On June 27, 2024 Tubulis reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to its lead antibody-drug conjugate (ADC) TUB-040 for the treatment of patients with platinum-resistant ovarian cancer (Press release, Tubulis, JUN 27, 2024, View Source [SID1234644591]). TUB-040 is a next-generation NaPi2b-targeting Exatecan ADC based on Tubulis’ proprietary P5 technology with superior biophysical properties that demonstrated effective and durable responses in a range of preclinical models, including ovarian cancer. The candidate is currently being evaluated in a multicenter Phase I/IIa study (NAPISTAR 1-01, NCT06303505) in patients with platinum-resistant high-grade ovarian cancer (PROC) or relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC), who have exhausted other available treatment options.

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"Almost all patients with ovarian cancer who are not cured by initial therapy will develop resistance to platinum-based therapy over time. Once platinum-resistant, therapeutic options for these patients are poor with highly unsatisfactory outcomes. The FDA´s Fast Track designation of TUB-040 is an important step in the development of TUB-040 to provide these women with urgently needed new therapeutic options," said Günter Fingerle-Rowson, MD, PhD, Chief Medical Officer of Tubulis. "The FDA decision brings us one step closer to our goal of delivering the true value of ADCs to patients in need, and we are grateful for the agency’s support on this path to develop TUB-040 fast and efficiently.

The Fast Track status granted by the FDA is designed to facilitate the development and expedite the review of new therapies that are intended to treat serious conditions and have the potential to address an unmet medical need. Programs granted Fast Track designation are subject to more frequent interactions with the FDA during clinical development and may be eligible for accelerated approval and/or priority review if certain criteria are met.

TUB-040 is currently being evaluated in a multicenter, first-in-human, dose-escalation and optimization Phase I/IIa study. The trial is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of TUB-040 as monotherapy and is being conducted in the US, UK, Spain, Belgium and Germany. Phase Ia includes dose escalation and will determine the safety and the maximum tolerated dose or identified dose for optimization, while Phase IIa will focus on dose optimization, safety, and preliminary efficacy of TUB-040.

About Platinum-resistant Ovarian Cancer

Ovarian cancer (OC) is the leading cause of death among women diagnosed with gynecological cancers. While early-stage disease has a high survival rate, OC is often diagnosed at later stages due to its non-specific clinical symptoms and lack of preventive screening methods.2 The current standard of care is platinum-based therapy, but approximately 20% of patients are platinum-resistant during each treatment line.3,4 Platinum-resistant OC is defined as disease recurrence during or within 6 months after completing the platinum-based chemotherapy. Platinum-resistant OC is associated with poor disease outcomes and low response rates to subsequent chemotherapy treatment. The median survival for these patients is 12-16 months, highlighting the high unmet medical need of this patient population. 5,6

About TUB-040 and the P5 Technology

Tubulis’ lead antibody-drug conjugate (ADC) TUB-040 is directed against Napi2b, an antigen highly overexpressed in ovarian cancer and lung adenocarcinoma. It consists of an IgG1 antibody targeting Napi2b connected to the Topoisomerase I inhibitor Exatecan through a cleavable linker system based on the company’s proprietary P5 conjugation technology with a homogeneous DAR of 8. P5 conjugation is a novel chemistry for cysteine-selective conjugation that enables ADC generation with unprecedented linker stability and biophysical properties. It originated from the fundamental work of Prof. Christian Hackenberger at the Leibniz-Forschungsinstitut für Molekulare Pharmakologie im Forschungsverbund Berlin e.V. (FMP), which unlocked the use of phosphorus chemistry for superior bioconjugation. Preclinical pharmacokinetic analysis also demonstrated that TUB-040 efficiently delivers its payload to the tumor while reducing off-site toxicities. The candidate is currently being investigated in a multicenter Phase I/IIa study (NAPISTAR 1-01, NCT06303505) that aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of TUB-040 as a monotherapy.

On June 27, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology, reported that the Company received productive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC) (Press release, Oncolytics Biotech, JUN 27, 2024, View Source [SID1234644572]). The FDA supports progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint. The Company’s proposed study will enroll patients who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy.

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"Aligning with the FDA on key design elements and objectives of our planned registrational trial for pelareorep marks a critical step towards bringing this innovative treatment to patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Our de-risked program builds on compelling data and key learnings from two randomized studies, BRACELET-1 and IND-213, which demonstrated clinically meaningful benefit in patients receiving pelareorep and paclitaxel compared to paclitaxel alone. Additionally, translational data from the AWARE-1 study highlights pelareorep’s immune-mediated mechanism of action in breast cancer patients. We are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options."

Wayne Pisano, Interim CEO and Chair of the Board of Oncolytics, commented, "We are appreciative of the thoughtful dialog with the FDA and are pleased to have reached an important regulatory milestone that provides a clear path forward for pelareorep’s advancement towards registration in HR+/HER2- mBC. Looking ahead, initiating a registration-enabling trial has become a major corporate objective, and in parallel, we remain on track to report survival data from the BRACELET-1 study in HR+/HER2- mBC in the second half of the year. We believe these data will further bolster our compelling data package and underscores the therapeutic potential of pelareorep. We remain committed to improving the standard of care and addressing the high unmet medical needs of these patients."

On June 27, 2024, Coherus BioSciences, Inc. (the "Company") entered into an exclusive license and distribution agreement (the "License Agreement") with Apotex, Inc. ("Apotex"), pursuant to which, the Company has granted to Apotex an exclusive license under the Company’s rights to toripalimab to commercialize toripalimab within Canada (Filing, 8-K, Coherus Biosciences, JUN 27, 2024, View Source [SID1234644648]). As previously disclosed, on February 1, 2021, Coherus BioSciences, Inc. (the "Company") announced that it had entered into the exclusive license and commercialization agreement (the "Collaboration Agreement") with Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences") for the co-development and commercialization of toripalimab, Junshi Biosciences’ anti-PD-1 antibody, in the United States and Canada. Pursuant to the Collaboration Agreement, the Company has the right to grant sublicenses to third parties to commercialize toripalimab within Canada.

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Pursuant to the License Agreement, Apotex agreed to pay to the Company an upfront payment of $6.25 million United States Dollars ("USD"). In addition, Apotex agreed to pay to the Company the USD equivalent of up to an aggregate of up to $51.5 million Canadian Dollars ("CAD") in milestone payments in connection with the achievement of certain regulatory and sales milestones with respect to toripalimab in Canada. Finally, Apotex agreed to pay to the Company a low double-digit percentage of any future net sales of toripalimab in Canada that the Company will subsequently pay to Junshi Biosciences pursuant to the Collaboration Agreement.

The License Agreement term continues until the tenth year after the first commercial sale of toripalimab in Canada, subject to an extension for a subsequent ten year term at the option of Apotex. Apotex may terminate the License Agreement for any reason after a specified notice period, the License Agreement will terminate automatically if the rights granted to the Company by the Collaboration Agreement are terminated, if there is material breach that is not cured, if there are certain challenges to licensed patents by Apotex and in the case of certain insolvency events.

The foregoing description of the material terms of the License Agreement is qualified in its entirety by reference to the full text of the License Agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024.

On June 27, 2024 Recursion Pharmaceuticals, Inc. ("Recursion") (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, reported that it intends to offer and sell $200.0 million of shares of its Class A common stock in an underwritten public offering (Press release, Recursion Pharmaceuticals, JUN 27, 2024, View Source [SID1234644573]). All of the shares of Class A common stock are being offered by Recursion. In addition, Recursion intends to grant to the underwriters a 30-day option to purchase up to an additional 15% of the shares of Class A common stock offered. The proposed 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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Goldman Sachs & Co. LLC and J.P. Morgan are acting as lead book-running managers for the offering. Allen & Company LLC is acting as book-running manager for the offering.

The shares will be offered by Recursion pursuant to a registration statement on Form S-3, which became automatically effective upon filing with the U.S. Securities and Exchange Commission ("SEC") on May 10, 2022. The offering is being made solely by means of a written prospectus and a prospectus supplement that form a part of the registration statement. A copy of the preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Alternatively, a copy of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained by contacting: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; or J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement and accompanying prospectus relating to the offering that will be filed with the SEC.

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

On June 27, 2024 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, reported that the underwriters of its previously announced public offering, which closed on June 24, 2024, have exercised an over-allotment option to purchase an additional 1,786,589 shares of the Company’s common stock at the public offering price of $4.00 per share, less underwriting discounts and commissions (Press release, Rezolute, JUN 27, 2024, View Source [SID1234644578]). After giving effect to the option closing, the total number of shares sold by the Company in the offering were 13,036,589 shares, which along with pre-funded warrants to purchase up to an aggregate of 3,750,000 shares of its voting common stock, resulted in aggregate gross proceeds to the Company of approximately $67 million before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.

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In addition, the Company has entered into an agreement for a concurrent private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), of 1,500,000 shares of its common stock, at a sale price of $4.00 per share.

Jefferies and Cantor served as the joint book-running managers for the public offering. BTIG, Craig-Hallum, H.C. Wainwright & Co., Jones and Maxim Group LLC are acting as co-managers for the public offering.

A registration statement on Form S-3 (File No. 333-275562) relating to the public offering was filed with the Securities and Exchange Commission (the SEC) on November 22, 2023, and was declared effective by the SEC on November 29, 2023. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC. These documents are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the public offering may also be obtained by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at 877-821-7388, or by email at [email protected] or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected]

This press release is being filed pursuant and in accordance with Rule 135(c) under the Securities Act of 1933 and does 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 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.