On March 13, 2025 aTyr Pharma, Inc. (Nasdaq: ATYR) ("aTyr" or the "Company"), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported fourth quarter and full year 2024 results and provided a corporate update (Press release, aTyr Pharma, MAR 13, 2025, View Source [SID1234651134]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2024 was an important year for aTyr, as we completed enrollment in our global pivotal Phase 3 EFZO-FIT study, which is the largest interventional study ever to be conducted in pulmonary sarcoidosis, a disease where incidence and prevalence are rising yet there are still limited treatment options," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "The stage is set for 2025 to be a potential milestone year as we look toward reporting topline data for EFZO-FIT in the third quarter. Leading into this pivotal readout, we are very pleased with the execution of the study to date and the continued favorable safety profile demonstrated for efzofitimod, including our most recent positive DSMB review, which recommended the study continue as designed. Efzofitimod is poised to potentially become a safe and effective alternative to the current standard of care and improve patients’ lives."

Fourth Quarter 2024 and Subsequent Period Highlights

Enrollment complete in the global pivotal Phase 3 EFZO-FIT study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously monthly for a total of 12 doses. The study enrolled 268 patients with pulmonary sarcoidosis at 85 centers in nine countries. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of sarcoidosis symptoms and lung function. Topline data from the study are expected in the third quarter of 2025. Patients who complete the study and wish to receive treatment with efzofitimod outside of the clinical trial are eligible to participate in an Individual Patient Expanded Access Program.
Held a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the statistical analysis plan (SAP) for the Phase 3 EFZO-FIT study. The main objective of the meeting was to finalize the way in which the study endpoints are assessed from a statistical standpoint. Based on FDA feedback, steroid reduction will be measured as the absolute change from baseline to week 48.
Announced the fourth positive data and safety monitoring board (DSMB) review for the Phase 3 EFZO-FIT study. The independent DSMB recommended that the study continue without modifications based on the pre-planned analysis.
Enrollment ongoing in the Phase 2 EFZO-CONNECT study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with limited and diffuse systemic sclerosis (SSc, or scleroderma)-related interstitial lung disease (SSc-ILD). This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo dosed intravenously monthly for a total of six doses. The study intends to enroll up to 25 patients at multiple centers in the United States. Patients who complete the study are eligible to participate in a 24-week open-label extension. Interim data from the study are expected in the second quarter of 2025 and will focus on skin assessments measured at baseline and week 12 in approximately 8 patients, including patients on drug and placebo. The data will include skin histopathology, including immune biomarkers, and the modified Rodnan skin score.
Manuscript demonstrating the immunomodulatory activity for efzofitimod in lung inflammation and fibrosis published in the peer-reviewed journal Science Translational Medicine. The publication describes efzofitimod’s unique anti-inflammatory effect on macrophages through neuropiln-2 (NRP2) and details the preclinical data supporting its development. The publication, which is entitled, "A human histidyl-tRNA synthetase splice variant therapeutic targets NRP2 to resolve lung inflammation and fibrosis," is available on the journal’s website and at: View Source
Posters for efzofitimod accepted for presentation at the upcoming American Thoracic Society (ATS) 2025 International Conference. The conference is scheduled to take place May 16 – 21, 2025, in San Francisco, CA.
Poster 9320 – Real-World Treatment Patterns Among Pulmonary Sarcoidosis Patients with Parenchymal Involvement in the US on Sunday May 18, 2025, at 11:30 a.m. PDT.
Poster 6808 – EFZO-FIT, Largest Placebo-Controlled Trial in Pulmonary Sarcoidosis – Trial Design and Patient Characteristics on Monday, May 19, 2025, at 11:30 a.m. PDT.
Poster 9092 – Incidence, Prevalence, and Mortality of Pulmonary Sarcoidosis with Parenchymal Involvement in the US on Tuesday May 20, 2025, at 11:30 a.m. PDT.
Presented preclinical research demonstrating anti-fibrotic effects of ATYR0101 in lung and kidney fibrosis in two posters at the Keystone Symposia on Fibrosis: Inflammation, Drivers, and Therapeutic Resolution. The findings demonstrated that ATYR0101 interacts with LTBP-1 to induce myofibroblast apoptosis through a novel anti-fibrotic mechanism and suggest that ATYR0101 has the potential to be a next generation anti-fibrotic drug for lung and kidney fibrosis.
Appointed Eric Benevich to the Company’s Board of Directors. Mr. Benevich currently serves as Chief Commercial Officer at Neurocrine Biosciences, Inc., where he is responsible for all aspects of commercial development, marketing, and sales of the Neurocrine product portfolio.
Year Ended 2024 Financial Highlights and Cash Position

Cash & Investment Position: Cash, cash equivalents, restricted cash and available-for-sale investments as of December 31, 2024, were $75.1 million. Subsequent to the end of the fourth quarter 2024, the Company raised approximately $18.8 million in gross proceeds from its at-the-market (ATM) offering with Jefferies LLC.
Financial Guidance: The Company updated its prior guidance and believes its cash runway will be sufficient to fund its operations for a period of one year following the Phase 3 EFZO-FIT readout, which includes the potential filing of a Biologics License Application (BLA) for efzofitimod in pulmonary sarcoidosis.
R&D Expenses: Research and development expenses were $54.4 million for the year ended 2024, which consisted primarily of clinical trial costs for the Phase 3 EFZO-FIT and Phase 2 EFZO-CONNECT studies, manufacturing costs for the efzofitimod program and research and development costs for the efzofitimod and discovery programs.
G&A Expenses: General and administrative expenses were $13.8 million for the year ended 2024.
Collaboration and License Revenue: Collaboration and license revenue related to the Kyorin Agreement was $0.2 million for the year ended 2024, which consisted of drug product material sold to Kyorin for the Japan portion of the EFZO-FIT study.
Conference Call and Webcast Details

aTyr will host a conference call and webcast today at 5:00 p.m. EDT / 2:00 p.m. PDT to discuss its financial results and provide a corporate update. Interested parties may access the call by registering here in order to obtain a dial in, personalized passcode and webcast information. Links to a live audio webcast and replay may be accessed on the aTyr website Events page at: View Source An audio replay will be available for at least 90 days following the event.

About Efzofitimod

Efzofitimod is a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. aTyr is currently investigating efzofitimod in the global Phase 3 EFZO-FIT study in patients with pulmonary sarcoidosis, a major form of ILD, and in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.