On March 13, 2025 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported the presentation of preclinical data investigating the potential of co-administration of deoxyribonuclease I (DNase I) with chimeric antigen receptor (CAR) T cells in a syngeneic B16 melanoma murine model of lung metastasis (Press release, Xenetic Biosciences, MAR 13, 2025, View Source [SID1234651133]).

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The poster titled, "DNase I Intervention Enhances CAR-T Cell Therapy in Solid Tumors by Targeting Neutrophil Extracellular Traps in Metastatic Melanoma," was presented on behalf of the Company by Alexey Stepanov, PhD, Institute Investigator at The Scripps Research Institute, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Spring Scientific 2025 Cell Therapy Meeting being held March 12 – 14, 2025 in San Diego, CA and virtually. 

"These findings further illuminate the crucial role of NETs in limiting CAR T cell function and underscore the potential of DNase I as an adjunctive treatment to improve patient responses to immunotherapies. We continue to be encouraged by the growing body of positive preclinical data and believe that our approach has the potential to prolong survival compared to treatment with CAR T cell monotherapy, including CAR T therapies directed against solid tumors, where there has been only limited activity to date. We are committed to advancing our DNase development program forward and further exploring the translational potential of this combinatorial approach, and to provide patients with a much-needed alternative treatment option that has the potential to address several unmet needs in cancer treatment," commented Reid Bissonnette, Ph.D., Executive Consultant for Translational Research and Development at Xenetic.

For the preclinical study, co-administration of DNase I with CAR T cells was investigated in a syngeneic B16 murine melanoma model of lung metastasis. Bioluminescent imaging of melanoma metastatic processes has shown that a single injection of DNase I (10 mg/kg) together with CAR T cells suppressed B16-EGFR lung metastasis at early stages in comparison to the vehicle control group and extended survival

Key Highlights

Using bioluminescent imaging, researchers observed that a single injection of DNase I (10 mg/kg) effectively suppressed B16-EGFR lung metastasis at early stages compared to vehicle controls. However, while DNase I demonstrated efficacy in reducing tumor growth, it did not significantly improve survival when administered alone.

The combination treatment of DNase I with murine EGFR-CAR T cells led to a marked suppression of tumor burden, a decrease in the number of metastatic foci, and substantial prolongation of survival compared to CAR T cell monotherapy. This therapeutic enhancement was associated with an increase in tumor-infiltrating T and CAR T cells, indicating improved immune engagement.

Analysis of the CD8 T cell population from DNase I-treated groups revealed a notable decrease in PD-1 and TIM-3 expression, markers of T cell exhaustion, suggesting that DNase I effectively mitigates the immunosuppressive effects of the tumor microenvironment (TME).

Xenetic continues to advance its DNase-based technology towards Phase 1 clinical development for the treatment of pancreatic carcinoma and other locally advanced or metastatic solid tumors. Preliminary preclinical studies evaluating the combinations of DNase I with chemotherapy and DNase I with immuno-therapies in colorectal cancer models as well as CAR-T therapy have been completed.

On March 13, 2025 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), an oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported its financial results for the full year 2024 and recent business highlights (Press release, Sutro Biopharma, MAR 13, 2025, View Source [SID1234651132]). The Company also announced the completion of a strategic portfolio review resulting in the prioritization of its next-generation ADC pipeline. A conference call will be held today at 2:00 p.m. PT/ 5:00 p.m. ET to discuss the pipeline reprioritization, team restructuring and next steps.

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Full Year 2024 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of December 31, 2024, Sutro had cash, cash equivalents and marketable securities of $316.9 million, as compared to $388.3 million as of September 30, 2024. Cash runway is expected into at least Q4 2026, excluding anticipated milestones from existing collaborations.

Revenue

Revenue was $62.0 million for the year ended December 31, 2024, as compared to $153.7 million for the year ended December 31, 2023, with the 2024 amount related principally to the Astellas collaboration and the Tasly agreement. Future collaboration and license revenue under existing agreements, and from any additional collaboration and license partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other agreement payments.

Operating Expenses

Total operating expenses for the year ended December 31, 2024 were $300.5 million, as compared to $243.0 million for year ended December 31, 2023. The year 2024 includes non-cash expenses for stock-based compensation of $24.7 million and depreciation and amortization of $7.2 million, as compared to $24.9 million and $6.8 million, respectively, in the year 2023. Total operating expenses for the year ended December 31, 2024 were comprised of research and development expenses of $252.0 million and general and administrative expenses of $48.5 million.

Restructuring Expenditures: Cash payments resulting from the strategic portfolio review and related restructuring are estimated to be $40 to $45 million. Cost reductions subsequently realized from the restructuring, combined with refocused clinical development priorities give the Company an expected cash runway into at least the fourth quarter of 2026, excluding anticipated milestones from existing collaborations.

Conference Call Details:

The Company will host a conference call and webcast today at 2:00 p.m. PT/ 5:00 p.m. ET. The webcast information will also be available through the News & Events section of the Investors portion of the Company’s website at www.sutrobio.com. An archived replay will be available for at least 30 days after the event.

On March 13, 2025 Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the "Company"), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, reported financial results for the full year ended December 31, 2024, and outlined recent corporate updates (Press release, Cartesian Therapeutics, MAR 13, 2025, View Source [SID1234651131]).

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"Following a year marked by tremendous progress, we remain committed to advancing our pipeline of mRNA cell therapies designed to be dosed in the convenient outpatient setting, without the need for preconditioning chemotherapy," said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. "Notably, we remain on track to commence our planned Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (MG) in the first half of this year. Supported by positive results from our Phase 2b trial demonstrating deep and durable improvements for Descartes-08-treated participants, along with our Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA), we are confident that we have a clear path toward potential approval of this promising new therapy."

Dr. Brunn continued, "Beyond MG, we remain on track to report preliminary data from our ongoing Phase 2 open-label trial of Descartes-08 in patients with systemic lupus erythematosus (SLE) and expect to initiate our Phase 2 pediatric basket trial of Descartes-08 in select autoimmune diseases in the second half of this year. With these anticipated milestones, along with our strong balance sheet, we believe we are well-positioned to deliver on our mission to expand the reach of cell therapy to autoimmunity."

Recent Pipeline Progress and Anticipated Milestones

•Phase 3 AURORA Trial of Descartes-08 in MG on Track to Commence in the First Half of 2025. The randomized, double-blind, placebo-controlled Phase 3 AURORA trial is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six once weekly outpatient infusions without preconditioning chemotherapy in approximately 100 participants with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo. Descartes-08, Cartesian’s lead product candidate, is an autologous anti-B cell maturation antigen (BCMA) mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T).
In January 2025, Cartesian announced that it has received written agreement from the FDA under the SPA process on the overall design of the planned Phase 3 AURORA trial. The SPA agreement indicates that the FDA has determined that the proposed trial design is acceptable to support a future Biologics License Application for Descartes-08 in MG, subject to the ultimate outcome of the trial.

•Announced Positive Updated Results from Phase 2b Trial of Descartes-08 in Participants with MG, with Deepening Response Observed Over Time, Durable Through Month 12. In December 2024, the Company announced updated efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with MG.

Participants included in the primary efficacy dataset (n=12)1 experienced an average MG-ADL reduction of 5.5 (±1.1) at Month 4. Responses were observed to be durable through Month 12, with 80% (4/5) of evaluable participants from the primary efficacy dataset maintaining a clinically meaningful response, defined as a reduction in MG-ADL score of at least 2 points. Descartes-08 continues to be observed as well-tolerated, supporting outpatient administration without the need for lymphodepleting chemotherapy.

•Dr. Tuan Vu, one of Cartesian’s Clinical Advisors, will Present at the American Academy of Neurology Annual Meeting on April 9, 2025 at 1:12 pm PT. The presentation and abstract are titled, "The Efficacy and Safety of Autologous BCMA-directed mRNA CAR T-Cell Therapy in Generalized Myasthenia Gravis: Results from a Phase 2b Randomized Placebo-controlled Trial."

•Preliminary Data from Ongoing Phase 2 Open-Label Trial of Descartes-08 in Patients with SLE Expected in the Second Half of 2025. The trial is designed to assess the safety, tolerability and clinical activity of outpatient Descartes-08 administration without preconditioning chemotherapy in patients with SLE. SLE is an incurable autoimmune disease marked by systemic inflammation that affects multiple organ systems and impacts approximately 1.5 million people in the United States.

•Phase 2 Pediatric Basket Trial of Descartes-08 in Select Autoimmune Diseases Expected to Initiate in the Second Half of 2025. This pediatric basket trial will target juvenile SLE, juvenile MG, juvenile dermatomyositis (JDM) and anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis. The FDA previously granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of JDM, which is a rare pediatric autoimmune disorder.

•Dosing Ongoing in First-in-Human Phase 1 Clinical Trial of Descartes-15. The Phase 1 dose escalation trial of Cartesian’s next-generation, autologous anti-BCMA mRNA CAR-T cell therapy, is designed to assess the safety and tolerability of outpatient Descartes-15 administration in patients with multiple myeloma. Following the Phase 1 dose escalation trial, the Company expects to subsequently assess Descartes-15 in autoimmune indications.

Corporate Updates

•Emily English Promoted to Chief Operations Officer. Emily English, formerly Cartesian’s Senior Vice President and Head of Manufacturing Operations, was promoted to Chief Operations Officer in January 2025. Emily’s significant contributions, including her leadership in the expansion of the new, state-of-the-art current good manufacturing practice (cGMP) facility in Frederick, Maryland, have been instrumental in Cartesian’s progress as the Company continues to advance its pipeline.

Full Year 2024 Financial Results

•Cash, cash equivalents and restricted cash as of December 31, 2024 was $214.3 million and is expected to support planned operations, including completion of planned Phase 3 AURORA trial for Descartes-08 in MG, into mid-2027.

•Research and development expenses were $45.1 million for the year ended December 31, 2024, compared to $71.3 million for the year ended December 31, 2023. The decrease was primarily a result of the Company’s restructuring in 2023 prior to the merger between Cartesian and Selecta Biosciences, including reductions in expenses for preclinical and clinical programs due to the strategic reprioritization, stock compensation in connection with the Selecta Biosciences/ Cartesian Therapeutics merger, and higher expenses in 2023 compared to 2024 due to one-time cash charges related to salaries and benefits.

•General and administrative expenses were $30.1 million for the year ended December 31, 2024, compared to $40.5 million for the year ended December 31, 2023. The decrease in expense for the year ended December 31, 2024 was primarily the result of reductions in expenses incurred for stock compensation and professional fees in connection with the merger between Cartesian and Selecta Biosciences.

•Net loss was $(77.4) million, or $(4.48) net loss per share (basic), for the year ended December 31, 2024, compared to net loss of $(219.7) million, or $(49.76) net loss per share (basic), for the year ended December 31, 2023.

About Descartes-08

Descartes-08, Cartesian’s lead mRNA cell therapy candidate, is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T) product targeting B-cell maturation antigen (BCMA) in clinical development for generalized myasthenia gravis (MG) and systemic lupus erythematosus. In contrast to conventional DNA-based CAR T-cell therapies, mRNA CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis.

About Descartes-15

Descartes-15 is a next-generation, autologous anti-BCMA mRNA CAR-T cell therapy. In preclinical studies, Descartes-15 has been observed to achieve an approximately ten-fold increase in CAR expression and selective target-specific killing, relative to Descartes-08. Similar to Descartes-08, Descartes-15 is designed to be administered without preconditioning chemotherapy and does not use integrating vectors.

On March 13, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that the U.S. Food and Drug Administration has cleared its Investigational New Drug ("IND") application filed in January 2025 to evaluate a combination of Versamune MUC1 (formerly PDS0103), its novel investigational MUC1-targeted immunotherapy candidate + PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma ("mCRC") in patients who failed previous treatment (Press release, PDS Biotechnology, MAR 13, 2025, View Source [SID1234651130]).

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"MUC1 is over-expressed in multiple solid tumors including colon, pancreatic, ovarian, breast, and NSCLC, and is associated with drug resistance and poor patient outcomes. This results in an unmet need for more effective, safer, better-tolerated targeted treatment options. Versamune MUC1 targets mCRC tumors that are MUC1-positive and will be studied in Proficient Mismatch Repair/Microsatellite Stable mCRC, which accounts for 95% of patients with mCRC. These tumors are typically more resistant to current immunotherapy, such as immune checkpoint inhibitors, and second-line chemotherapy," said Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. "Targeting MUC1 with an immunotherapy that elicits a strong and durable tumor-infiltrating T-cell response could represent a major advancement in cancer treatment."

The National Cancer Institute ("NCI"), under its Cooperative Research and Development Agreement ("CRADA") with PDS Biotech, will lead the Phase 1/2 clinical trial evaluating the combination of Versamune MUC1 + PDS01ADC in recurrent/metastatic colorectal cancer.

"The IND clearance of Versamune MUC1 marks progress for our Versamune platform and its potential to expand beyond HPV-related cancers," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "Though our focus remains on our recently initiated VERSATILE-003 Phase 3 clinical trial in HPV16-positive head and neck squamous cell carcinoma, we are pleased to support the NCI investigation of a therapy that shows promise in driving strong, durable anti-tumor immune responses."

U.S. Patent #12,201,685 covers the methods of using the proprietary combination of Versamune and cytokines to overcome immune suppression in the tumor and improve the anti-tumor immune response.

On March 13, 2025 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported 2024 year-end financial results and provides a corporate update (Press release, Intensity Therapeutics, MAR 13, 2025, View Source [SID1234651129]).

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Corporate Update

INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the standard of care ("SOC") drugs in second and third line treatment for certain soft tissue sarcoma subtypes. The INVINCIBLE-3 Study is expected to enroll 333 patients and initiate sites in eight countries. This study has been authorized by the US FDA, Health Canada, the European Medicines Authority (for France, Germany, Italy, Poland and Spain), and Australia’s Therapeutics Goods Administration. The primary endpoint in the INVINCIBLE-3 Study is overall survival.

In July 2024, the Company initiated and dosed its first patient in the INVINCIBLE-3 Study. The trial is actively enrolling patients across the US, Canada, Europe and Australia. Up to 60 sarcoma-focused institutions are expected to participate from these regions. The Company has contracted 32 sites with 25 patients screened to date. The Company expects to complete enrollment in the first half of 2026.

INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC treatment in patients with early-stage, operable triple-negative breast cancer ("TNBC") and SOC alone. The primary endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. The INVINCIBLE-4 Study is expected to enroll approximately 54 patients in Switzerland and France.

In October 2024, in collaboration with The Swiss Group for Cancer Research SAKK ("SAKK"), the Company initiated and dosed its first patient in Switzerland in the INVINCIBLE-4 Study. To date, the Company has activated eight sites in Switzerland and treated several patients. The Company expects to activate additional sites in Switzerland and France in the first half of 2025 and complete enrollment by the end of the first quarter of 2026.

"In 2024, Intensity Therapeutics finalized both Phase 3 and Phase 2 protocols, engaged leading hospitals around the world, and obtained regulatory authorization to recruit patients in 9 countries to initiate treatment," stated Lewis H. Bender, Intensity Founder, President, and CEO. "Our programs were again selected for presentation at major sarcoma and breast cancer societies. Many of the best sarcoma treatment centers from the US, Canada, Europe and Australia are either participating now or in contract discussions. For our breast cancer trial, our partners at SAKK have recruited interest by the leading hospitals in Switzerland and France to participate. Physicians are screening patients at an increasing rate. We believe in the potential for our drug to have a positive impact on the lives of metastatic sarcoma and presurgical breast cancer patients around the world, who so desperately need improved alternatives to current therapies."

2024 Year End Financial Results

Research and development expenses were $10.5 million for the year ended December 31, 2024, compared to $4.8 million for the year ended December 31, 2023. The increase was primarily due to an increase of $5.6 million in the INVINCIBLE-3 Study in 2024, in which we enrolled our first patient in the third quarter of 2024, and to a lesser extent, an increase of $0.5 million in the INVINCIBLE-4 Study, in which we enrolled and dosed our first patient in the fourth quarter of 2024. These increases were partially offset by a decrease of $1.1 million in our IT-01 Study due to the completion of enrollment in this study in mid-2022 and the completion of study-related costs in 2023. Research and development also increased due to higher salary, benefits, and stock-based compensation.

General and administrative expenses were $6.1 million for the year ended December 31, 2024, compared to $3.5 million for the year ended December 31, 2023. The increase was primarily due to increased expenses related to salary, benefits and stock-based compensation, higher legal and consulting fees, and higher directors and officers insurance.

Overall, net loss was $16.3 million for the year ended December 31, 2024, compared to a net loss of $10.5 million for the year ended December 31, 2023.

As of December 31, 2024, cash and cash equivalents totaled $2.6 million.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression which often occurs with systemic chemotherapy.