On February 9, 2024 Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb reported that ONO has received a supplemental approval of Opdivo (generic name: nivolumab) Intravenous Infusion ("Opdivo"), a human anti-human PD-1 monoclonal antibody in Japan, for expanded use for the treatment of unresectable advanced or recurrent malignant epithelial tumors, for a partial change in approved items of the manufacturing and marketing approval (Press release, Ono, FEB 9, 2024, View Source [SID1234646262]).

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 This approval is based on the result from the investigator-initiated clinical trial (NMSC-PD1 Study: KCTR-D014), conducted under the initiative of the Keio University Hospital, in 31 patients with malignant epithelial tumors. The trial met the primary endpoint of objective response rate (ORR) as assessed by central review, which was 19.4% (6/31 patients, 95% confidence interval: 7.5 – 37.5%). The safety profile of Opdivo in this trial was consistent with those previously reported in the clinical trials with Opdivo.

 The standard treatment for unresectable advanced or recurrent malignant epithelial tumors has not yet been established in Japan. With this approval, we expect Opdivo to become a new treatment option for patients with unresectable advanced or recurrent malignant epithelial tumors.

 Opdivo was designated as an orphan drug for the indication of unresectable advanced or recurrent malignant epithelial tumors in May 2023 by the Ministry of Health, Labor and Welfare (MHLW).

About NMSC-PD1 Study (KCTR-D014)
 This study is an investigator-initiated, multi-center, unblinded, non-comparative Phase 2 clinical trial evaluating the efficacy and safety of Opdivo in patients with unresectable advanced or recurrent malignant epithelial tumors. Patients received Opdivo at 480 mg every four weeks. The primary endpoint of the study is objective response rate (Central Judgment). Secondary endpoints include objective response rate (Physician Judgment), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), safety, etc.

About Malignant Epithelial Tumors
 Malignant epithelial tumors are a general term for skin cancers that are systematically classified as epithelial tumors, and include squamous cell carcinoma, basal cell carcinoma, extramammary Paget’s disease, skin appendage cancers (sweat gland carcinoma, sebaceous carcinoma, hair follicle carcinoma), etc. 1), 2)
 The number of patients with malignant epithelial tumors in Japan is estimated to be 25,000 to 38,315 patients (Patient survey in 2020) 3), 4). More than 90% of patients are expected to be cured by local treatment mainly with surgical therapy 5), 6). On the other hand, the number of patients with unresectable advanced or recurrent malignant epithelial tumors is reported to be 933 cases per year 7) with its poor prognosis in Japan.

Reference:

General Rules for Clinical and Pathological Studies on Malignant Neoplasms of the Skin (2nd edition), Japanese Skin Cancer Society. August 2010
Outlines of Various Rare Cancer (Skin Cancer), Rare Cancer Center, National Cancer Center. April 28, 2014 (updated on December 13, 2022)
View Source;(available only in Japanese)
Patient Survey 2020, Ministry of Health, Labour and Welfare. 2023
P-Market patient number analysis (August 2021 – July 2022). JMDC Inc.
Japanese Guidelines for Skin Cancer (3rd edition). 2022 Japanese Dermatological Association/Japanese Skin Cancer Society
Japanese Guidelines for Skin Cancer (2nd edition). 2015 Japanese Dermatological Association
Fujisawa Y, et al. J Dermatol Sci. 2018 Dec;92(3):230-6.
Overview of Opdivo Intravenous Infusion
Product name Opdivo Intravenous Infusion 20mg, 100mg, 120mg and 240mg
Generic name (JAN) Nivolumab (Genetical recombination)
Indication
Melanoma
Unresectable, advanced or recurrent non-small cell lung cancer
Neoadjuvant treatment of non-small cell lung cancer
Unresectable or metastatic renal cell carcinoma
Recurrent or refractory classical Hodgkin lymphoma
Recurrent or metastatic head and neck cancer
Unresectable advanced or recurrent gastric cancer
Unresectable advanced or recurrent malignant pleural mesothelioma
Malignant mesothelioma (excluding malignant pleural mesothelioma)
Microsatellite instability high (MSI-High) unresectable advanced or recurrent colorectal cancer that has progressed after chemotherapy
Unresectable advanced or recurrent esophageal cancer
Adjuvant treatment of esophageal cancer
Cancer of unknown primary
Adjuvant treatment of urothelial carcinoma
Unresectable advanced or recurrent malignant epithelial tumors
Dosage and administration

Usually, for adults, administer at 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion. In the adjuvant treatment of melanoma, the administration period does not exceed 12 months.
In combination therapy with ipilimumab for unresectable melanoma, usually, for adults, administer 80 mg of nivolumab every 3 weeks for 4 doses. After that, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion.

Usually, for adults, administer at 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion.
In combination therapy with other anti-tumor drugs, usually, for adults, administer 240 mg of nivolumab every 2 weeks or 360 mg every 3 weeks as intravenous infusion.

In combination therapy with other anti-tumor drugs, usually, for adults, administer 360 mg of nivolumab every 3 weeks as intravenous infusion. The administration frequency does not exceed 3 doses.

Usually, for adults, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion.
In combination with cabozantinib, usually, for adults, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion.
In combination therapy with ipilimumab for unresectable or metastatic renal cell carcinoma previously untreated with chemotherapy, usually, for adults, administer 240 mg of nivolumab as intravenous infusion every 3 weeks for 4 doses. After that, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion.

Usually, for adults, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion.
Usually for pediatrics, administer 3 mg/kg (body weight) of nivolumab every 2 weeks as intravenous infusion. For pediatrics weighing 40 kg (body weight) or more, nivolumab can be administered at 240 mg every 2 weeks or 480 mg every 4 weeks as intravenous infusion.

Usually, for adults, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion.

Usually, for adults, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion.
In combination therapy with ipilimumab, usually, for adults, administer 240 mg of nivolumab every 2 weeks or 360 mg every 3 weeks as intravenous infusion.

Usually, for adults, administer at 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion.
In combination therapy with ipilimumab, usually, for adults, administer 240 mg of nivolumab as intravenous infusion every 3 weeks for 4 doses. After that, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion.

Usually, for adults, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion.
In combination therapy with other anti-tumor drugs, usually, for adults, administer 240 mg of nivolumab every 2 weeks, 360 mg every 3 weeks or 480 mg every 4 weeks as intravenous infusion.

Usually, for adults, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion. The administration period does not exceed 12 months.

Manufacturer/
distributor Ono Pharmaceutical Co., Ltd.
Co-promotion Bristol-Myers Squibb K.K.
 Note: Underlined parts show the revised ones according to this approval.

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, China, 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 and malignant mesothelioma (excluding malignant pleural mesothelioma) in November 2023.
 In addition, ONO is conducting clinical development program including hepatocellular carcinoma, ovarian cancer, etc.

About the 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 February 9, 2024, Shattuck Labs, Inc. ("Shattuck") reported to have entered into a collaboration and license agreement (the "Collaboration Agreement") with Ono Pharmaceutical Co., Ltd ("Ono"), effective February 13, 2024, pursuant to which Shattuck and Ono will collaborate in the research and preclinical development of certain prespecified compounds directed toward a pair of targets selected by Ono from Shattuck’s pipeline of bifunctional fusion proteins (the "Development Compounds") (Filing, 8-K, Shattuck Labs, FEB 9, 2024, View Source [SID1234640046]). Shattuck is primarily responsible for carrying out the research activities in accordance with a mutually agreed upon research plan (the "Research Plan"), subject to the oversight of a joint research committee consisting of representatives from both Shattuck and Ono. Pursuant to the Collaboration Agreement, Shattuck granted to Ono an exclusive option (the "Option") to obtain an exclusive, sublicensable license to research, develop, manufacture and commercialize multiple products resulting from the Development Compounds in any therapeutic area worldwide. The option period will extend from the effective date of the Collaboration Agreement until 90 days after Shattuck delivers its final report pursuant to the Research Plan, and following any exercise of the Option, Ono will be responsible for further development and commercialization of the Development Compounds.

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In connection with entering into the Collaboration Agreement and conducting the Research Plan, Shattuck is entitled to receive up to $9 million consisting of an initial upfront payment and additional amounts payable upon the achievement of certain milestones specified in the Research Plan. Additionally, Ono has agreed to pay for all of Shattuck’s costs and expenses incurred in conducting the Research Plan.

In the event Ono exercises the Option for the Development Compounds, Shattuck is entitled to receive licensing, clinical and regulatory, and commercial milestone payments of up to $217.5 million upon the exercise of the Option, the achievement of certain specified clinical and regulatory milestones and commercial milestones and, in addition, a tiered percentage royalty on global net sales ranging from mid-single digits to low double digits. Royalties are payable by Ono on a licensed product-by-licensed product and country-by-country basis for a maximum of ten years after the first commercial sale of such licensed product in such country.

During the term of the Collaboration Agreement, Shattuck and Ono are prohibited from commercializing products anywhere in the world with the same mechanism of action as the Development Compounds.

The Collaboration Agreement may be terminated by mutual agreement of Shattuck and Ono or by either Shattuck or Ono upon an uncured material breach of the Collaboration Agreement or the insolvency of the other party. Ono may terminate the Collaboration Agreement at any time upon 90 days’ written notice to Shattuck. If Ono exercises such termination right, Ono will pay all of Shattuck’s costs up through the date of termination. In addition, after the conditions to exercise the Option have been met, Shattuck may terminate the Collaboration Agreement if Ono discontinues its development or commercialization efforts and other conditions are met.

The foregoing description of the Collaboration Agreement does not purport to be complete and is qualified in its entirety by reference to the Collaboration Agreement. Shattuck intends to file the Collaboration Agreement as an exhibit to its Quarterly Report on Form 10-Q for the quarter ended March 31, 2024.

On February 9, 2024 YS Biopharma Co., Ltd. (NASDAQ: YS) ("YS Biopharma") along with its subsidiaries ("YS Group" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, reported that it has entered into a share purchase agreement (the "Purchase Agreement") with an institutional investor (the "Purchaser") for the private placement of 95,269,762 ordinary shares of the Company, par value US$0.00002 per share (the "Shares") at a purchase price of $0.41986 per Share (the "Private Placement") for an aggregate of US$40 million in proceeds (Press release, YS Biopharma, FEB 9, 2024, View Source [SID1234639961]).

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Dr. David Shao, Director, President, and CEO of the Company, commented, "We are proud to announce the US$40 million private placement, exclusively through the issuance of ordinary shares. Through equity financing, without issuance of any warrants or options, we empower our investors with direct ownership, aligning their interests with the interests of existing shareholders striving for the long-term success of YS Biopharma. This infusion of capital significantly improves and strengthens our balance sheet. It bolsters our cash position, enhances liquidity, and provides additional financial resources to support our core operations and business growth."

The Shares being purchased are exempted from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act") pursuant to Regulation S promulgated thereunder. The Private Placement was made after the dismissal of the injunction order granted by the Grand Court of the Cayman Islands dated December 22, 2023. The Purchase Agreement contains customary representations, warranties and covenants of the Company and the Purchaser, and customary indemnification provisions for a transaction of this type. The Company also granted the Purchaser customary registration rights with respect to the Shares. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale of these securities would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 9, 2024 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported that the Compensation Committee of the Company’s Board of Directors granted seven new employees options to purchase a total of 71,900 shares of the Company’s common stock at an exercise price per share of $15.20, which was the closing price on February 8, 2024, and restricted stock units to acquire a total of 35,950 shares of the Company’s common stock (Press release, Arcus Biosciences, FEB 9, 2024, View Source [SID1234639960]). The equity awards were granted pursuant to the Company’s 2020 Inducement Plan, which was approved by the Company’s Board of Directors in January 2020 pursuant to the "inducement exception" under NYSE Listed Company Manual Rule 303A.08.

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On February 9, 2024 CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported the pricing of an offering of 3,875,000 shares of its common stock at an offering price of $2.00 per share, for gross proceeds of $7.75 million, before deducting underwriting discounts and offering expenses (Press release, Cel-Sci, FEB 9, 2024, View Source [SID1234639959]). All of the shares of common stock are being offered by the Company. The offering is expected to close on February 13, 2024, subject to satisfaction of customary closing conditions.

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The Company intends to use the net proceeds from this offering to fund the continued development of Multikine*, for general corporate purposes, and working capital.

ThinkEquity is acting as sole book-running manager for the offering.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2022 and declared effective on July 15, 2022. The offering will be made only by means of a written prospectus. A prospectus supplement and accompanying prospectus describing the terms of the offering has been or will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement, when available, and the accompanying prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

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