On March 6, 2024 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported its financial results and operational highlights for the fourth quarter and full year ended December 31, 2023 (Press release, Inovio, MAR 6, 2024, View Source [SID1234640858]).

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INOVIO’s President and Chief Executive Officer, Dr. Jacqueline Shea, said, "The past year has been transformative as we’ve reshaped INOVIO into a company that is focused on commercializing its first product candidate and bringing the benefits of DNA medicine to patients. We’ve done so by focusing on the strengths of our platform and our strategic objectives: advancing candidates with scientific promise, achievable pathways to market, and strong commercial potential, and maintaining an ongoing commitment to financial discipline and operational excellence."

Dr. Shea continued, "In the past year we have taken our lead candidate, INO-3107 for RRP, from positive Phase 1/2 trial results to Breakthrough Therapy designation and an established path to BLA submission under the FDA’s accelerated approval program. We’ve also announced a new clinical collaboration and supply agreement with Coherus BioSciences to advance our development of INO-3112 in combination with LOQTORZI (toripalimab-tpzi) for throat cancer, shared encouraging results for INO-4201 as an Ebola vaccine booster, continued to advance other clinical-stage candidates, and progressed important preclinical research opportunities. The year ahead will provide a critical opportunity to carry this positive momentum forward across our pipeline, particularly for INO-3107 as we prepare for BLA submission and the initiation of a confirmatory trial in the second half of 2024 and accelerate commercialization efforts for a potential 2025 launch."

Operational Highlights

INO-3107 – Recurrent Respiratory Papillomatosis (RRP)
INOVIO made significant progress with INO-3107 as a potential treatment for RRP. Key milestones included positive clinical results, regulatory progress, and the acceleration of commercialization efforts to be prepared to launch in 2025.

INOVIO announced and published positive data from a completed Phase 1/2 clinical trial evaluating INO-3107 for the treatment of HPV-6 and HPV-11-related RRP in adults.
In the trial, 81.3% (26/32) of patients had a decrease in surgical interventions in the year after INO-3107 administration compared to the year prior to treatment, including 28.1% (9/32) that required no surgical intervention during or after the dosing window.
Patients in the trial had a median range of 4 surgeries (2-8) in the year prior to dosing. After dosing, there was a median decrease of 3 surgical interventions (95% confidence interval -3, -2).
Prior to the outset of the trial (Day 0), patients had RRP tissue surgically removed, but any surgery performed after Day 0 during the dosing window was counted against the efficacy endpoint.
Treatment with INO-3107 generated a strong immune response in the trial, inducing activated CD4 T cells and activated CD8 T cells with lytic potential. T-cell responses were also observed at Week 52, indicating a persistent cellular memory response.
INO-3107 was well tolerated by participants in the trial, resulting in mostly low-grade (Grade 1) treatment-emergent adverse effects such as injection site pain and fatigue.
This data was presented at the 103rd Annual Meeting of the American Broncho-Esophageal Association at the 2023 Combined Otolaryngology Spring Meetings in May 2023, and published in The Laryngoscope in June 2023.
INOVIO announced its plans to submit its BLA for INO-3107 in the second half of 2024.
Breakthrough Therapy designation was granted by the FDA in September 2023.
FDA advised in October 2023 that INOVIO’s completed Phase 1/2 trial could be used to submit its BLA under the accelerated approval program.
European Commission granted Orphan Drug designation in May 2023, building upon the U.S. Orphan Drug designation granted by the FDA in 2020 and the CE marking issued by the European Union in 2018 to INOVIO’s delivery device, CELLECTRA.
INOVIO has accelerated its commercialization strategy to support a product launch in 2025 if regulatory approval is obtained on the anticipated timeline.
Plans underway include strategies for product distribution and logistics, payor engagement and reimbursement, specialty pharmacy identification, customer service programs, field force design, and other sales and marketing activities.
Continuing to deepen its market understanding of RRP as a disease, including patient and healthcare provider needs.
INO-3112 – Oropharyngeal Squamous Cell Carcinoma (OPSCC)
In January 2024, INOVIO announced a clinical collaboration and supply agreement with Coherus BioSciences, Inc. to evaluate the combination of INO-3112 and LOQTORZI as a potential treatment for patients with locoregionally advanced, high-risk, HPV-16/18 positive oropharyngeal squamous cell carcinoma (OPSCC), a type of head and neck cancer commonly known as throat cancer.

Under the terms of the agreement, Coherus will provide LOQTORZI for a planned clinical trial at no cost to INOVIO.
LOQTORZI is a PD-1 inhibitor recently approved by the FDA for the treatment of recurrent locally advanced/metastatic nasopharyngeal carcinoma.
INO-3112 is a DNA medicine candidate targeting HPV-16/18 combined with a DNA plasmid for IL-12 as an immune activator.
INOVIO has submitted the proposed design of a Phase 3 trial to the FDA with the intent to evaluate the clinical benefit of INO-3112 in combination with a PD-1 inhibitor. Feedback on the clinical development plan is expected in the second quarter of 2024. If cleared to proceed by the FDA, the trial will investigate if LOQTORZI can help boost the tumor-infiltrating abilities of the antigen-specific T cells generated by INO-3112.
INO-4201 – Ebola Booster for rVSV-ZEBOV (Ervebo)
INOVIO announced results from a Phase 1b clinical trial in healthy adult participants who previously received a single injection of Ervebo. In the trial, INO-4201 was well tolerated and boosted humoral responses in 100% (36 of 36) of treated participants. INOVIO believes these data indicate that DNA medicines could be an important part of global medical countermeasures against infectious diseases, either as primary vaccines or boosters to existing vaccines. The FDA has provided feedback on a potential development pathway to licensure and INOVIO expects to finalize these plans and discuss with collaborators and potential partners in the first half of 2024.

INO-5401 – Glioblastoma (GBM)
INOVIO is finalizing its clinical study report from a Phase 1/2 trial of INO-5401 and INO-9012 in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in newly diagnosed GBM patients. The data from this trial showed encouraging median overall survival results from 52 patients and evidence of antigen-specific T cells that may infiltrate GBM tumors. Through 2023, patients involved in the trial continued to receive drug. In the first half of 2024, INOVIO expects to finalize next steps for further development of INO-5401 in conjunction with Regeneron and investigators.

Fourth Quarter and Full Year 2023 Financial Results

Cash, Cash Equivalents and Short-term Investments: As of December 31, 2023, cash, cash equivalents and short-term investments were $145.3 million compared to $253.0 million as of December 31, 2022.

Revenues: Total revenue was $103,000 and $832,000 for the quarter and year ended December 31, 2023, respectively, compared to $125,000 and $10.3 million for the same periods in 2022, respectively. The revenue generated in 2022 was associated with a Procurement Contract with the U.S. Department of Defense for INOVIO’s devices and accessories to be used for delivery of its COVID-19 vaccine candidate, INO-4800, which the company has discontinued.

Research and Development (R&D) Expenses: R&D expenses for the quarter and year ended December 31, 2023 were $17.3 million and $86.7 million, respectively, compared to $42.1 million and $187.7 million, respectively, for the same periods in 2022. The decrease in R&D expenses was primarily the result of lower drug manufacturing, clinical trial expenses, outside services and expensed inventory related to INO-4800 and other COVID-19 studies and lower employee and consultant compensation, including stock-based compensation, among other variances.

General and Administrative (G&A) Expenses: G&A expenses were $10.2 million and $47.6 million, respectively, for the quarter and year ended December 31, 2023, versus $14.0 million and $90.2 million, respectively, for the same periods in 2022. The decrease in G&A expenses was primarily due to significant costs incurred in the second quarter of 2022 related to the settlement of class action litigation and related legal expenses, severance expenses incurred in 2022 and lower employee and consultant compensation in 2023, including stock-based compensation, among other variances.

Total Operating Expenses: Total operating expenses were $27.5 million and $144.8 million for the quarter and year ended December 31, 2023, respectively, compared to $56.1 million and $277.8 million for the same period in 2022. During the third quarter of 2023, the company recognized a non-cash goodwill impairment charge of $10.5 million.

Reverse Stock Split: INOVIO effected a reverse stock split of its outstanding shares of common stock on January 24, 2024, as a result of which every twelve shares of its common stock issued and outstanding was combined into one share of common stock. Any fractional post-split shares as a result of the reverse split were eliminated and redeemed in cash. Outstanding share amounts and per share amounts included in this press release have been restated to reflect the reverse stock split on a retroactive basis for all periods presented.

Net Loss: INOVIO’s net loss for the quarter and year ended December 31, 2023 was $25.0 million, or $1.10 per basic and diluted share, and $135.1 million, or $6.09 per basic and diluted share, respectively, compared to net loss of $54.5 million, or $2.61 per basic and diluted share, and $279.8 million, or $14.07 per basic and diluted share, for the quarter and year-ended December 31, 2022, respectively.

Shares Outstanding: As of December 31, 2023, INOVIO had 22.8 million common shares outstanding and 24.5 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting, and conversion, as applicable, of its outstanding options, restricted stock units, convertible preferred stock, and convertible debt.
INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s annual report on Form 10-K for the year ended December 31, 2023, which can be accessed at: View Source

Cash Guidance
INOVIO estimates its cash runway to extend into the second quarter of 2025. This projection includes an operational net cash burn estimate of approximately $26 million for the first quarter of 2024. This amount excludes the repayment of $17 million in remaining principal and accrued interest on convertible senior notes that matured on March 1, 2024. Including the repayment, the total net cash burn for the first quarter of 2024 is expected to be approximately $43 million. These cash runway projections do not include any funds that may be raised through the company’s existing at-the-market program or other capital-raising activities.

Conference Call / Webcast Information
INOVIO’s management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO’s financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

On March 6, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported the first patient was dosed in its Phase 1/2 multicenter trial (NCT06088654), investigating the safety and tolerability of IPH6501 in patients with Relapsed and/or Refractory CD20-expressing B-cell Non-Hodgkin’s Lymphoma (NHL) (Press release, Innate Pharma, MAR 6, 2024, View Source [SID1234640857]).

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IPH6501 is Innate’s first-in-class CD20-targeting tetraspecific ANKET (Antibody-based NK cell Engager Therapeutics) that co-engages CD20 as a target antigen on malignant B cells and three receptors on NK cells: two activating receptors (NKp46 and CD16) and the interleukin-2 receptor (but not its alpha subunit), with a human IL‑2 variant, hence providing proliferation and activation signals targeted to NK cells and promoting their cytotoxic activity against CD20 expressing malignant cells. The study is planned to enroll up to 184 patients.

"We are pleased to announce the dosing of a first patient in this Phase 1/2 study evaluating IPH6501, our proprietary ANKET asset and the first tetraspecific NK Cell Engager to enter the clinic." commented Dr Sonia Quaratino, Chief Medical Officer at Innate Pharma. "With the addition of the IL-2 variant, our second generation ANKET molecules can deliver proliferation signals to NK cells, and thus enhance their effector functions against cancer cells. Thanks to this novel format, IPH6501 represents a promising alternative strategy to T cell therapies for patients with B-cell non-Hodgkin’s lymphomas."

"The discovery and implementation of novel chemotherapies, T-cell based immunotherapies and targeted therapies have improved outcomes for patients with B-cell non-Hodgkin’s lymphomas compared with traditional chemotherapy." added Dr Lorenzo Falchi, Lymphoma Specialist at the Memorial Sloan Kettering Cancer Center, New-York, and principal investigator of the study. "However, many patients fail to achieve a response to or develop disease relapse after treatment. In this context, IPH6501 represents an innovative option for the treatment of patients with R/R B-cell non-Hodgkin’s lymphomas and has the potential to fulfil a large unmet need."

More information about the trial can be found on clinicaltrials.gov.

About B-Cell Non-Hodgkin’s Lymphoma
B-cell lymphomas are clonal tumors of mature and immature B cells that constitute the majority (80-85%) of NHLs. NHLs are a heterogeneous group of lymphoproliferative malignancies. NHL usually originates in the lymphoid tissues and can spread to other organs. NHL is the most common hematological malignancy worldwide, accounting for nearly 3% of cancer diagnoses and deaths.
According to the latest World Health Organization (WHO) classification, the most common B-NHL in Western countries is Diffuse large B cell lymphoma (DLBCL), accounting for around 31% of adult cases. Other common aggressive B-cell subtypes include Mantle Cell Lymphoma (MCL) (6% of cases) and Burkitt lymphoma (BL) (2% of cases). Among indolent B-cell NHL, Follicular Lymphoma (FL) accounts for 22% of cases in the Western world, followed by marginal zone lymphoma (MZL) (8% of cases).

About IPH6501
IPH6501 is the first Antibody-based NK cell Engager Therapeutic to co-engage activating receptors on NK cells (NKp46 and CD16), IL-2R (but not subunit) through a variant of human IL-2, and a tumor antigen (CD20) via a single molecule, hence providing proliferation and activation signals targeted to NK cells and promoting their cytotoxic activity against CD20 expressing malignant cells. IPH6501 has shown better anti-tumor efficacy than approved benchmark antibodies in preclinical tumor models (Demaria, EHA (Free EHA Whitepaper) 2023).

About ANKET
ANKET (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multispecific natural killer (NK) cell engagers to treat certain types of cancer. This fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

On March 6, 2024 Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs) reported that it will be presenting first efficacy data on its Phase I clinical trial with ATAC candidate HDP-101 as well as preclinical data on other drug candidates from its proprietary ADC technology platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held in San Diego, California on the 5 – 10 April 2024 (Press release, Heidelberg Pharma, MAR 6, 2024, View Source [SID1234640855]).

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Details of the conference and poster presentations are as follow:

Late Breaking Research: Poster: Multimeric linker-exatecan-based ADC targeting Guanylyl cyclase C (GCC) as novel therapeutic modality for treatment of colorectal cancer

Abstract number:

LB059, Section 53

Session:

Late-Breaking Research: Experimental and Molecular Therapeutics 1

Presentation time:

7 April 2024, 1:30 pm – 5:00 pm PDT

Speaker:

Dr. Sarah-Jane Neuberth

Link to abstract:

Late-breaking abstracts are available on 5 April 2024.

Clinical Trials 1: Poster: The anti-BCMA antibody-drug conjugate HDP-101 with a novel amanitin payload shows promising initial first in human results in relapsed multiple myeloma

Abstract number:

CT067, Section 48

Session:

Phase I Clinical Trials 1

Presentation time:

8 April 2024, 9:00 am – 12:30 pm PDT

Speaker:

Dr. András Strassz

Link to abstract:

Clinical-trials abstracts are available on 5 April 2024.

Poster: HDP-102 – a CD37-targeting Amanitin-based-ADC for the treatment of NHL – non-clinical data package

Abstract number:

1865, Section 22

Session:

Antibody-Based Technologies and New Inhibitors

Presentation time:

8 April 2024, 9:00 am – 12:30 pm PDT

Speaker:

Dr. Sarah-Jane Neuberth

Link to abstract:

View Source!/20272/presentation/8116

The poster presentation details preclinical data on ATAC candidate HDP-102, an Amanitin-based-ADC that is directed against the target molecule CD37. CD37 is found exclusively on immune cells, primarily B cells, and is overexpressed in malignant B-cell diseases such as Non-Hodgkin’s lymphoma (NHL).

HDP-102 has demonstrated excellent anti-tumor efficacy in in-Vivo-studies after a single administration and initial preclinical studies display good tolerability, indicating HDP-102 as a potential new treatment option for patients with NHL.

Poster: Liver toxicity of Amanitin-based Antibody drug conjugates (ATACs) is caused by unspecific uptake of the ATAC into liver cells

Abstract number:

7183, Section 24

Session:

Pharmacology and Pharmacogenetics

Presentation time:

10 April 2024, 9:00 am – 12:30 pm PDT

Speaker:

Dr. Christian Orlik

Link to abstract:

View Source!/20272/presentation/8047

The use of antibody-drug conjugates (ADCs), which combine high efficacy of cytotoxins with the specificity of antibodies, is still often limited by side effects. These include the binding of the ADCs independently of the target antigen (off-target toxicity mechanisms), which is responsible, for example, for the premature release of the transported cytotoxins.

The study details, the off-target toxicity mechanisms of ADCs that use amatoxins (RNA polymerase II inhibitors) as payload, so-called ATACs, were deciphered. The data reveals that liver toxicity is caused by non-specific uptake of the ATACs into liver cells. The substitution of two amino acids of the antibody (LALA mutation) that are responsible for the unspecific binding of the ATAC reduces the off-target toxicity. This significantly increases the tolerability of ATACs while leaving the antitumor efficacy unaffected, resulting in an improved therapeutic window of ATACs.

On March 6, 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 that its research collaborators will present at the upcoming 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 5-10, 2024 in San Diego, California (Press release, Genprex, MAR 6, 2024, View Source [SID1234640854]). The collaborators will present positive preclinical data from studies of its lead product candidate, Reqorsa Immunogene Therapy (quaratusugene ozeplasmid), as well as NPRL2 gene therapy, which both utilize the Company’s non-viral Oncoprex Delivery System for the treatment of lung cancer.

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"We are delighted to have our academic partners present this compelling body of preclinical evidence that support the therapeutic use of REQORSA to deliver the functioning TUSC2 gene to cancer cells. The data also highlights the potential use of our non-viral ONCOPREX Delivery System to deliver other tumor suppressor genes, such as the NPRL2 gene," said Rodney Varner, Chairman, President and Chief Executive Officer at Genprex. "We are pleased to have favorable results from three preclinical studies presented to an audience of global oncology specialists, providing further validation of the value of REQORSA and ONCOPREX in the fight against cancer."

Featured Genprex-supported posters to be presented at AACR (Free AACR Whitepaper) 2024 include:

Title: "Quaratusugene ozeplasmid mediated TUSC2 upregulation in EML4-ALK bearing Non-Small Cell Lung Carcinoma can induce cellular apoptosis"

Session Category: Molecular/Cellular Biology and Genetics

Session Title: Apoptosis and Ferroptosis

Session Date and Time: Sunday, April 7 from 1:30 pm – 5:00 p.m. PT

Location: Poster Section 15

Poster Board Number: 7

Abstract Presentation Number: 351

Anaplastic Lymphoma Kinase (ALK) is a strong oncogenic driver in non-small cell lung carcinoma (NSCLC) and contributes to ~5% of NSCLC as a distinct clinicopathological subset.

In this nonclinical study TUSC2 expression in three ALK+ cell lines were evaluated before and after exposure to REQORSA, referred to as TUSC2 gene therapy in the abstract, and to a TUSC2-containing plasmid. Researchers at the University of Michigan Rogel Cancer Center Judith Tam ALK NSCLC research initiative found that overexpressing TUSC2 via REQORSA treatment in ALK+ lung cancer cell lines had the ability to inhibit colony formation by 50%, which indicates that REQORSA inhibits growth of ALK+ lines. Additionally, researchers documented a strong pro-apoptotic response to TUSC2 expression in ALK+ NSCLC. The study found that the use of REQORSA or a TUSC2-containing plasmid to overexpress TUSC2 in ALK+ NSCLC cell lines was effective in decreasing cell growth and proliferation.

Researchers believe the results support further clinical study of REQORSA as an anti-ALK NSCLC treatment strategy.

Title: "Tumor Suppressor Gene TUSC2 suppresses energy metabolism in lung cancer cells with opposite effects in normal bronchial epithelial cells"

Session Category: Experimental and Molecular Therapeutics

Session Title: Cancer Biology and Metastasis

Session Date and Time: Monday, April 8 from 1:30 p.m. – 5:00 p.m. PT

Location: Poster Section 22

Poster Board Number: 6

Abstract Presentation Number: 3158

TUSC2 is a tumor suppressor gene often deleted in lung cancers and reduced TUSC2 expression is observed in approximately 80% of lung cancers. TUSC2 is also reduced in mesothelioma, breast, head-and neck, osteosarcoma, glioblastoma, and other cancers, which suggests the important anti-tumor role of TUSC2. Additionally, TUSC2 is known to play a critical role in mitochondrial respiration/energy metabolism as TUSC2 protein localizes to the mitochondria.

Here, researchers investigated how human lung cancer cell lines A549 and H358, with decreased TUSC2 expression, alter their energy metabolism when TUSC2 protein is re-introduced. The study found that the TUSC2-deficient cancer cells consistently exhibited decreased glycolytic rates and mitochondrial ATP production. This is significant as it left these cells without enough energy to support their vital functions. By comparison, when Beas2B, a normal human bronchial epithelial cell line with normal levels of TUSC2, was transfected with a TUSC2 containing plasmid, the glycolytic rate and mitochondrial metabolism was increased, which suggests that this may be the mechanism by which REQORSA treatment affects immune and other non-cancerous cells that leads to increased immune response against tumors.

The study further suggested that REQORSA may play an important role as a cancer treatment to target and disrupt the metabolism of cancer cells, leading to a decrease in the rate of glycolysis.

Genprex currently has three clinical trials evaluating REQORSA in lung cancer. All three clinical trials have received U.S. Food and Drug Administration (FDA) Fast Track Designation. The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Tagrisso (osimertinib) in patients with late-stage NSCLC with activating epidermal growth factor receptor (EGFR) mutations whose disease progressed after treatment with Tagrisso. Genprex completed the Phase 1 dose escalation portion of the trial and has already dosed the first patient in the Phase 2a expansion portion of the trial. The Acclaim-2 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Keytruda (pembrolizumab) in patients with late-stage NSCLC whose disease progressed after treatment with Keytruda. The Acclaim-3 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Tecentriq (atezolizumab) as maintenance therapy in patients with extensive-stage small-cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as an initial treatment. The Acclaim-3 clinical trial also has FDA Orphan Drug Designation.

Title: "Mechanism of NPRL2 gene therapy induced anti-tumor immunity in KRAS/STK11mt aPD1 resistant metastatic NSCLC"

Session Category: Immunology

Session Title: Inflammation, Host Factors, and Epigenetic Influences on Cancer Development and Treatment

Session Date and Time: Monday, April 8 from 9:00 a.m.– 12:30 p.m. PT

Location: Poster Section 5

Poster Board Number: 18

Abstract Presentation Number: 1420

Among other cancer types, NSCLC often has reduced NPRL2, a tumor suppressor gene, and the restoration of NPRL2 activates cell cycle arrest and apoptosis.

In this humanized mouse model, researchers investigated the anti-tumor immune responses to NPRL2 gene therapy in pembrolizumab resistant KRAS/STK11mt NSCLC. In the study, induced lung metastases in humanized mice were treated through I.V. injection of NPRL2 nanoparticles, made with the ONCOPREX Delivery System, with or without pembrolizumab. The study found that the NPRL2 treatment decreased lung metastases but pembrolizumab had no effect. Additionally, a greater anti-tumor effect was seen in humanized compared to non-humanized mice, demonstrating that immune cells play a role in the effects of the NPRL2 nanoparticle therapy.

Study findings suggest that NPRL2 gene therapy induces anti-tumor activity against KRAS/STK11mt tumors through dendritic cell-mediated antigen presentation and cytotoxic immune cell activation.

Genprex Commentary:

"Today’s bolus of compelling data validates the potential of REQORSA and the ONCOPREX Delivery System as innovative cancer treatments. We were very encouraged to see the data document REQORSA’s anti-tumor properties and demonstrate its ability to suppress cell growth and trigger cancer cell death," said Mark Berger, MD, Chief Medical Officer at Genprex. "These data are particularly significant as decreased TUSC2 expression is seen in approximately 80% of lung cancers, and REQORSA has the potential to address a large patient population. Additionally, data showing NPRL2 gene therapy induced anti-tumor activity further positions Genprex to expand its clinical pipeline with another drug candidate, and it reinforces the value of ONCOPREX’s ability to deliver genes beyond TUSC2. We look forward to continuing to evaluate the ONCOPREX Delivery System using both REQORSA and NPRL2 as potential treatments for lung cancer."

On March 6, 2024 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, reported that data on its novel OncoMimics approach to cancer immunotherapy will be presented in a poster at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 5-10 in San Diego, California (Press release, Enterome, MAR 6, 2024, View Source [SID1234640853]). The poster will be presented by Dr. Vincent Panneton, Postdoctoral Associate in Pharmacology at the Ludwig Collaborative Laboratory led by Dr. Taha Merghoub and Dr. Jedd Wolchok at Weill Cornell Medicine.

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Research conducted by Weill Cornell Medicine and Enterome shows that in animal models microbiome-derived antigenic peptides (OncoMimics peptides), selected for their mimicry of tumor-associated antigens (TAAs) and neoantigens, effectively trigger cytotoxic T-cell immune responses. Through tumor challenge experiments with OncoMimics and checkpoint inhibitors, the researchers have also identified key parameters that enable them to predict the cross-reactive potential of OncoMimics peptides and facilitate the development of novel cancer immunotherapies.

"We are pleased to announce the presentation of these promising preclinical data which provide novel insights into the design of OncoMimics peptides for both neoantigens and tumor-associated antigens. These results serve as an early validation of our approach to novel cancer immunotherapies," said Laurent Chêne, Head of Drug Discovery at Enterome.

Poster presentation details – Abstract 4090

Title: "Gut Microbiota Mimics as a Source of Cross-Reactive Tumor Rejection Antigens"

Presenting Author: Vincent Panneton, Ph.D., Postdoctoral Associate Weill Cornell Medicine

Session date: Tuesday Apr 9th, 2024 9 AM – 12:30

Location : Poster section 5, board number 1

The abstract will be published in an online supplement to Cancer Research, the official journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), on March 22nd, and the poster will be available on Enterome’s website after the AACR (Free AACR Whitepaper) Meeting.

About OncoMimics

OncoMimics immunotherapies are designed to activate pre-existing effector memory T cells that target bacterial (non-self) peptides, which are strongly cross-reactive against selected Tumor-Associated Antigens (TAAs), or B cell markers expressed on tumoral cells, resulting in a rapid, targeted cytotoxic response against cancer.