On February 26, 2025 Tyercan reported that its independently developed first-in-class drug, Tye1001, reported clinical trial approval from China’s NMPA, following its approval by the US FDA on July 12, 2024 (Press release, Shanghai Medicilon, FEB 26, 2025, View Source [SID1234651889]). This marks a significant milestone of dual approval in both China and the US.

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As Tyercan’s partner, Medicilon delivered comprehensive GLP-compliant preclinical services, including pharmacodynamics, pharmacokinetics, and safety assessment, accelerating the R&D process.

Tye1001: Redefining Targeted Tumor Therapy
Tye1001 is a novel anti-tumor protein drug for advanced solid tumors and lymphomas. It consists of a highly potent and toxic small-molecule toxin conjugated to a specific drug carrier. The drug primarily targets solid tumors through the EPR effect in tumor vasculature and specific receptors on cell surfaces. It enters tumor cells via endocytosis, degrades in lysosomes, and releases the toxin small-molecule, which targets cell microtubules to inhibit tumor growth.

Preclinical data shows that Tye1001 has broad anti-tumor activity, with significant efficacy in various mouse models of gastric cancer, lymphoma, nasopharyngeal cancer, and others. Its high safety profile offers a promising new treatment option for patients and strong scientific support for future clinical development.

The dual approval of Tye1001 in China and the US not only highlights Tyercan ‘s R&D strength but also demonstrates its innovation in the PDC field and leadership in tumor-targeted therapy.

Medicilon’s XDC R&D Platform: Accelerating Preclinical R&D and Dual Submissions
Medicilon’s close collaboration with Tyercan played a key role in Tye1001’s success. Tye1001 is a coupling drug based on the presence of corresponding endogenous protein, with high potential interference and high bioanalytical challenges, Medicilon’s analytical scientists overcame complex bioanalytical challenges through innovative tool antibody development and validation strategies.

It is also worth mentioning that Medicilon’s solid and comprehensive preclinical research capabilities, which have successfully helped 28 ADC drugs to be approved in the clinic, have laid a solid foundation for Tye1001’s dual reporting and approval in China and the US.

As one of China’s earliest CROs to offer full-service preclinical research compliant with both Chinese GLP and U.S. GLP standards, Medicilon has contributed to approximately 520 IND approvals, including 86 U.S. FDA approvals and 60 dual submissions (data as of the end of 2024).

Medicilon congratulates Tailikon on Tye1001’s dual IND approvals and looks forward to its continued success in clinical trials. Medicilon will continue to enhance its integrated preclinical R&D platform, empowering pharmaceutical companies to overcome drug R&D challenges.

On February 26, 2025 Crescent Biopharma, Inc. ("Crescent"), a private biotechnology company dedicated to advancing novel precision engineered molecules targeting validated biology to advance care for patients with solid tumors, reported management will present at the TD Cowen 45th Annual Health Care Conference on March 5, 2025, at 9:10 am ET (Press release, Crescent Biopharma, FEB 26, 2025, View Source [SID1234655971]).

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A live webcast of the presentation will be available at https://wsw.com/webcast/cowen177/cresc/2175696. An archived recording will be available for 90 days following the event.

In October 2024, Crescent entered into an acquisition agreement with Rockville, Maryland-based GlycoMimetics, Inc. (NASDAQ: GLYC). Following closing, the combined company will operate under the name Crescent and advance its portfolio of precision-engineered biologics to improve outcomes for patients with solid tumors.

On February 26, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported has it has dosed its final patient in the third cohort of its ongoing Phase 1 clinical trial evaluating its novel chimeric antigen receptor-T cell (CAR-T) therapy for recurrent ovarian cancer (Press release, Anixa Biosciences, FEB 26, 2025, View Source [SID1234650622]). The study is being conducted through a research partnership with Moffitt Cancer Center ("Moffitt"). The fourth cohort is expected to commence after a 30-day verification that there continue to be no adverse effects experienced by the third cohort.

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The third cohort in the trial received a dose of one million CAR-positive cells per kilogram of patient weight, which represents a tenfold increase compared to the first cohort. This escalation is an important step in evaluating the safety and efficacy of CAR-T therapy for ovarian cancer patients. The fourth cohort will increase the dosage by another factor of three.

Anixa’s FSHR-mediated CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells, tumor vasculature, and certain cancer cells. The first-in-human trial (NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The study is designed to evaluate safety, identify the maximum tolerated dose, and monitor efficacy.

Dr. Amit Kumar, Chairman and CEO of Anixa, stated, "With the completion of the third cohort, we are gaining important insights into the potential of CAR-T therapy for ovarian cancer. Increasing the dose is a key step in evaluating the therapy’s effectiveness while ensuring patient safety. Additionally, the recent approval of our protocol amendment allows eligible patients to receive a second dose if they may benefit from it. This amendment also expands enrollment criteria to include rare ovarian cancer subtypes, making the therapy accessible to more patients. Now, all eligible participants can receive a second dose without requiring separate IND approvals, helping us better assess the full potential of this treatment. As we move forward with the fourth cohort, we remain committed to advancing our CAR-T program with the goal of improving treatment options for ovarian cancer patients."

On February 26, 2025 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported fourth quarter and full year 2024 financial results and corporate highlights (Press release, Relay Therapeutics, FEB 26, 2025, View Source [SID1234650638]).

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"Our RLY-2608 breast cancer program continued to advance and develop rapidly in 2024, driven by positive maturation of the RLY-2608 + fulvestrant doublet dataset, now with over 100 patients dosed and median PFS of 11.4 months in second-line patients. We also continue to make progress with our investigational triplet combinations, which we believe could potentially allow RLY-2608 to address patients in earlier settings," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "Looking forward into 2025, it is our top priority to continue advancing our clinical programs, including the initiation of the RLY-2608 + fulvestrant Phase 3 trial in breast cancer patients. With a strong capital position that supports the execution of that pivotal trial, and a team with proven development experience, I am confident in our abilities to meaningfully advance these programs towards patients in oncology and genetic disease areas."

Initiation of ReDiscover-2 Phase 3 trial of RLY-2608 + Fulvestrant in the Middle of 2025

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Relay Tx has conducted an end of Phase 2 meeting with the Food and Drug Administration (FDA) and announces the Phase 3 trial design, dose, and plans to initiate the trial in mid-2025
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Design
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Planned Phase 3 registrational study (ReDiscover-2) is a randomized, open-label, multicenter clinical trial that will evaluate the safety and efficacy of RLY-2608 + fulvestrant in PI3Kα-mutated, HR+/HER2- advanced breast cancer patients previously treated with a CDK4/6 inhibitor
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Comparator arm will be capivasertib + fulvestrant
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Key inclusion criteria include:
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Patients must be CDK4/6-experienced (either in the adjuvant or metastatic setting)
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Patients must have been on frontline endocrine therapy containing regimen for >6 months
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Patients may have seen up to 1 prior chemotherapy and no ADC in the metastatic setting

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Metabolic inclusion criteria: HbA1c <7% and fasting plasma glucose <140 mg/dL at baseline
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Target enrollment is 540 patients
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The primary endpoint is progression free survival (PFS), per RECIST 1.1 criteria, tested hierarchically in patients with PI3Kα mutations in the kinase domain only and in patients with any PI3Kα mutation (kinase + non-kinase mutations)
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Overall survival is a key secondary endpoint with overall response rate (ORR), duration of response and quality of life as additional secondary endpoints
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Dose
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Phase 3 dose of RLY-2608 is 400mg twice daily (BID) in the fed state (fed)
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A positive food effect has been observed when RLY-2608 was administered to patients in the fed state, which increased the exposure level of RLY-2608 compared to the fasted state (fasted)
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The RLY-2608 400mg BID fed dose has been shown to achieve exposures equivalent to 600mg BID fasted in cancer patients.
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600mg BID fasted was the dose used in our expansion cohorts

Additional Corporate Highlights

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RLY-2608:
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RLY-2608 doublet: Presented interim clinical data from the open-label Phase 1b study for RLY-2608 + fulvestrant at the San Antonio Breast Cancer Symposium (SABCS) 2024, showing:
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11.4-month median PFS in second line (2L) patients with PI3Kα-mutated, HR+/HER2- advanced breast cancer
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39% confirmed ORR across patients with measurable disease (n= 31)
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67% Clinical Benefit Rate (CBR) across all evaluable patients (32 of 48 CBR-evaluable patients; CBR defined as the proportion of patients with complete response, partial response or stable disease for at least 24 weeks)
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Safety profile (n= 118) remained differentiated with mostly low-grade treatment- related adverse events
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RLY-2608 triplet: Continued to advance two potential front-line triplet regimens in patients with PI3Kα- mutated, HR+, HER2- advanced breast cancer who had previously received at least one prior CDK4/6 inhibitor, including:
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Initiation of triplet cohort for RLY-2608 + fulvestrant + atirmociclib (Pfizer’s selective CDK4 inhibitor) combination
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Continued advancement of the ongoing RLY-2608 + fulvestrant + ribociclib combination cohort
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Planning underway for development of next-generation endocrine therapy combinations with RLY-2608
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Lirafugratinib:
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Entered exclusive global licensing agreement, granting Elevar Therapeutics worldwide rights to develop and commercialize lirafugratinib
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NRAS program:
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Nominated development candidate, RLY-8161
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Research:
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Continued to consolidate and focus the research platform and portfolio on a small number of high-value targets

Anticipated 2025 Milestones

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RLY-2608 in Breast Cancer:
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Initiation of Phase 3 trial in the middle of 2025
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Additional Phase 1b doublet data in 2025

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Vascular malformations: RLY-2608 clinical trial initiation in the first quarter of 2025
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NRAS and Fabry programs continue to advance towards IND and timing of clinical start for each program will be phased to optimize resources to ensure the execution of the ReDiscover-2 Phase 3 trial

Fourth Quarter and Full Year 2024 Financial Results

Cash, Cash Equivalents and Investments: As of December 31, 2024, cash, cash equivalents, and investments totaled $781.3 million compared to approximately $750.1 million as of December 31, 2023. The company expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into the second half of 2027.

Revenue: There was no revenue for the fourth quarters of 2024 and 2023. Revenue was $10.0 million for the full year 2024, as compared to $25.5 million for the full year 2023. The decrease was primarily due to the timing of milestones achieved, as well as revenue recognized thereon, under the company’s Collaboration and License Agreement with Genentech, Inc.

R&D Expenses: Research and development expenses were $68.1 million for the fourth quarter of 2024, as compared to $77.5 million for the fourth quarter of 2023. Research and development expenses were $319.1 million for the full year 2024, as compared to $330.0 million for the full year 2023. The decreases were primarily due to the impact of prioritization of certain programs in the company’s pipeline, as previously disclosed.

G&A Expenses: General and administrative expenses were $16.9 million for the fourth quarter of 2024, as compared to $16.8 million for the fourth quarter of 2023. General and administrative expenses were $76.6 million for the full year 2024, as compared to $75.0 million for the full year 2023.

Net Loss: Net loss was $76.0 million for the fourth quarter of 2024, or a net loss per share of $0.45, as compared to a net loss of $83.5 million for the fourth quarter of 2023, or a net loss per share of $0.67. Net loss was $337.7 million for the full year 2024, or a net loss per share of $2.36, as compared to a net loss of $342.0 million for the full year 2023, or a net loss per share of $2.79.

On February 26, 2025 Eikon Therapeutics, Inc., a pivotal-stage biotechnology company that integrates advanced engineering with cutting-edge molecular and cell biology to accelerate drug discovery and development, reported the initial closing of a $350.7 million Series D financing. Since its founding in 2019, Eikon Therapeutics has privately raised in excess of $1.1 billion to support its mission of developing new medicines to address grievous illnesses (Press release, Eikon Therapeutics, FEB 26, 2025, View Source [SID1234650654]).

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The financing round was led by Eikon’s existing investors, with participation from new investors. The investment syndicate is composed of top mutual funds, sovereign wealth funds, and healthcare and technology-focused venture firms including Lux Capital, Alexandria Venture Investments, AME Cloud Ventures, The Column Group, E15 VC, Foresite Capital, General Catalyst, Soros Capital, StepStone Group, funds and accounts advised by T. Rowe Price Associates, Inc., and UC Investments (Office of the Chief Investment Officer of the Regents of the University of California), among others.

"Eikon has made remarkable progress in advancing a pivotal-stage clinical pipeline and early-stage development program powered by our single-molecule tracking technology and the deep expertise of our multidisciplinary team. With clinical studies now operating in 28 countries, across 5 continents, we are accelerating the development of much-needed therapies while continuing to expand our research and development capabilities," said Roger M. Perlmutter, M.D., Ph.D., CEO and Board Chair of Eikon Therapeutics. "This financing provides the resources necessary to build a fully-integrated, 21st-century biotechnology company that leverages advanced computing, data sciences, and decades of experience in bringing innovative medicines to patients. The continued support of our world-class syndicate of investors is a testament both to the progress we have already made, and to the confidence of investors in our ability to deliver important new medicines for the world."

Eikon’s clinical portfolio is anchored by its lead program, EIK1001, a systemically administered co-agonist of toll-like receptors 7 and 8 now in a Phase III trial for advanced melanoma. EIK1001 has demonstrated both single-agent efficacy and promising in-combination activity with anti-PD-(L)1 agents across multiple tumor types. In parallel, the company is advancing EIK1003, a highly selective PARP1 inhibitor currently undergoing Phase 1 evaluation in patients with breast, ovarian, prostate, or pancreatic cancers, and EIK1004, a central nervous system-penetrant PARP1-selective inhibitor poised to initiate Phase 1 studies targeting brain cancers.

Eikon’s early-stage pipeline features, among other undisclosed candidates, two androgen receptor antagonists and an internally derived WRN inhibitor (EIK1005) that is being studied for its potential as a therapy for patients with MSI-high and other DNA repair–deficient cancers.

"Eikon has engineered a next-generation drug discovery engine that seamlessly integrates automation, high-performance computing, and advanced data science to transform how new medicines are developed," said Lux Capital Co-founder and Managing Partner Josh Wolfe. "By harnessing its proprietary single molecule tracking technology, Eikon is uncovering biological processes in living cells with an unprecedented level of precision, generating insights at a pace that was previously out of reach. With a skilled leadership team that is deeply experienced in bringing groundbreaking therapies to patients, Eikon is setting a new standard for innovation in biotechnology."

Eikon Therapeutics will participate in the upcoming TD Cowen Healthcare Conference in Boston, March 3-5, 2025.