On March 20, 2024 Tyligand Bioscience, a clinical-stage biotechnology company dedicated to developing innovative therapeutics against drug resistant tumors, reported its participation at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 5-10, San Diego, where it will present results of preclinical studies of TSN1611 (Poster# 3315), a potent and selective small molecule inhibitor targeting tumors harboring KRAS G12D mutation, a pivotal driver of cancer progression in numerous malignancies (Press release, Tyligand Bioscience, MAR 20, 2024, View Source [SID1234644983]).

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On Feb 14th, an oral formulation of TSN1611 has received clearance from the U.S. Food and Drug Administration (FDA) for clinical trials, an essential step forward in the development of this promising therapy.

"Preclinical studies indicate that TSN1611 has the potential to make a meaningful difference in the lives of patients with KRAS G12D driven cancers, and we are excited to share our findings with the scientific and medical community," said Tony Zhang, Ph.D., CEO of Tyligand Bioscience. "We remain committed to advancing its development with quality and speed for the global cancer patients in need".

KRAS mutations are among the most prevalent oncogenic alterations in cancer patients, with the G12D mutation being one of the most challenging to target effectively. Despite significant advances in cancer research and therapy, KRAS-driven cancers present a substantial unmet medical need, underscoring the urgency for innovative treatment options.

The preclinical data to be presented by Tyligand Bioscience at AACR (Free AACR Whitepaper) 2024 demonstrates the promising efficacy and safety profile of TSN1611 in inhibiting KRAS G12D. FDA’s IND approvals marks the achievement of an important milestone in advancing TSN1611 towards clinical evaluations for its safety and efficacy.

On March 20, 2024 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported the closing of the previously announced private placement with certain accredited investors comprised of existing investors, Delcath Executives and members of its Board of Directors, for a private placement transaction (the "Private Placement") (Press release, Delcath Systems, MAR 20, 2024, View Source [SID1234641292]).

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Delcath issued and sold 876,627 shares of its common stock (the "Common Stock") at a price per share of $3.72, and, to certain investors, in lieu of shares of Common Stock, 1,008,102 pre-funded warrants to purchase up to 1,008,102 shares of Common Stock (the "Pre-Funded Warrants") at a price per Pre-Funded Warrant of $3.71. The Pre-Funded Warrants have an exercise price of $0.01 per share of Common Stock, be immediately exercisable and remain exercisable until exercised in full.

Delcath received gross proceeds from the Private Placement of approximately $7 million before deducting offering expenses payable by Delcath. Delcath intends to use the net proceeds from the Private Placement for working capital purposes and other general corporate purposes.

The securities to be sold in the Private Placement, including the shares of common stock underlying the Pre-Funded Warrants, have not been registered under the Securities Act of 1933, as amended, or state securities laws as of the time of issuance and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. Delcath has agreed to file one or more registration statements with the SEC registering the resale of the Common Stock and the shares issuable upon exercise of the Pre-Funded Warrants purchased in the Private Placement.

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 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.

On March 20, 2024 Clasp Therapeutics, a biotechnology company bringing unparalleled precision to immuno-oncology using next-generation T cell engagers (TCEs), reported to have launched with $150 million in financing (Press release, Clasp Therapeutics, MAR 20, 2024, View Source [SID1234641311]).

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The round was led by Catalio Capital Management, Third Rock Ventures and Novo Holdings, with participation from Vivo Capital, Cure Ventures, Blackbird BioVentures, Pictet Alternative Advisors, American Cancer Society’s Bright Edge and Alexandria Venture Investments. Clasp is developing modular TCEs tailored to each patient’s immune system that are directed to common oncogenic driver mutations, resulting in off-the-shelf, antibody-like medicines that can specifically target a wide variety of hard-to-treat tumor types.

"At Clasp we strive to help people with cancer lead longer and healthier lives by engaging each patient’s own immune cells to eradicate their cancer with absolute specificity," said Chief Executive Officer Robert Ross, M.D. "Clasp brings together leading researchers, clinicians and drug developers to develop groundbreaking cancer immunotherapies that are precise and potent, but without the toxicities commonly associated with on-target, off-tumor binding."

Clasp is leveraging advances made by its scientific founders at Johns Hopkins University, including leading cancer geneticist and HHMI investigator Bert Vogelstein, M.D., and immuno-oncology pioneer Drew Pardoll, M.D., Ph.D., who have envisioned a new approach to single out cancer cells for destruction by the immune system. The researchers’ structure-driven understanding of human leukocyte antigen (HLA)-antibody interactions enables the engineering of advanced TCEs that can precisely target common oncogenic mutations with exquisite specificity.

"We have the ability to redirect T cells to kill cancer cells while sparing healthy cells throughout the body," said Andrea Van Elsas, Ph.D., Partner at Third Rock Ventures and Chief Scientific Officer at Clasp. "Clasp’s proprietary technology enables immune targeting of intracellular oncogenic driver mutations to achieve durable tumor killing, even with low levels of surface presentation. Furthermore, the modularity of Clasp’s TCE platform gives it potential to address unmet need across a broad range of hard-to-treat tumor types."

Clasp’s TCEs are bispecific antibody-like molecules designed to simultaneously bind both a T cell and a tumor-specific mutant peptide, presented in the context of the patient’s HLA immune signature. A key aspect of this approach is Clasp’s ability to select patients for treatment by focusing on common tumor-specific driver mutations, including many that are unresponsive to standard immunotherapies. By binding both the T cell and the tumor cell with absolute specificity, this approach ensures immune activation against the tumor itself while sparing normal tissue, which lacks the tumor-specific mutated peptide.

"Clasp’s novel technology has tremendous potential to help the many cancer patients who are unable to benefit from existing treatments," said Jacob Vogelstein, Ph.D., and George Petrocheilos, Managing Partners of Catalio Capital Management. "We are excited to partner with Third Rock Ventures, Novo Holdings and the other members of the syndicate to support the company and advance immuno-oncology into a new era."

As part of the financing, Ray Camahort, Partner in the Venture Investments group at Novo Holdings U.S., and Jack Nielsen, Managing Partner of Vivo Capital, joined the Board of Directors.

On March 20, 2024 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it has entered into a definitive agreement with Lonza, under which Lonza will acquire the Genentech manufacturing facility in Vacaville, California, USA, for USD 1.2 billion in conjunction with a manufacturing agreement and related quality services and warehousing (Press release, Hoffmann-La Roche, MAR 20, 2024, View Source [SID1234641293]).

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Under the terms of the agreement, the approximately 750 Genentech employees at the Vacaville facility will be offered employment by Lonza and the products currently produced at the site by Roche will continue to be supplied by Lonza for a transition period.

"We decided to divest our Vacaville site as part of our long-term network strategy and optimisation plan, to deliver a more diversified portfolio including new drug modalities," Susanne Hundsbaek-Pedersen, Global Head of Pharma Technical Operations, stated. "Having gone through a competitive diligence process with multiple potential strategic partners for the facility, we believe that Lonza is the ideal owner for the Vacaville site to continue producing innovative medicines for patients in need. We are particularly pleased that the employees at the site will be offered employment by Lonza."

Subject to the completion of applicable regulatory approvals and subsequent transition preparations, the transaction is expected to close by H2 2024.

On March 20, 2024 NuCana plc (NASDAQ: NCNA) reported financial results for the fourth quarter and year ended December 31, 2023 and provided an update on its broad clinical development program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, MAR 20, 2024, View Source [SID1234641294]).

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As of December 31, 2023, NuCana had cash and cash equivalents of £17.2 million compared to £17.8 million as of September 30, 2023 and £41.9 million as of December 31, 2022. NuCana continues to advance its various clinical programs and reported a net loss of £7.7 million for the quarter ended December 31, 2023, as compared to a net loss of £15.2 million for the quarter ended December 31, 2022. Net loss for the year ended December 31, 2023 was £27.6 million, compared to a net loss of £32.0 million for the year ended December 31, 2022. Basic and diluted loss per share was £0.14 for the quarter and £0.53 for the year ended December 31, 2023, as compared to £0.29 per share for the comparable quarter and £0.61 for the year ended December 31, 2022.

"In 2023, we announced data that demonstrated encouraging signals of efficacy and favorable safety profiles for our ProTides, NUC-3373 and NUC-7738," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "Working towards our mission of improving treatment outcomes for patients with cancer by developing more effective and safer medicines, we look forward to providing important data readouts across our pipeline in 2024."

Mr. Griffith continued: "Our development programs for both NUC-3373 and NUC-7738 are progressing well. NUC-3373, our ProTide transformation of 5-FU, is being evaluated in three ongoing clinical studies. Our randomized Phase 2 study is comparing NUC-3373 in combination with irinotecan, leucovorin and bevacizumab (NUFIRI + bev) with the standard of care, 5-FU in combination with irinotecan, leucovorin and bevacizumab (FOLFIRI + bev) for the second-line treatment of patients with advanced colorectal cancer. We have now fully recruited all 171 patients to the study and we remain on track to announce data from this study in 2024. Additionally, we are completing our Phase 1b/2 study of NUFIRI + bev and NUFOX + bev in patients with metastatic colorectal cancer. We recently presented data from this study demonstrating that NUFIRI + bev and NUFOX + bev showed a favorable safety profile and encouraging signs of efficacy, including tumor volume reductions. In addition, several patients achieved a longer progression-free survival (PFS) on NUC-3373-based regimens as compared to the PFS achieved in their first-line treatment with 5-FU-based therapy. Lastly, we remain on track to announce data in 2024 from our Phase 1b/2 study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer."

Mr. Griffith continued: "Moving to NUC-7738, we recently presented data from the Phase 2 part of the Phase 1/2 study of NUC-7738 in combination with pembrolizumab in patients with melanoma. These data showed tumor volume reductions and prolonged time on treatment and indicated that NUC-7738 may potentiate the activity of anti-PD-1 agents in patients who were refractory to, or progressed on, prior immunotherapy, including anti-PD-1 therapy. We look forward to sharing additional updates from this study in 2024."

Mr. Griffith concluded, "With a cash runway that is expected to extend into 2025, we look forward to providing a number of important data updates in the coming year as we continue to advance our pipeline of ProTides."

2024 Anticipated Milestones

NUC-3373 (a ProTide transformation of 5-FU)
In 2024, NuCana expects to:

Announce data from the randomized Phase 2 (NuTide:323) study of NUFIRI + bev compared to the standard of care FOLFIRI + bev for the second-line treatment of patients with advanced colorectal cancer;
Announce data from the Phase 1b/2 (NuTide:302) study of NUFIRI + bev and NUFOX + bev for the second-line treatment of patients with advanced colorectal cancer; and
Announce data from the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer.
NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)
In 2024, NuCana expects to:

Announce data from the Phase 2 part of the Phase 1/2 study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with melanoma.