On August 13, 2025 CIT Therapeutics, Inc. (CIT), a biotechnology company focused on developing next-generation small molecule therapies targeting SUMOylation for cancer treatment, reported a strategic partnership with the Institute for Follicular Lymphoma Innovation (IFLI) (Press release, Institute for Follicular Lymphoma Innovation, AUG 13, 2025, View Source [SID1234655218]). As part of this collaboration, IFLI will invest up to $2.5 million to support CIT’s clinical development efforts, particularly in follicular lymphoma.

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!

CIT is advancing a first-in-class, orally bioavailable small molecule that selectively inhibits the SUMO E1 enzyme through an allosteric covalent mechanism. This novel approach has demonstrated high specificity in proteome-wide analyses, offering a promising therapeutic strategy to both kill cancer cells and stimulate the immune system.

The investment from IFLI will support CIT’s upcoming Phase 1/1b clinical trial of its lead candidate, SB-4826, in patients with Non-Hodgkin Lymphoma, including those with relapsed or refractory follicular lymphoma.

This partnership underscores IFLI’s commitment to accelerating the development of transformative therapies for follicular lymphoma and related blood cancers. It also highlights CIT’s innovative platform as a potential game-changer in the oncology landscape.

"We are pleased to collaborate with CIT in their mission to improve outcomes for patients with follicular lymphoma," said Dave McCullagh, Managing Director of IFLI.

"This partnership represents a significant step forward in bringing SUMOylation-targeted therapies to the clinic. We are proud to support CIT in pioneering this new therapeutic modality. Inhibiting SUMOylation can reprogram tumor microenvironments, sensitize tumors to chemo and radiotherapy, and suppress oncogenic signaling" Michel Azoulay, MD, Chief Medical Officer of IFLI.

"Our vision is to transform cancer care by developing therapies that target novel biological mechanisms, which aligns with that of IFLI," said Yuan Chen, PhD, Founder and CEO of CIT Therapeutics and Professor and Chief in the Division of Surgical Sciences and Professor in the Division Surgical Oncology in the Department of Surgery at University of California, San Diego (UCSD) and Moores Cancer Center. "We are excited for this partnership and eager to start our clinical trial to deliver meaningful benefit to patients."

On August 13, 2025 OncoBeta GmbH, a medical device company specialising in innovative epidermal radioisotope therapies, reported 12-months interim results from its international Phase IV, multi-centre clinical trial evaluating the efficacy and safety of Rhenium-SCT (Skin Cancer Therapy) in patients with non-melanoma skin cancer (NMSC) (Press release, OncoBeta, AUG 13, 2025, View Source [SID1234655217]).

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 EPIC-Skin Study (Efficacy of Personalised Irradiation with Rhenium-SCT for the Treatment of Non-Melanoma Skin Cancer) is designed to assess treatment efficacy and safety, as well as key patient-reported outcomes including quality of life, treatment comfort, and cosmetic results.1 The study is based on the clinically validated effect of the beta-emitter rhenium-188 in treating basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).2

Treatment data is available for 184 adult patients (with 254 lesions) across 7 study centres in Australia, Austria, Germany, the United Kingdom, and South Africa. All participants had histologically confirmed stage I or II NMSC. The median patient age was 70.3 years (range 27–95 years), and 53.3% of participants were male. Patients had one (71.2%), two (19.6%), or three (9.2%) lesions treated, which were located on the head & neck (11.8%), trunk (11.8%), lower limbs (11.8%), or upper limbs (9.1%).1

Treatment & Methodology

Rhenium-SCT was administered as a single 50-Gy topical dose of rhenium-188 embedded in a resin applied via adhesive film to the lesion site. Efficacy was assessed using modified RECIST criteria, at 12 months follow-up. Quality of life was assessed using the Skin Cancer Index (SCI) at baseline, 6 months, and 12 months. Treatment comfort was assessed using a patient questionnaire, whilst patient- and clinician-evaluated cosmetic outcomes were determined using a visual analogue scale (VAS) grading of 0-10 (0 = very poor; 10 = no wound detectable). Safety was assessed via treatment-emergent adverse events (TEAEs) and CTCAE (Common Terminology Criteria for Adverse Events) grading.

Key 12-Month Results:1

Overall response rate: 97.3%
Complete response rate: 94.1%
Partial response rate: 3.2%
Mean improvement in quality of life: +10.55 points from baseline
Pain/discomfort during treatment: None reported
Cosmetic outcomes: Favourable results reported by both patients and clinicians
Most common toxicity (12-month): Grade 1 hypopigmentation (60.4%)
No CTCAE toxicities above Grade 2 observed at 12 months
These findings confirm that Rhenium-SCT, administered in a single session, delivers sustained high efficacy and improved quality of life, with excellent cosmetic outcomes and minimal adverse effects.

"Rhenium-SCT has consistently demonstrated effectiveness and safety in prior studies," said Dr. Gerhard Dahlhoff, Medical Director at OncoBeta. "This 12-month interim data further reinforces its value as a non-invasive, targeted treatment option for NMSC, particularly for patients seeking alternatives to surgery due to cosmetic or health-related concerns."

"The 12-month results from the EPIC-Skin Study represent a major milestone for OncoBeta," added Shannon D. Brown III, CCO OncoBeta & Managing Director Europe. "These results support the efficacy, safety, and patient satisfaction associated with Rhenium-SCT. These are the three foundational pillars of our patient-first vision, emphasising not only clinical outcomes, but also the patient experience in achieving them."

About the Rhenium-SCT (Skin Cancer Therapy)
Non-melanoma skin cancer (NMSC) is the most common form of cancer in humans.3 The most common cause of NMSC is sun exposure, while other predisposing factors include genetic skin conditions and immunosuppressive diseases or treatments.4
The Rhenium-SCT is a painless*, non-invasive‡ therapy that provides aesthetic results, even in cases otherwise considered difficult to treat.1,5,6 The Rhenium-SCT utilises the radioisotope Rhenium-188 in an epidermal application with optimal properties for the treatment of NMSCs (non-melanoma skin cancers). The Rhenium-SCT is a precise, personalised therapy2 that is only applied to the area needed to treat without affecting the healthy tissue. The specially designed device ensures the Rhenium-SCT compound never comes in direct contact with the patient’s skin and the application is safe and simple for the applying physician. Scar-free healing of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment.

On August 13, 2025 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") reported financial results for the second quarter of 2025. Following the completion of the sale of INBRX-101 (the "101 Transaction") by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. and the Former Parent’s concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs in ongoing clinical trials, with data readouts for each expected within the current year (Press release, Inhibrx, AUG 13, 2025, View Source [SID1234655216]). Because the spin-off was accounted for as a reverse spin-off, for periods prior to the spin-off, the Company’s financial statements are the historical financial statements of the Former Parent.

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!

Upcoming Milestones

The ozekibart (INBRX-109) registration-enabling Phase 2 trial in unresectable or metastatic conventional chondrosarcoma completed full enrollment in July 2025. The completion of 151 progression free survival events are required to unblind the study. The Company expects to announce these results by late October 2025. The Company plans to announce interim data from the Ewing sarcoma and colorectal cancer expansion cohorts at that time as well.

Initial Phase 2 data from the INBRX-106 randomized Phase 2/3 trial in head and neck squamous cell carcinoma in combination with KEYTRUDA (pembrolizumab) are expected during the fourth quarter of 2025, as well as interim data from the Phase 1/2 checkpoint inhibitor refractory or relapsed non-small cell lung cancer trial.
Financial Results

Cash and Cash Equivalents. As of June 30, 2025, Inhibrx had cash and cash equivalents of $186.6 million, as compared to $216.5 million as of March 31, 2025.

Revenue. Revenue was $1.3 million during the second quarter of 2025, as compared to $0.1 million during the second quarter of 2024. The revenue recognized in the first quarter of 2025 was due to the completion of Inhibrx’s performance obligations under a license and assignment agreement with Scithera, Inc. The revenue recognized in the second quarter of 2024 was related to an option and license agreement with Regeneron Pharmaceuticals, Inc. and was recognized following the grant of a six-month extension of the option term for one of the selected programs.

R&D Expense. Research and development expenses were $22.3 million for the second quarter of 2025, as compared to $67.6 million for the second quarter of 2024. The decrease was primarily related to expenses in 2024 that did not recur in 2025, such as clinical trial and contract manufacturing activities under the INBRX‑101 program that were eliminated following the 101 Transaction, as well as additional stock option expense incurred upon acceleration of all unvested stock options as part of the 101 Transaction. Additionally, 2024 included other non-recurring expenses including sponsored research, preclinical activities, and purchases of bulk raw materials and lab supplies.

G&A Expense. General and administrative expenses were $6.4 million during the second quarter of 2025, compared to $93.4 million during the second quarter of 2024. The decrease was primarily related to 101 Transaction expenses in 2024 that did not recur in 2025, including legal, advisory, and consulting services, U.S. Securities and Exchange Commission ("SEC") filing fees, and additional stock option expense incurred upon acceleration of all unvested stock options as part of the 101 Transaction.

Other Income (Expense). Other expense was $1.3 million during the second quarter of 2025, as compared to other income of $2.0 billion during the second quarter of 2024. The decrease was primarily related to the $2.0 billion gain recorded in connection with the completion of the 101 Transaction in the second quarter of 2024. Additionally, interest expense decreased relative to the outstanding debt balance in each period and was offset in part by interest income earned on the Company’s sweep and money market account balances in each period.

Net Income (Loss). Net loss was $28.7 million during the second quarter of 2025, or $1.85 per share, basic and diluted, as compared to a net income of $1.9 billion during the second quarter of 2024, or earnings per share of $127.10, basic and $125.48, diluted. The decrease was primarily related to the $2.0 billion gain recorded in connection with the completion of the 101 Transaction in the second quarter of 2024, offset in both periods by operational losses.

On August 13, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) from the global ARROS-1 Phase 1/2 clinical trial, in addition to preliminary data for TKI-naïve patients, will be presented as part of the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer (WCLC 2025) (Press release, Nuvalent, AUG 13, 2025, View Source [SID1234655215]). The conference is hosted by the International Association for the Study of Lung Cancer and is being held September 6-9, 2025, in Barcelona, Spain.

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!

"Since the inception of our ROS1 research program, collaboration with physician-scientists has been central to understanding the specific opportunities for a new therapeutic option to make a meaningful impact for patients living with ROS1-positive NSCLC. This collaboration helped to shape our vision for a future where physicians and their patients facing their next treatment decision do not have to choose between tolerability and efficacy," said Christopher Turner, M.D., Chief Medical Officer of Nuvalent. "We are highly encouraged by these pivotal results for zidesamtinib in a TKI pre-treated ROS1-positive NSCLC population as well as the preliminary results in a TKI-naïve population, and look forward to engaging with the global lung cancer community on this important milestone at WCLC."

Details of the presentation are as follows:
Title: Pivotal ARROS-1 efficacy and safety data: zidesamtinib in TKI pre-treated patients with advanced/metastatic ROS1+ NSCLC
Session: PL02 – Presidential Symposium 1
Session Date and Time: Sunday, September 7, 2025, 8:15 a.m. – 10:30 a.m. CEST
Presenting Author: Alexander Drilon, M.D. (Memorial Sloan Kettering Cancer Center, New York, USA)

The company has initiated its rolling NDA submission for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive NSCLC. The FDA agreed to accept the NDA for participation in the Real-Time Oncology Review (RTOR) pilot program, which facilitates earlier submission of topline efficacy and safety results prior to the submission of the complete application to support an earlier start to the FDA’s evaluation of the application. Completion of the NDA submission is targeted for the third quarter of 2025, and the company continues to engage with the FDA on potential opportunities for line-agnostic expansion.

About Zidesamtinib and the ARROS-1 Phase 1/2 Clinical Trial
Zidesamtinib is an investigational, novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC.

Zidesamtinib is currently being investigated in the ARROS-1 trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ROS1-positive NSCLC patients who previously received at least one ROS1 TKI, or patients with other ROS1-positive solid tumors who had been previously treated. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of zidesamtinib, with additional objectives including determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The ongoing global, single arm, open label Phase 2 portion is designed with registrational intent for TKI-naïve and TKI pre-treated patients with advanced ROS1-positive NSCLC.

On August 13, 2025 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported financial results for the second quarter ended June 30, 2025, and provided a business update, including highlights of pipeline progress (Press release, Enliven Therapeutics, AUG 13, 2025, View Source [SID1234655214]).

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!

"We made tremendous progress this quarter. Notably, we reported updated positive clinical data for ELVN-001, which continue to compare favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs despite being evaluated in a more heavily pre-treated patient population," said Sam Kintz, Co-founder and Chief Executive Officer of Enliven. "These results reinforce our belief that ELVN-001 could ultimately compete across all lines of CML therapy based on its differentiated efficacy, tolerability and convenience – attributes that position it to be a potential best-in-class therapy for people living with CML. Building on the strength of these findings, we expect to initiate our first Phase 3 pivotal trial in 2026 and remain confident in ELVN-001’s potential within the CML treatment landscape. We also strengthened our balance sheet through our recent public offering, which generated gross proceeds of approximately $230 million and extended our cash runway into the first half of 2029."

Pipeline Updates

ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (CML).

In June 2025, the Company announced positive updated data from the ongoing ENABLE Phase 1 clinical trial evaluating ELVN-001 in patients with previously treated CML (NCT05304377) in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress.
As of the April 28, 2025, cutoff date, 25 of 53 (47%) evaluable patients were in major molecular response (MMR) by 24 weeks, with 13 of 41 (32%) achieving and 12 of 12 (100%) maintaining MMR.
ELVN-001 remains well-tolerated across all evaluated doses.
These data continued to compare favorably to precedent Phase 1 MMRs for approved BCR::ABL1 tyrosine kinase inhibitors (TKIs), particularly given the more heavily pretreated patient population in the ELVN-001 clinical trial.
Specifically, the achieved MMR rate by 24 weeks of 32% compares favorably with historical data from less heavily pretreated patients receiving asciminib, which showed achieved MMR rates of 24% in the Phase 1 trial and 25% in the ASCEMBL Phase 3 trial.
The Company plans to initiate a Phase 3 pivotal trial in 2026.
Second Quarter 2025 Financial Results

Cash Position: As of June 30, 2025, the Company had cash, cash equivalents and marketable securities totaling $490.5 million, which is expected to provide cash runway into the first half of 2029.
Research and development (R&D) expenses: R&D expenses were $21.5 million for the second quarter of 2025, compared to $18.8 million for the second quarter of 2024.
General and administrative (G&A) expenses: G&A expenses were $7.1 million for the second quarter of 2025, compared to $5.8 million for the second quarter of 2024.
Net Loss: Enliven reported a net loss of $25.3 million for the second quarter of 2025, compared to a net loss of $20.0 million for the second quarter of 2024.