter Agreements and described above) until the earlier of (i) a period of 90 calendar days after the closing of the offering and (ii) the day following the date that the Company’s closing price on five consecutive trading days equals or exceeds $6.50 (each of which shall be after 30 calendar days after the closing of the offering).

The gross proceeds to the Company from the exercise of the warrants are expected to be approximately $3.1 million, prior to deducting placement agent fees and estimated offering expenses. The closing of the offering occurred on July 12, 2024.

On June 27, 2024, the Company entered into an engagement letter with H.C. Wainwright & Co., LLC ("Wainwright"), pursuant to which Wainwright agreed, among other things, to serve as the exclusive placement agent for the Company, on a reasonable best-efforts basis, in connection with the above-mentioned transaction. The Company will pay Wainwright (i) an aggregate cash fee equal to 7.5% of the gross proceeds from the exercise of the Existing Warrants and, if the New Warrants are exercised for cash, upon such exercise, and (ii) a management fee equal to 1.0% of the aggregate gross proceeds from the exercise of the Existing Warrants and, if the New Warrants are exercised for cash, upon such exercise. In connection with the above-mentioned offering, the Company also agreed to pay Wainwright $35,000 for non-accountable expenses, $50,000 for accountable expenses and $15,950 for clearing fees. Additionally, in connection with the above-mentioned offering, the Company agreed to issue to Wainwright or its designees as compensation, warrants to purchase up to 40,896 shares of Common Stock, equal to 7.5% of the aggregate number of Existing Warrants exercised in the offering and, if the New Warrants are exercised for cash, further warrants to purchase shares of Common Stock equal to the 7.5% of the aggregate number of New Warrants so exercised (the "Placement Agent Warrants"). The Placement Agent Warrants have or will have a term of five and one half years from the closing of the offering or the exercise of the New Warrants, as applicable, and an exercise price of $6.8125 per share of Common Stock.

The foregoing summaries of the Inducement Letter Agreements, the New Warrants and the Placement Agent Warrants do not purport to be complete and are subject to, and qualified in their entirety by, the forms of such documents attached as Exhibits 10.1, 4.1, and 4.2, respectively, to this Current Report on Form 8-K, which are incorporated herein by reference.

On July 12, 2024 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, reported a poster presentation at the upcoming ESMO (Free ESMO Whitepaper) Congress, taking place in Barcelona, Spain, 13-17 September 2024 (Press release, Adagene, JUL 12, 2024, View Source [SID1234644801]).

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The poster will report results of an ongoing phase 1b/2 trial of Adagene’s masked anti-CTLA-4 SAFEbody in combination with the anti-PD-1 treatment pembrolizumab. The title is:

Increased Therapeutic Index of Muzastotug (Muza, ADG126), a Masked Anti-CTLA-4 SAFEbody, in Combination with Pembrolizumab (Pembro) Enables Significant Clinical Benefits and Supports Further Clinical Development in Patients with Metastatic MSS CRC

The poster will be published in accordance with the ESMO (Free ESMO Whitepaper) embargo policy on the company’s website at www.adagene.com/pipeline/publications.

On July 11, 2024, Relay Therapeutics, Inc. (the "Company") reported to have received notice of termination of the Collaboration and License Agreement, dated December 11, 2020, as amended from time to time (the "Agreement"), with Genentech, Inc. and F. Hoffmann-La Roche Ltd (collectively, "Genentech"). Genentech elected to terminate the Agreement without cause, and the termination will become effective 180 days after the date of receipt of the notice of termination (the "Termination Date") (Filing, Relay Therapeutics, JUL 11, 2024, View Source [SID1234644893]).

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Under the Agreement, the Company and Genentech (each a "Party" and together, the "Parties") collaborate on the development and commercialization of RLY-1971 (now referred to as migoprotafib or GDC-1971), the Company’s oral, small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2. Under the terms of the Agreement, the Company received aggregate consideration of $121.8 million from Genentech, including $75.0 million in an upfront payment, $45.0 million in milestone payments as well as reimbursement of certain research and development costs.

As a result of the termination of the Agreement, the Company will not be entitled to receive any further milestones or other payments due after the Termination Date. The Parties will also cease to have any development or commercialization obligations after the Termination Date and the licenses the Company granted to Genentech pursuant to the Agreement will cease to be in effect as of the Termination Date. Other material terms of the Agreement not related to termination are set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

The foregoing description of the termination of the Agreement is only a summary of the material terms thereof, and does not purport to be complete. The description is qualified in its entirety by reference to the Agreement which the Company filed as Exhibits 10.17 and 10.18 to its Annual Report on Form 10-K for the year ending December 31, 2023.

On July 11, 2024 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science reported that to help accelerate research into new treatments for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), it is partnering with the National Cancer Institute (NCI) – part of the National Institutes of Health – on the myeloMATCH (Molecular Analysis for Therapy Choice) precision medicine umbrella trial (Press release, Thermo Fisher Scientific, JUL 11, 2024, View Source [SID1234644800]). By testing patients’ bone marrow and blood for certain genetic biomarkers using Thermo Fisher’s next-generation sequencing (NGS) technology, clinical sites can more quickly match patients with an appropriate clinical trial that tests a treatment designed to target specific mutations present in the samples.

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AML is an aggressive cancer of the bone marrow and blood and is one of the most common types of leukemia. Because it can advance quickly with a five-year survival rate of only 30-40% for people under age 60, rapid detection and effective treatment are essential to improve patient outcomes. Further, clinical practice guidelines note the importance of rapid genetic analysis to identify biomarkers that may help match patients with optimal treatments based on their unique cancer profile.

"myeloMATCH breaks new ground in many ways, not least by assembling a portfolio of sub-studies to treat patients with specific subtypes of AML and MDS through all stages of their treatment journey," said Dr. Harry P. Erba, chair of the Southwest Oncology Group (SWOG) Leukemia Committee and co-chair of the myeloMATCH Senior Science Council. "Many more treatment options are available for people with AML and MDS than just 5-10 years ago, and many more targeted therapies are being developed. However, to choose the best treatment option for our patients requires knowledge of the genetic changes that underly the disease, which vary between patients. This information is needed quickly in order to begin effective therapy for very aggressive cancers. Our partnership with Thermo Fisher allows us to obtain the required genomic profiling rapidly and begin therapies specific for each subtype of the disease. Through this personalized approach to treatment, we believe we will increase the number of people who are leukemia survivors."

The study aims to complete genomic testing and deliver complete results within a few days across testing modalities to help quickly enroll patients into specific sub-studies based on their biomarker profile at time of diagnosis. As the first turnkey NGS solution that automates the specimen-to-report workflow designed to deliver results in a single day with just two user touchpoints, the Ion Torrent Genexus System* will help accelerate the process of matching patients with appropriate clinical trials.

myeloMATCH will be open in the U.S. and Canadian sites of the NCI National Clinical Trials Network, which includes more than 2,200 sites. Further, the NCI’s Division of Cancer Treatment and Diagnosis has developed cooperative research and development agreements with many pharmaceutical companies that will provide different drugs to support myeloMATCH. By conducting multiple treatment sub-studies specific to genomic types, myeloMATCH may help fuel the development of promising new therapies.

"myeloMATCH is an immense step forward for patients with aggressive and rapidly advancing cancers who need better treatment options," said John Sos, senior vice president and president, life sciences solutions at Thermo Fisher Scientific. "Using the Genexus System, clinical teams across sites can quickly match eligible patients with the right trials to ultimately better understand the clinical impact of these therapies. By helping to expedite this process, we can ensure that more patients have access to appropriate precision oncology treatments."

Patient samples will be sequenced in the myeloMATCH Molecular Diagnostics Laboratory Network (MDNet) using the Genexus System and reagents along with the Oncomine-based NCI Myeloid Assay as part of an approved Investigational Device Exemption (IDE) to assign participants to myeloMATCH treatment studies and has received Investigational New Drug authorization by the U.S. Federal Drug Administration. The MDNet sites at the Molecular Characterization Laboratory, part of the Frederick National Laboratory for Cancer Research, and the Fred Hutchinson Cancer Center in Seattle, Wash., are funded by NCI for this activity. As presented during the 2023 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, the assay demonstrated high sensitivity and reproducibility between sites.

To learn more about myeloMATCH, please visit View Source

On July 11, 2024 ADM Korea, a subsidiary of Hyundai Bioscience, reported on the 8th that the first clinical trial target population for its niclosamide-based oral metabolic anticancer drug will be ‘prostate cancer patients resistant to hormone therapy (Press release, Hyundai Bioscience, JUL 11, 2024, View Source [SID1234644799]).’

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Metabolic anticancer drugs regulate the metabolic pathways of cancer cells to induce their death. The niclosamide-based metabolic anticancer drug not only regulates the metabolic pathways of cancer cells to induce their death but also blocks the signaling pathways of cancer cells that avoid anticancer effects, thus inhibiting drug resistance.

Currently used anticancer drugs, including hormone therapies, chemotherapies, targeted therapies, and immunotherapies, all fail to resolve the issue of cancer cell drug resistance that arises with long-term treatment. Cancer cell resistance refers to the phenomenon where cancer cells activate cell signaling pathways that help them evade the effects of anticancer agents through repeated drug administration, thereby decreasing the efficacy of the drugs. The biggest challenge in anti-cancer treatment is solving the problem of cancer cell drug resistance, but no drug has yet been developed to address this.

Niclosamide is a drug that has been identified to inhibit the Wnt/β-catenin and STAT3 cell signaling pathways, which are activated when cancer cells develop resistance to anticancer drugs, thereby suppressing cancer cell drug resistance. Numerous studies have shown that when niclosamide is used in combination with chemotherapies (such as SN38 and azacitidine), immunotherapies (PD-L1 Ab), targeted therapies (erlotinib), and hormone therapies (enzalutamide), the anticancer effects are superior to those of single-agent treatments. However, due to the longstanding issues of low absorption and short half-life, niclosamide has not been repurposed as an anticancer drug over the past 60 years.

CNPharm, which plans to enter into an exclusive license agreement with ADM Korea, has overcome these two issues with its patented technology, successfully repurposing niclosamide as an oral metabolic anticancer drug.

In a triple-negative breast cancer model animal study conducted by CNPharm, the combination treatment of the chemotherapeutic agent docetaxel and the niclosamide-based metabolic anticancer drug showed 67% greater anticancer effects compared to the docetaxel-only treatment group. Additionally, in a three-month animal toxicity study of the oral niclosamide-based metabolic anticancer drug, the blood concentration at the NOAEL (No Observable Adverse Effect Level) of niclosamide was 7,888 ng/mL, and cancer cell proliferation was found to be reduced by 50% at a concentration of less than one-tenth of NOAEL level (65~654 ng/mL) in in vitro study, confirming the drug’s safety. The niclosamide-based drug is an oral medication offering convenience and ease of administration.

ADM Korea plans to conduct clinical trials combining existing treatments with the oral niclosamide-based metabolic anticancer drug for all terminal cancer patients who have developed resistance to existing anticancer drugs. Initially, in August, ADM Korea will submit an IND to the Ministry of Food and Drug Safety of the Republic of Korea for a clinical study combining hormone therapy and the niclosamide-based metabolic anticancer drug in prostate cancer patients resistant to hormone therapy. ADM Korea received a proposal for this combination therapy clinical study from a domestic prostate cancer expert in mid-May. ADM Korea decided to conduct the clinical trial on prostate cancer patients first, as the number of prostate cancer patients is steadily increasing, there is no suitable treatment for patients resistant to hormone therapy, the clinical trial period for prostate cancer is relatively shorter (taking about four weeks), and higher therapeutic effects compared to other cancers can be expected.

According to a recent paper published in the Lancet, the number of prostate cancer patients worldwide is expected to more than double from 1.4 million in 2020 to 2.9 million in 2040. The global prostate cancer market is predicted to reach approximately 29.8 trillion KRW by 2025.

Combining niclosamide with existing anticancer treatments is expected to solve the problem of drug resistance, significantly enhancing the effectiveness of anticancer therapy compared to single-agent treatments, and drastically improving the quality of life for cancer patients.

Vice President of ADM Korea Jin Geun-woo said, "The clinical trial is designed to verify the safety and efficacy of combining niclosamide-based metabolic anticancer drug and hormone therapy in prostate cancer patients over four weeks by observing PSA levels. According to Clinical Cancer Research article {20.12 (2014)}, in animal models with tumors resistant to secondary hormone therapies for prostate cancer, enzalutamide alone reduced tumors by only about 5%, while the combination of niclosamide and enzalutamide resulted in a tumor reduction of about 72%. The niclosamide-based metabolic anticancer drug will mark a historic turning point in prostate cancer treatment."