On March 13, 2025 OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, reported that it has been awarded a presentation slot at the MIB Agents Factor Osteosarcoma Conference to be held June 26-28, 2025 in Salt Lake City, Utah (Press release, OS Therapies, MAR 13, 2025, View Source [SID1234651143]). Key data will be presented from the Company’s Phase 2b clinical trial of OST-HER2 in the prevention of recurrent, fully resected, lung metastatic osteosarcoma. This data will be compared with a newly created regulatorily compliant synthetic control group comprised of case matched controls that will be used for the Company’s US Food & Drug Administration (FDA) OST-HER2 Biologics License Application (BLA) submission. Equivalent submissions with international regulatory authorities will be made in order to gain commercial marketing authorization. MIB Agents FACTOR is the most important annual osteosarcoma conference bringing together the leading osteosarcoma researchers, clinicians, patient families, osteosarcoma survivors, patients, and bereaved parents to "Make It Better" (MIB) for those battling this deadly cancer.

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The Company reiterates its intention to submit a BLA with FDA for OST-HER2 in osteosarcoma in the second quarter of 2025, positioning it to receive approval in the fourth quarter of 2025. OST-HER2 has received Rare & Pediatric Disease Designation (RPDD) from the FDA and Fast Track and Orphan Drug Designations from the FDA and European Medicines Agency (EMA). If OST-HER2’s BLA submission is approved by the FDA before September 30, 2026, the Company will be granted a Priority Review Voucher (PRV) that it will be able to sell to a third party. The most recent PRV transaction occurred last month when Zevra sold its PRV to an undisclosed third party for $150 million.

On March 13, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported financial results and business highlights for the fourth quarter and full-year ended December 31, 2024 (Press release, In8bio, MAR 13, 2025, View Source [SID1234651128]).

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William Ho, Chief Executive Officer and co-founder of IN8bio, commented, "In 2024, IN8bio made significant progress advancing its pipeline of gamma-delta T cell therapies and positioning the Company for long-term success. The INB-100 program continues to demonstrate 100% long term durable response rates as of January 17, 2025, reinforcing its potential to help treat and maintain remissions in high-risk AML patients." Mr. Ho continued, "We have also disclosed our novel INB-600 platform, which we believe has the potential to reshape the T cell engager landscape by potentially improving both the durability of response and safety compared to existing CD3 targeting TCE therapies. Throughout 2025, we remain focused on driving innovation, advancing our clinical programs and delivering value to patients and our stakeholders."

Key Highlights

Announced INB-600 Platform & INB-619, a Novel Preclinical Gamma-Delta TCE

Introduced INB-619, a proprietary next generation gamma-delta TCE targeting CD19 for potential use in oncology and autoimmune diseases (March 2025)
Demonstrated potent B-cell depletion and sustained gamma-delta T cell expansion in preclinical studies, offering commercial and scientific advantages by potentially improving durability and safety over existing CD3 targeting TCE therapies
Demonstrated Additional Clinical Progress with INB-100 (Allogeneic Gamma-Delta T Cell Therapy for AML & Leukemias) for High-Risk AML

Presented new Phase 1 data showing durable remissions with 100% of treated AML patients remaining relapse-free (February 2025)
Observed favorable safety profile with no cytokine release syndrome (CRS) or neurotoxicity (ICANs) reported to date
Presented expanded clinical data at 2025 Tandem Meetings reinforcing potential of INB-100 to significantly reduce post-transplant relapse in high-risk AML patients relative to historical real-world data
Presented Continued Durable Remissions in Phase 1 Trial of INB-200 (Autologous, Drug-Resistant Gamma-Delta T Cell Therapy for Glioblastoma)

Presented updated data in a plenary oral presentation at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting, showing the majority of patients exceeded their expected progression free survival based on age and tumor status
Highlighted potential long-term benefits of INB-200. As of October 18, 2024, five patients remained alive, three patients had returned to work, and one IDH-mutant, grade 4 glioma patient remained progression free for an impressive 40.5 months post treatment
Strategically Optimized Pipeline and Launched Operational Efficiency Initiatives

Paused enrollment in the Phase 2 INB-400 glioblastoma program – despite compelling data – to focus resources while exploring partnership and alternative funding opportunities
Implemented cost-saving measures to extend cash runway and prioritize pipeline development
Raised approximately $16.6 million in gross proceeds through various equity offerings, including through our at-the-market ("ATM") offering program and private placements, during 2024 through February 2025, extending the Company’s cash runway into March 2026
Upcoming Anticipated Pipeline Milestones and Important Events

INB-100: For the potential treatment of high-risk leukemias including AML

Accelerating patient enrollment in expansion cohort of ongoing Phase 1 clinical trial including the inclusion of an additional investigational center
Aim to complete enrollment into the expansion cohort in 2025. Guidance from the U.S. Food and Drug Administration (FDA) confirmed relapse-free survival (RFS) in AML patients as an acceptable primary endpoint for a potential pivotal randomized control trial
Expect to present updated clinical data in the second half of 2025
Advancing preparations for potential registrational Phase 2 trial with possible IND submission anticipated in 2026 based on receipt of additional funding
INB-200 and INB-400 (Autologous Gamma-Delta T Cell Therapy for Glioblastoma & Solid Tumors):

Continue to evaluate early clinical data for signs of efficacy and durability
Report additional findings at upcoming medical meetings in 2025
Seek additional funding sources to advance allogeneic product for glioblastoma and other solid tumors
INB-600 and INB-619 (Gamma-Delta T Cell Engager Targeting CD19 – Oncology & Autoimmune Diseases):

Present preclinical data evaluating potency, expansion potential, and safety profile at medical meetings in the second quarter of 2025
Plan to advance towards IND-enabling studies with additional funding to support future clinical development
Exploring partnership and collaboration options to accelerate development of the platform
Fourth Quarter and Full Year 2024 Financial Highlights

Research and Development (R&D) expenses: R&D expenses were $3.8 million for the three months ended December 31, 2024, compared with $4.5 million for the comparable prior year period. R&D expenses were $17.2 million for the year ended December 31, 2024, compared with $16.8 million in the prior year. The change was primarily due to increased clinical trial-related activities for the INB-100 and INB-400 programs and was partially offset by a decrease in personnel-related costs and facility-related and other expenses, in each case as a result of the Company’s pipeline prioritization announced in September 2024.
General and administrative (G&A) expenses: G&A expenses were $2.6 million for the three months ended December 31, 2024, compared with $3.1 million for the comparable prior year period. G&A expenses were $12.6 million for the year ended December 31, 2024, compared with $13.5 million in the prior year. The change was primarily due to cost savings related to director and officer insurance premiums, professional services, and personnel-related costs, partially offset by an increase in legal and consulting expenses.
Severance and related charges: Severance and related charges were $1.1 million for the year ended December 31, 2024, compared with zero in the prior year. These were one-time costs related to the September 2024 workforce reduction, including non-cash stock-based compensation expense and severance payments.
Net loss: The company reported a net loss of $6.4 million, or $0.08 per basic and diluted common share, for the three months ended December 31, 2024, compared with a net loss of $7.6 million, or $0.22 per basic and diluted common share, for the comparable prior year period. For the year ended December 31, 2024, net loss was $30.7 million, or $0.57 per basic and diluted common share, compared with a net loss of $30.0 million, or $1.00 per basic and diluted common share, for the prior year.
Cash position: As of December 31, 2024, the Company had cash of $11.1 million as of December 31, 2024, compared with $21.3 million as of December 31, 2023. Subsequently, in February 2025, the Company sold common stock under its ATM offering program and had Series C warrants exercised for aggregate net proceeds of $4.1 million.

On March 13, 2025 Exicure, Inc. (Nasdaq: XCUR) reported that the Australian Patent Office has issued Patent No. 2018388302, titled "GPCR Heteromer Inhibitors and Uses Thereof (Press release, Exicure, MAR 13, 2025, View Source [SID1234651144])." This patent covers the company’s innovative combination approach to cancer treatment, specifically targeting CXCR4 and GPCRx.

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The newly granted patent supports Exicure’s ongoing Phase 2 clinical trial (NCT05561751), which evaluates the combination of GPC-100 and propranolol in multiple myeloma patients. This method aims to improve hematopoietic stem cell mobilization by co-targeting CXCR4 and ADRB2, thereby enhancing the efficacy of CXCR4 inhibitors like GPC-100.

"This issuance reinforces the exclusivity of our lead clinical program," said Andy Yoo, CEO of Exicure, Inc. "By co-targeting CXCR4 and ADRB2, we can significantly enhance the potency of CXCR4 inhibitors like GPC-100. This opens new possibilities for these inhibitors to become more effective therapies, and our well-devised patent portfolio ensures strong intellectual property protection for this proprietary approach."

This patent family has already been granted in the United States, Japan, and Taiwan, with applications pending in other key jurisdictions.

On March 13, 2025 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported 2024 year-end financial results and provides a corporate update (Press release, Intensity Therapeutics, MAR 13, 2025, View Source [SID1234651129]).

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Corporate Update

INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the standard of care ("SOC") drugs in second and third line treatment for certain soft tissue sarcoma subtypes. The INVINCIBLE-3 Study is expected to enroll 333 patients and initiate sites in eight countries. This study has been authorized by the US FDA, Health Canada, the European Medicines Authority (for France, Germany, Italy, Poland and Spain), and Australia’s Therapeutics Goods Administration. The primary endpoint in the INVINCIBLE-3 Study is overall survival.

In July 2024, the Company initiated and dosed its first patient in the INVINCIBLE-3 Study. The trial is actively enrolling patients across the US, Canada, Europe and Australia. Up to 60 sarcoma-focused institutions are expected to participate from these regions. The Company has contracted 32 sites with 25 patients screened to date. The Company expects to complete enrollment in the first half of 2026.

INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC treatment in patients with early-stage, operable triple-negative breast cancer ("TNBC") and SOC alone. The primary endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. The INVINCIBLE-4 Study is expected to enroll approximately 54 patients in Switzerland and France.

In October 2024, in collaboration with The Swiss Group for Cancer Research SAKK ("SAKK"), the Company initiated and dosed its first patient in Switzerland in the INVINCIBLE-4 Study. To date, the Company has activated eight sites in Switzerland and treated several patients. The Company expects to activate additional sites in Switzerland and France in the first half of 2025 and complete enrollment by the end of the first quarter of 2026.

"In 2024, Intensity Therapeutics finalized both Phase 3 and Phase 2 protocols, engaged leading hospitals around the world, and obtained regulatory authorization to recruit patients in 9 countries to initiate treatment," stated Lewis H. Bender, Intensity Founder, President, and CEO. "Our programs were again selected for presentation at major sarcoma and breast cancer societies. Many of the best sarcoma treatment centers from the US, Canada, Europe and Australia are either participating now or in contract discussions. For our breast cancer trial, our partners at SAKK have recruited interest by the leading hospitals in Switzerland and France to participate. Physicians are screening patients at an increasing rate. We believe in the potential for our drug to have a positive impact on the lives of metastatic sarcoma and presurgical breast cancer patients around the world, who so desperately need improved alternatives to current therapies."

2024 Year End Financial Results

Research and development expenses were $10.5 million for the year ended December 31, 2024, compared to $4.8 million for the year ended December 31, 2023. The increase was primarily due to an increase of $5.6 million in the INVINCIBLE-3 Study in 2024, in which we enrolled our first patient in the third quarter of 2024, and to a lesser extent, an increase of $0.5 million in the INVINCIBLE-4 Study, in which we enrolled and dosed our first patient in the fourth quarter of 2024. These increases were partially offset by a decrease of $1.1 million in our IT-01 Study due to the completion of enrollment in this study in mid-2022 and the completion of study-related costs in 2023. Research and development also increased due to higher salary, benefits, and stock-based compensation.

General and administrative expenses were $6.1 million for the year ended December 31, 2024, compared to $3.5 million for the year ended December 31, 2023. The increase was primarily due to increased expenses related to salary, benefits and stock-based compensation, higher legal and consulting fees, and higher directors and officers insurance.

Overall, net loss was $16.3 million for the year ended December 31, 2024, compared to a net loss of $10.5 million for the year ended December 31, 2023.

As of December 31, 2024, cash and cash equivalents totaled $2.6 million.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression which often occurs with systemic chemotherapy.

On March 13, 2025 ImmunoPrecise Antibodies Ltd. (IPA) (NASDAQ: IPA) reported a strategic partnership with a leading biotechnology company with a multi-billion-dollar market capitalization to advance the discovery and development of Antibody-Drug Conjugates (ADCs) and bispecific antibodies for the treatment of cancer (Press release, ImmunoPrecise Antibodies, MAR 13, 2025, View Source [SID1234651145]). This collaboration focuses on leveraging contract research expertise while integrating IPA’s proprietary B-cell Select platform and artificial intelligence-driven discovery capabilities to enhance the efficiency and precision of therapeutic development.

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Under the terms of the agreement, the partnership will encompass the discovery, lead characterization, optimization, and preclinical-grade production of multiple antibody-based therapeutics, with a focus on developing highly selective and effective cancer treatments. IPA’s proprietary multi-omics AI-driven modeling and discovery platform, combined with its B-cell Select technology, will be integrated at key stages to optimize therapeutic selection and accelerate lead development.

The agreement, valued at an initial $8 million with the potential to expand to $10 million based on program progression, will span 18 to 24 months, integrating artificial intelligence across the workflow to enhance discovery and optimization. This collaboration aims to streamline the path from target discovery to preclinical candidate selection, marking a significant step toward advancing next-generation biologics for cancer treatment.

"This partnership underscores the power of combining AI-driven discovery with advanced antibody engineering," said Dr. Jennifer Bath, CEO of ImmunoPrecise Antibodies. "With the purchase order secured and work already underway, we are actively leveraging our proprietary B-cell Select platform and LENSai technology to accelerate the development of highly targeted cancer therapeutics. This collaboration highlights IPA’s role in shaping the future of next-generation biologics with data-driven precision and efficiency."