On August 9, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 2,857,143 American Depositary Shares (ADSs), having an exercise price of $1.75 per ADS, issued by Can-Fite in January 2023 and November 2023 (Press release, Can-Fite BioPharma, AUG 9, 2024, View Source [SID1234645674]). The ADSs representing ordinary shares issuable upon exercise of the warrants are registered pursuant to effective registration statements on Form F-3 (File No. 333-276000) and Form F-1 (File No. 333-269485). The closing of the offering is expected to occur on or about August 12, 2024, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash, Can-Fite will issue new unregistered warrants to purchase up to 5,714,286 ADSs. The new warrants will have an exercise price of $2.25 per ADS, will be immediately exercisable until the five-year anniversary from the date of issuance with respect to 2,987,012 new warrants and the twenty-month anniversary from the date of issuance with respect to 2,727,274 new warrants.

The gross proceeds to Can-Fite from the exercise of the warrants are expected to be approximately $5.0 million, prior to deducting placement agent fees and offering expenses. The Company intends to use the net proceeds for funding research and development and clinical trials and for other working capital and general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act"), and, along with the ADSs issuable upon exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. Can-Fite has agreed to file a registration statement with the SEC covering the resale of the shares of ADSs issuable upon exercise of the new warrants.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, 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 August 9, 2024 Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb reported the submission of supplemental application of Ono’s anti-PD-1 antibody, Opdivo (generic name: nivolumab) Intravenous Infusion ("Opdivo") and BMSKK’s anti-CTLA-4 antibody, Yervoy (generic name: ipilimumab) Injection ("Yervoy") in combination therapy in Japan, to expand the use for the treatment of unresectable hepatocellular carcinoma (HCC) (Press release, Ono, AUG 9, 2024, View Source [SID1234646251]). This application is related to the additional indication for a partial change in approved items of the manufacturing and marketing approval in Japan.

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 This application is based on the results from interim analysis of the CheckMate -9DW study, a global multi-center Phase 3 clinical study (CA209-9DW: ONO-4538-92), evaluating Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib monotherapy for patients with unresectable HCC who have not received prior systemic therapy. In this study, Opdivo plus Yervoy met its primary endpoint of overall survival (OS), demonstrating a statistically significant and clinically meaningful improvement in OS compared to lenvatinib or sorafenib monotherapy. The safety profile of Opdivo plus Yervoy was consistent with previously reported data, with no new safety signals identified.

About CheckMate -9DW Study (CA209-9DW: ONO-4538-92)
 CheckMate -9DW study is a global multicenter randomized open-label Phase 3 study evaluating the combination of Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib monotherapy in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.
 668 patients were randomized to receive Opdivo plus Yervoy (Opdivo 1 mg/kg plus Yervoy 3 mg/kg Q3W for up to four doses, followed by Opdivo monotherapy 480 mg Q4W) infusion, or single agent lenvatinib or sorafenib as oral capsules in the control arm. The primary endpoint of the study is overall survival (OS) and key secondary endpoints include objective response rate (ORR) and time to symptom deterioration (TTSD).

About Hepatocellular Carcinoma
 Liver cancer is the third most frequent cause of cancer death worldwide. It is estimated that there were approximately 866,000 new cases of liver cancer worldwide in 2022, with an estimated approximately 758,000 deaths1) . In Japan, it is estimated that there were approximately 41,000 new cases of liver cancer in 2022, with an estimated approximately 26,000 deaths1) . Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and accounts for 90% of all liver cancers2) . HCC is often diagnosed in an advanced stage, where effective treatment options are limited and are usually associated with poor outcomes.
 Up to 70% of patients experience recurrence within five years, particularly those still considered to be at high risk after surgery or ablation3) . While most cases of HCC are caused by hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, metabolic syndrome and nonalcoholic steatohepatitis (NASH) are rising in prevalence and expected to contribute to increased rates of HCC.

Globocan 2022: Available at: View Source
Kim E, Viatour P. Hepatocellular carcinoma: old friends and new tricks. Exp Mol Med. 2020; 52: 1898–07.
Forner A, Reig M, Bruix J. Hepatocellular carcinoma. Lancet. 2018; 391: 1301–14.
About Opdivo
 Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response by blocking the interaction between PD-1 and its ligands. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers since the approval for the treatment of melanoma in Japan in July 2014. Opdivo is currently approved in more than 65 countries, including Japan, South Korea, Taiwan, the US and European Union.
 In Japan, Ono launched Opdivo for the treatment of unresectable melanoma in September 2014. Thereafter, Opdivo received an approval for additional indications of unresectable advanced or recurrent non-small cell lung cancer in December 2015, unresectable or metastatic renal cell carcinoma in August 2016, relapsed or refractory classical Hodgkin lymphoma in December 2016, recurrent or metastatic head and neck cancer in March 2017, unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy in September 2017, unresectable advanced or recurrent malignant pleural mesothelioma which has progressed after chemotherapy in August 2018, microsatellite instability high (MSI-High) unresectable advanced or recurrent colorectal cancer that has progressed following chemotherapy and unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy in February 2020, cancer of unknown primary in December 2021, adjuvant treatment of urothelial carcinoma in March 2022, malignant mesothelioma (excluding malignant pleural mesothelioma) in November 2023 and unresectable advanced or recurrent malignant epithelial tumors in February 2024.
 In addition, Ono has been conducting clinical development program including hepatocellular carcinoma, etc.

About Yervoy
 Yervoy is a recombinant, human monoclonal antibody, and binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Yervoy binds to CTLA-4, and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is now approved in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types. In Japan, Yervoy was approved for the indication of unresectable malignant melanoma in July 2015.

About Ono and Bristol Myers Squibb Collaboration
 In 2011, through a collaboration agreement with Bristol Myers Squibb (BMS), Ono granted BMS its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to Opdivo except the US at the time. In July 2014, Ono and BMS further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agent and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

On August 9, 2024 GenScript reported its first quarter 2024 results (Presentation, GenScript, AUG 9, 2024, https://www.genscript.com/gsfiles/IPO/2024%2dInterim%2dResults%2dEN.pdf?v=0%2e2?1018088532 [SID1234647131]).

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On August 9, 2024, INmune Bio Inc. (the "Company"), reported to have entered into an Amended and Restated At-The-Market Sales Agreement (the "Sales Agreement") with RBC Capital Markets, LLC and BTIG, LLC as sales agents pursuant to which the Company may offer and sell, from time to time, in its sole discretion, shares of its common stock, having an aggregate offering price of up to $75,000,000, subject to certain limitations on the amount of common stock that may be offered and sold by the Company set forth in the Sales Agreement (Filing, 8-K, INmune Bio, AUG 9, 2024, View Source [SID1234645675]). The Company is not obligated to make any sales of common stock under the Sales Agreement and any determination by the Company to do so will be dependent, among other things, on market conditions and the Company’s capital raising needs.

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Any shares offered and sold in the at-the-market offering will be issued pursuant to the registration statement on Form S-3 (File No. 333-279036), filed with the Securities and Exchange Commission (the "SEC"), on May 1, 2024, and declared effective on August 7, 2024, and the prospectus supplement relating to the at-the-market offering filed with the SEC on August 9, 2024, and any applicable additional prospectus supplements related to the at-the-market offering that form a part of the registration statement.

The sales agents may sell the shares of common stock by any method deemed to be an "at the market offering" as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended, including sales made through The Nasdaq Capital Market ("Nasdaq"), or any other trading market for the common stock, sales made to or through a market maker other than on an exchange or through an electronic communications network, or in negotiated transactions pursuant to terms set forth in a placement notice delivered by the Company to the sales agents under the Sales Agreement. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the sales agents will use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations, and the rules of Nasdaq, to sell the shares from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. The sales agents are not obligated to purchase any shares of common stock on a principal basis pursuant to the Sales Agreement.

The Company will pay the sales agents a commission equal to 3.0% of the gross sales proceeds of any shares sold through the sales agents under the Sales Agreement, and also has provided the sales agents with customary indemnification and contribution rights. The Company also will reimburse the sales agents for certain specified expenses in connection with entering into the Sales Agreement, as well as certain specified expenses on a quarterly basis. The Sales Agreement contains customary representations and warranties and conditions to the placements of the shares pursuant thereto, obligations to sell shares under the Sales Agreement are subject to satisfaction of certain conditions, including customary closing conditions.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. A copy of the opinion of Sichenzia Ross Ference Carmel LLP relating to the legality of the issuance and sale of the shares in the at-the-market offering is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On August 9, 2024 C&Cure (CEO Min Jeong-jun and Park Jung-gon), an anticancer drug development company in Gwangju Metropolitan City, reported the company has developed a new concept of immunotherapy using bacteria for treating cancer (Press release, CNCure, AUG 9, 2024, View Source [SID1234649035]).

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According to C&Cure on the 9th, the company created bacteria for treating cancer by genetically engineering salmonella, E. coli, and Vibrio.

The independently developed salmonella strain has removed more than 70 genes that are harmful to the human body, reducing toxicity by more than 1 million times.

The company explains that this non-toxic salmonella has a strong affinity for cancer tissue.

When injected into the body, it has the characteristic of overproliferating in cancer tissue by more than 100,000 times more than in normal tissue.

The C&Cure research team genetically engineered the non-toxic salmonella to produce cytolysin A, a cell-lytic protein of E. coli, and flagellin B, a flagellar protein of Vibrio, in cancer tissue.

A company official said, "As a result of experiments on mouse models transplanted with various types of cancer, the fused salmonella dramatically changed the cancer immune microenvironment and caused an anticancer immune effect," adding, "It suggested that it can effectively treat not only primary cancer but also metastatic cancer."

With this technology, C&Cure is going through the clinical trial new drug approval process with the U.S. Food and Drug Administration ( FDA ). It is also conducting mammalian toxicity tests in accordance with standards. CEO Min Jeong-jun, director of Chonnam National University Hospital in Hwasun, and Professor Hong Young-jin of Chonnam National University College of Medicine, chief technology officer, conducted this research with support from the Ministry of Science and ICT’s Immunotherapy Innovation Platform Project and mid-level research project.