Nona Biosciences Announces Update on Its Collaborator DualityBio’s Antibody-Drug Conjugate (ADC) Collaboration with BeiGene

On January 3, 2025 Nona Biosciences, a global biotechnology company providing a total solution from "Idea to IND" (I to ITM), reported that BeiGene. Ltd. has exercised its exclusive option to acquire global development, manufacturing, and commercialization rights for an antibody-drug conjugate (ADC) from DualityBio, a collaborator of Nona Biosciences (Press release, Nona Biosciences, JAN 3, 2025, View Source [SID1234649403]).

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This ADC was developed under the collaboration agreement established between Nona Biosciences and DualityBio in 2022. Under the terms of the agreement, Nona Biosciences granted DualityBio exclusive rights to certain monoclonal antibodies targeting specific tumors, enabling the development of first-in-class ADC candidates worldwide.

Rakovina Therapeutics to Connect with Industry Leaders During 43rd Annual J.P. Morgan Healthcare Conference Week

On January 3, 2025 Rakovina Therapeutics, Inc. (TSX: RKV), a biopharmaceutical company focused on the development of new cancer therapies based on novel DNA-damage response technologies, reported its participation in events and meetings being held alongside the 43rd Annual J.P. Morgan Healthcare Conference, taking place January 13-16, 2025, in San Francisco (Press release, Rakovina Therapeutics, JAN 3, 2025, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-to-connect-with-industry-leaders-during-43rd-annual-j-p-morgan-healthcare-conference-week [SID1234649404]).

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Showcasing Innovation on a Global Stage

As the premier healthcare investment symposium, the J.P. Morgan Healthcare Conference attracts thousands of global leaders, investors, and innovators from the biopharmaceutical and healthcare sectors. Rakovina Therapeutics will leverage this opportunity to highlight its progress in AI-driven drug discovery and the transformative potential of its advancements in cancer treatment.

Rakovina will engage in meetings held outside the main conference with interested parties, including industry leaders, potential collaborators, and members of the investment community. These meetings aim to foster partnerships and explore new opportunities to advance the company’s mission.

"The conference and surrounding engagements serve as valuable platforms to showcase Rakovina Therapeutics’ progress in AI-driven drug discovery and its transformative potential for cancer treatment," said Jeffrey Bacha, Executive Chairman of Rakovina Therapeutics. "It is an opportunity to engage with industry leaders, partners, and the investment community as we continue to drive innovation in the DNA-damage response space."

2025: Accelerating Progress and Innovation

The upcoming year holds significant promise for Rakovina Therapeutics as it strives to make key advancements in its mission to develop innovative cancer treatments. The company plans to progress its AI-identified drug candidates through preclinical validation, preparing them for entry into clinical trials, marking a crucial step forward. Concurrently, it aims to enhance its AI-driven platforms, streamlining the drug discovery process to accelerate the development of novel therapies.

Strategic partnerships will remain a cornerstone of the company’s strategy, facilitating the swift development and delivery of innovative cancer treatments to patients. These initiatives exemplify Rakovina’s commitment to leveraging cutting-edge technology, fostering collaboration, and transforming the landscape of cancer care.

Stock Option Grant

The Company also announces that its board of directors approved the grant of 4,330,00 stock options ("Options") to certain officers and directors of the Company pursuant to the Company’s Long Term Incentive Plan. The Options are exercisable at $0.185 per share for five years from the grant date and will vest in equal parts every six months over the next three years.

SpringWorks Therapeutics to Present at the 43rd Annual J.P. Morgan Healthcare Conference

On January 3, 2025 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, reported that Saqib Islam, Chief Executive Officer, reported that it will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 11:15 a.m. PT (Press release, SpringWorks Therapeutics, JAN 3, 2025, View Source [SID1234649405]).

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To access the live webcast, please visit the Events & Presentations page within the Investors & Media section of the company’s website at View Source A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

First Australian patient dosed in Phase 1b azer-cel clinical trial

On January 3, 2025 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported that the first Australian patient has been dosed in the Phase 1b clinical trial of its allogeneic CAR T-cell therapy azer-cel (azercabtagene zapreleucel), at the Royal Prince Alfred Hospital (RPAH) in Sydney (Press release, Imugene, JAN 3, 2025, View Source [SID1234649406]). The trial is focused on patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), one of the most challenging and aggressive forms of non-Hodgkin’s lymphoma.

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Azer-cel is one of the few allogeneic CAR T-cell therapies currently being evaluated in Australia. Azer-cel offers an off-the-shelf alternative to traditional autologous CAR Tcell therapies, which require lengthy manufacturing processes involving a patient’s own cells. By utilising pre-manufactured donor T-cells, azer-cel has the potential to significantly shorten treatment timelines and expand accessibility for patients with limited options.

Imugene recently reported promising data from its US trial sites (see ASX announcement 2 September 2024), demonstrating the potential of azer-cel to deliver meaningful clinical outcomes. In the US cohorts, three patients achieved complete responses (CR) despite having relapsed following multiple prior treatments, including autologous CAR T therapies. Notably, patients treated in Cohort B – which includes lymphodepletion chemotherapy and interleukin-2 (IL-2) – have shown particularly robust and durable responses, with responses extending beyond 90 and 120 days.

Leslie Chong, Managing Director and CEO of Imugene, said: "Achieving first patient dosed for azer-cel in Australia represents a significant milestone for Imugene and for Australian patients battling this devastating disease. The trial’s opening at RPAH in Sydney reflects our commitment to accelerating the development of innovative, offthe-shelf immunotherapies that have the potential to improve outcomes for patients with relapsed or refractory DLBCL. We are proud to bring this trial to Australia and look forward to expanding recruitment across multiple sites."

Cyclacel Pharmaceuticals Announces Agreement for the Acquisition of Preferred Stock by David Lazar

On January 3, 2025 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company") reported that the Company entered into a securities purchase agreement ("Agreement") with investor David Lazar ("Lazar"), pursuant to which he agreed to purchase from the Company 1,000,000 shares of Series C Convertible Preferred Stock (the "C Preferred Stock") and 2,100,000 shares of Series D Convertible Preferred Stock (the "D Preferred Stock") of Cyclacel at a purchase price of $1.00 per share for aggregate gross proceeds of $3.1 million, subject to the terms and conditions of the Agreement (Press release, Cyclacel, JAN 3, 2025, View Source [SID1234649426]). The proceeds of the transaction will be used to settle outstanding liabilities of the Company and other general corporate and operating purposes.

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Lazar is purchasing 1,000,000 shares of C Preferred Stock for $1,000,000 at an initial closing to occur on or about January 3, 2025. Each share of C Preferred Stock is convertible into 2.65 shares of Company common stock. The aggregate number of shares of common stock issuable upon conversion of the C Preferred Stock is subject to a 5% beneficial ownership limitation prior to stockholder approval of the transaction. Subject to the satisfaction of certain closing conditions and within two business days of the date that the Company’s stockholders approve the issuance of all the shares of Common Stock upon conversion of the C Preferred Stock and D Preferred Stock, as required by the applicable rules and regulations of the Nasdaq Stock Market (the "Preferred Stock Stockholder Approval"), Lazar will pay an additional $2,100,000 in exchange for 2,100,000 shares of D Preferred Stock at a second closing. Each share of D Preferred Stock shall be convertible into 110 shares of common stock.

In connection with the Agreement, the Company’s Board of Directors will be reconstituted. Dr. Samuel Barker will continue to serve as Chairman, and Paul McBarron and Spiro Rombotis will continue as directors. David Natan, a seasoned financial executive with biopharmaceutical industry experience, will join the Board and will chair the audit committee. In addition, Spiro Rombotis stepped down from his position as Chief Executive Officer of the Company and David Lazar was appointed as interim Chief Executive Officer. Dr. Kenneth Ferguson, Dr. Christopher Henney, Dr. Brian Schwartz, Dr. Robert Spiegel and Ms. Karin Walker have resigned from the Board. The Company wishes to express its gratitude to the departing directors for their long and dedicated service and their support of Cyclacel’s efforts to serve the unmet medical needs of cancer patients.

On January 2, 2025, the Company also entered into a Warrant Exchange Agreement (the "Exchange Agreement") with the holder (the "Holder") of certain existing warrants (the "Exchanged Warrants") to purchase an aggregate of 24,844,725 shares of the Company’s common stock. Pursuant to the Exchange Agreement, on the closing date and subject to the receipt of approval of the Company’s stockholders as required by the applicable rules and regulations of the Nasdaq Stock Market with respect to the issuance of all of the shares of common stock to be issued pursuant to the Exchange Agreement (the "Warrant Exchange Stockholder Approval"), the Company agreed to exchange with the Holder the Exchanged Warrants for an aggregate of 24,844,725 shares of Common Stock (the "New Shares") and $1,100,000 in cash (collectively, the "Exchange"). To the extent the Holder would otherwise beneficially own in excess of any beneficial ownership limitation applicable to the Holder after giving effect to the Exchange, the Exchanged Warrants shall be exchanged for a number of New Shares issuable to the Holder without violating the beneficial ownership limitation and the remainder of the Holder’s Exchanged Warrants shall be issued as pre-funded warrants to purchase the number of shares of Common Stock equal to the number of shares of Common Stock in excess of the beneficial ownership limitation. The closing of the Exchange is expected to take place substantially concurrently with the date on which the Warrant Exchange Stockholder Approval is received, subject to the receipt by the Company of the Preferred Stock Stockholder Approval. The Company also agreed to register the New Shares for resale pursuant to certain registration rights set forth in the Exchange Agreement.

The Board has directed management to reduce operating costs while strategic alternatives are being explored. There can be no assurance that the exploration of strategic alternatives will result in any agreement or transaction, or as to the timing of any such agreement or transaction. Further, there can be no assurance that the Company will receive the Preferred Stock Stockholder Approval or the Warrant Exchange Stockholder Approval.

The Company has received a written communication from the Nasdaq Stock Market, and expects to receive formal notification, that, in response to the Company’s request for an extension, the new deadline to demonstrate compliance with Nasdaq’s minimum stockholders’ equity requirement is February 6, 2025. If the Company fails to regain compliance during the required compliance period, its securities would be subject to delisting.