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Sensei Biotherapeutics Reports New Clinical Results Highlighting Durable Progression Free Survival Data for Solnerstotug in PD-(L)1 Resistant Tumors at the ESMO Congress 2025

On October 17, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical-stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported results from the dose expansion portion of its Phase 1/2 trial evaluating solnerstotug (formerly SNS-101), a conditionally active monoclonal antibody targeting VISTA (V-domain Ig suppressor of T cell activation). The data will be shared today during a mini oral session at the ESMO (Free ESMO Whitepaper) Congress 2025.

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The Phase 1 dose expansion is a multi-center, open-label study evaluating solnerstotug as monotherapy and in combination with Libtayo (cemiplimab), Regeneron’s PD-1 inhibitor. The study enrolled patients with a basket of "hot" tumor types (that typically respond to immunotherapy) (n=44), of whom 41 had previously received and progressed on PD-(L)1 therapy, as well as patients with "cold" tumor types (that typically exhibit primary resistance to immunotherapy) (n=20).

Patients who progress following treatment with PD-(L)1 inhibitors ("secondary resistance") face a particularly poor prognosis, as resistance to immune checkpoint blockade is a significant challenge in oncology. For patients who develop secondary resistance, the likelihood of benefiting from a rechallenge with the same therapy is estimated to be 5% or less.1

Currently, treatment options for PD-(L)1 resistant tumors are limited, with many patients receiving chemotherapy, experimental therapies in clinical trials, or palliative care in the absence of effective alternatives. While historical benchmarks in this setting are limited, docetaxel, which is widely used in the 2nd line post-PD-(L)1 setting for Non-Small Cell Lung Cancer (NSCLC), typically has a 6-month PFS of 10-20% in similar patient populations.2 To date, immune checkpoint inhibitor (ICI) combination therapies have not been approved in this setting.

Emerging Clinical Signal and Favorable Tolerability Profile

As of the September 8, 2025, data cutoff, 35 efficacy-evaluable "hot tumor" patients had received cemiplimab with either 15 mg/kg (n=19) or 3 mg/kg dose (n=16) of solnerstotug. Six clinical responses, including five in patients with PD-(L)1 resistant tumors, occurred at the higher 15 mg/kg solnerstotug dose, and no objective responses were observed at the 3 mg/kg dose.

Among 41 "hot tumor" patients that received and progressed on a prior PD-(L)1 therapy, the overall 6-month PFS rate was 37%, which compares favorably with historical benchmarks in this setting. At 15 mg/kg, 6-month PFS reached 50% among PD-(L)1 resistant patients, surpassing rates historically seen in this treatment-refractory population. At 3 mg/kg, 6-month PFS was 24% among PD-(L)1 resistant patients.

Solnerstotug was well tolerated at both 3 mg/kg and 15 mg/kg doses in combination with cemiplimab:

Only six mild (Grade 1) CRS events were observed across all patients in Phase 1 (n=98), all manageable.
No new safety signals were identified across dose expansion (n=64).
The safety profile remains consistent with prior data and compares favorably to other checkpoint inhibitor combinations in this population.

"We believe solnerstotug’s emerging dose-dependent activity in refractory ‘hot’ tumors, combined with a favorable tolerability profile, support its advancement into Phase 2 studies," said Ron Weitzman, M.D., Chief Medical Officer of Sensei Biotherapeutics. "The data suggest that selective blockade of VISTA within the tumor microenvironment may help re-engage exhausted T cells, even after PD-1 failure, a goal long considered out of reach."

In addition to the "hot" tumor cohorts, 20 patients with Microsatellite Stable Colorectal (MSS CRC) "cold" tumors were treated with either solnerstotug as monotherapy or in combination with cemiplimab (350 mg). No responses were observed and the safety profile was consistent with previously reported data.

Durable Disease Control in "Hot" Tumors Followed by Late Onset Responses

Four out of six responders demonstrated prolonged disease control, followed by a late onset response (occurring between 18 and 54 weeks). PD-(L)1 therapies typically have a time to response of 2–3 months, indicating that the combination of solnerstotug plus cemiplimab has a unique and differentiated pattern of activity.

At the 15 mg/kg dose of solnerstotug, notable responses included:

A Merkel Cell Carcinoma (MCC) patient with a durable complete response at week 18 and a duration of response of 54+ weeks
A Microsatellite Instability-High Colorectal Cancer (MSI-H CRC) patient with a partial response (PR) at week 36 and a 33+ week duration
An NSCLC patient with a tumor proportion score less than 5% that was PD-1 naïve had a PR at week 54 and duration of response of 15+ weeks
An Esophageal Cancer patient with a PR at Week 24 and a duration of response of 6 weeks

"This pattern of delayed, durable responses is unusual among immunotherapies," said Kyriakos Papadopoulos, M.D., Co-Director of Clinical Research at START, San Antonio. "It may indicate that solnerstotug acts through a mechanism that is complementary to PD-(L)1 in resistant tumors."

Next Steps: Planned Phase 2 Studies to Evaluate Efficacy in a Commercially Attractive Indication and Potentially Pursue Accelerated Approval in a PD-1 Resistant Population

Sensei is planning two Phase 2 studies to begin in 2026, subject to FDA feedback and the Company’s ability to raise sufficient capital. The first is expected to be a randomized trial in 2nd line NSCLC where patients have received and failed anti-PD-(L)1 treatment. Patients would be randomized to receive either the combination of solnerstotug + a PD-(L)1 inhibitor or chemotherapy.

The second trial is expected to be a single arm study in PD-(L)1 resistant MCC patients where there is limited therapeutic optionality and potential for accelerated approval, subject to FDA feedback.

"We’re pleased by the emerging signs of dose-related activity, durability, and a favorable safety profile—key characteristics of a potentially differentiated immunotherapy," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "These results provide a foundation for our planned Phase 2 development program as we work to better define solnerstotug’s role in treating challenging patient populations."

(Press release, Sensei Biotherapeutics, OCT 17, 2025, View Source/news-releases/news-release-details/sensei-biotherapeutics-reports-new-clinical-results-highlighting" target="_blank" title="View Source/news-releases/news-release-details/sensei-biotherapeutics-reports-new-clinical-results-highlighting" rel="nofollow">View Source [SID1234656737])

Investor Webcast Information

Sensei will host an investor webcast on October 20th at 8:00 AM ET, featuring company leadership and Kyriakos Papadopoulos, MD, Co-Director of Clinical Research at START, San Antonio.

Register for the event here. A replay will be available after the webcast on the Investor Relations page of Sensei’s website: View Source

Novartis Kisqali® 5-year NATALEE data demonstrate 28% reduction in risk of recurrence in the broadest early breast cancer patient population

On October 17, 2025 Novartis reported results from the five-year analysis of the pivotal Phase III NATALEE trial of Kisqali (ribociclib) that demonstrated a sustained benefit at a median of two years after a three-year treatment with Kisqali (median follow-up: 58.4 months). Results showed a 28.4% reduction in risk of recurrence (HR=0.716; 95% CI 0.618-0.829; nominal p-value <0.0001) in the broadest population of patients with high-risk stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) treated with Kisqali plus endocrine therapy (ET) compared to ET alone1.

The five-year invasive disease-free survival (iDFS) rates were 85.5% in the Kisqali plus ET arm versus 81.0% in the ET alone arm, representing a clinically meaningful 4.5% improvement1. These late-breaking results will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025.

"For the thousands of people diagnosed with early breast cancer each year, the fear of recurrence, often as incurable advanced disease, weighs heavily on patients and their families," said Dr. John Crown, Consultant Medical Oncologist at St. Vincent’s University Hospital, Dublin, and NATALEE investigator. "These five-year results show that the benefit of ribociclib persists well beyond the completion of treatment, offering these at-risk patients a greater chance of living breast cancer-free."

As follow-up continued, the confidence intervals (CIs) became narrower1. This pattern held across clinically relevant subgroups, reinforcing the robustness of the observed iDFS benefit1.

"These data reinforce the potential of Kisqali to significantly reduce the long-term risk of breast cancer recurrence, extending well beyond the three-year treatment period. This provides physicians and patients with greater confidence in long-term disease management. Kisqali is redefining the standard of care in adjuvant therapy, including in patients with node-negative disease," said Dushen Chetty, Global Head of Oncology and Hematology Development at Novartis, Ad Interim. "The consistency of the benefit observed across both advanced and early breast cancer settings, together with Kisqali’s established safety profile, underscores its position as the CDK4/6 inhibitor with the most comprehensive Phase III evidence base for improving patient outcomes."

Overall survival (OS) continues to show an encouraging trend, with further improvement in the hazard ratio (HR) to 0.800 and narrowing CI (95% CI: 0.637-1.003; one-sided nominal p-value 0.026) compared to the final iDFS analysis (OS HR = 0.892 (0.661-1.203)), demonstrating a 20% reduction in the risk of death compared to ET alone1. The NATALEE trial will continue follow-up to ensure sufficient data is collected for OS and other long-term endpoints.

iDFS results across pre-specified subgroups1:

Subgroups Hazard ratio 95% CI Absolute risk reduction at 5 years
Overall population 0.716 0.618-0.829 4.5%
Stage II 0.660 0.493-0.884 3.7%
Stage III 0.730 0.615-0.865 5.6%
Node-negative (N0) 0.606 0.372-0.986 5.7%
Node-positive (N1-3) 0.737 0.631-0.860 4.4%
With a median of around two years after all patients completed Kisqali treatment, long-term safety shows no new safety signals1. Overall, rates of secondary primary malignancies (SPMs) were 2.7% (Kisqali plus ET) and 3.0% (ET alone), while SPMs leading to deaths were reported in one patient in each group1.

Kisqali remains the only CDK4/6 inhibitor to demonstrate statistically significant OS benefits across three randomized controlled trials in advanced breast cancer (MONALEESA-2, MONALEESA-3, and MONALEESA-7)2-12.

*OS data remain immature at the five-year NATALEE analysis

About NATALEE
NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali with ET as an adjuvant treatment versus ET alone in the broadest range of patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO13,14. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable13,14. The primary endpoint of NATALEE is invasive disease-free survival (iDFS) as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria13,14. A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial13,14.

About Kisqali (ribociclib)
Kisqali (ribociclib) is a selective cyclin-dependent kinase inhibitor, helping slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, enable cancer cells to grow and divide quickly. Targeting CDK4/6 with enhanced precision plays a role in tumor control.

Kisqali has been approved as a treatment for breast cancer by regulatory authorities in more than 100 countries worldwide, including the U.S. FDA and the European Commission15,16. In the US, Kisqali is indicated in combination with an AI as an adjuvant treatment for adults with HR+/HER2- stage II and III early breast cancer at high risk of recurrence, as well as for the treatment of adults with HR+/HER2- advanced or MBC as initial ET; Kisqali is also approved in the metastatic indication in combination with fulvestrant as initial ET or following disease progression on ET15. In the EU, Kisqali is approved in combination with an AI for the adjuvant treatment of patients with HR+/HER2- early breast cancer at high risk of recurrence; and for the treatment of women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression16. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist15,16.

In EBC, Kisqali is the only CDK4/6 inhibitor recommended by the NCCN Guidelines for breast cancer as Category 1 preferred for both all node-positive disease as well as for patients with no nodal involvement with high-risk disease characteristics, such as tumor size >5 cm, or for tumors sized 2-5 cm, either Grade 2 with high genomic risk/Ki-67 ≥20% or Grade 317. Kisqali approvals in EBC from regulatory authorities worldwide are ongoing, including recent approval from China’s National Medical Products Administration18. In MBC, Kisqali has consistently demonstrated statistically significant overall survival benefit across three Phase III trials2-12. The NCCN Guidelines also recommend Kisqali as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of people living with HR+/HER2- MBC when combined with an AI, making Kisqali the preferred first-line treatment of choice for US prescribers in HR+/HER2- MBC17.

In addition, Kisqali has achieved the highest score (A) on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for EBC19; and has the highest rating of any CDK4/6 inhibitor on the ESMO (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale, achieving a score of four out of five for first-line pre-menopausal patients with HR+/HER2- advanced breast cancer20. Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6 inhibitors, received a score of four out of five for post-menopausal patients with HR+/HER2- advanced breast cancer treated in the first line21.

Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals.

(Press release, Novartis, OCT 17, 2025, View Source [SID1234656736])

Novartis Scemblix® receives positive CHMP opinion for the treatment of adults with newly diagnosed CML

On October 17, 2025 Novartis reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Scemblix (asciminib) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) in all lines of treatment.

"For people living with CML, long-term therapy can be physically and emotionally demanding, and many face challenges in reaching treatment milestones without compromising quality of life," said David FitzGerald, Member of the CML Advocates Network. "The availability of more treatment options earlier in the care pathway is a welcome development that brings forward additional possibilities for patients and their healthcare teams to choose approaches that best support both clinical goals and patient well-being."

The positive CHMP opinion is based on data from the Phase III ASC4FIRST trial, which compared Scemblix with investigators’ choice of tyrosine kinase inhibitor (TKI) treatment in patients with newly diagnosed Ph+ CML-CP1,2. In the trial, Scemblix demonstrated superior major molecular response (MMR) rates when compared against all TKIs (imatinib, nilotinib, dasatinib and bosutinib) and also when compared against imatinib alone1,2. Patients treated with Scemblix also required fewer dose reductions and experienced half the rate of adverse events leading to discontinuation1,2.

"To give patients newly diagnosed with CML the best chance to reach key efficacy milestones while maintaining quality of life, it is critical to intervene early with a more selective treatment that combines superior efficacy with tolerability," said Professor Andreas Hochhaus, Head of the Department of Hematology and Medical Oncology at Jena University Hospital, Germany. "If approved, Scemblix could provide patients with a well-tolerated option that may deliver faster, deeper and longer-lasting molecular response with fewer treatment discontinuations due to adverse events, compared with available first-line treatments — potentially paving the way for more patients to reach treatment-free remission."

Scemblix is approved in earlier lines in more than 20 countries, including the US, Japan and China5,6. Scemblix is recommended for the treatment of patients with newly diagnosed Ph+ CML-CP by the 2025 European LeukemiaNet recommendations for the management of CML and by the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines)7,8. Since 2021, Scemblix has been a standard of care (SoC) in more than 80 countries for patients previously treated with two or more TKIs5,6,9.

"People newly diagnosed with CML need treatments that deliver both better efficacy and excellent tolerability to achieve early, deep molecular response, which is critical to achieve long-term outcomes like treatment-free remission," said Patrick Horber, M.D., President, International, Novartis. "Scemblix is the only treatment that has demonstrated superior efficacy and tolerability compared to current first-line treatments. Today’s positive CHMP opinion marks a major milestone in our 25-year journey to improve CML care and could help establish a new standard of care in Europe."

Following the CHMP’s recommendation to approve Scemblix for the treatment of adults with Ph+ CML-CP in all lines of treatment, the European Commission (EC) will make a final decision within two months.

About ASC4FIRST
ASC4FIRST (NCT04971226) is a Phase III, head-to-head, multi-center, open-label, randomized study of oral Scemblix 80 mg QD vs. investigator-selected first- or second-generation TKIs (imatinib, nilotinib, dasatinib or bosutinib) in 405 adult patients with newly diagnosed Ph+ CML-CP10. The trial met both primary endpoints with Scemblix demonstrating superior MMR rates at week 48 vs. investigator-selected SoC TKIs (67.7% vs. 49.0%) and imatinib alone (69.3% vs. 40.2%)1,10. Additionally, Scemblix showed a numerical improvement versus the 2G TKI stratum (66% vs. 57.8%)1,10. At week 96, Scemblix demonstrated sustained superior MMR vs. all investigator-selected TKIs (74.1% vs. 52%) and vs. imatinib alone (76.2% vs. 47.1%)2.47.1%), meeting both ASC4FIRST key secondary endpoints2.

About Scemblix (asciminib)
Scemblix is the first CML treatment that works by Specifically Targeting the ABL Myristoyl Pocket (referred to as a STAMP inhibitor in scientific literature)11-13. Other currently approved CML treatments are TKIs that target the ATP-binding site (ATP-competitive)13.

Scemblix is approved to treat newly diagnosed adults with Ph+ CML-CP in more than 20 countries, including the US, Japan and China4,5. It is also approved in more than 80 countries, including the EU, to treat those with Ph+ CML-CP who have previously been treated with two or more TKIs 5,6,7. In some countries, including the US, Scemblix is also approved in patients with Ph+ CML-CP with the T315I mutation5-7.

Scemblix has been studied across multiple treatment lines for Ph+ CML-CP, both as a monotherapy and as a combination therapy.

(Press release, Novartis, OCT 17, 2025, View Source [SID1234656735])

XOMA Royalty and LAVA Therapeutics Announce Amendment to Purchase Agreement

On October 17, 2025 XOMA Royalty Corporation ("XOMA Royalty") (Nasdaq: XOMA) and LAVA Therapeutics N.V. ("LAVA") (Nasdaq: LVTX) reported that they have reached an agreement to amend their previously announced definitive share purchase agreement (the "Purchase Agreement," and such amendment, the "Amendment").

Under the Amendment, LAVA shareholders who tender their shares will now receive (i) an initial cash amount per share of $1.04 (the "Cash Amount," as compared to the range between $1.16 and $1.24 that was originally agreed), plus (ii) a non-transferable contingent value right ("CVR") per share representing the right to receive certain cash payments, including (A) the previously announced rights to receive, among other things, 75% of the net proceeds related to LAVA’s two partnered assets plus 75% of any net proceeds from any out license or sale of LAVA’s unpartnered programs, plus (B) a new right to receive up to approximately $0.23 per CVR depending on the final determination after closing of certain potential liabilities (the "Offer"). In addition, LAVA and XOMA Royalty have agreed to amend LAVA’s minimum net-cash closing condition to be $24.5 million, compared to the previous minimum net-cash closing condition of $31.5 million. LAVA and XOMA Royalty are entering into the Amendment in light of their current understanding of potential liabilities, associated expenses, and the most recent estimates of LAVA’s expected cash balance at closing. LAVA will be filing the Amendment, including the amended form of CVR, on a Current Report on Form 8-K.

The Offer, which was previously scheduled to expire one minute after 11:59 p.m. Eastern Time on October 17, 2025, has been extended until one minute after 11:59 p.m. Eastern Time on November 12, 2025, unless the Offer is further extended or earlier terminated. The proposed acquisition is expected to close in the fourth quarter of 2025, subject to customary closing conditions.

LAVA shareholders who previously have tendered their shares do not need to re-tender their shares or take any other action in response to the extension of the Offer. LAVA shareholders have signed support agreements to tender their shares in the Offer prior to the expiration date and support the Offer.

The closing of the Offer is subject to certain conditions, including the tender of LAVA common shares representing at least 80% (or, in certain cases, 75%) of LAVA’s issued and outstanding shares, the condition that certain resolutions are adopted by LAVA’s shareholders meeting, a minimum net-cash balance at closing, and other customary closing conditions. Following a subsequent offering period, LAVA will undergo a corporate reorganization designed to result in XOMA Royalty acquiring 100% of the shares in LAVA’s successor and all then-remaining LAVA shareholders (other than XOMA Royalty) receiving the same cash and non-transferable contingent value right consideration per share as is provided in the Offer, subject to applicable withholding taxes.

LAVA intends to reconvene the Extraordinary General Meeting of Shareholders to approve matters related to the transactions between LAVA and XOMA Royalty including the resolutions mentioned above (the "EGM") to 2:00 p.m. (Central European Summer Time) on November 7, 2025 at the offices of NautaDutilh N.V., located at Beethovenstraat 400, 1082 PR Amsterdam, the Netherlands. The EGM was previously scheduled to occur on September 30, 2025. LAVA will file a revised definitive proxy statement related to the reconvened EGM.

(Press release, Lava Therapeutics, OCT 17, 2025, View Source [SID1234656734])

IMUNON Invited to Present PlaCCine® DNA Technology Proof-of-Concept Data in Platform Presentations at Leading Vaccine Conferences

On October 17, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapies and evaluating an adaptation of the platform’s potential as a next-generation vaccine, reported that members of its leadership team will deliver oral presentations highlighting IMNN-101, its investigational DNA plasmid vaccine based on the Company’s proprietary PlaCCine technology platform, including proof-of-concept clinical trial results at the following upcoming vaccine conferences:

5th Edition of International Vaccines Congress (IVC)

Keynote Oral Presentation Title: A promising novel approach to DNA vaccines
Presenting Author: Khursheed Anwer, Ph.D., M.B.A., Executive Vice President and Chief Science Officer, IMUNON, and IVC Scientific Committee Member
Date and Time: Thursday, October 23, 2025, 10:20 a.m. ET
Location: Orlando, Florida

10th International Conference on Vaccine Research and Development

Oral Presentation Title: Development of a PlaCCine DNA Technology for Safe, Effective and Durable Vaccines
Presenting Author: Douglas V. Faller, M.D., Ph.D., Chief Medical Officer, IMUNON
Date and Time: Thursday, November 6, 2025, 1:50 p.m. ET
Location: Boston, Massachusetts

In May 2025, IMUNON announced positive six-month data from the Phase 1 trial of IMNN-101 showing proof of concept of the PlaCCine technology, demonstrating better durability of protection compared to mRNA vaccines after a single dose targeting the SARS-CoV-2 Omicron XBB1.5 spike antigen variant. Results also showed IMNN-101 induced up to a 3-fold median increase in the serum neutralizing antibody (NAb) titers from baseline at six months, with initial evidence of a stronger immune response in the two higher dose cohorts (2.0 mg and 1.0 mg) compared to the lower dose cohort (0.5 mg). IMNN-101 was shown to be safe and well tolerated, with no serious adverse effects reported.

To accelerate the development and commercialization of the PlaCCine platform, IMUNON is actively seeking strategic partnerships with leading pharmaceutical and biotechnology companies. These collaborations aim to leverage PlaCCine’s unique advantages—enhanced durability, temperature stability, and scalable manufacturing—to address unmet needs in vaccines for infectious diseases and cancer, while securing non-dilutive funding to advance IMUNON’s broader oncology focused pipeline.

(Press release, IMUNON, OCT 17, 2025, View Source [SID1234656733])