On January 28, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS), ("Intensity" or "the Company") 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 that following its most recent periodic review meeting, the Data Monitoring Committee (DMC) overseeing the Company’s ongoing Phase 3 sarcoma study of INT230-6 (INVINCIBLE-3) (NCT06263231) has agreed that the study should continue without modification (Press release, Intensity Therapeutics, JAN 28, 2025, View Source [SID1234649915]). The DMC reviewed data covering the six months from July to December 2024.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The Data Monitoring Committee is designed to confidentially review data to determine whether safety concerns with the data collected to date exist. We are encouraged by the continuation of the trial and continue to believe that INT230-6 represents important potential in a treatment area that has significantly unmet medical need. We look forward to continuing enrollment and to providing further updates as they develop," commented Lewis H. Bender, Intensity’s President and Chief Executive Officer.

INVINCIBLE-3 Study Overview

The INVINCIBLE-3 Study is a global open-label, randomized, controlled study designed to evaluate INT230-6 administered intratumorally by an interventional radiologist or an equivalently trained physician using image guidance compared to systemically dosed standard of care ("SOC") chemotherapy. The study endpoints are overall survival and safety, along with an exploratory quality of life (QoL) assessment using the EORTC-30 survey. The study is testing the efficacy and safety of INT230-6 intratumoral (IT) injection compared to any of three standard-of-care therapies (pazopanib, trabectedin, or eribulin) in approximately 333 adult participants with locally recurrent, inoperable, or metastatic soft tissue sarcoma ("STS") patients who had disease progression prior to study enrollment following standard therapies, which must have included an anthracycline-based regimen unless contraindicated. Participants may also have received a maximum of one additional regimen. Randomization will occur after screening and eligibility confirmation. As this is a survival study, there is no crossover allowed between SOC and INT230-6. Disease progression will be determined by the World Health Organization (WHO) criteria. Participants will be prospectively stratified into 1 of 3 histologically defined STS strata:

leiomyosarcoma
liposarcoma (dedifferentiated, myxoid, round cell and pleomorphic)
undifferentiated pleomorphic sarcoma
The comparator agents used are all U.S., Europe, Canadian and Australian-approved agents for sarcomas: pazopanib tablets, trabectedin, and eribulin mesylate. Authorizations for the INVINCIBLE-3 Study have been obtained from the U.S. FDA, Health Canada, the European Medicines Agency, and Australia’s Therapeutic Goods Administration. Sites will be opened in 8 countries and the study is presently recruiting participants in the U.S., Canada, and Europe.

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 sulfate, 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 January 28, 2025 Cordance Medical, a pioneer in non-invasive medical technologies for brain disease treatment, and EXACT Therapeutics (Euronext Growth: EXTX), a clinical-stage precision medicine company, reported initial positive results indicating more than a doubling (+127-145%) of the uptake of a radiopharmaceutical in brain tumors of mice inoculated with glioblastoma cancer cells, one of the most aggressive and hard-to-treat brain cancers (Press release, Cordance Medical, JAN 28, 2025, View Source [SID1234649914]). The increased uptake resulted from combining Exact Therapeutics’ proprietary Acoustic Cluster Therapy (ACT) with a device designed by Cordance Medical to deliver ultrasound energy non-invasively into the brain. The studies were performed at The Arctic University of Norway and University Hospital North-Norway in Tromsø by Dr. Mathias Kranz.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The combination of ACT and the device can be used in a wide range of brain diseases to potentially access large regions of the brain. The combination can stimulate bioeffects including increasing the uptake of therapeutic agents and temporarily making the blood-brain barrier more permeable in these regions. The combination of ACT and the device may be utilized for both diagnostic and targeted therapeutic brain applications. Further experiments are ongoing to expand the early data, and the results will be submitted for publication in scientific journals.

"The combination of the Cordance technology and the ACT microcluster technology from Exact Therapeutics provides exciting possibilities for accessing and opening larger volumes in the brain without necessarily increasing the focused ultrasound procedure time or the total amount of ultrasound energy," said Dr. Bhaskar Ramamurthy Cofounder and CEO of Cordance Medical.

"These positive results in glioblastoma provide additional early evidence of the versatility of the noninvasive ACT microcluster technology in cancer therapy. Oncology is the key focus for Exact Therapeutics, spearheaded by our ongoing Phase 2 trial in locally advanced pancreatic cancer, which received IND clearance at the end of 2024," said Dr. Per Walday, CEO of Exact Therapeutics.

On January 28, 2025 Commit Biologics ("Commit"), a pioneer in the activation of the complement system to treat cancer and autoimmune disease, reported a €5.5m extension to its seed financing (Press release, Commit Biologics, JAN 28, 2025, View Source [SID1234649913]). The contribution from new investor Korys brings the total seed financing raised since Commit’s launch to €21.5m. Commit emerged from stealth last May, having raised €16m from Novo Holdings and Bioqube Ventures.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The proceeds of the financing, which will be used to advance the BiCE platform and work towards drug candidate selection, extend Commit’s runway into late 2026.

Commit is developing its Bispecific Complement Engaging (BiCE) platform, which uses single domain antibodies that bind to the complement protein C1q to activate and direct the complement system, a fast-acting and potent part of the innate immune system. BiCE is a modular system that can arm antibodies to direct the complement system in a highly targeted way to selectively kill tumor cells or cells implicated in autoimmune disease.

To execute the plan, Commit has appointed Chief Scientific Officer Mikkel Wandahl Pedersen as Interim CEO. Dr Pedersen is a seasoned R&D executive and scientific leader with over two decades of experience in immuno-oncology and autoimmune disease drug discovery and development. He joined Commit last year after previously serving as CSO of Oslo-based Nykode Therapeutics and Denmark-based Symphogen. Dr Pedersen retains his role as Commit’s CSO.

Dr Mikkel Wandahl Pedersen, Interim Chief Executive Officer, and CSO, of Commit Biologics, said: "This additional financing from Korys, a new investor, underscores the great potential of our BiCE platform to redefine the treatment of cancer and autoimmune disease. We welcome Eva to our Board of Directors, where her expertise will be invaluable as we work towards drug candidate selection. The additional financing further extends our cash runway into late 2026, and we remain hyper-focused on progressing our platform to the next stage of our development."

Eva Van Overmeire, Senior Investment Manager at Korys, said: "Commit is pioneering a unique platform technology that robustly activates the complement system and easily integrates with existing antibody formats in a plug-and-play fashion. This innovative technology holds the promise of significantly improving the lives of patients battling cancer and autoimmune diseases. We are impressed with the progress already made by the Commit team since the initial seed financing and we are confident they have the expertise to drive the platform forward."

On January 28, 2025 Lantheus Holdings, Inc. ("Lantheus" or the "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported a definitive agreement to acquire Evergreen Theragnostics, Inc. ("Evergreen"), in an all-cash transaction consisting of an upfront payment of $250 million and up to an additional $752.5 million in potential milestone payments (Press release, Lantheus, JAN 28, 2025, View Source [SID1234649912]). Evergreen is a clinical-stage radiopharmaceutical company engaged in Contract Development and Manufacturing (CDMO) services as well as drug discovery and commercialization of proprietary products.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This transaction is expected to solidify Lantheus’ capabilities as a fully integrated radiopharmaceutical company. The addition of Evergreen’s scalable manufacturing capabilities and infrastructure enhances Lantheus’ ability to meet the complex demands of radiopharmaceutical development and production. The acquisition also expands Lantheus’ oncology diagnostic pipeline by adding both OCTEVY, a registrational-stage PET diagnostic agent for certain neuroendocrine tumors (NETs) that could complement Lantheus’ therapeutic candidate PNT2003, as well as a number of clinical and pre-clinical novel theranostic pairs.

"As Lantheus continues to advance its industry leadership, this transaction, along with the agreement to acquire Life Molecular Imaging, enhances our operations across the radiopharmaceutical value chain," said Brian Markison, CEO of Lantheus. "With Evergreen’s manufacturing and development capabilities, we become fully integrated and will ultimately make a difference in the lives of more patients. We are pleased to welcome Evergreen’s talented team to Lantheus and are confident that their expertise in radiopharmaceutical theranostics and culture focused on developing new solutions for cancer patients will enrich our organization."

"Today marks an exciting new chapter for Evergreen as we look to join the Lantheus team," said James Cook, CEO of Evergreen. "Lantheus’ industry expertise and financial strength will help us bring our innovations to a broad patient population faster and support our mission to improve options for cancer patients through theranostic radiopharmaceuticals. We look forward to benefiting from Lantheus’ experience and resources to further advance our pipeline and continue developing cutting-edge therapies and diagnostics that have the potential to transform patient care. I am very pleased to have our Evergreen team join another industry-leading company with a shared vision."

Compelling Strategic and Financial Rationale

Enhanced Radiopharmaceutical Manufacturing Infrastructure: The acquisition advances Lantheus’ capabilities with the addition of Evergreen’s radioligand therapy (RLT) manufacturing infrastructure, including a revenue-generating CDMO business. Evergreen’s ability to work with a variety of diagnostic and therapeutic isotopes will enhance Lantheus’ ability to address the complexities of radiopharmaceutical development and production. Internalizing this infrastructure will enable Lantheus to develop technical and operational expertise, supply its clinical trials, scale manufacturing for commercial launches, mitigate third party risk, and support long-term growth.
Adds Near-Term Revenue with OCTEVY, which Complements PNT2003 Commercialization: Acquiring OCTEVY, a registrational-stage diagnostic imaging agent, provides Lantheus with additional growth potential while expanding its presence in NETs. Subject to FDA approval, OCTEVY is expected to be indicated for use with positron emission tomography (PET) for localization of somatostatin receptor-positive NETs in adult and pediatric patients. OCTEVY and Lantheus’ PNT2003 could be used as a theranostic pair.
Advanced Early Development Capabilities: Evergreen brings a fully integrated drug discovery and early-stage clinical development platform, promising early-stage oncology assets, and a highly skilled team that can generate novel targets and advance promising radiotherapeutic programs.
Additional Transaction Details
Under the terms of the agreement, Lantheus will pay an upfront amount of $250 million, payable in cash at closing, and up to $752.5 million in development and sales milestones related to OCTEVY and Evergreen’s clinical and pre-clinical pipeline. The transaction has been approved by the Boards of Directors of both companies and is expected to close in the second half of 2025, subject to customary closing conditions, including regulatory clearances.

Company Reaffirms Full Year 2024 Financial Guidance

Guidance Issued November 6, 2024

FY 2024 Revenue

$1.51 billion – $1.52 billion

FY 2024 Adjusted Fully Diluted
EPS

$6.65 – $6.70

Advisors
Solomon Partners Securities, LLC acted as financial advisor to Lantheus in this transaction, while Cooley LLP and Ropes & Gray LLP acted as legal advisors, and Ernst & Young LLP acted as financial and tax advisor.

Centerview Partners LLC acted as financial advisor to Evergreen, while Skadden, Arps, Slate, Meagher & Flom LLP and Lowenstein Sandler LLP acted as legal advisors, and Grant Thornton Advisors LLC acted as tax advisor.

Conference Call and Webcast Details
Lantheus will hold a conference call on Tuesday, January 28, 2025, at 8:30 AM ET. To access the live conference via webcast, please register here. A replay will be available after the conclusion of the call on Lantheus’ investor website at: View Source

On January 28, 2025 Taiho Pharmaceutical Co., Ltd., Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., reported that the REZILIENT1 trial, a Phase 1/2 clinical trial of zipalertinib (development code: CLN-081/TAS6417) monotherapy in patients with non-small cell lung cancer (NSCLC) harboring the epidermal growth factor receptor (EGFR) exon 20 insertion mutations who have received prior therapy, met its primary endpoint of overall response rate (Press release, Taiho, JAN 28, 2025, View Source [SID1234649911]). The safety profile was generally consistent with previous data presentations. These results are based on the Phase 2b part of this study.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Full results from REZILIENT1 will be submitted for presentation at an upcoming international medical conference. Pending discussions with the U.S. Food and Drug Administration (FDA), the companies plan to submit for U.S. regulatory approval in the second half of 2025.

About the REZILIENT1 Trial
REZILIENT1 is a Phase 1/2 clinical trial (NCT04036682) to evaluate efficacy and safety of zipalertinib in patients with NSCLC harboring EGFR exon 20 insertion mutations who have received prior therapy. The topline results obtained at this time are based on the Phase 2b part of this study. Preliminary results of REZILIENT1 have been published in the Journal of Clinical Oncology.1

REZILIENT: Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors

About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

About the EGFR exon 20 insertion mutations
NSCLC is a common form of lung cancer and up to 4% of all cases have EGFR exon 20 insertions, which makes them the third most common EGFR mutation subtype.2 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations, with insertions at exon 20 accounting for up to 12% of these mutations.