On May 23, 2024 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, tisotumab vedotin, an antibody-drug conjugate (ADC), and acasunlimab (also known as GEN1046/BNT311), an investigational bispecific antibody, will be presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago, IL and virtually, May 31-June 2, 2024 (Press release, Genmab, MAY 23, 2024, View Source [SID1234643596]).

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"The data being presented this year at ASCO (Free ASCO Whitepaper) demonstrate Genmab’s significant progress towards our mission to develop novel antibody therapies with the goal of improving the lives of people impacted by cancer," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab.

Presentations will include data from multiple clinical trials evaluating the efficacy and safety of epcoritamab in a variety of treatment settings and patient populations, including a rapid oral presentation evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with previously untreated follicular lymphoma (FL) and a second rapid oral presentation showcasing results from the pivotal and cycle 1 dose optimization cohorts of EPCORE NHL-1 evaluating epcoritamab in patients with relapsed/refractory (R/R) FL.

Data from the Phase 2 innovaTV 207 trial, evaluating tisotumab vedotin in pretreated patients with relapsed/metastatic head and neck squamous cell carcinoma will be presented during a rapid oral session. Additionally, results from the Phase 3 innovaTV 301 trial evaluating tisotumab vedotin in patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy will be presented.

Finally, data from the Phase 2 clinical trial evaluating acasunlimab as monotherapy and in combination with pembrolizumab in patients with previously treated metastatic non-small cell lung cancer (mNSCLC) will be presented for the first time during a poster presentation.

The safety and efficacy of these investigational medicines have not been established for these uses.

Virtual mid- to late-stage pipeline update at ASCO (Free ASCO Whitepaper) 2024
On Monday, June 3, at 9:00 AM CDT (10:00 AM EDT/4:00 PM CEST), Genmab will host a review of data presented at ASCO (Free ASCO Whitepaper) from its mid- to late-stage pipeline. The event will be virtual and webcast live. Details, including the webcast link and registration will be available on www.genmab.com. This meeting is not an official program of the ASCO (Free ASCO Whitepaper) Annual Meeting.

All abstracts accepted for presentation have been published and may be accessed online via the ASCO (Free ASCO Whitepaper) Meeting Library.

Abstracts accepted for presentation at ASCO (Free ASCO Whitepaper):

Epcoritamab:

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
7014 Epcoritamab with rituximab + lenalidomide (R2) in previously untreated (1L) follicular lymphoma (FL) and epcoritamab maintenance in FL: EPCORE NHL 2 arms 6 and 7 Rapid Oral June 2, 4:30-6:00 PM CDT
7015 EPCORE NHL 1 follicular lymphoma (FL) cycle (C) 1 optimization (OPT) cohort: Expanding the clinical utility of epcoritamab in relapsed or refractory (R/R) FL Rapid Oral June 2,
4:30-6:00 PM CDT
7029 Subcutaneous Epcoritamab (SC epcor) administered outpatient (outpt) for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL): Results from Phase 2 EPCORE NHL-6 Poster June 3, 9:00 AM-12:00 PM CDT
7032 Epcoritamab + R-DHAX/C in transplant-eligible patients (pts) with high-risk relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) Poster June 3, 9:00 AM-12:00 PM CDT
7037 Subcutaneous epcoritamab + GemOx in patients with relapsed or refractory DLBCL: Updated results from EPCORE NHL-2 Poster June 3, 9:00 AM-12:00 PM CDT
7039 Extended follow-up results beyond 2.5 years from the pivotal NHL-1 EPCORE trial: Subcutaneous epcoritamab monotherapy in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) Poster June 3, 9:00 AM-12:00 PM CDT

TPS7084 EPCORE FL-2: Phase 3 trial of epcoritamab with rituximab and lenalidomide (R2) vs chemoimmunotherapy or R2 in previously untreated follicular lymphoma Poster June 3, 9:00 AM-12:00 PM CDT
Tisotumab Vedotin:

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
6012 Tisotumab vedotin in head and neck squamous cell carcinoma: updated analysis from innovaTV 207 Part C Rapid Oral June 3, 8:00-9:30 AM CDT
5531 Tisotumab vedotin in 2L/3L recurrent or metastatic cervical cancer: subsequent therapy data from ENGOT-cx12/GOG-3057/innovaTV 301 Poster June 3, 9:00 AM-12:00 PM CDT
Acasunlimab:

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
2533 Acasunlimab (DuoBody-PD-L1x4-1BB) alone or in combination with pembrolizumab (pembro) in patients (pts) with previously treated metastatic non-small cell lung cancer (mNSCLC): initial results of a randomized, open-label, Phase 2 trial Poster June 1, 9:00 AM-12:00 PM CDT
About Epcoritamab
Epcoritamab-bysp is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T-cells and CD20 on B-cells and induces T-cell mediated killing of CD20+ cells.i Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration.

Epcoritamab has received regulatory approval in certain lymphoma indications in several territories. Use of epcoritamab in FL is not approved in the U.S. or in the EU or in any other territory. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes four ongoing phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT: 04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT: 05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide in patients with R/R FL (NCT: 05409066), and a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemotherapy in patients with previously untreated FL (NCT: 06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses.

About Tisotumab Vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity. Tisotumab vedotin is co-owned by Genmab and Pfizer, under an agreement in which the companies share costs and profits for the product on a 50:50 basis.

Tisotumab vedotin has received full approval by the U.S. FDA for the treatment of adult patients with recurrent or metastatic cervical cancer (r/mCC) with disease progression on or after chemotherapy. Tisotumab vedotin in HNSCC is not approved in any country, including the U.S. and the EU.

About Acasunlimab (GEN1046/BNT311)
Acasunlimab (GEN1046/BNT311) is an investigational PD-L1x4-1BB bispecific antibody fusing Genmab’s proprietary DuoBody technology platform and BioNTech’s proprietary immunomodulatory antibodies. Acasunlimab is designed to elicit an antitumor response via conditional activation of 4-1BB on T cells and natural killer (NK) cells, which is strictly dependent on simultaneous binding of the PD-L1 arm.
Acasunlimab is being developed in collaboration with BioNTech SE under a license and collaboration agreement and is currently in Phase 2 of development.

Please visit www.clinicaltrials.gov for more information about Genmab’s clinical trials.

On May 23, 2024 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that mature Phase 2 results describing the positive impact of trilaciclib administered in combination with the TROP2 antibody-drug conjugate (ADC) sacituzumab govitecan (SG) on overall survival (OS) and tolerability compared to SG alone based on historical data from the ASCENT trial will be presented in a poster session during the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting (Press release, G1 Therapeutics, MAY 23, 2024, View Source [SID1234643595]). ASCO (Free ASCO Whitepaper) will be held May 31 to June 4, 2024, in Chicago, IL. A copy of the poster will be made available on the G1 Therapeutics website following the presentation here.

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The abstract was made available by ASCO (Free ASCO Whitepaper) today and includes the initial Phase 2 trial results originally provided by the Company in January 2024. The poster that will be presented at ASCO (Free ASCO Whitepaper) will describe the mature results of the Phase 2 trial as an update to the initial results.

Poster Presentation Details:
Trilaciclib Combined with Sacituzumab Govitecan (SG) in Metastatic Triple Negative Breast Cancer (mTNBC): Updated Phase 2 Safety and Efficacy Results
Seneviratne, L. et al.
Poster and abstract number 1091
Poster session: Breast Cancer-Metastatic
Sunday, June 2, 2024. 9:00 AM-12:00 PM CDT

On May 23, 2024 FibroGen, Inc. (NASDAQ: FGEN) reported positive interim results from the dose escalation portion of the investigator-sponsored Phase 1b/2 study conducted by the University of California San Francisco of FG-3246 (FOR46), a potential first-in-class anti-CD46 antibody drug conjugate (ADC) with a MMAE-containing payload, in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, FibroGen, MAY 23, 2024, View Source [SID1234643594]).

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"We are excited to announce that FG-3246 in combination with enzalutamide in patients with mCRPC demonstrated clinically meaningful early signals of efficacy," commented Deyaa Adib, M.D., Chief Medical Officer of FibroGen. "These data further validate and build upon the encouraging activity we observed in the recently reported Phase 1 monotherapy data of FG-3246, as well as in preclinical models where the combination of FG-3246 with enzalutamide enhanced its tumor cytotoxic activity. We look forward to continuing our collaboration with the University of California San Francisco and plan to provide additional clinical data from this trial when available."

The presentation includes data from 17 biomarker unselected patients in the dose escalation portion of the trial. Eligibility criteria for the trial included patients who received at least one prior androgen receptor signaling inhibitor (ARSI) while patients who were treated with prior chemotherapy in the castration resistant setting were excluded. Over 70% of the patients in the study received at least two prior ARSIs, which included prior enzalutamide treatment. Dose escalation was explored with and without prophylactic granulocyte colony-stimulating factor (G-CSF) support. The primary endpoint was determination of the maximally tolerated dose (MTD) of FG-3246 in combination with enzalutamide. The combination treatment demonstrated an encouraging preliminary estimate of median radiographic progression free survival (rPFS) of 10.2 months. The MTD was established at 2.1 mg/kg ABW, with primary G-CSF prophylaxis, in combination with enzalutamide 160 mg/day.

The most frequent adverse events were consistent with other MMAE-based ADCs and included fatigue, weight loss, elevated transaminases, neutropenia, and peripheral neuropathy.

Additionally, a baseline CD46-directed PET imaging probe utilizing the same antibody backbone as FG-3246 (89Zr-DFO-YS5) was obtained in a subset of patients and demonstrated tumor uptake in multiple lesions.

"I am very encouraged by the preliminary evidence of efficacy we have seen with FG-3246 and enzalutamide, specifically the potential for clinically meaningful prolongation of rPFS, as well as the safety profile," added Dr. Rahul Aggarwal, Professor of Medicine at the University of California San Francisco, and Principal Investigator of the study. "We will continue to evaluate this combination in the Phase 2 portion of the trial and further explore the potential of 89Zr-DFO-YS5 as a predictive biomarker of response."

The poster presentation, titled "A Phase 1b dose escalation study of FOR46, a novel antibody-drug conjugate targeting a tumor-specific epitope of CD46, in combination with enzalutamide (Enza) in patients with metastatic castration resistant prostate cancer (mCRPC)" is scheduled for the poster session taking place on June 2, 2024 from 9:00 am to 12:00 pm CDT.

The Company plans to meet with the U.S. Food and Drug Administration (FDA) to discuss the development pathway for FG-3246 and anticipates the initiation of the Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in the second half of 2024.

About the Phase 1b/2 Study of FG-3246 in Combination with Enzalutamide
This Phase 1b/2 study is an investigator-sponsored trial being conducted at the University of California San Francisco to evaluate FG-3246 (FOR46) in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) after prior progression on at least one androgen receptor signaling inhibitor. The primary objective for the Phase 1b portion of the study is to determine the maximally tolerated dose (MTD) and recommended Phase 2 dose of FG-3246 in combination with enzalutamide in patients with mCRPC. The objectives of the Phase 2 portion of the study are to determine the composite response rate (CRR), proportion of participants with a greater than or equal to 50% change in prostate specific antigen (PSA50), objective response rate (ORR), median duration of response, median radiographic progression free survival (rPFS), and median overall survival (OS) of patients treated with FG-3246 in combination with enzalutamide. For more information about this study, which is currently enrolling, please visit www.clinicaltrials.gov (NCT05011188).

About FG-3246
FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3246 is currently in an ongoing Phase 1b/2 study being conducted at UCSF as an investigator-sponsored trial to evaluate FG-3246 in combination with enzalutamide, and another investigator-sponsored radiopharmaceutical marker trial using a PET with a zirconium tracer for CD46 using the same antibody backbone. The initiation of the Phase 2 monotherapy trial in metastatic castration-resistant prostate cancer is anticipated in the second half of 2024. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.

On May 23, 2024 Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN), a leading computational biology company aiming to revolutionize the development of life-science-based products, reported its financial results for the first quarter period ended March 31, 2024 (Press release, Evogene, MAY 23, 2024, View Source [SID1234643593]).

Mr. Ofer Haviv, Evogene’s President and CEO, stated: "Evogene’s mission is to direct and accelerate the development of life-science based products. During the past years we developed three innovative AI tech-engines addressing the main development challenges of 3 life-science based product categories:

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•
MicroBoost AI – for the development of microbe-based products,

•
ChemPass AI – for small-molecule-based products, and

•
GeneRator AI – for products based on genetic elements.

Our AI tech-engines were structured to be compatible with the tremendous potential of various market segments and not limited to only one specific segment.

In order to capture the value of our AI tech-engines, our business strategy is to establish diverse collaborative partnerships through licensing or collaboration, with expert partners in specific fields that complement our technology. Together, we’ll develop novel products, aiming for full or partial ownership upon project completion.

This approach maximizes the potential of our AI tech-engines, while reducing financial and development risks. We believe this strategy holds the potential for groundbreaking innovations and significant financial gains for Evogene.

Today, Evogene has 4 subsidiary companies, and diverse engagements with leading companies in additional market segments, not covered by our subsidiaries.

I am very pleased to share with you the main achievements made by Evogene and its subsidiaries from the beginning of the year."

Evogene Updates:

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Ceasing Canonic’s operation – Evogene has decided to cease its subsidiary Canonic, which specialized in customized medical cannabis products, following challenging market conditions in the medical cannabis sector. This decision results in annualized savings of approximately $1.5 million. Resources will be reallocated to areas with greater growth potential, such as funding Casterra’s needs for on-going capital.

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Establishment of Finally Foods – In March 2024, Evogene and The Kitchen FoodTech Hub by Strauss Group, established Finally Foods Ltd., an AI-driven company focused on sustainable protein production in plants, for the food sector. Finally Foods will leverage Evogene’s AI technology to modify plants for efficient protein production. The company has secured pre-seed funding from TKH and the Israeli Innovation Authority. Evogene holds approximately 40% stake in the company.

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Collaboration with Verb Biotics – In February 2024, Evogene and Verb Biotics entered into a collaboration agreement to advance probiotic innovation by developing new strains of probiotic bacteria that produce sustainable quantities of microbial metabolites, which enhance human health and vitality. The partnership will leverage Evogene’s MicroBoost AI tech-engine and Verb Biotics’ expertise in microbiome health.

Subsidiaries Updates:

Casterra Ag Ltd. – focuses on developing an integrated solution to enable large-scale commercial cultivation of castor to address the global demand for stable castor oil supply, mainly for the biodiesel industry. Casterra is utilizing GeneRator AI tech engine to direct and accelerate the development of its unique elite castor seed varieties.

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Under the supervision of Casterra’s new CEO, the company has recently engaged with castor seed growers in Africa and Brazil. These engagements are expected to yield approximately 900 tons of castor seeds in 2024, fulfilling all existing purchase orders and providing additional inventory later this year. The balance of the existing purchase orders is anticipated to be delivered in the second half of 2024.

Biomica Ltd. – a clinical-stage biopharmaceutical company developing innovative microbiome-based therapeutics, utilizing Evogene’s MicroBoost AI tech-engine.

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In January, 2024, Biomica reached a significant milestone by completing Phase I trial enrollment for its microbiome-based immuno-oncology drug BMC128 – a rationally designed consortia of 4 bacteria. Biomica recently announced that it will be presenting preliminary Phase 1 study data of BMC128 in a poster presentation at the 2024 ASCO (Free ASCO Whitepaper) Annual Conference, on June 3rd.

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Biomica is now preparing for advancing to Phase 2 of BMC128 clinical trial, and already conducted a pre-IND meeting with the FDA, aiming to initiate Phase 2 in 2025.

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Results from Biomica’s pre-clinical study in the IBS program, conducted in collaboration with NYU’s medical school, were presented at the Digestive Disease Week 2024 Annual Conference in May 2024.

Lavie Bio Ltd. – a leading ag-biologicals company that develops microbiome-based, computational-driven novel bio-stimulant and bio-pesticide products, utilizing Evogene’s MicroBoost AI tech-engine.

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In February, 2024, Lavie Bio announced that it had met the requirements of its licensing agreement for LAV311 & LAV312 with Corteva. This achievement enabled the successful receipt of the second half of an advanced payment, amounting to $2.5 million, bringing the total to $5 million.

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In February, 2024, Lavie Bio signed an agreement with Syngenta for the development of new biological insecticidal solutions.

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Lavie Bio has extended its joint validation trials with Bayer for its bio-fungicides, following successful laboratory and greenhouse testing. This joint effort, aimed at combating diseases affecting fruits and vegetables globally, has moved to field experiments for further validation.

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In March, 2024, Lavie Bio partnered with Ceres Global Ag Corp. to integrate its bio-inoculant, YalosTM, into regenerative agriculture programs across the North America. This announcement and other marketing and sales efforts support the penetration of YalosTM in US and Canada markets with additional crops being added for treatment. Based on initial orders and sale projections, 2024 revenues are anticipated to increase compared to the previous year.

AgPlenus Ltd. – a global leader in computational design and development of novel sustainable crop protection products, utilizing Evogene’s ChemPass AI tech-engine.

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In February, 2024, AgPlenus announced a licensing and collaboration agreement with Bayer to develop a novel mode of action broad-spectrum herbicide targeting the APTH1 protein. The agreement entitles AgPlenus to an upfront payment, which was received on March 2024, ongoing research funding, milestone payments, and royalties based on future product sales. Bayer will have the exclusive license for developing and commercializing products resulting from this collaboration.

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In March, 2024, AgPlenus announced achieving a milestone under its existing collaboration with Corteva to develop new herbicides through a novel mode of action, APCO12, discovered by AgPlenus. The next phase of this collaboration will focus on optimizing the herbicide candidates towards a commercial-level product.

Financial Highlights:

Cash Position: As of March 31, 2024, Evogene held consolidated cash, cash equivalents, and short-term bank deposits of approximately $26.6 million, compared to approximately $31.1 million as of December 31, 2023. The consolidated cash usage during the Q1 2024 was approximately $4.5 million. Excluding Lavie Bio and Biomica, Evogene and its other subsidiaries used approximately $3.4 million in cash. Projected cash usage for 2024, excluding Lavie Bio and Biomica, is expected to be around $8.0 million, marking a notable 36% decrease from approximately $12.5 million in 2023.

Revenue: Revenues for the first quarter of 2024 were approximately $4.2 million, a significant increase from approximately $0.6 million in the same period the previous year. This growth was primarily driven by revenues recognized from Lavie Bio’s licensing agreement with Corteva and AgPlenus’s new collaboration with Bayer. Evogene anticipates continued revenue growth in 2024 compared to the previous year, mainly in the second half of 2024 based on Casterra’s forecast for seed-order supply.

R&D Expenses: Research and development expenses for the first quarter of 2024 were stable at approximately $4.8 million, net of non-refundable grants, consistent with the same period in the previous year.

Sales and Marketing Expenses: These expenses increased to $992 thousand in the first quarter of 2024 compared to $800 thousand in the same period of the previous year. The increase was driven by heightened sales and marketing activities for Casterra’s elite seed varieties and Lavie Bio’s first commercial product, YalosTM.

General and Administrative Expenses: General and administrative expenses rose to approximately $1.7 million in the first quarter of 2024, compared to approximately $1.5 million in the same period of the previous year, mainly due to non-cash compensation for subsidiary CEOs.

Other Expenses: The decision to cease Canonic’s operations resulted in recording other expenses of approximately $0.5 million, mainly due to impairment of fixed assets.

Operating Loss: The operating loss for the first quarter of 2024 was approximately $4.1 million, a decrease from $6.8 million in the same period of the previous year, mainly due to increased revenues.

Financing Income: Financing income net for the first quarter of 2024 was $241 thousand, compared to financing expenses net of $230 thousand in the same period of the previous year. This improvement was primarily due to increased interest income and revaluation of convertible SAFE.

Net Loss: The net loss for the first quarter of 2024 was approximately $3.8 million, compared to approximately $7.0 million in the same period last year. The $3.2 million decrease in net loss was primarily due to increased revenues and financial income, partially offset by the one-time $519 thousand other expenses related to ceasing Canonic’s operations.

On May 23, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported its participation in the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, where it will present positive immune data form its ongoing EVX-01 Phase 2 study (Press release, Evaxion Biotech, MAY 23, 2024, View Source [SID1234643592]). The study assesses the personalized cancer vaccine EVX-01 in combination with anti-PD1 therapy in patients with advanced melanoma. The conference will take place in Chicago, IL, from May 31 – June 4, 2024.

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"We continue to see encouraging results from our ongoing Phase 2 study with EVX-01. The immune signatures induced by EVX-01 are both specific and strong, with booster immunizations pointing to further increased immune responses. The data makes us optimistic about the potential clinical benefit of EVX-01, and we eagerly await further data readouts on this novel personalized cancer vaccine. With our AI-Immunology platform, we can precisely select vaccine targets and design personalized vaccines that match each patient’s unique tumor signature and immune characteristics. This represents a novel approach to addressing an unmet medical need that remains dire, and we are excited about the interest we are seeing in the EVX-01 program," said Christian Kanstrup, CEO at Evaxion.

This ongoing Phase 2 study currently confirms findings from the previous Phase 1 study, reaffirming the ability of Evaxion’s AI-Immunology platform to precisely select therapeutically relevant vaccine targets and generate new valuable insights. Key highlights from the Phase 2 study are:

Analyses of patient samples demonstrated EVX-01 vaccine-induced specific and robust immune responses, mediated by both CD4+ and CD8+ T-cells
Booster immunizations tended to increase the immune response and did not impose any safety concerns
The EVX-01 vaccine candidate was found to be well-tolerated with only grade 1 and 2 adverse events
Poster Details:

Abstract Title: "Immunogenicity of an AI-designed personalized neoantigen vaccine, EVX-01, in combination with anti-PD-1 therapy in patients with metastatic melanoma"
Abstract #: 9561
Poster Bd #: 345
Track: Melanoma/Skin Cancers
Location: Hall A – McCormick Place
Date/Time: Saturday, June 1, 1:30 – 4:30 p.m. CDT
Presenter: Mads Lausen Nielsen, Senior Scientist

About EVX-01 Phase 2 Clinical Trial

EVX-01 is Evaxion’s lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The ongoing Phase 2 clinical study is a self-sponsored, open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC that, together with leading principal investigators and research centers from Italy and Australia. It aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with the anti-PD1 treatment pembrolizumab (more commonly known as KEYTRUDA) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421.