On June 3, 2024 IDRx, Inc., a clinical-stage biopharmaceutical company dedicated to transforming cancer treatment with purpose-built precision therapies, reported updated preliminary clinical data from the Phase 1 portion of the company’s ongoing StrateGIST 1 study of IDRX-42 in patients with advanced gastrointestinal stromal tumors (GIST) (Press release, IDRx, JUN 3, 2024, View Source [SID1234644065]). These data will be highlighted today in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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IDRX-42 is a novel, KIT mutant-selective, tyrosine kinase inhibitor (TKI) that has potent activity against both the key activating mutations and broad coverage of the clinically relevant resistance mutations in KIT-driven GIST. IDRX-42 was designed to overcome the twin challenges of on-target treatment resistance and off-target driven adverse events, which limit the clinical benefit of currently available TKIs.

"There is a significant unmet medical need for next-generation therapies for GIST patients. Current standards of care either lack the breadth of resistance mutation coverage necessary for patients to realize long durations of response or disease stabilization, or they lack selectivity, resulting in unwanted side effects, or both," said Professor Patrick Schöffski, M.D., M.P.H., Head of the Department of General Medical Oncology at the University Hospitals Leuven. "These promising Phase 1 data support the potential of IDRX-42 to provide meaningful clinical benefit for GIST patients, with encouraging evidence of clinical activity in patients with activating KIT mutations in exons 9 and 11, as well as in patients with clinically relevant resistance mutations in KIT, importantly those in exons 13 and 17."

Updated Preliminary Clinical Data Summary

As of the data cut-off date of April 28, 2024, 73 patients have been treated with IDRX-42 in the Phase 1 portion of the ongoing StrateGIST 1 trial across dose cohorts ranging from 120 mg once daily (QD) to 600 mg twice daily (BID). All 73 patients had KIT-mutant GIST. 66 patients were evaluable for efficacy as of the time of the data cut-off. Patients who were efficacy evaluable must have had at least 1 post-baseline tumor assessment or had clinical progression or death before the first post-baseline tumor assessment.
While a maximum tolerated dose was not reached, dose escalation in the Phase 1 portion of the trial has completed, and the Phase 1b dose confirmation portion of the trial has been initiated utilizing a dose of 300mg tablet formulation, which is equivalent to the 400mg capsule formulation.
Patients were heavily pretreated, with a median of four prior lines of therapy.
19% (14/73) patients had received one prior line of therapy.
11% (8/73) patients had received two prior lines of therapy.
70% (51/73) patients had received three or more prior lines of therapy.
74% of patients remained on study treatment, and the median duration of treatment was 16 weeks as of the data cut-off.
100% of second line patients remained on treatment as of the data cut-off.
The objective response rate (ORR) by modified RECIST v1.1 in the efficacy evaluable population was 23% (15/66) treated across all lines of therapy, of which all were partial responses (12 confirmed PRs, 3 pending confirmation).
The ORR across second line patients was 43% (6/14; 4 confirmed PRs, 2 pending confirmation).
In analyses of circulating tumor DNA (ctDNA), reductions in mutant allele fraction were observed consistently across KIT mutations detected in baseline samples.
Reductions in mutant allele fraction, including to undetectable levels, as best response were observed in exon 9 and 11 activating mutations, and in resistance mutations exon 13, 14, and 17.
IDRX-42 exhibited a favorable safety profile and treatment-related adverse events (TRAEs) were mainly low grade.
The most frequently reported TRAEs (≥20%) were gastrointestinal symptoms (diarrhea, nausea, decreased appetite, vomiting, dysgeusia) and fatigue.
Gastrointestinal adverse events were Grade 1 in most patients, when they occurred.
A low rate of dose modifications due to TRAEs was observed at the 400mg QD dose level, with only 6% dose reductions, 9% dose interruptions, and 0% discontinuations due to TRAEs.
Dose-limiting toxicities (DLTs) were observed in 3/73 patients at doses of 600 mg, 800 mg and 1200 mg, respectively. All 3 patients elected to reduce dose and remained on study as of the data cut-off (range: >3 to >11 months); 2 of these patients have achieved a confirmed PR at a reduced dose of 400 mg QD.
A flat and dose-linear pharmacokinetic profile was observed.
"In this dataset, IDRx has presented preliminary proof-of-concept of IDRX-42 supporting its potentially best-in-class profile in patients with GIST," said Tim Clackson, Ph.D., Chief Executive Officer of IDRx. "Importantly, we believe these efficacy and safety data support our plan to move IDRX-42 rapidly into early lines of therapy, including second-line and front-line, where patients haven’t seen a new treatment option in over 15 years."

"We are excited for these data to be presented today, as they support all aspects of our target product profile, including evidence of potent activity against relevant activating and resistance mutations in KIT, combined with a favorable safety profile," said David Kerstein, M.D., Chief Medical Officer of IDRx. "Across a wide dose range and in this heavily pre-treated patient population, promising signs of clinical activity have been observed, and the initial data compares favorably against approved therapies and those in clinical development. We are encouraged by the emerging safety and tolerability profile, characterized mainly by low grade, manageable gastrointestinal adverse events with a notable lack of adverse events generally associated with off-target activity, such as hand-foot skin reaction and hypertension, supporting the overall selectivity of the molecule. We would like to express our gratitude to the patients and investigators for their participation in the ongoing StrateGIST 1 study."

The Data Will be Highlighted in an Oral Presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting:

Title: StrateGIST 1: A first-in-human (FIH), phase 1 study of IDRX-42 in patients with metastatic gastrointestinal stromal tumors resistant to prior treatment with tyrosine kinase inhibitors (TKIs)
Presenter: Patrick Schöffski, M.D., M.P.H.
Abstract Number: 11501
Presentation Type: Oral Abstract Session
Session Title: Sarcoma (Sub Track Gastrointestinal Stromal Tumors)
Time: 3:12 P.M. CDT

About GIST

Gastrointestinal stromal tumors (GIST) are the most common subtype of soft tissue sarcoma. Approximately 80% of cases arise from gain of function mutations in the KIT receptor tyrosine kinase, driving the malignancy through constitutive activation of aberrant signaling. Resistance mutations in KIT emerge in ~90% of patients treated with imatinib, the current standard of care for GIST. In unresectable or metastatic GIST, clinical benefits from existing treatments can vary by mutation type.

About the StrateGIST 1 Study

StrateGIST 1 is an ongoing, open-label, first-in-human Phase 1/1b study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of IDRX-42 in patients with metastatic and/or surgically unresectable GIST after failure of imatinib and other approved drugs. The study is currently enrolling patients with documented pathogenic mutation in KIT or any platelet-derived growth factor receptor alpha (PDGFRA) mutation (other than PDGFRA exon 18) at sites in the U.S., Belgium, Germany and Spain. The Phase 1b portion will include expanded exploratory cohorts based on defined lines of prior TKI therapy.

About IDRX-42

IDRX-42 is a potent, oral, highly selective KIT inhibitor targeting all major categories of activating and resistance mutations in patients with KIT-mutant GIST (including variants in exons 9, 11, 13 and 17). In preclinical studies, IDRX-42 demonstrated superior antitumor activity compared to imatinib, the current first-line of therapy, in GIST human xenograft models expressing mutations in KIT exons 9 and 11. In xenograft models expressing secondary resistance mutations in KIT exon 13 or 17, IDRX-42 treatment resulted in potent and dose-dependent antitumor activity superior to the second-line standard of care agent, sunitinib. IDRX-42 is currently being evaluated in a first-in-human Phase 1/1b study.

On June 3, 2024 Fulgent Pharma, a subsidiary of Fulgent Genetics, Inc. (NASDAQ: FLGT) and a leading nanobiotechnology company specializing in innovative cancer therapeutics, reported that Phase 1 clinical data on its lead therapeutic development candidate, FID-007, to treat Head and Neck cancer, was presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 2, 2024 in Chicago, Illinois (Press release, Fulgent Pharma, JUN 3, 2024, View Source [SID1234644064]).

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Of eleven head and neck squamous cell carcinoma (HNSCC) evaluable patients with weekly dose levels from 15 mg/m2 to 160 mg/m2, five (45%) had a partial response and three (27%) had stable disease by RECIST. Three out of five HNSCC patients with PR had previously been treated with taxane. The duration of follow-up (months), median (range) is 4.0 (1.0 – 15.0). No high-grade neuropathy has been noted to date. FID-007 demonstrates preliminary evidence of anti-tumor activity in heavily pre-treated HNSCC patients across different primary tumor sites, with an overall response rate of 45%. Phase 2 study of FID-007 combination with cetuximab in patients with HNSCC has begun enrollment.

Commenting on the data, Ming Hsieh, Chairman of the Board and Chief Executive Officer, said, "We are very encouraged by the data from these Head and Neck cancer patients, in particular the preliminary evidence of relatively lower toxicity and improved treatment tolerance with FID-007 compared to prior therapies. These data support the Phase 2 clinical study we recently began in head and neck squamous cell carcinoma, and we look forward to bringing FID-007 to more patients as we continue enrollment."

The poster is available on the News & Events section of the company’s Investor Relations website at View Source

About FID-007

FID-007 consists of paclitaxel encapsulated in a polyethyloxazoline (PEOX) polymer excipient designed to enhance PK, biodistribution, and tolerability. In addition to allowing the drug to remain in solution until it can enter a cancer cell, the PEOX nanoparticle is designed to preferentially deliver paclitaxel to the tumor through the leaky hyperpermeable vasculature.

On June 3, 2024 Novocure (NASDAQ: NVCR) reported the presentation of clinical data from the phase 3 METIS trial, which investigated the use of Tumor Treating Fields (TTFields) therapy in the treatment of brain metastases from non-small cell lung cancer (NSCLC) (Press release, NovoCure, JUN 3, 2024, View Source [SID1234644063]). These data will be presented at the ongoing 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

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The METIS trial enrolled 298 adult patients with 1-10 brain metastases from NSCLC, who were randomized following stereotactic radiosurgery (SRS) to receive either TTFields therapy and best supportive care (BSC) (n=149) or BSC alone (n=149). METIS met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression. Patients treated with TTFields therapy and BSC exhibited a median time to intracranial progression of 21.9 months compared to 11.3 months in patients treated with BSC alone (hazard ratio=0.67; P=0.016). Median TTFields therapy duration was 16 weeks and median usage was 67%. Baseline patient demographics and characteristics were well balanced between arms.

Patients treated with TTFields therapy demonstrated improved quality of life deterioration-free survival, with median time to quality of life deterioration-free survival not reached in the TTFields therapy cohort compared to 7.7 months in control arm (P=0.038). A positive trend was observed in patients treated with TTFields therapy in the majority of scales and items assessed by the EORTC QLQ C30 and BN20 patient questionnaire. There was no evidence of worsening cognitive functioning in the TTFields therapy arm compared to the control arm. Consistent with prior clinical trials, TTFields therapy was well-tolerated with no additive systemic toxicity.

Preliminary analyses of key secondary endpoints did not demonstrate statistical significance. Median overall survival for patients randomized to receive TTFields therapy and BSC was 11.3 months compared to 10.6 months in patients treated with BSC alone. Full analysis of secondary endpoints is ongoing.

"One of the key challenges in combatting the spread of brain metastases is maintaining patients’ quality of life and cognitive function," said lead investigator Minesh Mehta, MD, Chief of Radiation Oncology and Deputy Director at Miami Cancer Institute, part of Baptist Health South Florida. "The ability of TTFields therapy to prolong the time to intracranial progression without negatively impacting either quality of life or cognitive function has the potential to change the way brain metastases from non-small cell lung cancer are treated."

"Despite the high incidence level of brain metastases from NSCLC, the treatment options available for patients are very limited," said Nicolas Leupin, MD, Novocure’s Chief Medical Officer. "The observations from the METIS trial are an important first step in potentially adding a new treatment option for these patients and we are eager to pursue the necessary steps to ensure TTFields therapy is available to those in need."

These data will be featured by Dr. Mehta in an oral presentation (abstract #2008) at 10:24 a.m. CDT on Monday, June 3, 2024 during ASCO (Free ASCO Whitepaper)’s Central Nervous System Tumors session. Novocure intends to publish these findings in a peer-reviewed scientific journal and submit these data to regulatory authorities.

About METIS

METIS [NCT02831959] is a phase 3 trial of stereotactic radiosurgery with or without TTFields therapy for patients with 1-10 brain metastases from NSCLC. 298 adult patients were enrolled in the trial and randomized to receive either TTFields therapy with supportive care or supportive care alone following SRS. Supportive care consisted of, but was not limited to, treatment with steroids, anti-epileptic drugs, anticoagulants, pain control or nausea control medications. Patients in both arms of the study were eligible to receive systemic therapy for their NSCLC at the discretion of their treating physician. Patients with known tumor mutations for which targeted agents are available were excluded from the trial.

The primary endpoint of the METIS trial is time to first intracranial progression, as measured from the date of first SRS treatment to intracranial progression or neurological death (per RANO-BM criteria), whichever occurs first. Time to intracranial progression was calculated according to the cumulative incident function. Patient scans were evaluated by a blinded, independent radiologic review committee. Secondary endpoints include, but are not limited to, time to distant progression, time to neurocognitive failure, overall survival, time to second intracranial progression, quality of life and adverse events. Key secondary endpoints (time to neurocognitive failure, overall survival, and radiological response rate) were planned to be used in labeling claims, if successful. Full analysis of secondary endpoints is ongoing. Patients were stratified by the number of brain metastases (1-4 or 5-10 metastases), prior systemic therapy, and tumor histology. Patients were allowed to crossover to the experimental TTFields therapy arm following confirmation of second intracranial progression.

About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

On June 3, 2024 Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, reported updated data from the ongoing Phase 1 first-in-human, dose-escalation study of OBX-115, a novel engineered tumor-derived autologous T-cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15), in patients with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma (Press release, Obsidian Therapeutics, JUN 3, 2024, View Source [SID1234644062]). These data were presented in an oral presentation delivered by Rodabe Amaria, M.D., professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center and principal investigator of the study, at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The oral presentation for the single-center study (NCT05470283) included a 3-month incremental data update (relative to published abstract) on safety (N=10) and efficacy (n=9 per-protocol efficacy analysis set) for patients with advanced or metastatic melanoma.

Summary of OBX-115 Safety and Efficacy Data (April 4, 2024 data cutoff):

OBX-115 Exhibits Positively Differentiated Safety Profile Relative to IL2-Dependent Non-Engineered TIL Cell Therapy:

All 10 infused patients were alive at data cutoff (median study follow up of 29.5 weeks).
No patient received care in the intensive care unit.
No dose-limiting toxicities were observed at any dose level.
No Grade 4 or higher non-hematologic treatment-emergent adverse events (TEAEs) were reported; 2 patients experienced limited Grade 3 non-hematologic TEAEs.
No confirmed events of cytokine release syndrome, capillary leak syndrome, or immune effector cell-associated neurotoxicity syndrome were reported.
OBX-115 Sustains Consistent Efficacy Profile, without IL2 Administration, in Patients with Substantially Pre-Treated Resistant/Refractory Disease:

Patients had disease that was predominantly ICI primary-resistant, with a median of 3.5 (range, 1–6) lines of prior systemic therapy, including a median of 2 (1–3) lines of prior ICI therapy.
44% objective response rate (ORR), including 2 complete responses (CRs), using investigator-assessed RECIST 1.1 criteria across all doses (n=9 per-protocol efficacy analysis set).
50% ORR in patients who received OBX-115 dose of >30 × 109 cells (n=6).
100% disease control, defined as CR, PR, or ≥12-week duration of stable disease post OBX-115 infusion.
Progression-free survival (PFS) was 75% at 24 weeks.
Tumor burden reduction in all 9 patients, including several with tyrosine kinase inhibitor (TKI)-refractory disease and / or prior treated brain metastasis.
Disease control and responses observed with both fresh and cryopreserved OBX-115 product.
Additional OBX-115 Data Contributing to an Optimized Cell Therapy Product:

Robust manufacturing process observed for OBX-115, including from tumor tissue obtained using core needle biopsy.
Median manufactured OBX-115 dose (N=10): 100 × 109 cells.
Translational data highlight that the OBX-115 infusion product is optimized for response and persistence: predominantly CD8+ cytotoxic T-cell population, effector memory phenotype, high proportion of CD8+CD39-CD69- (double-negative) "stem-like" progenitor cells and low levels of exhaustion markers.
Dr. Amaria commented, "OBX-115 continues to demonstrate positive safety and efficacy data in additional patients, which is encouraging, given this is a heavily pre-treated patient population with advanced disease. Unfortunately, late-line systemic therapy options offer limited benefit, with ORR of approximately 10% and mPFS of approximately 2–3 months. It is exciting to see a potential new option emerge for these patients with a positively differentiated safety profile and promising early activity achieved without IL2."

"We believe OBX-115 has the potential to advance the TIL cell therapy field in multiple ways, including enabling non-surgical tumor tissue procurement and abrogating the need for IL2. We are also exploring the ability to re-energize engrafted OBX-115 cells with acetazolamide re-dosing," commented Parameswaran Hari, M.D., Chief Development Officer of Obsidian. "We look forward to continuing to build on this momentum and apply key learnings from the first-in-human Phase 1 study to our ongoing Phase 1/2 multicenter study, where we are continuing to explore these attributes and optimize the OBX-115 regimen in melanoma and non-small cell lung cancer."

Obsidian is actively enrolling patients with advanced or metastatic melanoma and non-small cell lung cancer (NSCLC) at multiple sites in its ongoing Phase 1/2 multicenter study. Additional details may be found at clinicaltrials.gov, using identifier: NCT06060613.

About OBX-115

Obsidian’s lead investigational cytoTIL15 program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. OBX-115 is being investigated in two ongoing clinical trials in advanced or metastatic melanoma and NSCLC (NCT05470283 and NCT06060613).

On June 3, 2024 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based, biopharmaceutical company aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, reported the signing of an exclusive licensing agreement with Genome & Company (View Source), a publicly-traded, South Korea-based, biotechnology company focusing on discovery and development of novel target antibody therapeutics, for the development of antibody drug conjugates (ADCs) with first-in-class potential (Press release, Debiopharm, JUN 3, 2024, View Source [SID1234644061]). The agreement offers Debiopharm exclusive global rights to develop ADCs combining specific Genome and Company antibodies with Debiopharm’s innovative linker technology, Multilink, to create highly innovative therapeutic agents to outsmart hard-to-treat cancers.

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ADCs are cutting-edge oncology therapeutics that combine three components: a monoclonal antibody, a stable linker and one or more potent cytotoxic payload. These targeted compounds identify and dock onto specific antigens on cancer cell surfaces and promote targeted delivery of toxic payloads to antigen-expressing cancer cells. This modality improves therapeutic effectiveness while diminishing systemic toxicity and side effects typically associated with conventional cancer treatments. This distinctive capacity to selectively eliminate cancer cells while preserving healthy tissues has granted visibility to ADCs within the pharmaceutical development community. With the ever-growing interest in ADC development, linker design has increasingly become a critical determining factor, as few linkers provide satisfactory stability required for specific and effective drug release.1

"Building on our fruitful collaboration with Genome & Company, the potential of developing this novel antibody family with our proprietary MultilinkTM cleavable linker technology is an exciting opportunity. We recognized that Genome’s innovative antibodies were the right fit for our development focus due to the novelty of the target and its expression in tumor types with high unmet needs" expressed Frederic Levy, Chief Scientific Officer. "This extended collaboration with Genome & Company’s antibody against a novel target represents our commitment to form strategic partnerships for the development of first-in-class and best-in-class ADCs leveraging our proprietary Multilink technology, offering unique linker characteristics that grant a higher stability and DAR, thereby optimizing treatment specificity and effectiveness."

Debiopharm is focused on further expanding their ADC platform, exploring proprietary novel bispecific ADCs and potential game changing technologies such as novel payloads, dual payloads, and degraders, leveraging their solid drug development experience to accelerate ADC products to patients.

"This agreement represents our first out-license deal in the field of novel target anti-cancer therapy of Genome & Company, and we were able to achieve meaningful results in early preclinical stage based on our excellent research and development capabilities," commented Yoo Seok Hong, CEO of Genome & Company. "We expect to show results from our subsequent pipeline of novel target anti-cancer drugs in the near future, leveraging this license deal."

About Multilink

Multilink is a new cleavable linker platform suited for multidrug attachment and compatible with any conjugation technology to produce ADCs with high DAR (drug-to-antibody ratio). This unique and innovative technology allows the loading of multiple payloads on an antibody for an enhanced therapeutic effect. This highly effective and well-tolerated linker platform is available for use by other specialty biotech or pharmaceutical companies to generate proprietary, clinical-stage ADCs.