On April 1, 2025 Vivesto AB, an oncology-focused development company, reported that positive preclinical efficacy data was obtained in an animal model of hematological cancer (Press release, Vivesto, APR 1, 2025, View Source [SID1234651725]). The results support continued development of the candidate drug Cantrixil within this indication and are in line with previous positive preclinical data.

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The experimental trial demonstrates, for the first time, that Cantrixil can reduce tumor growth and increase survival times in a well-established mouse model of hematological cancer. The treatment was well tolerated and safe.

"This is a significant milestone for the Cantrixil program. Obtaining positive efficacy data in vivo is not only important from a regulatory perspective, but it is also imperative in the development path towards showing potential benefits of Cantrixil in hematological cancer also in patients. Importantly, the treatment was also well tolerated. With these new results we are increasingly confident that Cantrixil can make a significant impact to patients and as well as build shareholder value," said Erik Kinnman, CEO of Vivesto.

With the new positive data, Vivesto is continuing the planning of activities needed to bring Cantrixil into clinical trials and in parallel will investigate opportunities to partner the project in order to optimize the development program.

On April 1, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported financial results for fiscal year 2024 and provided a corporate update (Press release, TuHURA Biosciences, APR 1, 2025, View Source [SID1234651724]).

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"2024 was a transformative year for TuHURA. We became a NASDAQ-listed Company, raised capital to meet FDA’s manufacturing requirements to initiate our Phase 3 program anticipated for Q2 as forecasted and entered into a definitive agreement for, what we believe, is a best-in-class VISTA inhibiting antibody adding a Phase 2 program in AML to our development pipeline," commented James Bianco, President and CEO of TuHURA. "As we advance our late stage clinical programs in 2025 with the goal of completing enrollment in our Phase 3 trial next year, we are also making significant progress in the development of the first novel class of non-tumor targeting Antibody Drug or Antibody Peptide Conjugates that are demonstrating the potential ability to remove the immunosuppressive functions of key cellular populations that create an immunologic sanctuary for tumors leading to acquired resistance to cancer immunotherapies."

2024 Highlights

Successful SPA agreement with FDA
Single Phase 3 Accelerated Approval Trial1
Trial incorporates a key secondary endpoint (PFS) which, if achieved, may satisfy post approval confirmatory trial requirement
Entered into definitive agreement with Kineta Inc. to acquire Phase 2 ready VISTA inhibitor; Transaction targeted to close in Q2 2025
NASDAQ (HURA) listing via successful reverse merger with Kintara Therapeutics, Inc.
Raised $36 million in 2024 to fund development programs and operations through late fourth quarter of 2025 and secure right to acquire VISTA inhibiting antibody
Advancing Novel Technologies to Overcome Resistance to Cancer Immunotherapy

Innate Immune Agonists: TuHURA’s IFx technology utilizes a proprietary plasmid DNA or messenger RNA ("mRNA") which, when introduced into or targeted to a tumor, results in the expression of a highly immunogenic gram-positive, bacterial protein (Emm55) on the surface of the tumor cell, making the tumor look like a bacterium. Gram-positive bacterium has molecular patterns, or motifs, preserved over evolution which are recognized by receptors on our immune cells called "toll like receptors" (TLR). TLR 2 specifically recognizes the pattern of gram-positive bacterial proteins, like Emm55, leading to the activation of antigen presenting cells (APCs). Once activated, APCs digest the tumor cell and present non-self, tumor neoantigens to newly produced T and B cells, activating a tumor-specific adaptive immune response. Through its activation of tumor-specific T cells, IFx-2.0 administration can potentially overcome primary resistance to checkpoint inhibitors.

TuHURA is preparing to initiate a single, randomized, placebo-controlled Phase 3 accelerated approval trial of IFx-2.0 administered as an adjunctive therapy to Keytruda (pembrolizumab) versus pembrolizumab plus placebo in first line treatment for checkpoint inhibitor-naïve patients with advanced or metastatic MCC. The data from the Company’s Phase 1b trial in patients with advanced or metastatic MCC who exhibited primary resistance to CPI was used to support a potential single registration directed trial. Consistent with the FDA’s Project Front Runner Initiative, the FDA’s Oncology Center of Excellence (OCE) recommended investigating IFx-2.0 in the first line setting rather than in patients progressing on first line therapy.

Project Front Runner is an FDA OCE initiative to encourage drug sponsors to consider when it may be appropriate to first develop and seek approval of new cancer drugs for advanced or metastatic disease, in an earlier clinical setting rather than the usual approach to develop and seek approval of a new drug for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options.

The FDA also requested the Company to consider designing the trial to include a key secondary endpoint shown to be of clinical benefit like PFS allowing this accelerated approval trial to potentially satisfy both the requirements for accelerated approval based on ORR, while satisfying the requirement for a post-approval confirmatory trial if the secondary PFS endpoint is achieved. The trial will be conducted under an SPA agreement with the FDA.

Tumor Microenvironment Modulators: Leveraging its delta opioid receptor technology, TuHURA is developing the first class of non-tumor targeting bi-specific immune modulating Antibody Drug Conjugates or Antibody Peptide Conjugates targeting MDSCs to inhibit their immune suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.

Potential Acquisition of Novel Anti-VISTA Checkpoint Inhibitor: As previously announced, the Company entered into a definitive merger agreement in which TuHURA would acquire Kineta, Inc. (OTC Pink: KATN) including the rights to Kineta’s novel KVA12123 antibody, for a combination of cash and shares of TuHURA common stock via a merger transaction. The merger is currently targeted to close in Q2 2025 pending the satisfaction of funding conditions and other closing conditions.

2025 Milestone Targets

IFx-2.0
Q2: FDA complete response letter lifting partial clinical hold
Q2: Initiating enrollment in IFx-2.0 Phase 3 accelerated approval trial
Q3: Initiate checkpoint inhibitor resistant metastatic cancer "basket" trial
IFx-3.0
Q4: Advance characterization toward lead compound selection
VISTA Inhibiting mAb
Q2: Target closing of Kineta acquisition
Q2: Phase 1 VISTA inhibitor +/- pembrolizumab results
Q4: Initiate Phase 2 trial VISTA trial in NPM1 mutated AML
Novel bi-specific non-tumor targeting immune modulating Antibody Drug or Antibody Peptide Conjugates
Advance delta opioid receptor technology platform
Presentations at key scientific meetings
Summary of Financial Results for the Full Year 2024

Research and development (R&D) expense was $13.3 million and $9.4 million for the years ended December 31, 2024 and 2023, respectively. The increase in R&D of $3.9 million is mainly related to:

an increase of approximately $1.6 million due to ongoing clinical development of IFx-2.0;
an increase of approximately $0.4 million due to preclinical research of IFx-3.0 and MDSCs; and
an increase of approximately $1.9 million in salary and personnel related costs.
General and administrative (G&A) expenses were $4.3 million and $4.1 million for the years ended December 31, 2024 and 2023, respectively. The increase in G&A of $0.2 million was mainly attributable to increases in non-cash stock compensation expense and costs associated with being a public company incurred in 2024 offset by decrease in legal fees associated with the subsequently terminated proposed merger with CohBar, Inc. which were incurred in 2023.

On April 1, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported 11 oral and poster presentations will be featured at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, held from April 25 – 30, 2025 (Press release, Revolution Medicines, APR 1, 2025, View Source [SID1234651723]).

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The first clinical data in non-small cell lung cancer from the Phase 1 study of zoldonrasib, a RAS(ON) G12D-selective inhibitor, will be featured in a late breaking oral presentation.

Details of the abstracts are listed below:

Revolution Medicines Oral Presentations:

Title: Preliminary safety and antitumor activity of zoldonrasib (RMC-9805), an oral, RAS(ON) G12D-selective, tri-complex inhibitor in patients with KRAS G12D non-small cell lung cancer (NSCLC) from a Phase 1 study in advanced solid tumors
Presenter: Kathryn Arbour, M.D., Memorial Sloan Kettering Cancer Center
Abstract Number: CT019
Session: New Frontiers in Precision Oncology
Date/Time: April 27; 5:00 p.m. – 5:15 p.m. CST

Title: Discovery of RMC-5127, an oral, RAS(ON) G12V-selective, noncovalent, tri-complex inhibitor
Presenter: Anne Edwards, Ph.D.
Abstract Number: ND06
Session: New Drugs on the Horizon: Part 2
Date/Time: April 27; 3:25 p.m. – 3:40 p.m. CST

Revolution Medicines Poster Presentations:

Title: Early reduction in circulating tumor DNA (ctDNA) is associated with clinical activity of daraxonrasib (RMC-6236) in RAS mutant non-small cell lung cancer (NSCLC)
Presenter: Jia Luo, M.D., Dana-Farber Cancer Institute
Abstract Number: LB218
Session: Late-Breaking Research: Clinical Research 1
Date/Time: April 28; 2:00 p.m. – 5:00 p.m. CST

Title: Mechanisms of resistance to the RAS(ON) multi-selective inhibitor daraxonrasib (RMC-6236) in RAS mutant PDAC and potential resolution with RAS(ON) combination therapies
Presenter: Mallika Singh, Ph.D.
Abstract Number: LB281
Session: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Date/Time: April 29; 9:00 a.m. – 12:00 p.m. CST

Title: Combination of RAS(ON) mutant-selective and multi-selective inhibitors sensitizes immune-refractory, RAS-driven preclinical models to immunotherapy
Presenter: Mariela Moreno Ayala, Ph.D.
Abstract Number: 6046
Session: Adaptive Immunity in Tumors / Oncogenic Pathway-Mediated Regulation of Inflammation and Tumor Immunity
Date/Time: April 29; 2:00 p.m. – 5:00 p.m. CST

Collaborator Presentations

Title: Distinct regulation of Cyclin D mediates heterogenous response to RAS inhibition in colorectal cancer models
Presenter: Philip Choi, M.D., Ph.D., Memorial Sloan Kettering Cancer Center
Abstract Number: LB293
Session: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Date/Time: April 29; 9:00 a.m. – 12:00 p.m. CST

Title: Combining RAS(ON) G12C-selective and RAS(ON) multi-selective inhibitors overcomes sotorasib resistance driven by KRAS G12C amplification or NRAS G13R mutation
Presenter: Hitendra Singh Solanki, Ph.D., Moffitt Cancer Center
Abstract Number: 5512
Session: Drug Resistance in Molecular Targeted Therapies 3
Date/Time: April 29; 2:00 p.m. – 5:00 p.m. CST

Title: A RAS(ON) multi-selective inhibitor combination therapy triggers long-term tumor control through senescence-associated tumor-immune equilibrium in preclinical models of PDAC
Presenter: Caroline Broderick, Ph.D., Memorial Sloan Kettering Cancer Center
Abstract Number: 5336
Session: CDK Inhibitors
Date/Time: April 29; 2:00 p.m. – 5:00 p.m. CST

Title: Preclinical evaluation of RMC-7977, a multi-selective RAS(ON) inhibitor, as a therapeutic strategy for KRAS-mutant cholangiocarcinoma
Presenter: Jingjing Jiang, Ph.D.
Abstract Number: 5691
Session: Oncogenes, Tumor Suppressor Genes, and Gene Products as Targets for Therapy 2
Date/Time: April 29; 2:00 p.m. – 5:00 p.m. CST

Title: Mechanisms of resistance to RAS-GTP inhibition in pancreatic cancer
Presenter: Joshua H. Choe, Dana-Farber Cancer Institute
Abstract Number: 5507
Session: Drug Resistance in Molecular Targeted Therapies 3
Date/Time: April 29; 2:00 p.m. – 5:00 p.m. CST

Title: T-cell dependency of tumor regressions and complete responses with RAS(ON) multi-selective inhibition in preclinical models of PDAC
Presenter: Margo I. Orlen, Penn Medicine
Abstract Number: 6405
Session: Checkpoints and Modulators of Tumor Microenvironment
Date/Time: April 29; 3:25 p.m. – 3:40 p.m. CST

On April 1, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported that the Company’s CEO, Gil Efron will participate in a panel discussion at the Canaccord Genuity Horizons in Oncology Virtual Conference on Monday, April 7, 2025 (Press release, Purple Biotech, APR 1, 2025, View Source [SID1234651722]). The panel titled "New Radiotherapy and Targeted Therapy Approaches" will take place from 2:00 PM to 2:50 PM ET. Management will also participate in 1×1 meetings.

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On April 1, 2025 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies, including gene elimination, gene insertion, and gene excision programs, reported that management will present at the 24th Annual Needham Virtual Healthcare Conference taking place on April 7, 2025 (Press release, Precision Biosciences, APR 1, 2025, View Source [SID1234651721]).

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Presentation Details:

Date: Monday, April 7, 2025
Time: 3:00 PM ET in Track 2
Format: Presentation
Webcast Registration: Link

A live webcast will also be accessible on Precision’s website in the Investors section under Events & Presentations at investor.precisionbiosciences.com. An archived replay of the webcasts will be available for approximately 30 days following the event.