On February 2, 2023 Nighthawk Biosciences, Inc. (the "Company") reported its subsidiaries listed below, where applicable, notified the University of Miami of its termination of the following license agreements (the "Agreements") due to a change in the Company’s commercial focus (Filing, 8-K, NightHawk Biosciences, FEB 2, 2023, View Source [SID1234626786]). The termination date will be ninety (90) days from the date of notice for each Agreement.

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(i) License Agreement (UMSS-114 (previously UM97-14), concerning certain patents and patent applications related to a cell-based gp96 vaccine for treating cancer) between the University of Miami and Heat Biologics, Inc. (now known as Nighthawk Biosciences, Inc.) effective July 11, 2008, as amended ("UMSS-114 Agreement");

(ii) License Agreement ((UMSS114A), concerning certain patents and patent applications related to allogeneic cancer cell-based Immunotherapy methods and regimens) between the University of Miami and Heat Biologics I, Inc. effective February 18, 2011, as amended ("UMSS114A Agreement"); and

(iii) License Agreement ((UMD-107), concerning certain patents and patent applications related to heat shock protein gp96 vaccination) between the University of Miami Heat Biologics I, Inc. effective February 18, 2011, as amended ("UMD-107 Agreement");

(iv) Exclusive License Agreement ((UMIP-114/Strbo), concerning certain patents and patent applications related to a gp96-based cell vaccine for Zika infections) between the University of Miami and Zolovax, Inc., effective October 24, 2016 ("UMIP-114 Agreement");

(v) Exclusive License Agreement ((UMPIP-510), concerning certain patents and patent applications related to a gp96-based cell vaccine for coronavirus infections) between the University of Miami and Zolovax, Inc. dated as of December 31, 2020 (("UMPIP-510 Agreement");

(vi) Exclusive License Agreement, concerning certain patents and patent applications related to modulating regulatory T cell (Treg) proliferation by targeting DR3/TNFRSF25/TL1A signaling, between the University of Miami and Pelican Therapeutics, Inc. f/k/a Heat Biologics II, Inc., effective July 11, 2008, as amended (("UM03-31 UM05-39 Agreement");

(vii) Exclusive License Agreement, concerning certain patents and patent applications related to methods of modulating CD8 T cells and treating cancer by targeting DR3/TNFRSF25/TL1A signaling, between the University of Miami and Pelican Therapeutics, Inc. f/k/a Heat Biologics II, Inc., effective December 12, 2010 (("UMI-176 Agreement"); and

(viii) Exclusive License Agreement, concerning certain patents and patent applications related to certain TL1A fusion proteins, between the University of Miami and Pelican Therapeutics, Inc., effective November 19, 2013 (("UMM-143 Agreement").

The material terms of the Agreements are set forth under Item 1 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 11, 2022, and are incorporated by reference herein

The Agreements set forth in clauses (i)-(v) above granted the licensee that was a party to the agreement exclusive, worldwide rights to make, use or sell licensed materials based upon the patent-related rights set forth in the license agreements. Under the Agreements set forth in clauses (i)-(v) above, the licensees obtained exclusive rights to different patent families each directed to therapeutic compositions and methods related to targeting gp96. Under Agreements pursuant to which Pelican is the licensee, as set forth in (vi)-(viii) above, Pelican obtained exclusive rights to six different patent families each directed to therapeutic compositions and methods related to targeting DR3/TNFRSF25/TL1A for the purpose of modulating immune responses.

Upon termination of the Agreements, among other things, the licenses will terminate, and the licensees shall have no rights, express or implied, under any intellectual property rights of University of Miami, which are the subject matter of the license. The licensee will no longer be responsible for the development and commercialization of any products under the licenses and will have no further payment obligations under the Agreements except with respect to payments that accrued prior to the effective date of the termination. Neither the Company nor any of its subsidiaries incurred any early termination penalties.

On February 2, 2023 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company focused on improving stem cell transplantation, reported that it has completed a review of its business, including the status of its programs, resources, and capabilities (Press release, Magenta Therapeutics, FEB 2, 2023, View Source [SID1234626785]). Magenta has made the determination to halt further development of its programs and conduct a comprehensive review of strategic alternatives focused on maximizing shareholder value.

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As part of this review process, Magenta will explore potential strategic alternatives that may include, but are not limited to, an acquisition, merger, business combination, or other transaction. There can be no assurance that this review process will result in Magenta pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms. Magenta has not set a timetable for completion of this review process and does not intend to comment further unless or until the Board of Directors has approved a definitive course of action, the review process is concluded, or it is determined that other disclosure is appropriate.

Magenta is based in Cambridge, Mass. For more information, please visit www.magentatx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended. These statements include, without limitation, implied and express statements relating to: Magenta conducting a comprehensive review of strategic alternatives focused on maximizing shareholder value; exploring potential strategic alternatives that may include, but are not limited to, an acquisition, merger, business combination, or other transaction; and the completion of such a review process.

Words such as "anticipate," "believe," "continue," "could," "designed," "endeavor," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "seek," "should," "target," "preliminary," "will," "would" and similar expressions are intended to identify forward-looking statements. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: volatility and uncertainty in the capital markets for biotechnology companies; availability of suitable third parties with which to conduct contemplated strategic transactions; whether Magenta will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed on attractive terms; and whether Magenta’s cash resources will be sufficient to fund Magenta’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in additional detail in Magenta’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, and its other filings made with the Securities and Exchange Commission from time to time. Any forward-looking statements contained in this press release represent Magenta’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Magenta explicitly disclaims any obligation to update any forward-looking statements, except to the extent required by law.

On February 2, 2023 EXACT THERAPEUTICS AS ("EXACT-Tx", Euronext Growth: EXTX), a clinical stage precision health company utilising Acoustic Cluster Therapy (ACT) across multiple therapeutic areas, reported that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has approved reopening of the clinical phase I ACTIVATE trial (Press release, Exact Therapeutics, FEB 2, 2023, View Source [SID1234626783]).

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As communicated in a press release of 8 March 2022, EXACT-Tx received a request from the MHRA for an additional submission and approval of medical device documentation associated to the protocol amendment filed with the ACTIVATE phase I clinical trial. EXACT-Tx responded to the request and has now received MHRA’s approval on both the medical device documentation and the amended protocol. The approvals were made without objections.

For EXACT-Tx, this mean that the ACTIVATE phase I trial will be reopened and additional patients will be recruited for the trial.

So far, there have been seven patients enrolled in the study with five patients’ data being evaluable for the study endpoints. Several valuable and encouraging insights have been gained from this first cohort of treated patients.

On February 2, 2023 Cellectis S.A. ("Cellectis" or the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported the launch of a global offering of USD 22 million of its American Depositary Shares ("ADS"), each representing one ordinary share of Cellectis, nominal value €0.05 per share (the "Global Offering") pursuant to an underwriting agreement, to be entered into by Cellectis, Jefferies LLC and Barclays Capital Inc (Press release, Cellectis, FEB 2, 2023, View Source [SID1234626781]). The Global Offering is comprised of a public offering of ADS in the United States of America only and a private placement in other countries, including in European Union member States, exclusively to "qualified investors" within the meaning of Article 2(e) of Regulation (EU) 2017/1129, as amended (the "Prospectus Regulation").

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Jefferies LLC and Barclays Capital Inc. (the "Underwriters") are acting as joint book-running managers for the Global Offering.

The Company plans to use the net proceeds of the Global Offering to fund the continued clinical development of UCART123, UCART22, UCART20x22, and UCARTCS1, and for working capital and other general corporate purposes.

The Global Offering is subject to market and other conditions and the final aggregate amount of the Global Offering is subject to change. The aggregate amount of the Global Offering, the price in dollars at which ADSs will be sold in the proposed Global Offering, as well as the final number of ADSs, up to a maximum amount of 13,645,293 ADSs represented by ordinary shares of the Company, will be determined by the Chief Executive Officer following an accelerated bookbuilding process commencing immediately, in accordance with a sub-delegation granted by the Company’s Board of Directors (Conseil d’Administration) on February 2, 2023. The corresponding subscription price of the new ordinary shares underlying the ADSs will not be less than the volume weighted-average of the trading prices of the Company’s ordinary shares on the Euronext Growth in Paris over the three trading sessions prior to pricing of the Global Offering, subject to a maximum discount of 20%. The new ordinary shares underlying the ADSs will be issued through a capital increase without shareholders’ pre-emptive rights under the provisions of Article L. 225-136 of the French Commercial Code and in accordance with the delegations granted pursuant to the 17th resolution adopted at the combined meeting of the Company’s shareholders held on June 28, 2022.

In connection with the Global Offering, Cellectis expects to grant the Underwriters a 30-day option to purchase up to an additional 15% of the actual aggregate Global Offering size on the same terms and conditions provided that the aggregate number of new ordinary shares issued in the Global Offering and pursuant to the option shall not exceed 13,645,293, pursuant to Article L. 225-135-1 of the French Commercial Code and the 19th resolution adopted at the combined meeting of the Company’s shareholders’ held on June 28, 2022.

A shelf registration statement on Form F-3 (including a prospectus) relating to Cellectis’ American Depositary Shares was filed with the Securities and Exchange Commission ("SEC") on June 24, 2022 and subsequently declared effective on July 7, 2022. Before purchasing American Depositary Shares in the Global Offering, you should read the preliminary prospectus supplement and the accompanying prospectus filed with the SEC on February 2, 2023, together with the documents incorporated by reference therein. You may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the preliminary prospectus supplement (and accompanying prospectus) relating to the Global Offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388 or by email at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone (888) 603-5847 or by email at [email protected]. The preliminary prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein, do not include any inside information (as defined under Article 7 of Regulation (EU) No 596/2014 of the European Parliament and of the Council of April 16, 2014 on market abuse as amended (MAR)).

This press release shall not constitute an offer to sell or the 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. In particular, no public offering of the ADSs will be made in Europe.

On February 2, 2023 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported the formation of a scientific advisory board consisting of four world-renowned non-small cell lung cancer (NSCLC) experts from top oncology centers around the globe to enhance the development of bemcentinib for the treatment of NSCLC patients with STK11 mutations (STK11m) (Press release, BerGenBio, FEB 2, 2023, View Source [SID1234626780]).

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"We are very proud and honored to have assembled a group of leading international NSCLC experts to guide us as we investigate bemcentinib in 1st line NSCLC STK11m in combination with today’s standard of care," said Cristina Oliva, M.D., Chief Medical Officer of BerGenBio. "Their expertise will play an integral role in our evaluation of bemcentinib and its potential to provide significant benefits to patients who today face a particularly poor prognosis."

Despite significant advances in immuno-oncology treatments, NSCLC is still one of the leading causes of cancer-related deaths worldwide. Patients harboring STK11m, which represent approximately ~20% of non-squamous NSCLC cases, almost universally demonstrate high levels of AXL activation and show lower response rates to current standard of care therapy of anti-PD-1/L1 combined with chemotherapy. BerGenBio’s lead compound, bemcentinib, is designed to selectively inhibit AXL, which may potentially sensitize STK11m NSCLC patients to checkpoint inhibitors and improve the effects of chemotherapy. The Company has initiated a global Phase 1a/2b trial to assess bemcentinib with standard of care in 1st line NSCLC patients with STK11m.

Members of the BerGenBio NSCLC Scientific Advisory Board:

View Source

Enriqueta Felip, M.D., Ph.D.

Dr. Enriqueta Felipis the Head of the Thoracic Cancer Unit at Vall d’Hebron University Hospital, Spain, where she is responsible for thoracic malignancy management and all lung cancer trials. She is President of the Spanish Society of Medical Oncology (SEOM) 2021-23, a member of the Spanish Lung Cancer Group (SLCG) and a Professor of Medicine at the Universitat de Vic. Previously, Dr. Felip was on the Board of Directors of the International Association for the Study of Lung Cancer (IASLC). She received her M.D. and Ph.D. from Autonomous University of Barcelona.

John Heymach, M.D., Ph.D.

Dr. John Heymach is the Chair of Thoracic/Head and Neck Medical Oncology at the MD Anderson Cancer Center, Texas, and holds the David Bruton Endowed Chair in Cancer Research. Dr. Heymach is a co-leader of the MD Anderson Lung Cancer Moon Shot, in addition to serving as a Principal Investigator of lung cancer programs funded by the National Cancer Institute (NCI), LUNGevity and American Association for Cancer Research (AACR) (Free AACR Whitepaper), and earning several prestigious awards for excellence in basic science, translational research and mentoring. He received his M.D. and Ph.D. from Stanford University.

Tony Mok, M.D., BMSc

Dr. Tony Mok is a Professor and Chairman of the Department of Clinical Oncology at the Chinese University of Hong Kong. Dr. Mok’s research was instrumental in establishing the use of precision medicine in advanced lung cancer. He co-founded the Lung Cancer Research Group and served as the associate editor for thoracic oncology for the Journal of Clinical Oncology. Dr. Mok is a Fellow of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), former President of IASLC and received the ESMO (Free ESMO Whitepaper) Lifetime Achievement Award. He received his M.D. and BMSc from the University of Alberta, Canada.

Solange Peters, M.D., Ph.D.

Dr. Solange Peters is a Professor and Head of Medical Oncology and Thoracic Malignancies at the Department of Oncology at Lausanne University, Switzerland, where she is also building a translational program in collaboration with molecular oncology laboratories. Dr. Peters was recently the President of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2020-22, and was formerly an IASLC Board member and co-chair of the Swiss Lung Cancer Research Group. She is Associate Editor of the Annals of Oncology and Deputy Editor of Lung Cancer. She received her M.D. and Ph.D. from the University of Lausanne.