On July 6, 2021 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") reported it has entered into a Clinical Trial Collaboration and Supply Agreement ("Agreement") with Merck (known as MSD outside the United States and Canada) to evaluate the combination of OncoSec’s DNA-plasmid interleukin-12 (IL-12) TAVO (tavokinogene telseplasmid) with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a global Phase 3 randomized clinical trial, KEYNOTE-C87 (Press release, OncoSec Medical, JUL 6, 2021, View Source [SID1234584630]). The planned clinical trial will evaluate the overall survival of patients treated with the TAVO in combination with KEYTRUDA versus standard of care in late-stage patients with metastatic melanoma who are refractory to immune checkpoint therapy.

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TAVO has received Fast Track designation from the U.S. Food and Drug Administration (FDA), as a potentially first-in-class, intratumoral anti-cancer gene therapy that expresses IL-12 for the treatment of metastatic melanoma, following progression on KEYTRUDA or OPDIVO (nivolumab). KEYNOTE-C87 is intended to support accelerated approval by the U.S. FDA and/or serve as a pivotal study to support a full licensure. Under the terms of the Agreement, Merck will provide KEYTRUDA , while OncoSec will provide the investigational drug, TAVO. Each party will be responsible for its own internal costs, with OncoSec covering third party costs. Eligible patients must have Stage III or IV unresectable, metastatic melanoma, and must be refractory to prior checkpoint therapy. KEYNOTE-C87 intends to enroll approximately 400 patients and is planned to be conducted in the U.S., Canada, EU, and Australia.

"We are thrilled to enter into this collaboration and supply agreement with Merck – one of the world’s leading immuno-oncology companies – to help bring TAVO to patients with metastatic melanoma whose disease did not respond to initial checkpoint inhibitor therapy or who have developed progressive disease and therefore do not have additional treatment options available," said Brian Leuthner, Interim Chief Executive Officer of OncoSec. "This Phase 3 collaboration represents a crucial milestone for OncoSec as we advance TAVO through the clinic and toward potential approval globally, and expands upon our initial 2017 clinical collaboration and supply agreement with Merck. We look forward to our continued work and progress with Merck and its experienced team of immuno-oncology leaders as we continue to explore TAVO in combination with KEYTRUDA with the goal of helping more patients with cancer."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. OPDIVO is a registered trademark of Bristol Myers Squibb.

About TAVO
OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.

On July 6, 2021, OPKO Health, Inc. ("OPKO") reported that it entered into an Exclusive License Agreement (the "Agreement") with CAMP4 Therapeutics Corporation ("CAMP4"), pursuant to which OPKO granted to CAMP4 an exclusive license to develop, manufacture, commercialize or improve therapeutics utilizing the AntagoNAT technology, an oligonucleotide platform developed under OPKO CURNA, which includes the molecule for the treatment of Dravet syndrome, together with any derivative or modification thereof (the "Licensed Compound") and any pharmaceutical product that comprises or contains a Licensed Compound, alone or in combination with one or more other active ingredients ("Licensed Product"), worldwide (Filing, 8-K, Opko Health, JUL 6, 2021, View Source [SID1234584784]). The License grant covers human pharmaceutical, prophylactic, and therapeutic and certain diagnostic uses.

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OPKO will receive an initial upfront payment of $1.5 million and 3,373,008 shares of CAMP4’s Series A Prime Preferred Stock ("Preferred Stock"), which equates to approximately 5% of the outstanding shares of CAMP4, and is eligible to receive up to $3.5 million in development milestone payments for Dravet syndrome products, and $4 million for non-Dravet syndrome products, as well as sales milestones of up to $90 million for Dravet syndrome products and up to $90 million for non-Dravet syndrome products. OPKO will also receive double digits royalty payments on the net sales of royalty bearing products, subject to adjustment. In addition, upon achievement of certain development milestones, OPKO will be eligible to receive equity consideration of up to 5,782,299 shares of Preferred Stock in connection with Dravet syndrome products and up to 1,082,248 shares of Preferred stock in connection with non-Dravet syndrome products.
Unless earlier terminated, the Agreement will remain in effect on a Licensed Product-by-Licensed Product and country by-country basis until such time as the royalty term expires for a Licensed Product in a country, and expires in its entirety upon the expiration of the royalty term for the last Licensed Product in the last country. CAMP4’s royalty obligations expire on the later of (i) the expiration, invalidation or abandonment date of the last patent right in connection with the royalty bearing product, or (ii) ten (10) years after a royalty bearing product’s first commercial sale in a country. In addition to termination rights for material breach and bankruptcy, CAMP4 is permitted to terminate the Agreement after a specified notice period.
The foregoing description of the Agreement is only a summary and is qualified in its entirety by reference to the complete text of the Agreement, which will be filed as an exhibit to OPKO’s Quarterly Report on Form 10-Q for the period ending June 30, 2021.

On July 6, 2021 Genmab A/S (Nasdaq: GMAB) reported that it will increase its share capital by 47,974 shares as a consequence of the exercise of employee warrants (Press release, Genmab, JUL 6, 2021, View Source [SID1234584615]).

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The increase is effected without any preemption rights for the existing shareholders of the company or others. The shares are subscribed in cash at the following price per share of nominally DKK 1:

Proceeds to the company are approximately DKK 42.04 million. The increase corresponds to approximately 0.07% of the company’s share capital.

The new shares are ordinary shares without any special rights and are freely transferable negotiable instruments. The new shares give rights to dividends and other rights in relation to the company as of subscription. The new shares will be listed on Nasdaq Copenhagen after registration with the Danish Business Authority. The capital increase is expected to be finalized shortly.

Pursuant to section 32 of the Danish Capital Markets Act No. 1767 of November 27, 2020, it is hereby announced, that the total nominal value of Genmab A/S’ share capital after the capital increase is DKK 65,668,714 which is made up of 65,668,714 shares of a nominal value of DKK 1 each, corresponding to 65,668,714 votes.

On July 6, 2021 IDEAYA Biosciences, Inc. (Nasdaq:IDYA) reported that it intends to offer and sell up to $80 million of shares of its common stock in an underwritten public offering (Press release, Ideaya Biosciences, JUL 6, 2021, View Source [SID1234584631]). In addition, IDEAYA intends to grant the underwriters a 30-day option to purchase up to $12 million of shares of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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IDEAYA intends to use the net proceeds of the offering, along with its existing cash, cash equivalents and short-term and long-term marketable securities to fund (i) clinical development of IDE397, its MAT2A inhibitor development candidate, (ii) preclinical and clinical development of other product candidates in its research pipeline targeting poly (ADP-ribose) glycohydrolase, or PARG, a MTAP synthetic lethality target (other than MAT2A), and DNA damage targets, as well as its share of costs for targeting WRN under the Company’s Collaboration, Option and License Agreement with GSK, (iii) ongoing early clinical development of darovasertib (IDE196), its PKC inhibitor, in metastatic uveal melanoma, or MUM, and other solid tumors having GNAQ/11 hotspot mutations, including as monotherapy and as combination therapies with binimetinib, a MEK inhibitor, and independently with crizotinib, in each case pursuant to a clinical trial and drug supply agreement with Pfizer, (iv) synthetic lethality target and biomarker research and development activities and (v) working capital and other general corporate purposes.

J.P. Morgan, Citigroup, Jefferies and Guggenheim Securities are acting as joint book-running managers for the offering.

The securities described above are being offered by IDEAYA pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC"). The offering will be made only by means of a written prospectus and a prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at [email protected]; Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146, or by email at [email protected]; Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; or Guggenheim Securities, by mail at Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, or by telephone at (212) 518-5548 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 July 6, 2021 XBiotech Inc.’s (NASDAQ: XBIT) ("XBiotech") Board of Directors reported that it has declared an extraordinary cash dividend of approximately $2.50 per share, or up to an aggregate of $75 million, to holders of its common stock (Press release, XBiotech, JUL 6, 2021, View Source [SID1234584616]). This one-time, special dividend will be payable on July 23, 2021 to stockholders of record at the close of business on July 16, 2021.

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"XBiotech’s proven ability to develop highly valued drug candidates, revenue from contract operations, judicious deployment of operating capital, absence of debt, and very significant emerging opportunities in our pipeline, has created the balance sheet flexibility that enables us to provide shareholders this dividend," commented John Simard, chairman and CEO of XBiotech.

The Company cannot guarantee any future dividends. The declaration and payment of future dividends, if any, will be at the sole discretion of the Company’s Board of Directors based on its consideration of various factors, including the Company’s operating results, financial condition and anticipated capital requirements.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.