On August 6, 2024 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, reported financial results for the second quarter ended June 30, 2024, and provided business updates (Press release, Immuneering, AUG 6, 2024, View Source [SID1234647169]).

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"Our IMM-1-104 Phase 2a trial is enrolling well across all arms, and we are on track to share initial data from multiple arms this year," said Ben Zeskind, Ph.D., Co-founder, and Chief Executive Officer of Immuneering. "Each arm represents an important unmet need, including first-line pancreatic cancer patients, which are the focus of both our recent Fast Track designation and multiple arms of the trial, including two arms evaluating IMM-1-104 in combination with established chemotherapy regimens. As we reported at AACR (Free AACR Whitepaper) in April, these combinations in animal models showed deeper and more durable tumor growth inhibition than either treatment alone. We believe these arms are also of interest because of the Phase 1 topline data we released in March, in which IMM-1-104 monotherapy was observed to be exceptionally well-tolerated and shrank at least one target lesion in about half of pancreatic cancer patients. We are also evaluating IMM-1-104 in monotherapy arms for patients with RAS mutant melanoma and RAS mutant lung cancer, cancer types for which IMM-1-104 has demonstrated encouraging preclinical data, along with a monotherapy arm evaluating IMM-1-104 in first and second-line pancreatic cancer patients. Finally, the Phase 1 dose escalation of IMM-6-415 is progressing well in patients with advanced solid tumors with RAF or RAS mutations, and we plan to report initial PK, PD and safety data this year. All in all, we are looking forward to a data-rich second half of 2024."

Corporate Highlights

FDA Fast Track Designation for IMM-1-104 in First-line Pancreatic Cancer: In July 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for IMM-1-104, as a first-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC).

Preclinical Data Presented at AACR (Free AACR Whitepaper) Demonstrating that IMM-1-104 is Synergistic with Chemotherapy in Pancreatic Cancer Models: In April 2024, Immuneering presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, demonstrating that combining IMM-1-104 with chemotherapies used in the treatment of first-line pancreatic cancer yielded deeper and more durable tumor growth inhibition than either treatment alone, which the Company views as supportive of its ongoing Phase 2a clinical trial of IMM-1-104 in RAS-mutated advanced or metastatic solid tumors.
Near-Term Milestone Expectations

IMM-1-104

Initial data from multiple arms of the Phase 2a portion of the Company’s Phase 1/2a trial expected in 2H 2024.
IMM-6-415

Initial pharmacokinetic (PK), pharmacodynamic (PD) and safety data from the Phase 1 portion of the Company’s Phase 1/2a trial expected in 2H 2024.
Second Quarter 2024 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2024 were $59.7 million, compared with $85.7 million as of December 31, 2023.

Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2024, were $10.7 million compared with $9.5 million for the second quarter of 2023. The increase in R&D expenses was primarily attributable to higher clinical costs related to the Company’s lead program and increased personnel to support ongoing research and development activities.

General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2024 were $4.3 million, compared with $4.0 million for the same period of 2023. The increase in G&A is primarily attributed to an increase in the Company’s stock-based compensation costs and various other costs related to the general and administrative functions.

Net Loss: Net loss attributable to common stockholders was $14.1 million, or $0.47 per share, for the second quarter ended June 30, 2024, compared to $12.2 million, or $0.43 per share, for the second quarter ended June 30, 2023. 

2024 Financial Guidance

Based on cash and cash equivalents as of June 30, 2024, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into the second half of 2025.

On August 6, 2024 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the second quarter ended June 30, 2024 (Press release, Corvus Pharmaceuticals, AUG 6, 2024, View Source [SID1234645414]).

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"We have seen growing evidence supporting the central role of ITK in T cell biology and the significant potential of ITK inhibition as a new mechanism to treat a broad range of immune diseases and cancers," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "This includes early data from our Phase 1 clinical trial of soquelitinib in atopic dermatitis and our ongoing preclinical work exploring ITK inhibition in autoimmunity and inflammation. Based on this, we are increasingly optimistic that our ITK platform has the potential to improve clinical outcomes for a range of indications as an oral medication with an attractive tolerability profile. We have leveraged our experience in T cell lymphomas which has allowed us to gain a deeper understanding of the role of ITK in T cell biology that we can now apply to immune diseases. We remain on track to initiate a Phase 3 registrational trial in PTCL in the third quarter."

Business Update and Strategy

Prioritized Program: Soquelitinib (formerly CPI-818, Corvus’ selective ITK inhibitor)

Soquelitinib for Immune Diseases

Corvus continues to enroll patients at multiple clinical sites in its randomized, placebo-controlled Phase 1 clinical trial of soquelitinib in patients with moderate to severe atopic dermatitis. The trial is planned to enroll 64 patients that have failed at least one prior therapy across four different 28-day dosing regimens of soquelitinib compared to a placebo group. The endpoints include safety and improvement in Eczema Area and Severity Index. Patients and physicians will be blinded to treatment assignment.
Initial results, as of July 31, 2024, from three evaluable patients in the first cohort of the trial that completed the 28-day dosing regimen and follow-up visit demonstrated signs of clinical activity and corresponding changes in serum cytokine levels that are consistent with soquelitinib’s mechanism of action. These patients received a dose of 100 mg two-times a day, the lowest dose level planned for the study.
Corvus anticipates interim data from the Phase 1 clinical trial will be presented in the fourth quarter of 2024.
Recent published data from researchers at Cornell University demonstrated that ITK controls the fate of inflammatory Th17 cells. When ITK is inhibited by soquelitinib, the Th17 cells convert or switch to Treg cells that suppress inflammation. Soquelitinib treatment in an asthma model of mice with allergic airway inflammation significantly reduced the percentage of Th17 cells in the lung resulting in an increase in the ratio of Treg to Th17 cells. These studies confirm our understanding of the role of specific ITK inhibition in inflammation and are relevant to many immune diseases.
Corvus continues to advance its next-generation ITK inhibitor preclinical product candidates, which were designed to deliver precise T-cell modulation that is optimized for specific immunology indications. The next-generation ITK inhibitor candidates are part of the Company’s ongoing business development efforts to maximize the potential of the Company’s ITK inhibitor programs in immune diseases and cancers.

Soquelitinib for T Cell Lymphoma

Corvus continues to follow patients with relapsed T cell lymphoma in its Phase 1/1b clinical trial (no longer enrolling new patients) evaluating single agent therapy with soquelitinib. Updated interim data as of July 16, 2024:
A total of 25 patients were enrolled in the Phase 1/1b trial at the optimum 200 mg two-times a day dose and meet the eligibility criteria for the planned registrational Phase 3 clinical trial based on ≥1 and ≤3 prior therapies, including 23 evaluable patients.
For the 23 evaluable patients, objective responses (complete response, CR plus partial response, PR) were seen in nine patients (39%), including six CRs (26%) and three PRs. Compared to the prior data reported as of May 3, 2024, one patient with continued tumor regression achieved a CR that previously had a PR at the first follow up visit. See waterfall plot below.
Disease control (CR, PR and stable disease) was seen in 14 of 23 patients (61%). The stable disease group included five patients who achieved tumor reductions that did not meet the criteria for a PR.
Corvus anticipates initiating a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL in the third quarter of 2024. There are currently no FDA fully approved agents for the treatment of relapsed PTCL and the FDA has granted Orphan Drug Designation for soquelitinib for the treatment of T cell lymphoma. Recently, the Company received a Pediatric Waiver from the FDA indicating that it would not be required to conduct clinical trials in a pediatric population for this indication.
As recently announced, soquelitinib has received Fast Track designation for treatment of adult patients with relapsed or refractory peripheral T cell lymphoma after at least 2 lines of systemic therapy.

Waterfall Plot for Patients in the 200 mg Dose Cohort of the Soquelitinib Phase 1/1b Clinical Trial for Peripheral T Cell Lymphoma. The plot shows the best percent change in tumor volume in the 23 evaluable patients (eligible patient population), as of July 16, 2024, that were measurable by CT scan or by Modified Severity-Weighted Assessment Tool (mSWAT) for patients with cutaneous involvement. PTCL-NOS, peripheral T cell lymphoma not otherwise specified; CTCL, cutaneous T cell lymphoma of either Sezary or mycosis fungoides type; NKTCL, natural killer cell T cell lymphoma; ALCL, anaplastic large cell lymphoma; AITL, angioimmunoblastic T cell lymphoma.

Collaboration with Kidney Cancer Research Consortium: Ciforadenant (adenosine A2a receptor inhibitor)

Corvus is collaborating with the Kidney Cancer Research Consortium in a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The efficacy endpoint for the trial is deep response rate, defined as CR plus PRs of greater than 50% tumor volume reduction. The clinical trial is expected to enroll up to 60 patients and as of May 31, 2024 a total of 32 patients were enrolled in the trial. The protocol defined, interim pre-specified statistical threshold for efficacy is a 50% increase above the 32% deep response rate seen with previous ipilimumab/nivolumab combination trials in RCC conducted by investigators at the Kidney Cancer Research Consortium. As of May 31, 2024, the interim analysis of the clinical trial has met the threshold for efficacy and therefore enrollment continues.
In July 2024, a new U.S. patent was issued (United States Patent No. 12,023,337) by the U.S. Patent and Trademark Office that covers the use of ciforadenant for the treatment of cancer; foreign counterparts are pending.
Partner Led Program: Mupadolimab (anti-CD73)

Angel Pharmaceuticals, Corvus’ partner in China, is enrolling patients in an expansion cohort of a Phase 1/1b clinical trial of mupadolimab in patients with relapsed non-small cell lung cancer (NSCLC). In this clinical trial, patients will receive mupadolimab monotherapy.

Financial Results

As of June 30, 2024, Corvus had cash, cash equivalents and marketable securities of $47.2 million as compared to $27.1 million as of December 31, 2023. During the quarter ended June 30, 2024, the Company completed a registered direct offering in which it sold shares of common stock, pre-funded warrants and common warrants, generating $30.3 million in net proceeds.

Corvus expects full year 2024 net cash used in operating activities to be between approximately $24 million and $27 million, resulting in a projected cash balance of between approximately $31 million and $34 million at December 31, 2024. Based on its current plans, Corvus expects its cash to fund operations into the fourth quarter of 2025.

Research and development expenses for the three months ended June 30, 2024 totaled $4.1 million compared to $4.0 million for the same period in 2023. The increase of $0.1 million was primarily due to higher clinical trial costs associated with the development of soquelitinib.

The net loss for the three months ended June 30, 2024 was $4.3 million compared to a net loss of $6.5 million for the same period in 2023. Total stock compensation expense for the three months ended June 30, 2024 was $0.8 million compared to $0.5 for the same period in 2023 and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $0.6 million for the three months ended June 30, 2024 compared to a loss of $1.3 million for the same period in 2023. In addition, the Company recorded a non-cash gain of $1.8 million from the change in fair value of its warrant liability during the three months ended June 30, 2024 due to the warrants issued in the registered direct offering.

Conference Call Details
Corvus will host a conference call and webcast today, Tuesday, August 6, 2024, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2024 financial results. The conference call can be accessed by dialing 1- 800-717-1738 (toll-free domestic) or 1- 646-307-1865 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

On August 6, 2024 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines, reported financial results for the second quarter ended June 30, 2024, and highlighted recent Company progress (Press release, Omega Therapeutics, AUG 6, 2024, View Source [SID1234645430]).

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"We are excited by the meaningful progress achieved to date with our MYCHELANGELO I trial, having generated clinical proof-of-platform data that validates the potential of epigenomic controllers as a new class of programmable mRNA therapeutics. As we approach identification of the recommended dose for expansion for OTX-2002, we look forward to sharing updated dose escalation data and initiating expansion cohorts in monotherapy and combination settings in the fourth quarter of this year," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "We are equally energized by the advances we have made with the OMEGA platform, including new preclinical data presented at this year’s ASGCT (Free ASGCT Whitepaper) Annual Meeting showing durable and robust upregulation of gene expression with epigenomic controllers across a broad range of targets. We believe these achievements underscore the potential of our platform to create tremendous value through its ability to prospectively engineer epigenomic controllers with diverse and meaningful therapeutic applications across nearly any human disease."

Recent Highlights and Key Anticipated Milestones

Development Pipeline and Platform

•
Progressed dose escalation portion of Phase 1/2 MYCHELANGELO I clinical trial evaluating OTX-2002 in patients with hepatocellular carcinoma (HCC): Made steady progress towards identifying the recommended dose for expansion (RDE) of OTX-2002, with patient enrollment ongoing in Cohort 6 at the 0.2 mg/kg dose level across sites in the U.S. and Asia. The Company expects to report updated clinical data and is planning for expansion into monotherapy and combination settings in the fourth quarter of 2024.

•
Presented new preclinical data demonstrating durable upregulation of gene expression at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 27th Annual Meeting: Data demonstrated durable and robust upregulation of gene expression across a diverse set of gene types and regulatory mechanisms, including turning on inactive genes, augmenting expression of genes with existing but low baseline expression levels, and increasing expression of poised genes that are typically only responsive to certain external stimuli. Additional data showed reversible downregulation and multiplexed upregulation of gene expression. These findings further demonstrate the OMEGA platform’s potential to engineer an entirely novel therapeutic modality to directly target key drivers of disease across therapeutic areas.
•
Continued to advance and enhance the OMEGA platform: The Company is evaluating multiple epigenomic controller programs in preclinical studies, including OTX-2101 for non-small cell lung cancer (NSCLC), an HNF4A program in liver regeneration, and development of an epigenomic controller for the management of obesity in collaboration with Novo Nordisk. Core work on platform biology, epigenomic controller design, and characterization of LNP delivery to the lung and other high-value tissues continues to progress.

Corporate

•
Strengthened leadership team with appointment of Kaan Certel, Ph.D., as Chief Business Officer and election of Richard N. Kender to Board of Directors:
Dr. Certel is a seasoned biopharmaceutical leader and is responsible for Omega’s global business development activities, including strategic partnerships. Mr. Kender brings extensive expertise across corporate finance, business development and corporate licensing, among other roles he held during his career in the pharmaceutical industry, including 35 years spent at Merck & Co., Inc.

Second Quarter 2024 Financial Results

As of June 30, 2024, the Company had cash and cash equivalents totaling $45.9 million, which is expected to fund operations into Q1 2025.

Research and development (R&D) expenses for the second quarter of 2024 were $12.9 million, compared to $25.0 million for the second quarter of 2023. The $12.1 million decrease in R&D expenses was primarily driven by a decrease in external research costs, contract manufacturing costs, and personnel-related expenses.

General and administrative (G&A) expenses for the second quarter of 2024 were $5.8 million, compared to $6.6 million for the second quarter of 2023. The $0.8 million decrease in G&A expenses was primarily driven by a decrease in personnel-related expenses and consulting and professional fees.

Net loss for the second quarter of 2024 was $16.3 million, compared to $29.7 million for the second quarter of 2023. The decrease in net loss was driven predominantly by the decrease in R&D expenses.

On August 6, 2024 Thermo Fisher Scientific Inc., the world leader in serving science, reported that its SeCore CDx HLA A Sequencing System has been granted 510(k) clearance by the United States Food and Drug Administration (FDA) for use as a companion diagnostic with TECELRA (afamitresgene autoleucel), Adaptimmune’s newly approved T-cell receptor (TCR) therapy for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices (Press release, Thermo Fisher Scientific, AUG 6, 2024, View Source [SID1234645447]). Synovial sarcoma is a rare, soft tissue cancer that most commonly impacts young adults.

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Cancer immunotherapies, including TCR therapies, have become increasingly powerful tools in cancer treatment, particularly for patients with metastatic or unresectable tumors. TCRs interact with specific human leukocyte antigen (HLA) proteins to activate an immune response, making high-resolution HLA typing a critical step in identifying patients most likely to benefit from engineered TCR T-cell therapies like TECELRA.

While the origins of HLA typing are most closely associated with transplant diagnostics, a critical component of matching patients and donors to reduce the risk of immune-mediated rejection, HLA proteins have wide-reaching effects on the immune system and may play a role in many immune-mediated conditions. Thermo Fisher’s Transplant Diagnostics business is committed to leveraging its history of innovation in immunology to help customers develop novel treatments that enable better patient outcomes, regardless of therapeutic area.

"We are thrilled to expand the labeling of our companion diagnostic SeCore CDx HLA A Sequencing System to include TECELRA and to support clinicians in identifying which patients may benefit from this first-of-its-kind treatment," says Tina Liedtky, president, Transplant Diagnostics, Thermo Fisher Scientific. "Our knowledge of the human immune system and how it might impact treatment options across the healthcare continuum continues to evolve. We look forward to ongoing opportunities to collaborate with innovative companies like Adaptimmune to expand patient access to breakthrough treatments that improve quality of life."

For more information about the SeCore CDx HLA Sequencing System, visit www.thermofisher.com/us/en/home/clinical/transplant-solutions/pre-transplant-testing/hla-typing.html

For full TECELRA Prescribing Information, including Important Safety Information, visit www.tecelra.com.

On August 6, 2024 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported promising initial data from the dose escalation portion of the ongoing Phase 1 clinical trial of EO-3021 in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction (GEJ), pancreatic or esophageal cancers (Press release, Elevation Oncology, AUG 6, 2024, View Source;utm_medium=rss&utm_campaign=elevation-oncology-announces-promising-initial-data-from-phase-1-clinical-trial-evaluating-eo-3021-in-patients-with-advanced-unresectable-or-metastatic-solid-tumors-likely-to-express-claudin-18-2 [SID1234645415]).

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"Gastric and GEJ cancers are devastating diseases, which occur frequently in the U.S. and globally and which, despite recent advancements, still have high levels of mortality," said Kohei Shitara, M.D., Chief, Department of Gastrointestinal Oncology, National Cancer Center Hospital East in Kashiwa, Japan and principal investigator on the Phase 1 clinical trial. "There is a particular need for highly selective therapies that benefit patients with Claudin 18.2-expressing tumors. To that end, I am excited by the initial data with EO-3021, which suggest it could change the treatment paradigm for a significant portion of patients with gastric or GEJ cancer. I am excited to evaluate EO-3021 in the expansion portion of this Phase 1 clinical trial."

"We are pleased to share initial data from our Phase 1 clinical trial of EO-3021," said Valerie Malyvanh Jansen, M.D., Ph.D., Chief Medical Officer of Elevation Oncology. "EO-3021 was designed to maximize efficacy while minimizing the potential for free MMAE, with the goal of offering patients an improved safety profile and physicians a more readily combinable agent. We are encouraged to see the benefits of EO-3021’s site-specific conjugation translate clinically, with minimal MMAE-associated toxicities observed in our Phase 1 trial. Coupled with the promising anti-tumor activity reported in patients with gastric or GEJ cancer, the data suggest that EO-3021 is a potential best-in-class Claudin 18.2 antibody drug conjugate. We look forward to advancing into monotherapy dose expansion and initiating our combination cohorts in the months ahead, as well as reporting additional data from our ongoing trial in the first half of 2025."

Data from the Ongoing Phase 1 Clinical Trial

EO-3021 was evaluated in the dose escalation stage of a Phase 1 clinical trial in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, GEJ, pancreatic or esophageal cancers. As of the data cutoff date of June 10, 2024, 32 patients had been treated in the dose escalation portion of the Phase 1 clinical trial at four dose levels (ranging from 1.0 mg/kg to 2.9 mg/kg once every three weeks (Q3W), including 26 patients with gastric or GEJ cancer. The median age was 65 years (ranging from 45 to 83) and the median number of prior lines of therapy was three (ranging from one to seven).

Initial Safety Data

As of the data cutoff of June 10, 2024, EO-3021 was observed to be generally well-tolerated. No Grade 4 or 5 treatment-related adverse events were reported, and less than 10% of patients discontinued EO-3021 due to adverse events. Importantly, no neutropenia or peripheral neuropathy/hypoesthesia, both known toxicities associated with monomethyl auristatin E (MMAE), were observed in the safety population of 32 patients treated with EO-3021.

Across all grades, the most common treatment-emergent adverse events (reported in ≥20% of patients) were nausea (56%), decreased appetite (47%), fatigue (41%) and diarrhea (28%). Four dose-limiting toxicities (one each of Grade 3 fatigue, encephalopathy, worsening decreased appetite, and Grade 2 decreased appetite requiring a dose reduction at Cycle 2) were observed at the 2.9 mg/kg dose level, leading to the decision to select the 2.0 mg/kg and 2.5 mg/kg Q3W doses for evaluation in the dose expansion portion of the Phase 1 trial.

Initial Efficacy Data in Gastric and GEJ Cancer

As of the data cutoff date of June 10, 2024, 15 patients with gastric or GEJ cancers were evaluable for efficacy with measurable disease, at least one post-baseline scan, and available Claudin 18.2 IHC results. Seven of these 15 patients (47%) had tumors with Claudin 18.2 expression in ≥20% of tumor cells at IHC 2+/3+. Claudin 18.2 expression was determined retrospectively using a Claudin 18.2-specific IHC assay.

In seven patients with Claudin 18.2 in ≥20% of tumor cells at IHC 2+/3+, the objective response rate (ORR) was 42.8% (three confirmed partial responses, one of which was confirmed following the June 10, 2024, data cutoff) and the disease control rate (DCR) was 71.4%, including two patients with stable disease (SD).
In eight patients with Claudin 18.2 in <20% of tumor cells at IHC 2+/3+, the ORR was 0% and the DCR was 50%, including four patients with SD.
Clinical Development Plans for EO-3021

Elevation Oncology plans to initiate enrollment in the dose expansion portion of the ongoing Phase 1 clinical trial, further exploring two doses of EO-3021: 2.0 mg/kg IV Q3W and 2.5 mg/kg IV Q3W. These doses were selected with the goal of further characterizing EO-3021 in order to select an optimized dose for further clinical development.

The primary objective of the study is to evaluate the safety, tolerability and preliminary anti-tumor activity of EO-3021 in patients with gastric or GEJ cancer, who have progressed on or after standard therapy or who are intolerable of available standard therapy. An exploratory objective of the study is to assess the association of Claudin 18.2 expression and objective response. Additionally, data from the dose escalation portion of Elevation Oncology’s Phase 1 trial suggest that a biomarker patient selection strategy will be an important component of future clinical development. Elevation Oncology is working to identify the appropriate biomarker threshold and plans to introduce a biomarker cutoff as part of the dose expansion portion of this Phase 1 trial. Elevation Oncology expects to share additional data from the Phase 1 trial, including from the dose expansion cohort, in the first half of 2025.

Additionally, Elevation Oncology plans to expand its ongoing Phase 1 clinical trial to include combination cohorts evaluating EO-3021 for the treatment of advanced or metastatic gastric or GEJ cancer in the first- and second-line setting. As previously disclosed, the combination cohorts will evaluate EO-3021 in combination with ramucirumab, a VEGFR2-inhibitor, in the second-line setting, and in combination with dostarlimab, a PD-1 inhibitor, in the first-line setting. Elevation Oncology expects to initiate dosing in the combination portion of the Phase 1 trial by year-end 2024.

Conference Call Information

Elevation Oncology will host a live conference call and webcast at 8:30 a.m. ET today to discuss the initial safety and efficacy data announced today. Participants may register for the conference call here. It is recommended that participants join the call ten minutes prior to the scheduled start.

A webcast of the call will also be available on the Events page of Elevation Oncology’s investor relations website at View Source The archived webcast will be available on the website approximately two hours after the conference call and will be available for 90 days following the call.

About EO-3021

EO-3021 (also known as SYSA1801) is a differentiated, clinical-stage antibody drug conjugate (ADC) with best-in-class potential comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2. EO-3021 is site-specifically conjugated to the monomethyl auristatin E (MMAE) payload via a cleavable linker with a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is normally expressed in gastric epithelial cells. During malignant transformation, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Elevation Oncology is evaluating EO-3021 in a Phase 1 study (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers.

Elevation Oncology has the exclusive rights to develop and commercialize EO-3021 in all global territories outside Greater China.