On March 20, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided recent business updates (Press release, Immuneering, MAR 20, 2025, View Source [SID1234651309]).

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"We were delighted to report updates from our ongoing Phase 2a trial of IMM-1-104 in January 2025 demonstrating excellent response rates for IMM-1-104 in combination with chemotherapy in first-line pancreatic cancer patients. Highlights of these data included an observed ORR of 43% and DCR of 86% for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel (mGnP) and an observed ORR of 50% for IMM-1-104 in combination with modified FOLFIRINOX (mFFX). Historic benchmarks for either chemotherapy agent alone are 23% ORR and 32% ORR, respectively. IMM-1-104 in combination with each of mGnP and mFFX was observed to be generally well tolerated. Based on these promising results, we have begun planning for a potential IMM-1-104 global pivotal trial in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer, as we aim to get this exciting potential new treatment option to patients as quickly as possible," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering.

"Importantly, the results demonstrated with IMM-1-104 to date point to its potential combinability, set to continue with our recently announced plans to study IMM-1-104 in combination with a BRAF inhibitor in melanoma, with a G12C inhibitor in non-small cell lung cancer, and with a PD-1 inhibitor in both melanoma and non-small cell lung cancer. We subsequently announced a clinical trial supply agreement with Regeneron for Libtayo in combination with IMM-1-104 in patients with non-small cell lung cancer and aim to get these new trials up and running this year. In support of these plans, we were pleased to announce that Dr. Igor Matushansky has joined Immuneering as Chief Medical Officer to oversee clinical activities, including medical and operational leadership for our development programs."

Zeskind concluded: "As we look ahead to the rest of the year – with our cash balance recently fortified – we expect multiple data events, beginning with an update from our IMM-1-104 Phase 2a trial in the second quarter of 2025. We are continuing to build a growing data set that we believe positions our lead asset with the potential to offer an improved profile in comparison to current MEK inhibitors, which currently represents an existing approximately $2.4 billion annual global opportunity in the aggregate."

Corporate Highlights

Phase 1 Pancreatic Cancer Patient Passes 13-month Mark on IMM-1-104 Monotherapy: Today, Immuneering provided a case study update for a Phase 1 pancreatic cancer patient in the third-line setting who has been receiving IMM-1-104 monotherapy for over 13 months so far. The patient – who previously progressed on first-line FOLFIRINOX and second-line Gem/Cis/nab-Pac – has been on IMM-1-104 monotherapy at 240 mg once daily. As of the most recent available scan, the patient has maintained stable disease with a RECIST SLD change of -24.2%. In addition to a 91% reduction in peak CA 19-9 levels, IMM-1-104 has been well tolerated by the patient, who has reported improved quality of life and approximately 12% weight gain.
Named Dr. Igor Matushansky as Chief Medical Officer: In March, Immuneering announced that Igor Matushansky, MD, PhD, joined the company as Chief Medical Officer. In this role, Dr. Matushansky will direct Immuneering’s clinical activities, providing medical and operational leadership for the company’s development programs including the ongoing Phase 2a study of IMM-1-104 in pancreatic cancer, lung cancer, and melanoma, and plans to initiate a pivotal Phase 3 clinical trial in pancreatic cancer.
Announced Clinical Trial Supply Agreement with Regeneron Pharmaceuticals to Evaluate IMM-1-104 in Combination with Libtayo (cemiplimab): In February, Immuneering announced a clinical trial supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo. The agreement supports the intended evaluation of Immuneering’s lead product candidate, IMM-1-104, in combination with Libtayo in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer (NSCLC).
Positive Data Update from Three Pancreatic Cancer Arms of Ongoing Phase 2a Trial of IMM-1-104: In January, Immuneering announced a positive data update from three pancreatic cancer arms of its ongoing Phase 2a trial of lead program IMM-1-104, as well as plans to expand the Phase 2a trial to include additional combination arms.
Launched Pancreatic Cancer Advisory Board: In December, Immuneering announced the formation of its Pancreatic Cancer Advisory Board. The advisory board, which comprises world-renowned oncology clinical researchers, will provide strategic medical and clinical guidance to the company as its pipeline, including lead clinical program IMM-1-104, continues to advance.
FDA Fast Track Designation for IMM-1-104 in Advanced Melanoma: In December, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for IMM-1-104, as a treatment for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors.
FDA Orphan Drug Designation for IMM-1-104 in the Treatment of Pancreatic Cancer: In October 2024, the FDA granted Orphan Drug designation to IMM-1-104 in the treatment of pancreatic cancer.
Near-Term Milestone Expectations
IMM-1-104

Further IMM-1-104 Phase 2a data expected in the second quarter of 2025.
Initiation of Phase 2a arm of IMM-1-104 in combination with Libtayo in NSCLC planned for 2025.
Initiation of Phase 2a arm of IMM-1-104 in combination with a G12C inhibitor in NSCLC planned for 2025.
Initiation of Phase 2a arm of IMM-1-104 in combination with a PD-1 inhibitor in melanoma planned for 2025.
Initiation of Phase 2a arm of IMM-1-104 in combination with a BRAF inhibitor in melanoma planned for 2025.
Fourth Quarter and Full Year 2024 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2024, were $36.1 million, compared with $85.7 million as of December 31, 2023. These amounts exclude net proceeds of $13.7 million from the Company’s ATM facility raised in January 2025.
Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2024 were $14.9 million compared with $11.9 million for the fourth quarter of 2023. Full year 2023 R&D expenses were $48.0 million compared to $41.6 million for full year 2023. The increase in fourth quarter and full year 2024 R&D expenses as compared to the same respective periods of 2023 was primarily attributable to higher clinical costs related to the Company’s lead IMM-1-104 program and increased personnel to support ongoing research and development activities.
General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2024 were $3.7 million compared with $4.4 million for the fourth quarter of 2023. Full year 2024 G&A expenses were $16.1 million compared to $16.8 million for full year 2023. The decrease in fourth quarter and full year 2024 G&A expenses as compared to the same respective periods of 2023 was primarily due to lower external professional fees and a reduction in employee-related costs, partially offset by higher stock-based compensation related to the general and administrative functions supporting the business.
Net Loss: Net loss attributable to common stockholders was $18.1 million, or $0.58 per share, for the quarter ended December 31, 2024, compared to $15.1 million, or $0.52 per share, for the quarter ended December 31, 2023. Net loss attributable to common stockholders for full year 2024 was $61.0 million, or $2.04 per share, compared to $53.5 million, or $1.88 per share, for full year 2023.
2025 Financial Guidance

Based on cash and cash equivalents as of December 31, 2024, plus proceeds from the Company’s subsequent utilization of its ATM facility, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2026.

On March 20, 2025 ImmunoGenesis, a clinical-stage biotech company developing innovative, science-driven immunotherapies, reported its participation in the 2025 NeauxCancer Conference organized by the Cancer Advocacy Group of Louisiana (CAGLA), being held March 27 – 29, 2025 in New Orleans (Press release, ImmunoGenesis, MAR 20, 2025, View Source [SID1234651325]).

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President and CEO James Barlow will discuss how ImmunoGenesis plans to transform immuno-oncology with its pipeline of products designed to overcome immune resistance. He will provide an update on the active Phase 1a/1b study of their lead compound, IMGS-001, including preliminary data on enrolled subjects. IMGS-001 is a novel dual-specific PD-L1/PD-L2 antibody with killing function designed to treat immune-excluded, cold tumors that are resistant to existing immunotherapy. Mr. Barlow will also discuss the recently initiated phase 2 trial for the company’s second clinical asset, IMGS-101 (evofosfamide), a hypoxia reversal agent being studied in combination with checkpoint inhibition.

Attendees at the conference will include oncologists and other clinicians interested in learning and discussing the latest practices for treating and taking care of cancer patients. The Innovation Track will enable the medical professionals attending the conference, as well as regional investment professionals, to learn about emerging technologies for cancer treatment and prevention.

"We are excited to have ImmunoGenesis as a new presenter in this year’s Innovation Track. The company has recently expanded the Phase 1a/1b clinical trial of its lead candidate, IMGS-001, to Ochsner MD Anderson Cancer Center in southeastern Louisiana. This is an excellent opportunity for clinicians and investors to hear their story."
— Chadwick K. Landry, Portfolio Manager at Poydras Capital Partners and President of CAGLA

Registration and attendance at the conference for investors is complimentary. Investors can register via the link below.

Innovation Track Details:

ImmunoGenesis Presentation

Friday, March 28 2:00PM CST

Conference Registration

View Source

complimentary registrations are available for investors

The 2025 NeauxCancer Conference has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Ochsner Clinic Foundation and CAGLA. The Ochsner Clinic Foundation is accredited by the ACCME to provide continuing medical education for physicians.

About CAGLA
The Cancer Advocacy Group of Louisiana is a nonprofit corporation organized and operated to advocate for state legislation and administration regulations that facilitate cancer research and education, and foster the well-being and care of cancer patients, survivors, and their families.

On March 20, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that the external Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor the safety data of the BriaCell clinical study to determine if the study should continue, be modified, or be halted, has completed its second safety data review of BriaCell’s pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer ( NCT06072612 ) and recommended continuation of the ongoing study without any modifications (Press release, BriaCell Therapeutics, MAR 20, 2025, View Source [SID1234651956]). BriaCell’s pivotal Phase 3 study is currently being conducted under Fast Track Designation with the Food and Drug Administration (FDA).

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"We are very pleased with the safety and tolerability profile of Bria-IMT plus immune checkpoint inhibitor (CPI) combination in metastatic breast cancer to date," stated Dr. William V. Williams, BriaCell’s President & CEO. "The DSMB’s second positive data review and recommendation to continue with patient enrollment in BriaCell’s pivotal Phase 3 study clinical trial is highly encouraging and further highlights the potential of our groundbreaking novel immunotherapy to treat this urgent medical need."

"Metastatic breast cancer is a devastating disease for patients and their families, and the DSMB’s positive review represents an important step forward towards our goal of transforming cancer care, and improving patients’ survival and quality of life outcomes," noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "We look forward to sharing additional updates from BriaCell’s pivotal Phase 3 trial in the coming months."

On March 20, 2025 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported an update on its recent corporate progress and reported financial results for the year ended December 31, 2024 (Press release, MacroGenics, MAR 20, 2025, View Source [SID1234651310]).

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"We concluded 2024 with the achievement of multiple clinical development milestones, including the completion of enrollment in the LORIKEET Phase 2 study evaluating lorigerlimab in combination with docetaxel in patients with mCRPC. We look forward to building upon this momentum in 2025 as we work to advance our novel pipeline of clinical product candidates, including lorigerlimab, MGC026 and MGC028," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Finally, we have determined that the results of the TAMARACK Phase 2 study of vobra duo in mCRPC do not support additional financial investment by MacroGenics. We believe the B7-H3 target continues to have potential and are pleased with the progress being made with our alternate anti-B7-H3 ADC, MGC026."

Updates on Proprietary Investigational Programs

Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART molecule designed to enhance CTLA-4 blockade on dual-expressing, tumor-infiltrating lymphocytes compared to a PD-1/CTLA-4 monoclonal antibody (mAb) combination therapy, while maintaining maximal PD-1 blockade on all PD-1-expressing cells.

Enrollment is now complete in the ongoing LORIKEET Phase 2 trial, a 150 patient randomized study of lorigerlimab in combination with docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). The Company expects to provide a clinical update in the second half of 2025.
Based on MacroGenics’ cumulative experience to date from its Phase 1 and Phase 2 studies of lorigerlimab, including in mCRPC – a tumor setting historically insensitive to checkpoint inhibition – the Company plans to conduct the LINNET Phase 2 study. This clinical trial will evaluate lorigerlimab as monotherapy in patients with either platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC); both represent areas of unmet need and historically have been relatively insensitive to checkpoint inhibitor therapy. The study’s primary endpoint is ORR, with multiple secondary endpoints to be explored. The Company anticipates enrolling up to 40 patients with PROC and up to 20 patients with CCGC in LINNET, which is expected to commence by mid-2025.
Emerging ADC Pipeline. MacroGenics is developing two clinical and one preclinical antibody-drug conjugate (ADC) molecules that each incorporate a novel, glycan-linked topoisomerase I inhibitor (TOP1i)-based payload developed by the Company’s collaboration partner, Synaffix (a Lonza company). These three candidates are described below.

MGC026 is a TOP1i-based ADC that targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation. MGC026 shares the same variable domain as that of vobra duo. MGC026 is currently being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors, with dose expansion in selected indications expected to initiate in 2025.
MGC028 is a TOP1i-based ADC that targets ADAM9, a member of the ADAM family of multifunctional type 1 transmembrane proteins that play a role in tumorigenesis and cancer progression and is overexpressed in multiple cancers. The Company previously presented preclinical data showing antitumor activity of MGC028 in in vivo models. Also, in a non-human primate study, MGC028 was well tolerated at high dose levels with mild, reversible side effects and no ocular toxicity, which is often a concern with tubulin-inhibitor-based ADCs. The first patient was recently dosed in a Phase 1 study of MGC028 in patients with advanced solid tumors.
MGC030 is a preclinical TOP1i-based ADC that targets an undisclosed antigen expressed across several solid tumors. There are currently no approved therapeutics to this target. An Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MGC030 is planned for 2026.
Updates on Selected Partnered Programs

MGD024 is a next-generation CD123 × CD3 DART molecule. Under an October 2022 exclusive option and collaboration agreement with Gilead Sciences, Inc. (Gilead), MacroGenics continues to enroll patients in a Phase 1 dose escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes. Gilead has the option to license MGD024 at predefined decision points during the Phase 1 study.
ZYNYZ (retifanlimab-dlwr) is a monoclonal antibody targeting PD-1 that the Company licensed to Incyte Corporation (Incyte) in 2017. In July 2024, Incyte announced positive Phase 3 top-line results for its registrational studies of retifanlimab in squamous cell carcinoma of the anal canal (SCAC) and non-small cell lung cancer (NSCLC) and continues to conduct global studies of retifanlimab across multiple indications. In February 2025, Incyte disclosed that its supplemental Biologics License Application (sBLA) for retifanlimab in advanced/metastatic SCAC was filed with the FDA in December 2024, with approval anticipated in the second half of 2025. To date, MacroGenics has received $365.0 million in upfront and milestone payments from Incyte under the agreement and remains eligible for up to $540.0 million in additional development, regulatory and commercial milestones.
MARGENZA (margetuximab-cmkb) global rights were sold to TerSera Therapeutics LLC (TerSera), a privately-held biopharmaceutical company with a focus on oncology and non-opioid pain management, pursuant to an agreement previously announced. TerSera made a payment of $40.0 million to MacroGenics at closing in November 2024 and MacroGenics may receive additional sales milestone payments of up to an aggregate of $35.0 million. MacroGenics subsequently paid an $8.0 million amendment fee to its former commercialization partner during the fourth quarter of 2024. MacroGenics will manufacture MARGENZA drug substance on behalf of TerSera going forward.
Update on Vobramitamab Duocarmazine

Vobramitamab duocarmazine (vobra duo) is an ADC with a cleavable peptide linker designed to deliver a DNA-alkylating duocarmycin payload to solid tumors that express B7-H3.

Results for the concluded TAMARACK Phase 2 study included, based on a February 21, 2025 data cut-off, mature median radiographic progression-free survival (rPFS) of 9.5 months for the 2.0 mg/kg cohort (95% CI, 8.5-11.2) and 10.0 months for the 2.7 mg/kg cohort (95% CI, 7.4-11.4) in patients with mCRPC. Safety data from the study remained consistent with prior data disclosures.
Based on its assessment of the vobra duo safety and efficacy profile and an internal resource and portfolio review, MacroGenics has decided not to pursue further internal development of vobra duo and will instead explore potential alternatives for partnering this program.
2024 Financial Results

Cash Position: Cash, cash equivalents and marketable securities balance as of December 31, 2024, was $201.7 million, compared to $229.8 million as of December 31, 2023.
Revenue: Total revenue was $150.0 million for the year ended December 31, 2024, compared to total revenue of $58.7 million for the year ended December 31, 2023. The increase was primarily due to a net increase of $85.0 million in revenue recognized from milestones achieved under the Incyte License Agreement.
R&D Expenses: Research and development expenses were $177.2 million for the year ended December 31, 2024, compared to $166.6 million for the year ended December 31, 2023. The increase was primarily due to increased research, development, manufacturing and clinical costs related to MGC028, the Company’s preclinical ADC pipeline and lorigerlimab, offset by decreased development and clinical trial costs related to the Company’s discontinued projects and margetuximab.
SG&A Expenses: Selling, general and administrative expenses were $71.0 million for the year ended December 31, 2024, compared to $52.2 million for the year ended December 31, 2023. The increase was due to an amendment fee paid by MacroGenics to its former commercial partner pursuant to the sale of MARGENZA and increased non-cash stock-based compensation and accrued severance expenses related to the separation agreement with the Company’s Chief Executive Officer.
Other Income: Other income for the year ended December 31, 2024, reflected a $36.3 million gain recognized on the sale of MARGENZA.
Net Loss: Net loss was $67.0 million for the year ended December 31, 2024, compared to net loss of $9.1 million for the year ended December 31, 2023.
Shares Outstanding: Shares of common stock outstanding as of December 31, 2024 were 62,819,857.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $201.7 million as of December 31, 2024, in addition to projected and anticipated future payments from partners should extend its cash runway into the second half of 2026. The Company’s expected funding requirements reflect anticipated expenditures related to the ongoing Phase 2 LORIKEET study of lorigerlimab in mCRPC as well as MacroGenics’ other clinical and preclinical studies currently ongoing.
Conference Call Information

To participate via telephone, please register in advance at this link. 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.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on MacroGenics’ website for 30 days following the call.

On March 20, 2025 Linnaeus Therapeutics, Inc. ("Linnaeus"), a privately held biopharmaceutical company focused on the development and commercialization of novel, small molecule oncology therapeutics, reported that seminal data describing Linnaeus’s clinical candidate, LNS8801, was published in Cancer Research Communications (Press release, Linnaeus Therapeutics, MAR 20, 2025, View Source [SID1234651326]). This paper characterizes LNS8801 as a developable pharmaceutical drug candidate, demonstrating its activity in cancer and highlighting a predictive biomarker.

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The manuscript, entitled "LNS8801: An enantiomerically pure agonist of the G protein-coupled estrogen receptor suitable for clinical development," was authored by Natale et al. The publication can be viewed at: View Source

This new study highlights the potential of LNS8801, a first-in-class, oral compound targeting the G protein estrogen receptor (GPER), to be used as a novel cancer therapy. Linnaeus researchers and collaborators discovered that LNS8801 is the active component of the widely studied GPER agonist, G-1. In preclinical models, LNS8801 demonstrated potent, oral, GPER-dependent anticancer effects. This study also demonstrates that a common genetic variant of GPER may influence patient response, offering a potential mechanism-linked biomarker for patient selection and personalized therapy. These findings complement the data generated in ongoing clinical trials of LNS8801 for cancer.

"The validation of our science by the acceptance of this paper in Cancer Research Communications underscores the importance of GPER as a therapeutic target," said Patrick Mooney, MD, Chief Executive Officer of Linnaeus. "This data demonstrates that using LNS8801 to target GPER has therapeutic effects in melanoma and other GPER-positive cancers and is the appropriate molecule for clinical development. We are excited by the data we have seen in our clinical phase 1/2 study, and we are poised to open enrollment in a randomized, controlled study in the near future."

Linnaeus anticipates initiating a randomized controlled clinical trial testing LNS8801 in unresectable, treatment-refractory, cutaneous melanoma patients this year. This study will randomize 135 biomarker-positive patients to receive either LNS8801 monotherapy, LNS8801 in combination with pembrolizumab, or physician’s choice therapy. The study will assess progression-free survival and overall survival between the groups.

About LNS8801

LNS8801 is an orally bioavailable and highly specific and potent agonist of GPER whose activity is dependent on the expression of GPER. GPER activation by LNS8801 rapidly and durably depletes c-Myc protein levels. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory.

In the ongoing clinical study in humans, LNS8801 has been safe and well tolerated. Additionally, LNS8801 has demonstrated target engagement, c-Myc protein depletion, and clinical benefit in patients with advanced cancers, and a predictive biomarker has been identified.