On May 22, 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 publication of three Versamune HPV abstracts now available on the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting website (Press release, PDS Biotechnology, MAY 22, 2025, View Source [SID1234653313]). These abstracts summarize Versamune HPV (PDS0101) studies to be presented during the Head and Neck Cancer Poster Session taking place May 30-June 3, 2025, in Chicago, Illinois.

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Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech stated, "We continue to be excited about the strength and durability of the VERSATILE-002 data showing the longest survival reported to date in 1L recurrent/metastatic (r/m) head and neck cancer (HNSCC). These results further strengthen our confidence in the ongoing VERSATILE-003 trial, which is the only registrational trial for the rapidly growing population of patients with HPV16-positive r/m HNSCC. Based on our estimates1, HPV16-positive patients are as likely to progress to recurrent and/or metastatic stage as HPV-negative patients, and HPV16-positive patients currently comprise 40-60% of patients in the ICI-naïve r/m HNSCC population in the US."

VERSATILE-002: Overall Survival of HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients Treated with T Cell Stimulating Immunotherapy PDS0101 and Pembrolizumab (Abstract #6037) – Poster Presentation. June 2, 2025, 9:00 a.m.-12:00 p.m. CDT

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Enrollment in the trial (n=53) is complete; 23 patients (including 3 still on treatment) continue to be followed for survival. No new safety signals have emerged

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Survival Results:

o
39.3 months mOS in patients with CPS ≥ 20 (95% Confidence interval, lower limit of 18.4 months, upper limit net yet estimable (NE); published mOS for pembrolizumab is approximately 15 months

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30.0 months mOS (95% CI 23.9, NE) in patients with CPS ≥ 1; published result for pembrolizumab is approximately 12 months

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29.5 months mOS (95% CI 15.3, NE) in patients with CPS 1-19; published result for pembrolizumab is approximately 10 months

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Median follow up of 18.4 months (range 0.2-42.7 months) represents one of the most extended follow-up periods to date of subjects receiving a therapy for HPV16-positive r/m HNSCC.

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Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at University of North Carolina, and Principal Investigator of the VERSATILE-002 Phase 2 clinical trial, will present the poster.

VERSATILE-003: A Phase 3, Randomized, Open-label Trial of PDS0101 and Pembrolizumab compared with Pembrolizumab for First-Line Treatment of Patients with HPV16-positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma" (Abstract #TPS6111) – Poster Presentation. June 2, 2025, 9:00 a.m.-12:00 p.m. CDT

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Highlights study objectives and design of the ongoing VERSATILE-003 (NCT06790966) trial

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Median overall survival is primary endpoint – 2 interim readouts planned

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351 patients to be accrued in 2:1 randomization

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Katharine Price, M.D., Associate Professor of Oncology, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center, and Principal Investigator of the VERSATILE-003 clinical trial, will present.

Initial results of MC200710 investigating therapeutic vaccine (PDS0101) alone or with pembrolizumab prior to surgery or radiation therapy for locally advanced HPV associated oropharyngeal carcinoma, a Phase 2 window of opportunity trial" (Abstract #6061) – Poster Presentation. June 2, 2025, 9:00 a.m.-12:00 p.m. CDT

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In the prospective Phase 2 trial, newly diagnosed patients were administered two (2) cycles of Versamune HPV alone or in combination with pembrolizumab before surgical resection or chemoradiotherapy (CRT).

•
Results:

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Clinical activity was seen with only 2 cycles of Versamune HPV alone and with 2 cycles of Versamune HPV with pembrolizumab

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70% of patients who received Versamune HPV alone had stable disease

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100% of patients who received Versamune HPV with pembrolizumab had stable disease or partial response

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The combination of Versamune HPV and pembrolizumab met the trial’s primary endpoint of 50% reduction in circulating tumor DNA (ctDNA) response.

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David M. Routman, M.D., Assistant Professor of Radiation Oncology, Department of Radiation Oncology, Mayo Clinic, will present the poster.

Conference Call Details

Date: May 23, 2025
Time: 8:00 a.m. Eastern Time
Dial-in: 1-877-704-4453 (Domestic); 1-201-389-0920 (International)
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On May 22, 2025 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported the presentation of new data from two clinical trials evaluating its cancer immunotherapy candidates — VB10.16 and VB10.NEO, both in combination with atezolizumab (Tecentriq), — at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, Nykode Therapeutics, MAY 22, 2025, View Source [SID1234653312]).

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The two posters highlight the potential of Nykode’s targeted immunotherapy platform in inducing robust immune responses in heavily pre-treated patient populations across multiple tumor types, with encouraging safety profiles.

"These new data add to the growing body of clinical evidence supporting our vaccine candidates VB10.NEO and VB10.16," said Agnete Fredriksen, CSO and Co-founder of Nykode Therapeutics. "The quality of the immune responses seen in both trials and the increased understanding of the relation between the immune responses and patient characteristics—reinforce the potential of our APC-targeted technology and help define the best path forward for these promising assets."

Sunday, June 1, 2025 | 9:00 AM–12:00 PM

CT Abstract #: 5538

Title: Integrative analysis of VB10.16 and atezolizumab in advanced HPV16-positive cervical cancer: Linking biomarker insights to clinical outcomes.

Presenter: Kristina Lindemann, Department of Gynecological Oncology, Oslo University Hospital & Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway

Session Type and Title: Poster Session – Gynecologic Cancer

Poster Board Number: 436

• In patients with persistent, recurrent, or metastatic HPV16-positive cervical cancer, VB10.16 combined with atezolizumab induced durable clinical responses. • The VB C-02 trial demonstrated that stronger HPV16-specific T cell responses were associated with reduced systemic immunosuppression during treatment. • Tumor microenvironment (TME) characteristics are associated with higher response rates. • These findings support the importance of identifying the right patient population as well as elucidating the treatment effect on the systemic immunosuppression and highlights the promise of VB10.16 in combination with atezolizumab, warranting further exploration.

Monday, June 2, 2025 | 1:30 PM–4:30 PM CT

Abstract #: 2639

Title: Induction of neoantigen-specific immune responses by VB10.NEO in combination with atezolizumab in heavily pretreated patients with advanced solid tumors: Final analysis of the phase 1b VB N-02 trial.

Presenter: Sebastian Ochsenreither, Charité University of Medicine Berlin Comprehensive Cancer Center, Berlin, Germany Session Type and Title: Poster Session – Developmental Therapeutics – Immunotherapy

Poster Board Number: 286

• VB10.NEO, Nykode’s personalized cancer neoantigen vaccine, in combination with atezolizumab, induced neoantigen-specific immune responses. • Neoantigen-specific immune responses were observed in 100% of the patients and de novo immune responses were observed in 85% of patients, as measured by in vitro stimulated IFNγ ELISpot. • Expansion of durable T cell clones was seen in 82% of patients, suggesting persistence of the immune response. • The trial enrolled heavily pre-treated patients across more than 10 indications, a median of 5 prior therapy lines and predominantly low or negative PD-L1 expression resulting in a median PFS reached before 2 months, limiting the opportunity for thorough assessment of long-term immune responses and clinically meaningful responses. • VB10.NEO in combination with atezolizumab demonstrated a favorable safety profile. • These results support further development of VB10.NEO in additional solid tumor settings.

On May 22, 2025 Nona Biosciences, a global biotechnology company providing integrated solutions from "Idea to IND" (I to ITM), reported that its collaborator, Pfizer, will present an abstract detailing the first-in-human Phase 1 clinical study design of MesoC2 (HBM9033/PF-08052666), a first-in-class mesothelin (MSLN)-targeting antibody-drug conjugate (ADC), at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Nona Biosciences, MAY 22, 2025, View Source [SID1234653311]).

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MesoC2, originally developed using Nona’s proprietary Harbour Mice and integrated ADC platforms, was licensed to Pfizer in December 2023 under a global rights agreement. Pfizer is currently evaluating the ADC in a Phase 1, open-label study in patients with advanced solid tumors, including mesothelioma, platinum-resistant ovarian cancer (PROC), pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), endometrial cancer (EC), and colorectal cancer (CRC).

Poster Presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting

Title: A phase 1 study to evaluate the safety and tolerability of the antibody–drug conjugate (ADC) MesoC2 (PF-08052666) in patients with advanced solid tumors

Abstract Number: TPS3163

Poster Board Number: 475a

Session Title: Poster Session – Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Session Date and Time: 02 June 2025; 1:30 PM-4:30 PM (CDT)

Key Highlights from the Presentation:

MesoC2 is an ADC composed of a human IgG1 anti-MSLN monoclonal antibody conjugated to a cleavable tripeptide linker carrying a topoisomerase 1 inhibitor (TOP1i) payload (average drug-to-antibody ratio of 8).
MesoC2 has shown potent antitumor efficacy in in vitro assays and xenograft models and an acceptable safety profile in cynomolgus monkeys.
The Phase 1 trial (NCT06466187) will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy per RECIST v1.1 criteria of MesoC2 in up to 365 patients across dose escalation, optimization, and expansion cohorts.
"We are excited to see Pfizer advancing MesoC2 into clinical development rapidly, highlighting the potential of Nona’s Harbour Mice and integrated ADC platforms to deliver innovative cancer therapies," said Dr. Jingsong Wang, Chairman of Nona Biosciences. "The initiation of this Phase 1 trial marks a significant milestone in our collaboration and underscores our shared commitment to addressing unmet needs in oncology."

Pfizer’s presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting will provide further insights into the trial design. Additional details on the study can be found at ClinicalTrials.gov (NCT06466187).

About MesoC2 (HBM9033/PF-08052666)

MesoC2 (HBM9033/PF-08052666)is an ADC drug that targets human MSLN, a tumor-associated antigen (TAA) upregulated in various solid tumors. The fully human monoclonal antibody (mAb) in MesoC2 is derived from the Harbour Mice platform and possesses well-tuned properties, exhibiting reduced binding to soluble MSLN while maintaining strong binding and internalization to membrane-bound MSLN. The unique design of the mAb was created to enhance potency in various preclinical tumor models with differing MSLN expression levels, positioning MesoC2 as a potential globally best-in-class therapeutic option.

On May 22, 2025 Mythic Therapeutics, a clinical-stage biotechnology company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of a wide range of cancers, reported it will present data from its Phase 1 KisMET-01 study evaluating its investigational cMET-targeting ADC, MYTX-011, in patients with non-small cell lung cancer (NSCLC) at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Mythic Therapeutics, MAY 22, 2025, https://mythictx.com/2025/05/22/mythic-therapeutics-to-present-compelling-efficacy-data-from-phase-1-kismet-01-study-supporting-best-in-class-potential-of-investigational-cmet-adc-mytx-011-in-non-small-cell-lung-cancer/?utm_source=rss&utm_medium=rss&utm_campaign=mythic-therapeutics-to-present-compelling-efficacy-data-from-phase-1-kismet-01-study-supporting-best-in-class-potential-of-investigational-cmet-adc-mytx-011-in-non-small-cell-lung-cancer [SID1234653310]). The presentation, which includes an updated data cut as of April 24, 2025, is the first disclosure of efficacy data for MYTX-011, demonstrating meaningful anti-tumor activity in cMET+ NSCLC across cMET levels, histologies, and actionable genetic alterations.

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Details of the presentation are as follows:

Abstract Title: MYTX-011, a cMET-targeting antibody-drug conjugate (ADC), in patients with previously treated, advanced NSCLC: Updated dose escalation results in the phase 1 KisMET-01 study.
Presenter: Rebecca Heist, M.D., M.P.H., Medical Oncologist, Massachusetts General Hospital, Cancer Center
Format: Poster Session
Session Name: Lung Cancer – Non-Small Cell Metastatic
Session Date and Time: Saturday, May 31, 2025, at 1:30 – 4:30 PM CDT
Poster Board Number: 93
Abstract Number: 8613

About KisMET-01

KisMET-01 (NCT05652868) is a multicenter, first-in-human Phase 1 study of MYTX-011 in patients with previously treated, locally advanced or metastatic NSCLC. The study is comprised of two parts: dose escalation (Part 1) in patients with NSCLC of any histology of cMET expression with cMET analyzed whenever tumor tissue is available, followed by dose expansion (Part 2) in cMET-positive (cMET+) patients selected by immunohistochemistry (Ventana SP44). cMET levels are defined as high (≥50% tumor cells with 3+ staining), intermediate (≥25% and <50% with 3+ staining), low (≥25% with 2+ staining, excluding high and intermediate), and ultra-low (≥75% excluding high, intermediate, and low).

About MYTX-011

MYTX-011 is an investigational cMET-targeting ADC, which leverages Mythic’s innovative FateControl technology. FateControl ADCs are pH engineered to unbind their target after internalization, intended to improve both tumor uptake and drug exposure for improved safety, tolerability and efficacy. MYTX-011 is currently being evaluated in the Phase 1 KisMET-01 clinical trial, a first-in-human, open-label, multi-center, dose escalation and dose expansion study enrolling patients with locally advanced, recurrent or metastatic NSCLC (NCT05652868).

On May 22, 2025 Kura Oncology, Inc. (Nasdaq: KURA, "Kura") and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported that an abstract highlighting the full data analyses from the KOMET-001 registration-directed trial of ziftomenib, a once-daily, oral investigational menin inhibitor, has been accepted for oral presentation at the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held in Chicago, IL from May 30 – June 3, 2025 (Press release, Kura Oncology, MAY 22, 2025, View Source [SID1234653309]).

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The KOMET-001 registration-directed trial (NCT #04067336) is designed to assess evidence of clinical activity, safety and tolerability of ziftomenib, the only investigational therapy to receive Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for treatment of relapsed/refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML). NPM1 mutations are among the most common, representing approximately 30% of AML cases, and there are no FDA approved therapies for NPM1-m AML. Kura and Kyowa Kirin previously announced positive topline results from the KOMET-001 trial, which achieved its primary endpoint of complete remission (CR) plus CR with partial hematological recovery (CRh) and the primary endpoint was statistically significant. Ziftomenib was well‑tolerated with limited myelosuppression and 3% ziftomenib-related discontinuations. The benefit-risk profile for ziftomenib is highly encouraging, and safety and tolerability were consistent with previous reports.

"These data highlight ziftomenib’s potential use as a treatment option for R/R NPM1-mutant AML," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We are encouraged by the safety and tolerability profile as well as the clinical efficacy observed for this subset of AML patients, and together, Kura and Kyowa Kirin are committed to advancing ziftomenib toward commercialization. We look forward to sharing a more comprehensive dataset at the ASCO (Free ASCO Whitepaper) Annual Meeting in the coming weeks."

In addition to the oral presentation, a trial-in-progress abstract for the KOMET-015 trial has been accepted for poster presentation on May 31, 2025. Session titles and information for both abstracts are listed below and are now available on the ASCO (Free ASCO Whitepaper).org website. Updated data from the published abstract for KOMET-001 will be disclosed during the oral presentation.

Ziftomenib in Relapsed/Refractory (R/R) NPM1-Mutant Acute Myeloid Leukemia (AML): Phase 1b/2 Clinical Activity and Safety Results from the Pivotal KOMET-001 Study (#6506)
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Session Date and Time: Monday, June 2, 2025; 3:00PM – 6:00PM CDT
Presentation Time: 4:36PM – 4:48PM CDT
Location: McCormick Place, S100a

Phase 1a/1b Study of the Safety, Pharmacokinetics, and Antitumor Activity of Ziftomenib in Combination with Imatinib in Patients with Advanced Gastrointestinal Stromal Tumors (GIST) After Imatinib Failure
Session: Poster Session – Sarcoma
Session Date and Time: Saturday, May 31, 2025; 9:00AM – 12:00PM CDT
Location: McCormick Place, Hall A – Posters and Exhibits

Copies of the presentations will be available on Kura’s website at www.kuraoncology.com/pipeline/publications/ following presentation at the meeting.

Virtual Investor Event

Kura will host a virtual investor event featuring company management and investigators from the KOMET-001 trial of ziftomenib in R/R NPM1-m AML at 7:30pm ET / 4:30pm PT on Monday, June 2, 2025. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here.The event can also be accessed on the Investors section of Kura’s website at www.kuraoncology.com. An archived replay will be available shortly after the conclusion of the live event.