On January 5, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company"), a clinical-stage, fully-integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell therapies with a focus on immuno-oncology, reported favorable safety and tolerability from the first patient 23 days after Deltacel infusion in the Phase 1 clinical trial for treatment of stage 4 metastatic non-small cell lung cancer (NSCLC) at Beverly Hills Cancer Center, located in Beverly Hills, California, USA (Press release, Kiromic, JAN 5, 2024, View Source [SID1234639013]). Specifically, laboratory test results and observations by clinical staff identified no adverse events and confirmed that Deltacel is being well tolerated with initial safety profile. Continued monitoring of safety and tolerability will provide more insights as the trial enrolls additional patients.

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Kiromic expects to report preliminary efficacy results from this patient by the end of January 2024. Two more patients are expected to be enrolled between January and February 2024.

"Our first-in-human clinical trial of Deltacel is proceeding very well and on plan," said Pietro Bersani, Chief Executive Officer of Kiromic. "With no adverse events observed during the first 23 days post-treatment, we have strong indication that Deltacel is well tolerated. We look forward to discussing updates with members of the investment community during our meetings next week in San Francisco, concurrent with the 42nd Annual J.P. Morgan Healthcare Conference."

Investment professionals interested in meeting with Mr. Bersani, Chief Financial Officer Brian Hungerford and Chief Scientific Officer Dr. Leonardo Mirandola at LHA’s offsite event being held January 8-10 should contact Tirth Patel at [email protected].

"We are very pleased to see favorable initial safety and tolerability data from the first patient treated in our Deltacel-01 study," said Dr. Afshin Eli Gabayan, Medical Oncologist, Medical Director, and Principal Investigator at Beverly Hills Cancer Center. "Seeing no adverse events reported 23 days after Deltacel infusion provides early validation that this novel cell therapy is well tolerated when combined with low dose radiation for lung cancer patients. We look forward to further evaluating optimal dose level, efficacy, and long-term safety outcomes as additional patients are enrolled and treated. If this promising initial data is replicated in more patients, Deltacel could become a new alternative treatment option for NSCLC patients."

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the study is to evaluate safety, while secondary ones include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial focus on NSCLC, the most prevalent type of lung cancer and representing about 80% to 85% of lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On January 5, 2024 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported its strategic priorities for 2024 and announced the addition of two new pre-clinical candidates for autoimmune diseases to its pipeline (Press release, Immunocore, JAN 5, 2024, View Source [SID1234639012]).

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"We continue the global commercial roll out of KIMMTRAK, now launched in 10 countries, and are pursuing future growth opportunities for KIMMTRAK with two registrational trials in advanced cutaneous melanoma and in adjuvant uveal melanoma," said Bahija Jallal, Chief Executive Officer of Immunocore. "We are advancing our PRAME ImmTAC including our first Phase 3 clinical trial in melanoma and expect to present clinical data from our Phase 1/2 clinical trial in melanoma, ovarian, and lung cancer throughout 2024. Today we add two new autoimmune candidates to our pipeline, expanding the potential of our platform to a third therapeutic area."

Key Strategic Priorities 2024
Our strategic priorities are to bring transformative medicines to patients with cancer, infectious diseases, and autoimmune diseases. In 2024, our priorities will be:

Growing sales of KIMMTRAK (tebentafusp-tebn) in the United States and globally in patients with HLA-A*02:01-positive metastatic uveal melanoma, and expanding KIMMTRAK beyond its initial approved indication with the registrational trials for advanced (second-line or later) cutaneous melanoma (TEBE-AM) and adjuvant uveal (or ocular) melanoma (ATOM).
Advancing our PRAME franchise in multiple solid tumors and broadening the addressable population. Randomization is expected to begin in the first quarter of 2024 in the registrational trial for IMC-F106C in first-line advanced cutaneous melanoma (PRISM-MEL-301), and we expect to present data from the Phase 1/2 clinical trial monotherapy and combination cohorts throughout 2024. We further expect to submit investigational new drug (IND) applications or clinical trial applications (CTA) for IMC-P115C (PRAME HLA-A2 Half-Life-Extended) and IMC-T119C (PRAME HLA-A24) candidates in 2024.
Bringing novel ImmTAC candidates to the clinic, leading with IMC-R117C, a first-in-class ImmTAC candidate targeting PIWIL1 with focus on colorectal and gastrointestinal cancers.
Evaluating the potential for a functional cure in infectious diseases with lead candidates for human immunodeficiency virus (HIV) and hepatitis B virus (HBV).
Initiating CMC manufacturing for the Company’s first two autoimmune candidates – including the first in class, tissue-specific, TCR bispecific PD1 agonist for type 1 diabetes and a novel non-HLA restricted (universal) PD1 agonist for dermatological diseases.

KIMMTRAK expansion strategy
In 2024, the Company plans to expand access to KIMMTRAK to more patients in the United States, Europe and globally, as it continues to establish the therapy as standard of care for the first line treatment for metastatic uveal melanoma in countries where it is launched. As of 2023 year-end, KIMMTRAK has been launched in ten countries and is approved in 38 countries.

The Company also continues to enroll patients into a Phase 2/3 clinical trial (TEBE-AM) to investigate the potential of KIMMTRAK in advanced cutaneous melanoma, with randomization expected to be completed in the Phase 2 portion during the third quarter of 2024. Topline data from the Phase 2 portion of the trial is expected to be available by the fourth quarter of 2024.

In addition, in 2023, the Company signed an agreement for a European Organisation for Research and Treatment of Cancer (EORTC)-sponsored trial to study KIMMTRAK as adjuvant therapy for uveal (or ocular) melanoma (ATOM). The Company anticipates that the EORTC will randomize the first patient in the second half of 2024.

PRAME franchise

PRISM-MEL301 – First PRAME Phase 3 clinical trial with IMC-F106C in first-line advanced cutaneous melanoma

In August 2023, the Company announced plans to start a registrational Phase 3 trial with IMC-F106C in cutaneous melanoma. The trial will randomize patients with HLA-A*02:01-positive, first-line advanced cutaneous melanoma to IMC-F106C + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab, depending on the country where the patient is enrolled. The Company plans to randomize the first patient in this trial in the first quarter of 2024.

Phase 1/2 clinical trial of IMC-F106C targeting PRAME-A02 in multiple solid tumors

In addition to progressing IMC-F106C into a registrational trial in cutaneous melanoma, the Company is continuing to enroll patients in the monotherapy and combination arms of the Phase 1/2 clinical trial across multiple tumor types, including expansion arms for patients with advanced ovarian, non-small cell lung carcinoma, endometrial, and melanoma. In August 2023, the Company provided an updated analysis of the original 18 melanoma patients (initially presented at ESMO (Free ESMO Whitepaper) in September 2022), which continued to show promising durability of the clinical activity (range of duration of partial response from 6 months to 17 months). The Company expects to report clinical data from the ongoing monotherapy and combination cohorts throughout 2024 including cutaneous melanoma (expected in Q2 2024), ovarian (expected by Q3 2024), and non-small cell lung carcinoma (expected by Q4 2024).

IMC-P115C (PRAME-A02 Half-Life Extended) & IMC-T119C (PRAME-A24)

The Company is expanding the PRAME franchise with two new PRAME ImmTAC candidates, IMC-P115C (PRAME-A02 HLE) and IMC-T119C (PRAME-A24) for solid tumors, which are both on track for investigational new drug (IND) or clinical trial application (CTA) submissions for IMC-P115C in the second quarter of 2024 and the second half of 2024 for IMC-T119C.

IMC-R117C (PIWIL1) for colorectal and other gastrointestinal cancers

The Company has leveraged its proprietary peptidomic (ImmSPECT) database to validate a novel target, PIWIL1. PIWIL1 is believed to play a role in tumor progression and is expressed across a range of tumors, including colorectal which is historically insensitive to immune checkpoints, as well as gastrointestinal and pancreatic cancers. PIWIL1 is also reported to be a negative prognostic marker and the Company believes IMC-R117C is the first PIWIL1-targeted immunotherapy. The Company submitted a CTA to regulatory authorities in December 2023, and expects the trial to start this year.

Enrolling ImmTAV candidates for a functional cure in infectious diseases

The Company continues to enroll people living with HIV in the multiple ascending dose (MAD) part of a Phase 1 clinical trial with IMC-M113V, to identify a safe and tolerable dosing schedule. This study will also test whether IMC-M113V could lead to reduction in the viral reservoir and, after stopping all therapies (antiretroviral therapies and IMC-M113V), delay or prevent HIV rebound (known as functional cure). The MAD part of the trial will enroll up to 28 participants. The Company expects to present a data update from the Phase 1 clinical trial in the second half of 2024.

In 2023, the Company amended the design of the ongoing Phase 1 trial with IMC-I109V for people living with HBV to include HBV-positive hepatocellular carcinoma. The Company continues to enroll patients into the trial in 2024.

Tissue-specific down modulation of the immune system for autoimmune diseases
The Company is expanding its platform into autoimmune with two first in class new bispecific candidates entering the Company’s pipeline. The key differentiator of the ImmTAAI platform is tissue-specific down modulation of the immune system. When tethered to the tissue of interest, the new candidates supress pathogenic T cells via PD1 receptor agonism.

The first candidate, IMC-S118AI (PPIxPD1), is targeted specifically to the pancreatic beta-cell and is intended for disease-modifying treatment in type 1 diabetes. IMC-S118AI recognizes a peptide from pre-proinsulin presented by HLA-A*02:01 on beta-cells.

The second target is present in the skin and intended to treat inflammatory dermatological diseases. The candidate is an antigen presenting cell (APC) tethered ImmTAAI and is not HLA restricted (e.g. universal for all populations).

Preliminary Year-End 2023 cash position
Preliminary unaudited cash and cash equivalents is approximately $443 million USD as of December 31, 2023.

42nd Annual J.P. Morgan Healthcare Conference

The Company has updated its corporate presentation to reflect these business and strategic updates. Additionally, the Immunocore management team will discuss these updates during a live and webcast presentation at the 42nd Annual J.P. Morgan Healthcare Conference, on Wednesday January 10, 2024, at 9:00 a.m. Pacific Standard Time (PST). The presentation and webcast will be available in the ‘Investors/Media’ section of Immunocore’s website at www.immunocore.com. A replay of the presentation will be made available for a limited time.

On January 5, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported a review of its 2023 achievements and a preview of plans for advancing its diabetes and oncology gene therapy programs in 2024 (Press release, Genprex, JAN 5, 2024, View Source [SID1234639011]).

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"We are very proud of what we accomplished in 2023, particularly with the successful completion of the Phase 1 portion of our Acclaim-1 clinical trial in lung cancer," said Rodney Varner, Chairman, President and Chief Executive Officer at Genprex. "In 2023, we also received a third Fast Track Designation for Reqorsa Immunogene Therapy from the U.S. Food and Drug Administration, this time in combination with Tecentriq for the treatment of small cell lung cancer, and REQORSA was also granted Orphan Drug Designation for the treatment of small cell lung cancer. We believe these designations underscore and further validate the potential of REQORSA. Our accomplishments in 2023, which also include process improvements in our manufacturing operations and securing new supplies of REQORSA, sets the foundation for a strong 2024."

Oncology Gene Therapy Platform

Genprex’s oncology program utilizes its systemic, non-viral Oncoprex Nanoparticle Delivery System which encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company’s lead product candidate, REQORSA (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for non-small cell lung cancer ("NSCLC") and small cell lung cancer ("SCLC"), andeach of the three lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population.

REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis (programmed cell death) in cancer cells, and modulates the immune response against cancer cells. In early studies, REQORSA has been shown to be complementary with targeted drugs and immunotherapies. Genprex’s strategy is to develop REQORSA in combination with currently approved therapies and believes that REQORSA’s unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers.

Important events of the year included:

In April, at the 2023 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2023), Genprex collaborators presented preclinincal gene therapy data with NPRL2, another tumor suppressor gene, that further validates the ONCOPREX Nanoparticle Delivery System as a platform
In October, Genprex hosted a Key Opinion Leader virtual event, "Bringing Gene Therapy to the Fight Against Lung Cancers" which discussed the use of gene therapies, including REQORSA, in the fight against lung cancer
In December, Genprex completed the successful production of a new batch of REQORSA thereby securing REQORSA supply for its Acclaim clinical studies
Collaborators submitted abstracts in 2023 and are expecting to present data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting in April 2024
Acclaim-1: 

The Acclaim-1 study is a Phase 1/2 clinical trial that has three portions – a Phase 1 dose escalation which has been completed, a Phase 2a expansion, and a Phase 2b randomized portion. Acclaim-1 uses a combination of REQORSA and AstraZeneca’s Tagrisso in patients with late-stage NSCLC that has activating epidermal growth factor receptor mutations and progression after treatment with Tagrisso. This novel approach to targeting lung cancer has demonstrated a strong safety profile with early signs of efficacy.

In May, Genprex completed the Phase 1 portion of the Acclaim-1 clinical trial and reported encouraging results. The Acclaim-1 Phase 1 study had no Dose Limiting Toxicities and results established a Phase 2 Recommended Dose, as well as provided data showing efficacy of REQORSA in combination with Tagrisso
In May, after completion of the Phase 1 portion of the Acclaim-1 trial, the Safety Review Committee ("SRC") approved advancement from the Phase 1 dose escalation portion of the trial to the Phase 2a expansion portion of the trial
In October, clinical collaborators presented a poster presentation at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) showing the Phase 1 results of the Acclaim-1 study
In January 2024, Genprex expects to open the Phase 2a expansion portion of the Acclaim-1 study for enrollment
Genprex expects to complete the enrollment of 19 patients in each cohort of the Phase 2a expansion portion of the study by the end of 2024
Acclaim-2:

The Acclaim-2 study is a Phase 1/2 clinical trial that has three portions – a Phase 1 dose escalation portion, a Phase 2a expansion portion, and a Phase 2b randomized portion.  The Acclaim-2 trial uses a combination of REQORSA and Merck & Co.’s Keytruda in patients with late-stage NSCLC whose disease has progressed after treatment with Keytruda. Patients are treated at the 0.06 mg/kg dose level in the first cohort of patients and, subject to the Acclaim-2 SRC approval, will be treated at successive dose levels of 0.09 mg/kg and 0.12 mg/kg.

Expanding on the previously granted patents in the U.S., Japan, Mexico and Russia, Genprex was granted patents in Australia, Chile and China to cover the use of REQORSA in combination with immune checkpoint inhibtors, e.g., PD1 and PDL1 inhibitors. These patents are applicable to Genprex’s Acclaim-2 and Acclaim-3 clinical trials.
In the second half of 2024, Genprex expects to complete enrollment in the Phase 1 dose escalation portion of the Acclaim-2 study
Acclaim-3:

The Acclaim-3 study has two portions – a Phase 1 dose escalation portion and a Phase 2 expansion portion. In November 2022 Genprex filed with the FDA the protocol for the Phase 1/2 Acclaim-3 clinical trial using a combination of REQORSA and Genentech, Inc.’s Tecentriq as maintenance therapy for patients with extensive stage small cell lung cancer ("ES-SCLC") who develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced.

In June, the FDA granted Fast Track Designation for the Acclaim-3 treatment combination of REQORSA and Tecentriq as maintenance therapy in patients with ES-SCLC who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment
In August, the FDA granted Orphan Drug Designation to REQORSA for the treatment of SCLC
In January 2024, Genprex expects to open the Phase 1 portion of the Acclaim-3 study for enrollment, and expects to complete the Phase 1 portion of the study by the second half of 2024
In the second half of 2024, Genprex expects to start the Phase 2 portion of the Acclaim-3 study
Diabetes Gene Therapy Platform

Genprex’s diabetes gene therapy approach is comprised of an infusion process that uses an adeno-associated virus ("AAV") vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells. Genprex has exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education ("University of Pittsburgh") multiple technologies relating to the development of a gene therapy product for each of Type 1 and Type 2 diabetes. In October 2023, Genprex entered into a one-year extension to the August 2022 sponsored research agreement with the University of Pittsburgh. The extension includes a revised research plan to encompass the Company’s most recent technologies to which Genprex acquired exclusive rights from the University of Pittsburgh in July 2023. These include a MafB promoter to drive expression of the Pdx1 and MafA transcription factors that can potentially be used for both Type 1 and Type 2 diabetes. This research is expected to be initially conducted in a Type 1 animal model.

In February, Genprex’s research collaborators at the University of Pittsburgh presented preclinical data in a NHP model of Type 1 diabetes highlighting the therapeutic potential of GPX-002. These data, presented during an oral presentation at the 16th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2023), showed statistically significant decreases in insulin requirements, increased c-peptide levels and improved glucose tolerance compared to baseline.
In April, the Company hosted a Key Opinion Leader virtual event, "Novel Gene Therapy to Treat Type 1 Diabetes," which discussed preclinical data reported at ATTD 2023 supporting gene therapy to treat Ttype 1 diabetes
Finalized the components of the diabetes construct to take forward for nonclinical studies
In December, Genprex submitted a request to meet with the FDA to obtain their guidance on the nonclinical studies needed to file an Investigational New Drug application and initiate first-in-human studies. As a result of the FDA’s response, the Company will continue with its planned additional nonclinical studies before requesting regulatory guidance in 2024 for the IND-enabling studies.

On January 5, 2024 Genprex presented its corporate presentation (Presentation, Genprex, JAN 5, 2024, View Source [SID1234639009]).

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On January 5, 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 program updates and upcoming 2024 milestones (Press release, Elevation Oncology, JAN 5, 2024, View Source;utm_medium=rss&utm_campaign=elevation-oncology-announces-program-updates-and-upcoming-2024-milestones [SID1234639008]).

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"Our vision is to leverage our ADC and oncology drug development expertise to deliver innovative, selective cancer therapies to millions of patients with significant unmet needs. In 2023, we made meaningful progress toward this goal, focusing our resources on advancing EO-3021, our anti-Claudin 18.2 ADC therapy," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "As evidenced by initial clinical data presented by our partner, we believe EO-3021 represents a highly differentiated, potentially best-in-class molecule, able to deliver better tolerability and improved anti-tumor activity to patients with tumors expressing varying levels of Claudin 18.2. We look forward to sharing an update from our ongoing trial in mid-2024."

Mr. Ferra continued, "We are also expanding our development program to realize the full potential of anti-Claudin 18.2-targeting as a therapeutic approach. To expand on available treatment options and optimize outcomes, particularly in the gastric cancer setting, we plan to evaluate EO-3021 in combination with both immunotherapy and targeted agents and will share details on our planned Phase 1 combination study in the first half of 2024. In addition, we are excited to reveal that our second program, an ADC targeting HER3, continues to advance and we expect to nominate a development candidate later this year."

Program Updates and Upcoming Milestones

EO-3021: Elevation Oncology is advancing EO-3021, a differentiated antibody drug conjugate (ADC) for the treatment of patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction, pancreatic or esophageal cancers.

Single Agent:

Elevation Oncology plans to provide an update from its ongoing Phase 1 trial in mid-2024, with additional data expected in the first half of 2025.
In June 2023, Elevation Oncology’s partner, CSPC Pharmaceutical Group Limited, presented initial clinical data for SYSA1801 (EO-3021) from their ongoing Phase 1 dose escalation and expansion study in China. Initial data showed promising signs of efficacy, including a 47.1% overall response rate (ORR) in patients with resistant/refractory gastric cancer expressing Claudin 18.2, with a well-tolerated safety profile.
In August 2023, Elevation Oncology began enrolling patients in an open-label, multi-center, dose escalation and expansion Phase 1 clinical trial (NCT05980416), designed to evaluate the safety, tolerability and preliminary anti-tumor activity of EO-3021.
Combination:

Elevation Oncology plans to expand its clinical development program to evaluate EO-3021 in combination. The Company believes a combination approach has the potential to offer optimal outcomes to patients, particularly in the gastric cancer setting, and plans to explore combination strategies with both immunotherapy and targeted agents. Elevation Oncology expects to share details on its planned Phase 1 combination study in the first half of 2024.
HER3-ADC: Elevation Oncology’s second program is a differentiated HER3-targeting ADC. HER3 is a well-validated ADC target, which is overexpressed across solid tumors and often associated with poor outcomes. There are currently no HER3-targeted ADC agents approved for the treatment of cancer.

Elevation Oncology is currently evaluating its HER3-ADC program and plans to nominate a development candidate in 2024.
Financial Guidance

Elevation Oncology expects that its cash, cash equivalents and marketable securities as of September 30, 2023, will be sufficient to fund its current operations into the second half of 2025.

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 transformations, 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.