On June 2, 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, JUN 2, 2025, View Source [SID1234653620]). These abstracts summarize Versamune HPV (PDS0101) studies that were presented during the Head and Neck Cancer Poster Session taking place May 30-June 3, 2025, in Chicago, Illinois.

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!

It is estimated that over 50% of head and neck squamous cell carcinoma (HNSCC) cases in the US are HPV16-positive.1 HPV-positive and HPV-negative HNSCC are two distinct diseases with different underlying causes, origin, risk factors, and contributions to the development of HNSCC. Multiple types of HPV are associated with HSNCC, and those cases are commonly identified with a p16 histochemistry test and referred to as p16-positive. A p16-positive test result suggests that the patient’s cancer may be due to any of the over 100 types of HPV. PDS Biotech is specifically addressing HNSCC related to HPV type 16 (HPV16), the most carcinogenic type of HPV. 2 HPV16-positive HNSCC has been identified as a rapidly growing and severe medical need.3,4 HPV16 is a specific type of HPV that must be confirmed using a polymerase chain reaction (PCR) test.

PDS Biotechnology’s trial differs from the other ongoing Phase 3 clinical trials addressing 1L r/m HNSCC based on its specific HPV16-positive HNSCC target population and its therapeutic approach.

Phase 3 Development

EGFR Bispecific Antibodies

PDS Biotechnology
Therapeutic Approach

Blocking antibodies targeting EGFR and a second receptor

HPV16-targeted T cell immunotherapy
Treated Populations

Predominantly HPV-negative and no confirmed HPV16-positive HNSCC patients#

100% HPV16-positive HNSCC*
Mechanism of Action

Inhibition of EGFR signaling and either LGR5 or TGF-β

Promotes multi-functional CD4 (helper) and CD8 (killer) T cell response targeting HPV16 E6 and E7 expressing tumors
#P16 histochemistry test to determine infection with any of > 100 types of HPV
*Confirmatory PCR test for HPV16-positive specific infection

Kevin Harrington, M.D., Ph.D. of The Institute of Cancer Research in the United Kingdom stated, "HPV-positive HNSCC is today seen as a different disease from HPV-negative HNSCC. HPV-positive HNSCC has different biological characteristics and requires a more targeted approach that treats the underlying HPV integration and persistence into the patient’s tumor DNA. Cytotoxic drugs and the EGFR inhibitor cetuximab have not worked as well in HPV-positive HNSCC to date."

HPV16 has been reported to suppress the immune system’s ability to respond to the virus, resulting in more difficult-to-treat and non-immunogenic tumors.5 At least two studies have compared patients with HPV16-positive HNSCC with p16-positive patients (excluding HPV16) and patients with HPV-negative HNSCC, and shown patients with HPV16-positive HNSCC to have significantly worse survival prognosis than other p16-positive HNSCC, and in an advanced oral cancer study, patients with HPV16-positive HNSCC had significantly worse survival than patients with HPV-negative HNSCC.6,7

To accurately identify and appropriately treat patients with HPV16-positive HNSCC, the U.S. Food and Drug Administration (FDA) recommended that a companion diagnostic be developed and included in the ongoing VERSATILE-003 Phase 3 trial.

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

The trial was performed across 31 sites in the US and Europe. Median follow-up time is 22.1 months (range 0.2-43.0 months), representing one of the most extended follow-up periods to date of subjects receiving treatment for HPV16-positive 1L r/m HNSCC.

Median overall survival (mOS) has remained steady at 30.0 months over the last 1.5 years, suggesting durability of the Versamune HPV-induced clinical responses. The lower limit of the 95% confidence interval for mOS has, however, increased from 18.4 months in 2023 to 23.9 months as the data has matured. All data are reported according to RECISTv1.1 criteria, requiring clinical responses on at least two consecutive tumor scans at least 4 weeks apart. Enrollment in the trial (n=53) is complete; 22 patients (including 3 still on treatment) continue to be followed for survival. No new safety signals have emerged.

Summary of results for Versamune HPV with pembrolizumab stratified by patient CPS status.

Versamune HPV (PDS0101) + Pembrolizumab (VERSATILE-002)

CPS ≥ 1
N=53 (100%)
CPS ≥ 20
N=21/53 (40%)
CPS 1-19
N=32/53 (60%)

Median Overall Survival (mOS)
30.0 months
(95% Confidence interval,
lower limit of 23.9 months,
upper limit not yet estimable
(NE))
39.3 months
(95% CI 30.0, NE)
26.1 months
(95% CI 15.3, NE)

Median Progression Free Survival (PFS)
6.3 months
(95% CI 2.8, 14.1)
14.1 months
(95% CI 2.1, NE)
5.1 months
(95% CI 2.2, 8.1)

Objective Response Rate (ORR)
19/53 (35.8%)
10/21 (47.6%)
9/32 (28.1%)

Tumor Shrinkage of 90-100%

11/53 (20.8%)
6/21 (28.6%)
5/32 (15.6%)

Disease Control Rate (DCR)

41/53 (77.4%)
17/21 (81.0%)
24/53 (75.0%)

Median Duration of Response (DoR)
21.8 months
(95% CI 11.5, NE)
NE
(95% CI 5.6, NE)
21.8 months
(95% CI 4.2, NE)
The longest published mOS reported to date with pembrolizumab monotherapy and combinations with pembrolizumab in patients with 1L r/m HNSCC and CPS ≥ 1 is 17.9 months8.

Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at the University of North Carolina, and Principal Investigator of the VERSATILE-002 Phase 2 clinical trial, stated, "The mOS results are highly encouraging in patients with advanced HPV Type 16-positive HNSCC. This is great news for patients, and we are encouraged that mOS has remained durable over the last 1.5 years. We look forward to the randomized Phase 3 trial, which is the only ongoing registrational trial to specifically address this rapidly growing population of patients."

Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech, continued, "We are very pleased with the overall survival (OS) results. As stated in a 2023 Journal of Clinical Oncology article authored by the FDA, OS is considered the gold standard for oncology approvals. The article discussed the discordance between ORR, PFS and OS. In recently published registrational 1L r/m HNSCC studies, improved ORR and PFS have not translated to improved OS. We look forward to the two interim survival data readouts from the ongoing Phase 3 study as well as the final OS results."

On June 2, 2025 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, reported updated interim results from its ongoing dose escalation Phase 1 study evaluating PAS-004 in advanced cancer patients in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting (Press release, Pasithea Therapeutics, JUN 2, 2025, View Source [SID1234653619]).

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 Phase 1 clinical trial is a multi-center, open-label, dose escalation, modified 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation, or patients who have failed BRAF/MEK inhibition (NCT06299839).

As of the cut-off date of April 2, 2025, a total of 21 patients had been enrolled and received at least one dose of PAS-004 in six cohorts (Capsules: 2mg, 4mg, 8mg, 15mg, 22mg / Tablets: 4mg). The most common cancer diagnosis was pancreatic cancer (28.6%), colorectal cancer (28.6%), and melanoma (23.8%).

All treatment-related adverse events (AEs) have been either grade 1 or grade 2. No known MEK inhibitor class-related AEs such as ocular toxicities, cardiotoxicities, and skin toxicities were observed during the DLT observation period. No DLTs were reported, and dose escalation is ongoing.

Preliminary PAS-004 PK analysis suggests linear PK with an estimated half-life in excess of 60 hours. The Cmax (peak) to Cmin (trough) ratio was below 2 at steady state in all dose levels and has achieved potentially sufficient exposures for target engagement. This is supported by previously reported preliminary pERK inhibition observed in cohort 3 (8mg capsule), with pERK inhibition of up to 91%.

PAS-004 has demonstrated a dose-dependent PK profile and preliminary clinical activity as a monotherapy in patients with heavily pre-treated, refractory solid tumors. In the efficacy evaluable population (n=16), early response evaluation reveals stable disease (SD) by RECIST 1.1 in 10 patients at some point during the trial, with progression free survival of up to 159 days and overall survival of up to 253 days. In Cohort 4A (15mg capsule), two out of three patients achieved stable disease and remain on therapy. One patient with stage 4 KRAS G12R-mutated pancreatic cancer, having progressive disease while on three prior lines of therapy, achieved a tumor diameter reduction of -9.8% and remains on study for over 5 months. The second patient with Stage 4 BRAF-mutated melanoma, having progressed on two prior lines of therapy, including a prior MEK inhibitor + BRAF inhibitor combination treatment, achieved tumor diameter reduction of -14.9% and remains on study for over 5 months.

"The interim results from our ongoing Phase 1 study are encouraging and we believe underscore the potential of PAS-004 as a best-in-class MEK inhibitor to serve patients with a broad range of MAPK pathway driven tumors," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "MEK inhibitors have been a transformative class of treatment therapies and we continue to witness groundbreaking advances and new approvals with this class of drug across tumor types and mutational profiles. At ASCO (Free ASCO Whitepaper) 2025, over 15 data sets featuring MEK inhibitors are being presented underscoring the growing momentum in this field. Additionally, we have recently seen approval of two novel MEK inhibitors, mirdametinib and avutometinib, highlighting the continued relevance of this drug class in the past several months alone. As a macrocyclic compound, PAS-004 potentially represents a significant advancement in the MEK inhibitor field by offering high selectivity and sustained pathway suppression while maintaining good tolerability. This profile may make it optimal for both monotherapy and combination therapy, including in patients who have failed prior MEK inhibitors."

The poster presentation will be available on the Pasithea website on the date of the poster session.

On June 2, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported that Sanofi has exercised its option to exclusively license Nurix’s STAT6 program, including the drug development candidate NX-3911, an oral, highly selective STAT6 degrader (Press release, Nurix Therapeutics, JUN 2, 2025, View Source [SID1234653618]). STAT6 (signal transducer and activator of transcription 6) plays a central role in type 2 inflammation, which drives diseases such as atopic dermatitis and asthma.

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!

"Using our DEL-AI platform, we identified novel DEL-derived chemical matter from which we developed, together with Sanofi, a potential best-in-class STAT6 degrader, NX-3911, which achieves rapid and complete STAT6 degradation," said Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix. "NX-3911 is a potent, selective, orally administered degrader of STAT6 that shows robust efficacy in multiple preclinical models of atopic dermatitis and asthma, demonstrating anti-inflammatory efficacy in animal models equivalent to a STAT6 gene knockout."

"This is the second license extension of a Nurix autoimmune disease program by Sanofi in the last 90 days, highlighting the power of our proprietary DEL-AI drug discovery platform to fuel the discovery of novel medicines to a range of therapeutically important targets like STAT6," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "Notably, our STAT6 program also includes additional differentiated discovery-stage assets, which could represent an additional product opportunity within our Sanofi collaboration."

Under the 2019 collaboration agreement, Nurix is deploying its proprietary DEL-AI drug discovery platform to identify novel agents that use E3 ligases to induce degradation of specified drug targets. Sanofi has an option to license drug candidates resulting from the work, and Nurix retains its option to co-develop and co-promote up to two future products in the United States after studies to assess dosing, efficacy, and safety that provide clinical proof of concept. For those programs for which Nurix exercises its option to co-develop and co-promote, the parties will split U.S profits and losses evenly and Nurix will be eligible to receive royalties on ex-U.S. sales on all optioned products. For programs that Nurix does not exercise its option, Nurix will receive milestones and royalties based on global development and sales. Upon signing the agreement in December 2019, Sanofi made an upfront payment of $55 million and subsequently paid an additional $22 million one year later to expand the scope of the collaboration. To date, Nurix has received a total of $127 million from Sanofi as part of this collaboration and remains eligible for up to $465 million in development, regulatory, and commercial milestones per licensed program as well as royalties on future sales.

About STAT6

STAT6 is a key transcription factor within the IL-4/IL-13 signaling pathways which act as drivers of inflammation in allergic conditions. Degrading STAT6 as a therapeutic strategy is supported by insights from mouse and human genetic studies as well as through clinical validation with either biologics targeting IL4/13 or small molecule inhibitors targeting the Janus Kinase (JAK) family. JAK proteins, which are upstream of STAT6, mediate the signaling of multiple cytokines, and as a result, JAK inhibition is associated with safety concerns. A potent, selective, and orally administered STAT6 degrader offers the potential for antibody-like efficacy and safety, with the convenience of a pill.

On June 2, 2025 NuCana plc (NASDAQ: NCNA) reported financial results for the first quarter ended March 31, 2025 and provided an update on its clinical development program with its two lead anti-cancer medicines (Press release, Nucana, JUN 2, 2025, View Source [SID1234653616]).

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!

"We have entered 2025 with a clear focus on the advancement of our pipeline through key milestones, into late-stage development, and towards commercialization," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "Our lead program, NUC-7738, continues to show significant promise. NUC-7738 is a novel agent that profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. In our ongoing Phase 1/2 NuTide:701 study, we have observed a favorable safety profile, meaningful tumor volume reduction and prolonged progression free-survival in patients with PD-1 inhibitor refractory and resistant metastatic melanoma. Based on these compelling results, we have recently initiated an expansion trial of NUC-7738 in an additional 28 patients with PD-1 inhibitor-resistant melanoma, that supports our registrational path. Based on this, we plan to meet with the U.S. Food and Drug Administration to determine the optimal regulatory strategy forward towards commercialization."

Mr. Griffith continued, "Turning to our second program, NUC-3373 is a targeted thymidylate synthase inhibitor with immune modulating properties. We are encouraged by the data from the ongoing Phase 1b/2 NuTide:303 study. This study is evaluating NUC-3373 in combination with pembrolizumab in patients with advanced solid tumors, and NUC-3373 with docetaxel in patients with lung cancer. To date, we have seen notable tumor volume reductions and prolonged progression free survival in these patients. We look forward to sharing additional data from this trial later this year."

Mr. Griffith concluded, "Lastly, we strengthened our balance sheet with a financing in May, extending our cash runway through key value-driving milestones. With multiple data readouts ahead, we are well-positioned to deliver on our mission of improving treatment outcomes for patients with cancer."

2025 Anticipated Milestones

NUC-7738

Initiate an expansion of the Phase 1/2 study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant melanoma;

Announce data from the Phase 1/2 expansion study (NuTide:701) of NUC-7738 in combination with pembrolizumab; and

Obtain regulatory guidance from the U.S. Food and Drug Administration on pivotal study design for NUC-7738 in melanoma.

NUC-3373

Announce additional data from the Phase 1b/2 modular study (NuTide:303) of NUC-3373 in combination with pembrolizumab in patients with solid tumors.

First Quarter 2025 Financial Highlights and Cash Position

As of March 31, 2025, NuCana had cash and cash equivalents of £4.0 million compared to £6.7 million at December 31, 2024. Subsequent to March 31, 2025, NuCana completed a financing, raising an additional £8.8 million in gross proceeds before expenses and commission. NuCana expects that its cash and cash equivalents as of March 31, 2025, together with amounts raised through its financing, will be sufficient to fund its planned operations into Q4 2026.

NuCana continues to advance its numerous clinical programs and reported a net loss of £2.5 million for the quarter ended March 31, 2025, as compared to a net loss of £6.8 million for the quarter ended March 31, 2024. Basic and diluted loss per ordinary share was £0.02 for the quarter ended March 31, 2025, as compared to £0.13 per ordinary share for the comparable quarter ended March 31, 2024.

On June 2, 2025 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on the development of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported additional interim Phase 1 clinical data for emiltatug ledadotin (Emi-Le; XMT-1660), the company’s B7-H4-directed Dolasynthen ADC (Press release, Mersana Therapeutics, JUN 2, 2025, View Source [SID1234653615]). These data are being presented in an oral session today at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting in Chicago, Illinois.

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 presentation will focus on Emi-Le’s Phase 1 dose escalation and backfill cohorts as of a March 8, 2025 data cut-off in patients with triple-negative breast cancer (TNBC); hormone-receptor-positive, human epidermal growth factor receptor 2-negative breast cancer; ovarian cancer; endometrial cancer and adenoid cystic carcinoma type 1 (ACC-1).

"We are excited to share additional interim data in an oral presentation at ASCO (Free ASCO Whitepaper)," said Martin Huber, M.D., President and Chief Executive Officer of Mersana Therapeutics. "The results from our dose escalation and backfill cohorts led us to focus our initial expansion work on patients with TNBC who have previously been treated with a topoisomerase-1 inhibitor ADC, a population with high unmet need that we believe Emi-Le may be uniquely suited to address within the B7-H4 ADC field. We also continue to be encouraged by the activity observed in other B7-H4-expressing tumor types, demonstrating Emi-Le’s broader development potential. On behalf of the Mersana team, we would like to express our gratitude to the patients and investigators who have participated in this clinical trial."

Safety and tolerability as of the March 8, 2025 data cut-off were consistent with initial data previously reported in January 2025, and no new safety signals were observed. Additionally, the following clinical activity data are being presented from evaluable patients (those with measurable disease at baseline and at least one post-baseline scan):

· 31% confirmed objective response rate (ORR) (8/26) across all enrolled tumor types with B7-H4 high tumor expression (defined as a tumor proportion score of 70% or higher) receiving intermediate Emi-Le doses (38.1 milligrams per meter squared (mg/m2) to 67.4 mg/m2 per cycle).

o 44% confirmed ORR (7/16) in the subset of patients with ≤4 prior lines of therapy.

· 56% ORR (5/9, including one unconfirmed response as of the March 8, 2025 data cut-off that was subsequently confirmed) in ACC-1 regardless of dose and B7-H4 expression. Among all ACC-1 patients who were enrolled in the Phase 1 clinical trial, the median progression free survival (PFS) had not yet been reached as of the March 8, 2025 data cut-off. ACC-1 is a rare and aggressive cancer that most frequently originates in the salivary glands. With no approved therapies, median PFS and median overall survival for patients with ACC-1 are reported to be 2-3 months and 2-3 years, respectively.

"The clinical activity observed for emiltatug ledadotin across all enrolled tumor types is encouraging, and its safety and tolerability profile appears differentiated from many other ADCs," said Antonio Giordano, MD, Ph.D., Assistant Professor of Medicine, Harvard Medical School, Dana-Farber Cancer Institute. "The objective responses were particularly notable in patients with late-stage triple-negative breast cancer who were previously treated with topoisomerase-1 inhibitors and in patients with ACC-1, both of which are aggressive and difficult-to-treat cancers with high unmet need."

The 2025 ASCO (Free ASCO Whitepaper) Annual Meeting data presentation can be accessed on the Publications section of the Mersana website at www.mersana.com.

About Emi-Le

Emi-Le is a B7-H4-directed Dolasynthen ADC with a precise, target-optimized drug-to-antibody ratio (DAR 6) and a proprietary auristatin payload with controlled bystander effect. This candidate is being investigated in Mersana’s ongoing Phase 1 clinical trial. The dose expansion portion of the Phase 1 clinical trial is enrolling patients with triple-negative breast cancer (TNBC) who have received one to four prior treatment lines, including at least one topoisomerase-1 inhibitor (topo-1) ADC.

The U.S. Food and Drug Administration has granted two Fast Track designations to Emi-Le for the treatment of 1) adult patients with advanced or metastatic triple-negative breast cancer, and 2) advanced or metastatic HER2 low / HER2 negative breast cancer post-topo-1 ADC (including TNBC and certain HR+ breast cancers). For more information about Mersana’s ongoing Phase 1 trial of Emi-Le, please visit clinicaltrials.gov (NCT05377996).