On February 25, 2025 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that members of management will participate in the following upcoming investor events (Press release, Mersana Therapeutics, FEB 25, 2025, View Source [SID1234650539]):

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!

TD Cowen 45th Annual Health Care Conference
Format: Presentation/fireside chat
Date/Time: Tuesday, March 4, 2025, at 1:50 p.m. Eastern Time

Leerink Global Healthcare Conference
Format: Fireside chat
Date/Time: Tuesday, March 11, 2025, at 1:40 p.m. Eastern Time
Live webcasts of these events will be available on the Investors & Media section of Mersana’s website at www.mersana.com. Archived replays will be available for approximately 90 days following the events.

On February 25, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, then continued as adjuvant treatment in combination with standard of care radiotherapy with or without cisplatin and then as a single agent (Press release, Merck & Co, FEB 25, 2025, View Source [SID1234650538]). The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 23, 2025.

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 sBLA is based on data from the Phase 3 KEYNOTE-689 trial. Results from a pre-specified first interim analysis, which will be presented at an upcoming medical meeting, showed that in patients with resectable LA-HNSCC, the KEYTRUDA perioperative treatment regimen demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) compared to adjuvant radiotherapy (with or without cisplatin) alone. The study also showed a statistically significant improvement in major pathological response (mPR), a key secondary endpoint, for patients in the KEYTRUDA arm compared with adjuvant radiotherapy alone. The safety profile of KEYTRUDA was consistent with that observed in previously reported studies; no new safety signals were identified.

"The standard of care for patients with resectable locally advanced head and neck squamous cell carcinoma has remained the same for over two decades, representing a significant unmet need for new treatment options," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "Based on the compelling results of the KEYNOTE-689 trial, we hope to reduce the risk of recurrence and disease progression in earlier stages of disease. We look forward to working with the FDA to potentially bring KEYTRUDA to these patients as soon as possible."

This review is being conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for coordinated submission and review of oncology drugs among its international partners. Health authorities in Israel, Canada, Australia, Singapore, Brazil and Switzerland will review this application as part of Project Orbis.

KEYTRUDA is currently approved as monotherapy and in combination regimens for appropriate patients with metastatic or with unresectable, recurrent HNSCC in the U.S., Europe, China, Japan and other countries around the world. For more information, please see the "Selected KEYTRUDA (pembrolizumab) Indications in the U.S." section below.

About KEYNOTE-689

KEYNOTE-689 is a randomized, active-controlled, open-label Phase 3 trial (ClinicalTrials.gov, NCT03765918) evaluating KEYTRUDA as neoadjuvant treatment and KEYTRUDA in combination with standard of care radiotherapy (with or without cisplatin) as adjuvant treatment in treatment-naïve patients with newly diagnosed, stage III or IVA resectable, locally advanced, head and neck squamous cell carcinoma. Efficacy outcomes are classified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary endpoint is EFS, and key secondary endpoints include overall survival, major pathological response, pathological complete response and safety. The study enrolled an estimated 704 patients who were randomized (1:1) to receive either:

KEYTRUDA (200 mg intravenously [IV] every three weeks [Q3W] for two cycles) as neoadjuvant therapy prior to surgery, followed by either KEYTRUDA (200 mg IV Q3W for 15 cycles) plus standard of care radiotherapy with cisplatin (100 mg/m2 IV Q3W for three cycles) as adjuvant therapy following surgery for high-risk patients or KEYTRUDA (200 mg IV Q3W for 15 cycles) plus standard of care radiotherapy without cisplatin as adjuvant therapy following surgery for low-risk patients; or
No neoadjuvant therapy prior to surgery, followed by either standard of care radiotherapy with cisplatin (100 mg/m2 IV Q3W for three cycles) as adjuvant therapy following surgery for high-risk patients or standard of care radiotherapy without cisplatin as adjuvant therapy following surgery for low-risk patients.
About head and neck cancer

Head and neck cancer describes a number of different tumors that develop in or around the throat, larynx, nose, sinuses and mouth. Most head and neck cancers are squamous cell carcinomas that begin in the flat, squamous cells that make up the thin surface layer of the structures in the head and neck. Locally advanced head and neck squamous cell carcinoma (LA-HNSCC) is cancer that has grown outside the original location, but has not yet spread to distant parts of the body. There are several factors that greatly increase the risk of developing head and neck cancer, including tobacco and alcohol use and human papillomavirus (HPV). It is estimated there were more than 891,500 new cases of head and neck cancer diagnosed and over 458,100 deaths from the disease in 2022 globally. In the U.S., it is estimated there will be more than 58,450 new cases of head and neck cancer diagnosed and more than 12,230 deaths from the disease in 2024.

On February 25, 2025 LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, reported it has added the Robert H. Lurie Comprehensive Cancer Center (Lurie Cancer Center) of Northwestern University as a second site in a clinical trial combining the Company’s proprietary compound LB-100 with GSK’s Dostarlimab to treat ovarian clear cell cancer (Press release, Lixte Biotechnology, FEB 25, 2025, View Source [SID1234650537]).

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!

Emily M. Hinchcliff, MD, MPH, will lead the clinical trial at Lurie Cancer Center, a renown Chicago-based National Cancer Institute-designated Comprehensive Cancer Center, which is located at Northwestern Memorial Hospital’s downtown medical campus. Patient recruitment is underway, and the first patient has been dosed.

"Clinical trials testing potentially effective therapies are essential to move our field forward, with many recent great successes," said Dr. Hinchcliff. "We are pleased to be participating in this important clinical trial to assess whether adding LIXTE’s LB-100 to GSK’s Dostarlimab will enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma, a disease of high unmet need."

Bas van der Baan, LIXTE’s Chief Executive Officer, said, "The addition of Lurie Cancer Center is a positive step in expanding the patient population and accelerating this clinical trial, which was initiated in January 2024 at The University of Texas MD Anderson Cancer Center. The trial is directed by lead clinical investigator Amir Jazaeri, MD, Professor of Gynecologic Oncology."

On February 25, 2025 Kura Oncology, Inc. (the "Company") (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in three upcoming investor conferences (Press release, Kura Oncology, FEB 25, 2025, View Source [SID1234650536]):

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!

A fireside chat at the TD Cowen Health Care Conference in Boston at 2:30 p.m. ET / 11:30 a.m. PT on March 4, 2025;

A fireside chat at the Barclays Global Healthcare Conference in Miami at 9:30 a.m. ET / 6:30 a.m. PT on March 11, 2025; and

A fireside chat at the Leerink Partners Global Biopharma Conference in Miami at 8:00 a.m. ET / 5:00 a.m. PT on March 12, 2025.
Live audio webcasts will be available in the Investors section of Kura’s website at View Source, with archived replays available following all three events.

On February 25, 2025 Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications, reported fourth quarter and full year 2024 financial results and recent portfolio execution (Press release, Kiniksa Pharmaceuticals, FEB 25, 2025, View Source [SID1234650531]).

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!

"Strong commercial execution in 2024 resulted in 79% year-over-year ARCALYST sales growth to $417.0 million. We believe substantial opportunity remains for ARCALYST, and expect 2025 sales of between $560 and $580 million," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "Today, we are excited to announce the development program for KPL-387, which we believe could expand the treatment options for recurrent pericarditis patients by enabling a single monthly subcutaneous injection in a liquid formulation. We have interacted with the FDA and plan to initiate a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in mid-2025. In line with our prioritization of cardiovascular indications, we plan to discontinue the development of abiprubart in Sjögren’s Disease. On behalf of our entire organization, I would like to thank the patients, caregivers, and investigators who contributed to our study."

Corporate Update

· Kiniksa continues to focus development on diseases with unmet need, prioritizing cardiovascular indications.

o Kiniksa announced today the development of KPL-387 in recurrent pericarditis, with a target profile of monthly subcutaneous (SC) dosing. KPL-387 is a fully human immunoglobulin G2 (IgG2) monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling of the cytokines interleukin-1α (IL-1α) and interleukin-1β (IL-1β).

o Kiniksa announced today that it is advancing KPL-1161 towards clinical development with a target profile of quarterly SC dosing. KPL-1161 is an Fc-modified IgG2 monoclonal antibody that binds IL-1R1, inhibiting the signaling of the cytokines IL-1α and IL-1β.

o Kiniksa announced today that it plans to discontinue abiprubart development in Sjögren’s Disease. The company will explore strategic alternatives for the asset.

o Kiniksa announced today that it has exercised its right to terminate its exclusive license agreement for mavrilimumab with MedImmune.

Portfolio Execution

ARCALYST (IL-1α and IL-1β cytokine trap)

· ARCALYST net product revenue was $122.5 million and $417.0 million for the fourth quarter and full year 2024, respectively.

· Since launch, more than 2,850 prescribers have written ARCALYST prescriptions for recurrent pericarditis.

· As of the end of the fourth quarter of 2024, average total duration of ARCALYST therapy in recurrent pericarditis was approximately 27 months.

· As of the end of the fourth quarter of 2024, approximately 13% of the target 14,000 multiple-recurrence patients were actively on ARCALYST treatment.

KPL-387 (monoclonal antibody IL-1 receptor antagonist)

· Kiniksa is conducting a single ascending dose (SAD) and multiple ascending dose Phase 1 clinical trial of KPL-387 in healthy volunteers.

o Topline data from the SAD portion of the Phase 1 trial support potential monthly SC dosing in recurrent pericarditis.

· Kiniksa has interacted with the U.S. Food and Drug Administration (FDA) and expects to initiate a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in mid-2025, with Phase 2 data expected in the second half of 2026.

KPL-1161 (Fc-modified monoclonal antibody IL-1 receptor antagonist)

· Kiniksa is conducting Investigational New Drug (IND)-enabling development activities with a target profile of quarterly SC dosing.

Financial Results

· Total revenue for the fourth quarter of 2024 was $122.5 million, compared to $83.4 million for the fourth quarter of 2023. Total revenue for the full year 2024 was $423.2 million, compared to $270.3 million for the full year 2023.

— Total revenue for the fourth quarter of 2024 did not include any license and collaboration revenue, compared to $12.2 million for the fourth quarter of 2023.

— Total revenue for the full year 2024 included $6.2 million in license and collaboration revenue, compared to $37.1 million for the full year 2023.

· Total operating expenses for the fourth quarter of 2024 were $141.8 million, compared to $83.3 million for the fourth quarter of 2023. Total operating expenses for the full year 2024 were $468.9 million, compared to $295.5 million for the full year 2023.

— Total operating expenses for the fourth quarter of 2024 included $48.2 million in collaboration expenses, which are driven by ARCALYST collaboration profitability, compared to $16.9 million for the fourth quarter of 2023. Total operating expenses for the full year 2024 included $128.3 million in collaboration expenses, compared to $56.5 million for the full year 2023.

— Total operating expenses for the fourth quarter of 2024 included $8.3 million in non-cash, share-based compensation expense, compared to $7.8 million for the fourth quarter of 2023. Total operating expenses for the full year 2024 included $30.7 million in non-cash, share-based compensation expense, compared to $27.1 million for the full year 2023.

· Net loss for the fourth quarter of 2024 was $8.9 million, compared to a net income of $25.2 million for the fourth quarter of 2023. Net loss for the full year 2024 was $43.2 million, compared to net income of $14.1 million for the full year 2023.

— Net loss for the fourth quarter of 2024 included a tax benefit of $8.1 million, compared to a tax benefit of $22.8 million for the fourth quarter of 2023, both primarily due to the treatment of non-cash deferred tax assets.

— Net loss for the full year 2024 included a tax expense of $7.0 million, compared to a tax benefit of $30.7 million for the full year 2023, both primarily due to the treatment of non-cash deferred tax assets.

· As of December 31, 2024, Kiniksa had $243.6 million of cash, cash equivalents, and short-term investments and no debt, compared to $206.4 million as of December 31, 2023.

Financial Guidance

· Kiniksa expects 2025 ARCALYST net product revenue of between $560 million and $580 million.

· Kiniksa expects its current operating plan to remain cash flow positive on an annual basis.

Conference Call Information

· Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, February 25, 2025, to discuss fourth quarter and full year 2024 financial results and to provide a corporate update.

· Individuals interested in participating in the call via telephone may register here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. To access the webcast, please visit the Investors and Media section of Kiniksa’s website. A replay of the event will also be available on Kiniksa’s website within approximately 48 hours after the event.