Kinnate Biopharma Inc. Adds Two New Drug Candidates to Its Growing Targeted Oncology Pipeline and Provides Cash Runway Guidance

On April 17, 2023 Kinnate Biopharma Inc. (Nasdaq: KNTE) (Kinnate), a clinical-stage precision oncology company, reported the addition of two new internally developed next generation development candidates to its targeted oncology pipeline – a brain penetrant mitogen-activated protein kinase (MEK) inhibitor and a highly selective mesenchymal-epithelial transition factor gene (c-MET) inhibitor (Press release, Kinnate Biopharma, APR 17, 2023, View Source [SID1234630162]).

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The company also announced that it had approximately $231 million of cash, cash equivalents and investments as of March 31, 2023, which is anticipated to fund planned operations into early 2025.

"We are proud of our growing portfolio of precision oncology programs comprised of highly selective therapeutics with optimized drug properties designed to address broad alteration coverage, resistance mechanisms and now brain penetrance," said Robert Kania, Ph.D., senior vice president, drug discovery, Kinnate Biopharma Inc. "The addition of Kinnate’s next generation MEK and c-MET research programs to our development pipeline illustrates the productivity of our capability-based discovery engine, which is delivering on our goal of bringing forward one new IND a year. Targeted therapies have tremendous potential to help patients, but only about ten percent of patients with advanced or metastatic cancer are eligible for currently approved targeted therapies. We look forward to continued progress powered by our Kinnate Discovery Engine and the impact we can have on the lives of those battling cancer."

In-House Brain-Penetrant MEK Inhibitor Designed for Optimal Control in Potential Commercial Opportunities

KIN-7136 is designed to be a next generation brain-penetrant MEK inhibitor for investigation in advanced adult solid tumors, primarily non-small cell lung cancer (NSCLC), that are MAPK pathway-driven, including those with brain metastases.

Kinnate expects to enter the clinic with KIN-7136 in the second half of 2023, pending U.S. Food and Drug Administration (FDA) clearance on its investigational new drug (IND) application. The goal of the Phase 1 clinical trial will be to establish safety and tolerability, and generate understanding of the pharmacokinetics, pharmacodynamics and early clinical activity of KIN-7136 as a monotherapy.

In parallel, the company intends to evaluate KIN-7136 combined with exarafenib, Kinnate’s investigational pan-RAF inhibitor. Kinnate plans to prioritize exploring the KIN-7136 and exarafenib combination in BRAF Class I patients with NSCLC that have been previously treated with a RAF inhibitor and patients with NRAS mutant melanoma. This approach enables access to a potentially broader patient population to be evaluated with exarafenib, including those with brain metastases. KIN-7136 may serve as part of the company’s long-term RAF combination strategy.

Today, the company separately provided a preliminary update on the combination arm of the ongoing Phase 1 KN-8701 clinical trial evaluating exarafenib with binimetinib, a first generation MEK inhibitor with minimal brain penetrant properties, in patients primarily with NRAS mutant melanoma.

In-House, Highly Selective c-MET Inhibitor Designed for Broad Mutational Coverage

Research has shown that acquired resistance to approved and in-development c-MET inhibitors limits clinical benefit. Up to 35% of patients treated with approved c-MET inhibitors develop on-target resistance mutations, leaving them with limited treatment options and a poor prognosis. In patients with NSCLC, about 3-4% of patients present with actionable MET exon 14 alterations.

KIN-8741 is designed to be a highly selective c-MET inhibitor with broad mutational coverage, including acquired resistance mutations, across a variety of solid tumors in which c-MET is overexpressed, such as NSCLC.

Kinnate expects to enter the clinic with KIN-8741 in the first half of 2024, pending FDA clearance on its IND application.

CDK12 Program Update

The company will deprioritize development for its CDK12 program and evaluate strategic alternatives as it deepens focus on its two clinical-stage assets and advances development of its MEK and c-MET programs.

Virtual Investor Webcast Information

Kinnate will host a webcast today, April 17, 2023, at 5:30 p.m. ET. Investors and the general public are invited to listen to a live webcast of the session through the "Investors and Media" section on Kinnate.com or by dialing the U.S. toll free number +1-888-256-1007 and entering confirmation code: 7465233. An archived edition of the session will be available following the event.

First Report of Positive Dose Escalation Data Supports Best-in-Class Profile for Investigational Exarafenib as a Single Agent and in Combination with Binimetinib in BRAF-altered Cancers and NRAS Mutant Melanoma

On April 17, 2023 Kinnate Biopharma Inc. (Nasdaq: KNTE) (Kinnate), a clinical-stage precision oncology company, reported positive monotherapy dose escalation data for its investigational, highly selective and potent pan-RAF inhibitor, exarafenib, from Part A1 of its ongoing global Phase 1 KN-8701 clinical trial (Press release, Kinnate Biopharma, APR 17, 2023, View Source [SID1234630161]). These results will be featured in an oral presentation today at 3:35 p.m. ET during the Clinical Trials Mini Symposium Session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2023 Annual Meeting. (Abstract #CT032)

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The company today also provided details around its monotherapy dose expansion strategy (Part B) and a preliminary update on the combination arm (Part A2) evaluating exarafenib with binimetinib, a MEK inhibitor, in patients with BRAF-altered solid tumors and/or who have NRAS mutant melanoma.

Kinnate will host a virtual investor webcast today at 5:30 p.m. ET to discuss these updates, along with the expansion of its early development pipeline announced separately.

"The exarafenib dose escalation data provide striking proof of concept for a monotherapy pan-RAF inhibitor," said Alexander Spira, MD, PhD, FACP, co-director, Virginia Cancer Specialists Research Institute. "For the first time, a pan-RAF inhibitor has shown both promising tolerability as a single agent and has achieved compelling breadth of activity with durable responses in targetable mutations. Responses in patients with BRAF Class II or NRAS alterations is meaningful because no approved targeted therapy is available today, and physicians are left with limited treatment options for advanced cancers, which means patients often have poor survival outcomes. I look forward to the further study of exarafenib’s therapeutic potential to address these patients who are currently medically underserved."

Key Exarafenib Monotherapy Data Presented at AACR (Free AACR Whitepaper) 2023

The data at AACR (Free AACR Whitepaper) were based on a February 28, 2023 data cutoff. Sixty patients with a median of three prior therapies had been enrolled into six monotherapy dose escalation cohorts: 25 mg bid (dose level; DL 1), 50 mg bid (DL 2), 100 mg bid (DL 3), 200 mg bid (DL 4), 300 mg bid (DL 5) and 400 mg bid (DL 6). Treated patients included those with solid tumors driven by BRAF Class I (41.7%), Class II (13.3%) and Class III (30%) alterations or melanoma with NRAS mutations (15%). BRAF and NRAS alterations were identified by local laboratories either in tumor or plasma. As of the data cutoff, all 60 patients enrolled were part of the safety analysis population, of which 49 patients were efficacy evaluable.1

Favorable Tolerability Profile; Only 3% (n=2/60) of Patients Discontinued Therapy Due to Treatment-Related Adverse Events

The maximum tolerated dose (MTD) was determined to be 300 mg bid (n=29). At therapeutically relevant exposures, there was no cutaneous (skin) evidence of paradoxical activation. Dose limiting toxicities observed at the highest dose level (400 mg bid) were Grade 3 acneiform rash (n=1) and Grade 3 macular rash (n=1).

Treatment-related adverse events (TRAEs) reported by investigators at any Grade occurred in 73.3% (n=44) of patients, with 18.3% of TRAEs reported as Grade 3 or higher (n=11). There were no Grade 5 TRAEs reported as of the data cutoff.

The most common TRAEs of any Grade were skin related (21.7%; n=13), with 3.3% (n=2) of patients having skin events that were Grade 3 or greater.

Grade 2 gastrointestinal (GI) TRAEs occurred in 3.3% of patients (n=2). No Grade 3 GI TRAEs were observed.

Reversible, asymptomatic increased alanine transaminase and/or increased aspartate aminotransferase TRAEs were reported at Grade 3 (n=4; 6.7%) and Grade 4 (n=1; 1.7%).

In all patients (n=60) treated with exarafenib, the overall relative mean dose intensity was 97% and was 95% in patients treated at 300 mg bid (n=29). The median for both patient sets was 100%.2
Dose Dependent and Steady State Unbound Exposures with Exarafenib Treatment

Pharmacokinetic analyses demonstrated dose-dependent increases in exarafenib exposure (Cmax; peak plasma concentration and area under the curve) with increasing dose.

Exarafenib had a half-life of eight hours in patients, which is a longer duration range than the predicted half-life preclinically, supporting a bid dosing strategy.

At 300 mg bid, exarafenib delivered high target coverage in patients. Unbound exposures exceeded the IC50 values across BRAF and NRAS cell lines by two-to-ten-fold, while remaining below the wild type cells IC50. We believe multiple fold target coverage is ultimately necessary for meaningful outcomes in these patient subtypes.

Treatment with exarafenib also led to significant reductions in circulating tumor DNA across BRAF and NRAS-altered tumor types.
Promising Early Efficacy, Including RECIST Responses in Priority BRAF Class II and NRAS Subtypes

In total, 6 patients achieved a partial response (PR) with exarafenib monotherapy treatment during dose escalation, including five confirmed PRs as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST). For responders, the average tumor reduction was 61% and treatment duration was 7 months. Four of the 6 responders continue exarafenib therapy.

Treatment with exarafenib at 300 mg bid, the MTD, in patients with BRAF Class II or NRAS alterations led to a 30% (3 of 10) overall response rate (ORR).

The ORR in patients with BRAF Class II alterations was 33% (1 of 3) at 300 mg bid, which included a patient with non-small cell lung cancer (NSCLC) harboring a BRAF Class II fusion.

In addition, 71% (5 of 7) of patients with BRAF Class II alterations achieved an objective tumor reduction. In all treated patients with Class II alterations, the disease control rate was 86% (6 of 7).

The ORR in patients with NRAS alterations was 29% (2 of 7) at 300 mg bid and included patients with NRAS mutant melanoma and a patient with colorectal cancer harboring an NRAS alteration co-occurring with a BRAF Class III alteration.

The two additional subtypes with confirmed PRs included RAF inhibitor naïve patients with BRAF Class I (V600E) papillary thyroid cancer and squamous cell carcinoma. One unconfirmed PR was reported in a RAF pretreated patient with BRAF Class I melanoma.

Twenty-two patients achieved stable disease (SD) across dose levels, including 10 patients with objective tumor shrinkage (up to 20%), showing encouraging breadth of activity and prolonged disease control in a broad range of alterations and tumor types.
1Efficacy evaluable set includes all participants with documented BRAF (or melanoma with NRAS) genomic alterations (as specified for each study Part) who received at least 1 dose of exarafenib and have >= 1 measurable lesion at baseline for disease response assessment and at least 1 post-baseline efficacy assessment per RECIST Version 1.1 criteria. Response assessments performed by each respective clinical trial site (local, investigator-assessed radiology). Disease control rate is defined as the percent of participants who achieved a complete response, PR or SD as their best overall response in accordance with RECIST v1.1.

2Overall relative dose intensity based on assigned dose will use the full course of dose received (including intrapatient dose escalation or de-escalation) divided by the total planned dose as per the originally assigned.

Exarafenib Monotherapy Dose Expansion Strategy Optimized for Probability of Success

The expansion cohorts of the KN-8701 clinical trial opened year-end 2022 and are currently enrolling patients at the 300 mg bid dose.

Kinnate refined its dose expansion strategy to include greater enrichment of more sensitive tumor and alteration types based on the emerging profile and clinical signals observed during dose escalation.

The priority cohorts will enroll patients with BRAF Class II alterations, including BRAF fusions, across solid tumors, primarily melanoma and NSCLC. These cohorts are expected to enroll approximately 55 patients.

The company expects to provide initial monotherapy dose expansion data in the first half of 2024.

Exarafenib + Binimetinib Dose Escalation Ongoing; Early Clinical Activity Observed

Key combination updates as of March 31, 2023 include:

Enrolled 12 patients primarily with NRAS mutant melanoma into 3 combination dose cohorts: (1) exarafenib 100 mg bid and binimetinib 45 mg bid, (2) exarafenib 100 mg bid and binimetinib 15 mg bid, and (3) exarafenib 200 mg bid and binimetinib 15 mg bid.

Enrollment continues at exarafenib 200 mg bid dose and binimetinib 15 mg bid, with safety evaluation ongoing.

Two of the 7 efficacy evaluable patients achieved RECIST PRs, including an unconfirmed PR in a patient with NRAS mutant melanoma and a confirmed PR in a patient with BRAF Class II pancreatic cancer. One additional patient with NRAS mutant melanoma experienced a 25% reduction in their target lesions. Patients who responded continue combination therapy.

Kinnate will prioritize development of the exarafenib combination in patients with NRAS mutant melanoma. The trial will also enroll RAF pre-treated patients with a BRAF Class I alteration.

The company expects to provide an update in the second half of 2023 on the combination dose that will be taken into dose expansion.
"With the selection of the maximum tolerated dose for exarafenib, we initiated monotherapy dose expansion with enrollment ongoing in patients with a meaningful unmet medical need and where we believe we have the highest probability of success with a single-agent pan-RAF, including in patients with advanced lung cancer and melanoma that harbor a BRAF Class II alteration," said Richard Williams, MBBS, PhD, chief medical officer, Kinnate Biopharma Inc. "In addition, with a well-tolerated monotherapy profile, compelling PK/PD and responses as the backbone, we continue to pursue priority pan-RAF combination approaches, such as with a MEK inhibitor in NRAS mutant melanoma, where a combination may offer additive benefit to patients."

Nima Farzan, Kinnate Biopharma Inc. chief executive officer, commented, "Kinnate was formed just five years ago, and in that time, we have evolved from a start up to a global, precision oncology company with two programs in the clinic and a growing pipeline of targeted therapy candidates developed by our own scientists. Today, we are proud to share the first clinical data from the company on exarafenib, showing early efficacy both as a monotherapy and as a combination regimen in BRAF and NRAS-altered cancers. This potential best-in-class pan-RAF inhibitor anchors our growing pipeline and positions the company for future growth."

Today’s AACR (Free AACR Whitepaper) presentation is available on the company’s website at Kinnate.com.

Virtual Investor Webcast Information

Kinnate will host a webcast today, Monday, April 17, 2023, at 5:30 p.m. ET. Investors and the general public are invited to listen to a live webcast of the session through the "Investors and Media" section on Kinnate.com or by dialing the U.S. toll free number +1-888-256-1007 and entering confirmation code: 7465233. An archived edition of the session will be available following the event.

About Exarafenib

Exarafenib is an orally administered, potent and selective investigational small molecule pan-RAF inhibitor. Unlike currently available treatments that target only Class I BRAF kinase mutations, exarafenib is designed to target BRAF Class II and Class III alterations, where it has the potential to be a first-line targeted therapy, in addition to covering BRAF Class I alterations, and as a potential treatment for NRAS mutation-positive melanoma.

KN-8701 Clinical Trial Background

KN-8701 is an ongoing, global Phase 1 clinical trial (NCT04913285) evaluating exarafenib in patients with advanced solid tumors harboring BRAF Class I, II and III alterations, and/or who have NRAS mutant melanoma. KN-8701 contains a two-part dose escalation: Part A1 is evaluating exarafenib as a monotherapy across BRAF alterations and tumor types, and Part A2 is evaluating exarafenib in combination with binimetinib, a MEK inhibitor. Part B, dose expansion, is evaluating exarafenib at the recommended dose and schedule in patients with BRAF-altered cancers including lung cancer, melanoma and other solid tumors.

Kineta Unveils New VISTA Biomarker Data and KVA12123 Phase 1/2 Clinical Trial Update at AACR Annual Meeting 2023

On April 17, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported the presentation of new VISTA biomarker data and an update on the KVA12123 Phase 1/2 clinical trial at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 (Press release, Kineta, APR 17, 2023, View Source;utm_medium=rss&utm_campaign=kineta-unveils-new-vista-biomarker-data-and-kva12123-phase-1-2-clinical-trial-update-at-aacr-annual-meeting-2023 [SID1234630160]). Thierry Guillaudeux, Ph.D., Chief Scientific Officer at Kineta, presented the company’s poster unveiling the new data in the AACR (Free AACR Whitepaper) poster session entitled "Biomarkers of Therapeutic Benefit 1".

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"These biomarker data provide additional compelling rationale supporting VISTA as a promising new immuno-oncology target for patients with a range of different cancers" said Dr. Guillaudeux. "A better understanding of VISTA expression in the tumor microenvironment as well as in the blood could potentially inform patient selection and treatment optimization with KVA12123 in the future"

Key results from the AACR (Free AACR Whitepaper) poster presentation:

VISTA expression was detected by immunohistochemistry on tumor infiltrating immune cells, especially in non-small cell lung cancer, colorectal cancer, ovarian cancer, cervical cancers, melanoma and hepatocellular carcinomas and
VISTA expression was also detected on rare tumor cells in lung, head and neck, ovary and kidney malignancies
Multiplex IHC will be performed to confirm VISTA-positive tumor-infiltrating myeloid cells
High levels of soluble VISTA were found in colorectal, head & neck, kidney, lung and ovarian cancer patient serum samples
In the ongoing Phase 1/2 clinical trial, tumor tissues and serum samples will be collected from cancer patients prior to treatment with KVA12123 to inform the possible significance of these biomarkers
This work will help to better understand the clinical response to KVA12123 in relation to the expression level of VISTA in cancer tissues as well as in the blood and opens the possibility to consider VISTA expression as a potential biomarker for efficacy
Presentation Details:
Poster Title: VISTA expression in patients with advanced solid tumors: A potential biomarker in VISTA-101 clinical trial
Abstract Number: 972
Session Title: Biomarkers of Therapeutic Benefit 1
Session Date and Time: Sunday, April 16, 2023 at 1:30 P.M. – 5:00 P.M. Eastern Time
Location: Section 39

The poster presentation is available for viewing under Publications in the KVA12123 section of the company’s website at www.kinetabio.com.

IN8bio Announces Positive Preclinical Data for Gamma-Delta CAR Platform and Launches New CD33 Program at AACR Annual Meeting 2023

On April 13, 2023 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company discovering and developing innovative gamma-delta T cell therapies, reported positive preclinical data for its novel non-signaling CAR (nsCAR) platform and the launch of its INB-330 program in AML (Press release, In8bio, APR 17, 2023, View Source [SID1234630159]). The new data included preliminary results for the nsCAR platform targeting CD33, a challenging but potentially impactful target in AML. The data were presented in a poster session (abstract #1777) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023.

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"The pairing of an nsCAR with the innate killing ability of gamma-delta T cells has the potential to become a cornerstone in the treatment of both solid and liquid cancers, given the increased anti-tumor efficacy and preservation of healthy cells," remarked William Ho, CEO and co-founder of IN8bio. "IN8bio’s unique knowledge of the biology and manufacturing of gamma-delta T cells positions it as a leader in next generation CAR platforms for the treatment of previously undruggable targets."

IN8bio’s nsCAR platform is based on the natural ability of gamma-delta T cells to distinguish between healthy and malignant tissue. By using a CAR that lacks a signaling domain, IN8bio believes it has created a technology that enables these cells to differentiate between tumor and healthy tissue, even when both express the CAR-targeted antigen. The power of the nsCAR technology to selectively target tumor cells was shown in proof-of-concept studies against the validated target of CD19. Preliminary data showed a gamma-delta CD19 nsCAR (ns19CAR) killed 80% of leukemia cells versus only 5% of healthy B cells, which both express the CD19 target.

The new data presented at AACR (Free AACR Whitepaper) includes early preclinical results for the INB-330 program targeting CD33 for AML, an important but challenging target due to its expression on both leukemic cells and hematopoietic stem cells (HSCs). Previous therapies targeting CD33 were limited due to the significant side effects resulting from the unintended targeting of these HSCs. The data presented at AACR (Free AACR Whitepaper) showed that a CD33 targeting nsCAR construct (ns33CAR) was successfully engineered into gamma-delta T cells. The ns33CAR cells were able to distinguish

between leukemic cells and healthy monocytes isolated from peripheral blood, both of which express CD33. The ns33CAR demonstrated anti-leukemic activity against AML, B-cell acute lymphoblastic leukemia (B-ALL), and chronic myeloid leukemia (CML) cell lines. These preliminary findings support the ongoing evaluation of INB-330 in AML and improvements in transduction and CAR optimization are ongoing.

"We are thrilled to present this promising preclinical data from our next-generation nsCAR platform, which shows the potential of our INB-300 platform and INB-330 program to differentiate between cancerous and healthy tissue," said Lawrence Lamb, Ph.D., co-founder and Chief Scientific Officer of IN8bio. "Our goal is to improve upon existing technologies with a targeted but potentially less toxic approach for patients who require more innovative therapies. The ability of this platform to avoid on-target off-tumor killing also allows us to explore previously "undruggable" targets in complex diseases such as AML and solid tumors. We are encouraged by these results and look forward to seeking potential partners and further evaluating the nsCAR platform with additional targets."

About INB-300

INB-300, is a non-signaling CAR (nsCAR) gamma-delta T cell platform, with several preclinical product candidates, including the INB-330 program against AML targets, that combine our expertise in gamma-delta T cells and genetic engineering. These nsCAR constructs lack signaling domains in order to take advantage of the unique properties of gamma-delta T cells to differentiate between healthy and tumor tissues. IN8bio is advancing new nsCAR constructs against multiple targets to treat both solid and liquid tumors.

Imvax Presents New Data at AACR 2023 Supporting the Mechanism of Action of its Lead Program, IGV-001, for Glioblastoma

On April 17, 2023 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported a poster presentation providing additional mechanistic insights into its Goldspire platform based on preclinical studies of its lead product candidate, IGV-001, for the treatment of glioblastoma (GBM) (Press release, Imvax, APR 17, 2023, View Source;utm_medium=rss&utm_campaign=imvax-presents-new-data-at-aacr-2023-supporting-the-mechanism-of-action-of-its-lead-program-igv-001-for-glioblastoma [SID1234630158]). These data are being presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Orlando, FL, running from April 14-19, 2023.

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"These new data provide us with deeper insights into the unique mechanism of our personalized immunotherapy platform, Goldspire, that combines whole-tumor derived cells with an antisense nucleotide in proprietary implanted chambers," said Mark A. Exley, Ph.D., Chief Scientific Officer. "The Goldspire platform is designed to induce a durable, broad-spectrum immune response against tumors, and additional studies like this one are key to furthering our understanding of both IGV-001 and our platform."

The data published in the AACR (Free AACR Whitepaper) poster presentation examined the effect on tumor cells of the Goldspire process, the release of subcellular immunogenic particles, their transit across the diffusible membrane of the implanted chambers and related immunological changes. IGV-001 was found to impose oxidative and endoplasmic reticulum stress onto GBM cells. Particle analysis confirmed that a human variant of IGV-001 prepared with human GBM cells produced particles that can efficiently diffuse through the membrane of the implanted chambers. Finally, the results indicated that lymph nodes through which IGV-001 drains are enriched in mature antigen-presenting cells and lymphoid effector cells.

The poster can be found on the Imvax website and the details for the presentation are below:

Title: ROS-dependent activation of immunogenic glioblastoma cell death & release of immunogenic particles by an autologous cell-based immunotherapeutic platform
Number: 1812
Timing: Monday, April 17, 2023, 9:00 AM – 12:30 PM
Presenter: Jenny Zilberberg, Ph.D.

About IGV-001
IGV-001 is an autologous biologic-device combination product derived from Imvax’s proprietary Goldspire immuno-oncology platform for solid tumors, which involves a unique approach to inducing a broad and durable immune response against tumors. Phase 1 studies showed that IGV-001 was safe and well tolerated, and a Phase 1b study in newly diagnosed GBM (ndGBM) patients also yielded several efficacy signals, including significant improvements in PFS, OS, radiographic evidence of tumor response and multiple biomarker changes that supported the presence of an immune response (Andrews DW, et al., Clin Cancer Res. 2021;27(7):1912-1922). In ten Stupp-eligible ndGBM patients in the highest dose cohort treated with IGV-001, median PFS was 17.1 months, compared with 6.5 months in historical standard-of-care (SOC) treatment, and median OS was 38.2 months, compared with 16.2 months in historical SOC. In March 2023, Imvax initiated a Phase 2b clinical trial of IGV-001 in ndGBM patients (NCT04485949).