On June 17, 2025 The Lung Cancer Research Foundation (LCRF) reported a new research collaboration with Boehringer Ingelheim creating two funding mechanisms designed to address HER2 mutations in lung cancer: a new Team Science Award and an Early Career Investigator Award (Press release, Boehringer Ingelheim, JUN 17, 2025, View Source [SID1234653959]).

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Lung cancer is responsible for more deaths worldwide than any other cancer, accounting for an estimated 130,180 deaths annually in the United States alone.1 In the last 10 to 15 years, accelerated clinical trials and FDA approvals of targeted therapies for non-small cell lung carcinoma have been possible in part due to advances in molecular profiling of tumors. Many of these targeted therapies are directed against oncogenic drivers.

The HER family of tyrosine kinases include HER1 (epidermal growth factor receptor [EGFR] or ERBB1), HER2 (HER2/neu or ERBB2), HER3, and HER4. EGFR mutations were one of the first oncogenic drivers that were successfully targeted with the use of tyrosine kinase inhibitors. Despite substantial progress in this area, available treatments are generally not curative, and resistance invariably develops. HER2 mutations have also been identified as potential oncogenic drivers in lung cancer and occur in up to 4% of NSCLC.2,3 In the past two decades, several clinical trials have investigated the use of anti-HER2 therapies in lung cancer but led to disappointing results. On August 11, 2022, the Food and Drug Administration granted accelerated approval to trastuzumab deruxtecan for patients with unresectable or metastatic NSCLC whose tumors have activating HER2 mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.4 This was a positive step forward for patients with NSCLC whose tumors harbor these mutations. Most recently there are orally administered tyrosine kinase inhibitors of HER2 that have demonstrated promising results in the treatment of HER2-mutant NSCLC.

Immunotherapeutic strategies have not been successful in the treatment of lung cancers with EGFR or HER2 mutations. It is of vital importance that there is a better understanding of the biology of HER2-mutated lung cancer as well as the mechanism of tumor response and resistance. Moreover, given that therapeutic options available to date are not curative, there is a need for novel approaches to treat HER2-mutant lung cancers. Boehringer Ingelheim and LCRF share the belief that a team approach to solving complex issues has the greatest likelihood to have near-term impact for patients, and funding early career investigators maintains the research continuum needed for scientific discovery that leads to breakthroughs.

"We believe that supporting scientists to pursue their curiosity is key to driving meaningful progress and innovation—and that collaboration is essential to bringing groundbreaking treatments to patients," said Bjoern Rueter, U.S. Vice President, Clinical Development and Medical Affairs. "We are excited to join forces with Lung Cancer Research Foundation as we embark on a new era for cancer research and create the Team Science and Early Career Investigator awards."

"Delivering impact to patients is what drives LCRF’s research program," says Dr. Antoinette Wozniak, Chief Scientific Officer for LCRF. "Research collaborations like this will accelerate the pace of scientific discovery moving forward. Our shared commitment to improving outcomes for people living with lung cancer continues to provide hope."

The LCRF|Boehringer Ingelheim Team Science Award on Innovative Approaches Toward the Treatment of HER2-Driven Lung Cancer award, is a $1.5 million, three-year award to a team of researchers whose proposals have a program of closely integrated projects focused on the science behind HER2 mutations as oncogenic drivers of malignancy and/or the development of novel therapeutic approaches for patients with tumors harboring HER2 mutations.

The LCRF|Boehringer Ingelheim Early Career Investigator’s Award on Innovative Approaches Toward the Treatment of HER2-Driven Lung Cancer is expected to total $750,000 for up to three, two-year awards of $250,000 each, focused on HER2 mutations.

Submissions to the Request for Proposals will be reviewed through a two-step process: Letters of Intent will be accepted until midnight on July 29, 2025; if selected, projects will then be chosen to submit full proposals. All applications will be subject to a rigorous review by LCRF’s Scientific Advisory Board. More details about the Request for Proposal, along with eligibility, requirements, and deadlines can be found at LCRF.org/FundingOpportunities.

On June 17, 2025 Orion Corporation and Glykos Finland Oy reported that they have extended their research collaboration and licensing agreement for the development of next-generation antibody-drug conjugates (ADCs) (Press release, Orion, JUN 17, 2025, View Source [SID1234653956]).

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Under the extended agreement, Orion gains access to Glykos’ proprietary ADC technologies with the potential to expand into three additional programs in the future, in addition to the three ADC programs outlined in the previous agreement. Orion will be responsible for the target selection, research, development, and commercialization of up to three next-generation ADCs, with a focus on solid tumors.

The financial terms of the extended agreement for the three new ADC projects are the same as in the original agreement for the first three projects. Glykos is entitled to milestone payments related to the development of the ADCs and product sales. Glykos is also entitled to receive royalties from the commercial sales generated by the three ADC programs.

"This successful collaboration with Glykos allows us to continue leveraging their advanced ADC technology and underscores our commitment to developing new treatment options for cancer patients," said Professor Outi Vaarala, Executive Vice President, Innovative Medicines and Research & Development at Orion.

"The extension of our agreement with Orion highlights the potential of our ADC technology. We are excited to expand our collaboration with Orion, whose expertise in cancer therapies and strong clinical development capabilities are crucial for bringing new, effective treatments to cancer patients," said Juhani Saarinen, CEO of Glykos.

On June 17, 2025 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company developing first-of-its-kind targeted therapies for primary and metastatic breast cancer, reported the peer-reviewed publication in PLOS-One of their dose optimization in-vivo study results of ZetaMast (Zeta-MBC-005) (Press release, Zetagen Therapeutics, JUN 17, 2025, View Source [SID1234653955]).

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Zetagen identified two concentrations of ZetaMast (Zeta-MBC-005) which demonstrated superior effectiveness, reduction in tumor burden, and increased survival rate over control Doxorubicin.

"Patients with disseminated metastatic breast cancer involving the liver, face a poor prognosis and new approaches are urgently needed., stated Debasish Tripathy, MD, Professor and Chairman, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX "Although some therapies have been designed for direct administration for liver metastases, they have not demonstrated efficacy in significantly improving survival. ZetaMast is an innovative therapeutic approach that has demonstrated systemic biological effects potentially extending beyond liver metastases in preclinical models, offering promising potential to enhance outcomes in this setting."

ZetaMast (Zeta-MBC-005) Increased Survival in a Mouse Xenograft Liver Metastases Model. The 4T1, TNBC cell line, tagged with luc2 luciferase (4T1-luc2), was implanted directly into the liver of BALB/c mice. Seven days after tumor inoculation, mice were treated with various concentrations via a single administration of ZetaMast (Zeta-MBC-005) (30-, 60-, 120-, 180-, 240-, or 480-μg) in combination with 5-mg/kg doxorubicin. Mice in the Control group received 5 mg/kg of doxorubicin and the ZetaMast (Zeta-MBC-005) carrier without Zetagen’s small molecule, administered every72-hours.

ZetaMast (Zeta-MBC-005) has the ability to deliver Zetagen’s small molecules intratumorally as well as other therapies, avoiding off-target side effects.

"Effective locoregional therapies are likely the key to reducing breast cancer mortality for patients with disseminated metastatic disease and increasing 5-year survival above 31%. If treatments like ZetaMast (Zeta-MBC-005) can be given when and where needed, increasing the duration of overall tumor control, which may be enough to tip the balance towards a favorable impact on survival.," stated Bryan S. Margulies, MS, Ph.D., CSO of Zetagen.

To view the ZetaMAST (Zeta-MBC-005) dose optimization study results go to View Source

About ZetaMAST (Zeta-MBC-005)
ZetaMast (Zeta-MBC-005) is a proprietary drug eluting carrier designed for locoregional administration, controlled release of two small molecules in the treatment of multifocal, unresectable, liver metastases from breast cancer with the potential to increase survival rates.

The USPTO has granted Zetagen a "Composition of Matter" patent for ZetaMast (Zeta-MBC-005), and Zetagen has also submitted a filing to the FDA for Orphan Drug Designation.

Zetagen is finalizing preparations for an FDA IND submission this fall, with a Phase Ib clinical trial set to commence early 2026.

On June 17, 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 the initiation of a Phase 2 clinical study evaluating NT219 in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) (Press release, Purple Biotech, JUN 17, 2025, View Source [SID1234653952]).

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NT219 is a novel small molecule designed to target two key oncogenic pathways: IRS1/2 (Insulin Receptor Substrates 1 and 2) and STAT3 (Signal Transducer and Activator of Transcription 3). NT219 induces the degradation of IRS1/2 and inhibits the phosphorylation of STAT3, thereby, blocking their respective signaling pathways. The Phase 2 study will evaluate NT219 in combination with either pembrolizumab (KEYTRUDA) or cetuximab, both of which are standard-of-care treatments in R/M SCCHN patients. Additionally, the study aims to evaluate potential biomarkers identified in a previous clinical study of NT219.

The investigator-initiated study is being conducted in collaboration with the University of Colorado Anschutz Medical Campus, and is led by Dr. Antonio Jimeno, Director of the Head and Neck Cancer Program, and the Principal Investigator, Dr. Alice Weaver. The study is structured into two single-arm cohorts: one evaluating NT219 in combination with pembrolizumab, and the other evaluating NT219 in combination with cetuximab. Each cohort will follow a Simon 2-stage design, beginning with 10 patients per arm and potentially expanding to a total of 29 patients per arm.

"We are excited to initiate this Phase 2 study evaluating NT219 in combination with standard-of-care therapies and to deliver on our milestones for this year," said Gil Efron, Chief Executive Officer of Purple Biotech. "This study marks an important milestone in our clinical development of NT219 and reflects our commitment to advancing therapies that may potentially overcome resistance and improve outcomes for the vast majority of patients with recurrent and/or metastatic head and neck cancer, who do not respond to current treatments."

This Phase 2 study builds upon encouraging results from our Phase 1 study, that demonstrated the safety and anti-tumor activity of NT219 in combination with cetuximab, as evidenced by two partial responses and five patients with stable disease. In preclinical models, NT219 has also been shown to reverse resistance to PD-1 inhibition and restore immune activity within the tumor microenvironment.

The SCCHN treatment market is projected to reach $5 billion by 2030. It is believed that the development of more effective treatments for R/M SCCHN is primarily hindered by tumor heterogeneity, therapeutic resistance, and a lack of reliable biomarkers.

On June 17, 2025 Ratio Therapeutics Inc. (Ratio), a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment and monitoring, and Nusano, a physics company enabling breakthrough radioisotope supplies, reported a long-term supply agreement designed to support the Ratio’s product pipeline and enable innovation (Press release, Nusano, JUN 17, 2025, View Source [SID1234653951]).

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The agreement gives Ratio access to reliable, high-volume, commercial-scale supplies of copper-64 (Cu-64) for PET imaging diagnostics produced by Nusano, as well as lutetium-177 (Lu-177) and actinium-225 (Ac-225) for therapeutic applications.

"We are pleased to enter into this agreement with Nusano, a company whose isotope production platform enables Ratio to secure a critical supply chain advantage. By gaining access to Cu-64 for imaging and Ac-225 for therapies, we can confidently advance our radiopharmaceutical clinical programs," said Jack Hoppin, Ph.D., Chairman and Chief Executive Officer of Ratio Therapeutics. "Limited supply and high costs of Cu-64 have put significant constraints on its clinical use. By accessing Nusano’s production capabilities, we’re removing a critical bottleneck and enabling broader adoption across the field. This agreement de-risks our development pipeline and positions us to deliver innovative radiopharmaceuticals to patients across the U.S. and beyond."

Nusano is a radioisotope producer with a proprietary platform capable of generating more than 40 different isotopes for medical and industrial applications. The company intends to use these capabilities to help stabilize the existing medical radioisotope market and enable oncology innovation by providing researchers and drugmakers with isotopes yet to be fully explored for their cancer-fighting properties.

"This agreement is the foundation for a strategic alliance aimed at unlocking the full potential of radiopharmaceuticals," said Chris Lowe, Chief Executive Officer of Nusano. "We’re seeing strong, sustained growth in the use of Cu-64 for PET imaging and rapidly increasing interest in isotopes such as Ac-225 for targeted cancer treatments. By collaborating with forward-thinking radiopharmaceutical companies like Ratio, we’re working to meet current clinical needs and support the development of next-generation radiopharmaceuticals."

This supply agreement reflects the shared vision of the two companies to accelerate innovation in the radiopharmaceutical field as the demand for diagnostic and therapeutic isotopes continues to grow. The close proximity of Ratio’s new manufacturing facility in Utah, just miles from Nusano’s operations, will streamline the logistics involved in scale-up and delivery. Supplies of Lu-177 and Ac-225 from Nusano will also play an important role in Ratio’s growing radiopharmaceutical pipeline. Leveraging its proprietary Trillium platform, Ratio is designing highly selective, targeted radiotherapeutics for cancer treatment, including a FAP-targeted radiotherapy in development for soft tissue sarcoma which is expected to enter the clinic this year.