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.

On March 6, 2024 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported financial results for the quarter and full-year ended December 31, 2023, and highlighted recent business achievements (Press release, Elevation Oncology, MAR 6, 2024, View Source;utm_medium=rss&utm_campaign=elevation-oncology-reports-fourth-quarter-and-full-year-2023-financial-results-and-highlights-recent-business-achievements [SID1234640852]).

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"We are entering 2024 with tremendous momentum across our pipeline of differentiated ADC therapies," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "We continue to advance EO-3021 and remain on-track to share an update from our Phase 1 clinical trial mid-year, as well as details on our combination strategy in the months ahead. In addition, we recently expanded our Phase 1 clinical trial into Japan, a geography with a particularly high prevalence of gastric cancer. This will allow us to potentially address a significant unmet need for new gastric cancer therapies outside of the U.S., while also enabling us to characterize the safety and efficacy profile of our anti-Claudin 18.2 agent in a diverse patient population."

"In parallel, we continue to advance our HER3-ADC program and look forward to sharing preclinical proof-of-concept data at AACR (Free AACR Whitepaper) next month, which highlight the promising therapeutic potential of our program and support our plans to nominate a development candidate later this year. We look forward to continuing our efforts to advance important therapies for patients with significant unmet medical needs."

Recent Business Achievements

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.

In February 2024, Elevation Oncology dosed the first patient in Japan in the ongoing Phase 1 clinical trial of EO-3021.
HER3-ADC: A HER3-targeting ADC for the treatment of patients with solid tumors that overexpress HER3.

In March 2024, Elevation Oncology announced plans to present preclinical proof of concept data from its HER3-targeting ADC program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 5-10, 2024, in San Diego, CA. The abstract includes proof-of-concept data from in vitro and in vivo studies, which highlight the therapeutic potential of Elevation Oncology’s HER3-ADC program across a range of HER3-expressing cancers.
Corporate:

Elevation Oncology recently announced the appointment of three new members to its Board of Directors.
Darcy Mootz., Ph.D. – Dr. Mootz is an experienced life sciences executive, who brings expertise across corporate strategy, corporate development, finance, and operations to the Board.
Julie M. Cherrington, Ph.D. – Dr. Cherrington is an experienced life sciences executive, who brings insights and extensive experience advancing novel product candidates into the clinic and through commercialization to the Board.
Alan Sandler, M.D. – Dr. Sandler is an accomplished leader in oncology and drug development, who brings experience leading clinical development and operations, regulatory affairs, drug safety and asset development strategy across industry and academia to the Board.
In March 2024, Elevation Oncology refinanced its debt facility with existing lender, K2 HealthVentures (K2HV). Under the refinanced debt facility, the interest-only payment period was extended from March 1, 2025, to June 1, 2026. Elevation Oncology issued a new common stock purchase warrant to an affiliate of K2HV, and certain terms relating to the lenders’ conversion election were amended.
Expected Upcoming Milestones:

EO-3021:

Share detail on planned Phase 1 combination study evaluating EO-3021 in the first half of 2024.
Provide update from ongoing Phase 1 clinical trial of EO-3021 in mid-2024, with additional data expected in the first half of 2025.
HER3-ADC:

Present preclinical proof-of-concept data on HER3-ADC program at the AACR (Free AACR Whitepaper) Annual Meeting in April 2024.
Nominate development candidate from HER3-ADC program in 2024.
Fourth Quarter and Full Year 2023 Financial Results

As of December 31, 2023, Elevation Oncology had cash, cash equivalents and marketable securities totaling $83.1 million, compared to $90.3 million as of December 31, 2022. The decrease in cash reflects cash used to fund operating activities, partially offset by net proceeds of approximately $46.5 million from Elevation Oncology’s underwritten public offering, which closed in June 2023. Subsequent to year-end, Elevation Oncology raised net proceeds of approximately $17.0 million through its at-the-market (ATM) facility.

Research and development (R&D) expenses for the fourth quarter of 2023 were $4.7 million, compared to $14.5 million for the fourth quarter of 2022. The decrease in R&D expenses in the fourth quarter of 2023 was primarily due to decreased clinical trial expenses associated with Elevation Oncology’s former lead program, partially offset by increased clinical trial expenses associated with the EO-3021 clinical trial. For the year ended December 31, 2023, R&D expenses were $25.4 million, compared to $78.7 million for the year ended December 31, 2022. The decrease was primarily due to the cost related to the license agreement between Elevation Oncology and a subsidiary of CSPC Pharmaceutical Group Limited for rights to develop and commercialize EO-3021, which was recorded in the third quarter of 2022, and decreased clinical trial expenses associated with Elevation Oncology’s former lead program, partially offset by increased clinical trial expenses associated with the EO-3021 clinical trial.

General and administrative (G&A) expenses for the fourth quarter of 2023 were $3.3 million, compared to $4.0 million for the fourth quarter of 2022. The decrease in G&A expenses in the fourth quarter of 2023 was primarily due to decreased administrative costs, including directors’ and officers’ insurance, and decreased personnel costs, including stock-based compensation. For the year ended December 31, 2023, G&A expenses were $14.9 million, compared to $15.8 million for the year ended December 31, 2022. The decrease was primarily related to a decrease in administrative costs, including directors’ and officers’ insurance.

Net loss for the fourth quarter of 2023 was $7.9 million, compared to $19.0 million for the fourth quarter of 2022.

Financial Outlook

Elevation Oncology expects its existing cash, cash equivalents and marketable securities as of December 31, 2023, together with the approximately $17.0 million in net proceeds raised under its ATM facility, to be sufficient to fund its current operations into the fourth quarter of 2025.