On June 25, 2025 Gilead Sciences, Inc. (NASDAQ: GILD) and Kymera Therapeutics, Inc. (NASDAQ: KYMR), reported that they have entered into an exclusive option and license agreement to accelerate the development and commercialization of a novel molecular glue degrader (MGD) program targeting cyclin-dependent kinase 2 (CDK2) with broad oncology treatment potential including in breast cancer and other solid tumors (Press release, Gilead Sciences, JUN 25, 2025, View Source [SID1234654124]).

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!

CDK2-directed MGDs are a new type of drug designed to remove CDK2 – a key contributor in tumor growth – rather than just inhibiting its function. Traditional inhibitors of CDK2 prevent it from working but often interfere with similar proteins, which can cause undesired side effects. MGDs have the potential to provide more precise, safe and effective treatments for cancers that rely on CDK2 activity by selectively removing this protein from cells.

"MGDs are opening exciting new possibilities in cancer research by offering a way to eliminate disease-driving proteins rather than just blocking them. This mechanism aligns within our oncology scientific framework where we evaluate therapeutic agents that selectively target and kill cancer cells with minimal impact on healthy tissue," said Flavius Martin, MD, Executive Vice President, Research, Gilead Sciences. "We are delighted to partner with Kymera to advance this novel oral program with the potential to drive meaningful improvements in the standard of care for patients living with breast cancer and other cancers that are inadequately served with existing therapies."

"We are excited to announce this strategic collaboration with Gilead Sciences, highlighting our dedication to innovation in the field with our first disclosed molecular glue program. We are committed to developing highly selective, potent, oral degrader medicines that address key disease-causing proteins and pathways that are undrugged or inadequately drugged by existing technologies," said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. "Our highly specific, orally active, CDK2 molecular glue degraders have demonstrated a compelling preclinical profile and have the potential to transform the therapeutic landscape for breast cancer patients and other tumor types with high unmet medical need. We are excited to work with the talented Gilead team to accelerate the development and commercialization of this important program."

Terms of the Agreement

Under the terms of the agreement, Kymera is eligible to receive up to $750 million in total payments, including up to $85 million in upfront and potential option exercise payments. In addition, Kymera may also receive tiered royalties ranging from high single-digit to mid-teens on net product sales under the collaboration. Kymera will lead all research activities for the CDK2 program. If Gilead exercises its option to exclusively license the program, Gilead will have global rights to develop, manufacture and commercialize all products resulting from the collaboration.

Gilead does not exclude acquired IPR&D expenses from its non-GAAP financial measures. This transaction with Kymera is expected to reduce Gilead’s GAAP and non-GAAP 2025 EPS by approximately $0.02 – $0.03.

On June 25, 2025 UP Oncolytics, a neuro-oncology biotechnology company based in Milwaukee and a spin-out of the Advocate Aurora Research Institute, reported to have received a $75,000 matching grant from the Wisconsin Economic Development Corporation (WEDC) in partnership with the University of Wisconsin (Press release, UP Oncolytics, JUN 25, 2025, View Source [SID1234654123]). The grant supplements the company’s $500,000 SBIR Phase I Fast Track award from the National Institutes of Health (NIH), received last year.

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 funding will support further preclinical development of UP Oncolytics lead therapy — an oncolytic virus targeting gliomas, the most common form of brain cancer. The company is also exploring its application in other cancer types.

In early 2025, UP Oncolytics established and expanded its research laboratories at Rosalind Franklin University’s Helix 51 biomedical incubator. Under the leadership of Dr. Parvez Akhtar, chief scientific officer and co-founder, the company recruited senior scientist Dr. Steven Markwell from AbbVie. Dr. Markwell, a cell and molecular biologist, previously served as a postdoctoral research fellow at Northwestern University, specializing in pre-clinical glioblastoma models and tumor microenvironment research.

UP Oncolytics has also strengthened its leadership team. Dr. Gary Gordon, a former oncologist trained at Johns Hopkins, has joined the board. He brings more than 13 years of experience as vice president of oncology development at AbbVie, and has held senior roles at Abbott, Ovation Pharmaceuticals, Pharmacia, and G.D. Searle.

Michael Rosen, MBA, managing director of RFU’s Innovation and Research Park and Helix 51, has joined the board as an observer. With more than 20 years of industry experience at Pfizer, Bristol-Myers Squibb, and G.D. Searle, and, as CEO, Mr. Rosen has contributed to the development of three cancer biotech companies in Europe and the U.S., including one that successfully went public.

In the fourth quarter of 2024, the FDA granted Orphan Drug designation to UP Oncolytics for its oncolytic virus therapy for gliomas.

"We are pleased with our progress over the past year, including the establishment of our new laboratories at Helix 51," said neurosurgeon and UP Oncolytics President and CEO Dr. Richard Rovin. "There is an urgent, unmet need for new treatments for malignant gliomas. We are working hard to bring our oncolytic virus into clinical trials."

"We share Dr. Rovin’s enthusiasm for these milestones and look forward to the impact this work could have on glioma patients," said RFU Executive Vice President for Research Dr. Joseph DiMario.

On June 25, 2025 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company, held its 2025 Annual Shareholders’ Meeting, chaired by Chairman Mr. Benny T. Hu, reported that the company delivered updates on its ongoing drug development programs, outlining four key strategic milestones poised to drive its transformative growth (Press release, Senhwa Biosciences, JUN 25, 2025, View Source [SID1234654122]):

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!

Launch of a new HIV "Functional Cure" strategic program
Advancement of partnership discussions with leading global immunotherapy companies
Active negotiations of multiple licensing opportunities
Dual-engine therapeutic breakthroughs from CX-4945 and CX-5461
Silmitasertib (CX-4945): Unlocking New Hope for HIV Cure

In March, Senhwa made the strategic decision to discontinue its Community-Acquired Pneumonia clinical trial, prompting investor concern. This shift, based on compelling interim findings, redirected focus to the promising potential of CX-4945 in HIV treatment.

Dr. Jason Huang, Acting CEO and Chief Medical Officer, revealed that in HIV-positive participants within the Community-Acquired Pneumonia study, a significant and rapid increase in a key immune biomarker was observed, potentially reflecting a marked restoration of previously impaired immune function. This finding suggests that CX-4945 may represent a novel therapeutic option and a new opportunity for those affected by HIV.

At the same time, to address gastrointestinal side effects observed in previous studies, Senhwa is in the final stages of developing a new formulation of CX–4945. The updated formulation is designed to significantly reduce GI discomfort while also extending the compound’s intellectual property protection for an additional 20 years, supporting both patient tolerability and long-term commercial value.

The company is currently consulting with the U.S. FDA on its clinical development pathway and is planning a small-scale pilot study in Taiwan. The trial will focus on evaluating the combined effects of CX–4945 on latent HIV reactivation and immune enhancement. Given the lifelong adherence required by current HIV therapies, a successful approach incorporating CX-4945 could present a scalable and transformative path to functional cure for tens of millions of HIV patients worldwide.

CX-4945 for Basal Cell Carcinoma (BCC): Strong Clinical Efficacy in Refractory Patients

Recent trial results from CX-4945 in patients with advanced BCC who had failed standard and immunotherapy treatments showed highly encouraging outcomes. Among 25 evaluable patients: 3 achieved Partial Response (PR) and 10 achieved Stable Disease (SD). Two patients had Progression-Free Survival (PFS) exceeding 21 months. Senhwa is currently in active discussions with several potential collaborators.

Pidnarulex (CX-5461): Broad-Spectrum Oncology Innovation

As another globally first-in-class asset, CX-5461 is advancing through multiple clinical programs, including the NIH 5-Year Anti-Cancer Initiative and a trial in North America targeting solid tumors with specific genetic deficiencies (BRCA1/2, PALB2). In addition to a monotherapy study in late-stage solid tumors (HRD/non-HRD), the NIH NExT Program is preparing three other protocols: CX-5461 with immunotherapy for colorectal cancer, CX-5461 with ADC, now a major focus in oncology innovation, for breast cancer and CX-5461 monotherapy for MYC-driven lymphomas. All three projects are underway, with IND submissions and patient enrollment expected soon.

Among North American patients in the ongoing trial, several have achieved PR or SD despite failing previous treatments. Most notably, a patient with pancreatic cancer, considered one of the most lethal and treatment-resistant malignancies, has survived over 22 months on CX-5461 while maintaining quality of life. This represents an extraordinary outcome in clinical oncology. Senhwa aims to complete enrollment and data analysis for this trial in 2026 and is concurrently evaluating out-licensing or joint development options.

CX-5461 + Immunotherapy: A Dual-Engine Powerhouse

CX-5461 uniquely reprograms the tumor microenvironment (TME) by activating tumor-infiltrating lymphocytes (TILs) and dendritic cells (DCs), converting "cold" tumors into "hot" tumors. This transformation significantly enhances the responses to immune checkpoint inhibitors (e.g., PD-1/PD-L1), which currently benefit only 20–30% of patients.

Senhwa is planning clinical programs combining CX-5461 with immunotherapy across multiple cancers, including pancreatic cancer, head and neck cancer, and melanoma. The company is in strategic discussions with global immuno-oncology companies and aims to launch these studies in 2026, targeting a share of the multibillion-dollar global immunotherapy market.

A Year of Execution and Transformative Progress Ahead

From HIV to pancreatic cancer and beyond, Senhwa’s multi-front strategy signals its commitment to addressing unmet medical needs. The management team expressed sincere gratitude to shareholders for their patience and continued trust, and reaffirmed its commitment to delivering on key milestones in the shortest possible time to realize the value of shareholder support. Senhwa is positioning itself as a global leader in next-generation therapeutics and a comprehensive solutions provider for unmet medical needs.

On June 25, 2025 Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, reported that dosing has begun in a phase 3 clinical study for BAT8006, an antibody drug conjugate targeting folate receptor α for the treatment of platinum-resistant ovarian cancer (Press release, BioThera Solutions, JUN 25, 2025, View Source;for-the-treatment-of-platinum-resistant-ovarian-cancer-302490679.html [SID1234654121]). The phase 3, randomized, open-label, parallel-group clinical trial (Clinical Trial Registration Number: CTR20251345) of BAT8006 is designed to assess the efficacy of BAT8006 versus investigator’s choice of single-agent chemotherapy in patients with platinum-resistant high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.

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!

At the Rapid Oral Abstract Session of the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, early clinical data of BAT8006 demonstrated promising results in platinum-resistant ovarian cancer. Among 133 enrolled patients (regardless of FRα expression levels or prior lines of therapy) in the dose-escalation and expansion study, the therapy achieved a median progression-free survival (PFS) of 7.63 months, with an objective response rate (ORR) of 40.7% and disease control rate (DCR) of 80.5%. Importantly, no cases of interstitial lung disease or ocular toxicity were observed. These findings indicate that BAT8006 exhibits significant clinical efficacy and a favorable safety profile, highlighting its strong clinical potential for platinum-resistant ovarian cancer.

Platinum-resistant ovarian cancer remains a significant clinical challenge with poor patient prognosis and limited treatment options. Currently, only one FRα-targeting antibody-drug conjugate (ADC) is approved globally, and its indication is restricted to patients with FRα expression ≥75% (only 25%-30% of the platinum-resistant population). This approved therapy demonstrates limited median progression-free survival (mPFS) and is associated with ocular toxicity.

As one of the first FRα ADCs in China entering a pivotal phase 3 clinical trial, BAT8006 has the potential to demonstrate clinically meaningful efficacy across the full spectrum of platinum-resistant ovarian cancer patients (regardless of FRα expression levels). These promising data suggest BAT8006 may offer a novel therapeutic option for this difficult-to-treat population.

On June 25, 2025 Blue Earth Therapeutics reported radiation dosimetry results for its radiohybrid lutetium labelled, PSMA targeted, investigational radioligand therapy at the Society for Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting (Press release, Blue Earth Therapeutics, JUN 25, 2025, View Source [SID1234654120]). The Phase 1 clinical trial results were presented by Professor James Nagarajah of Radboud University Medical Centre, the Netherlands. Data were evaluated from 34 cycles of treatment across 13 metastatic castrate resistant prostate cancer patients in the radiation dosimetry portion of a Phase 1/2 clinical trial (NCT05413850) of Lutetium (177Lu) rhPSMA-10.1 Injection.

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 abstract can be found here: View Source;sid=46736&abid=146032

The data presented analysed tumour, kidney, salivary gland, and other healthy organ-absorbed radiation doses, and calculated tumour-to-kidney (T:K) and tumour-to salivary gland (T:S) ratios. These data used a tumour dosimetry methodology in which PET or SPECT scans identified lesions for evaluation that is in line with those reported in the literature for other radioligand therapies.

Mean tumour-absorbed dose was 8.87 Gy/GBq
Mean kidney-absorbed dose was 0.30 Gy/GBq
Mean salivary gland-absorbed dose was 0.13 Gy/GBq
The tumour:kidney ratio was 32.09
The tumour:salivary gland ratio was 73.19
An additional "anatomy-based" dosimetry evaluation was also performed, which used tumour volumes defined only on CT scan by a blinded radiologist, thereby capturing all regions of the tumour irrespective of uptake of the drug. In this analysis, the T:K and T:S ratios were 9 and 19, respectively.

David Gauden DPhil, CEO of Blue Earth Therapeutics, said, "Numerous studies across various cancer types have shown the therapeutic value of delivering high radiation doses to tumours. At the same time, due to the risk of normal organ toxicity, one cannot simply administer unlimited amounts of radioactivity to patients. The solution is to develop therapeutic agents that improve the tumour:normal organ ratios so that the proportion of injected radioactivity reaching the tumors is scaled up to maximise efficacy. The Phase 1 dosimetry data being presented here at SNMMI is an important validation of the concept that improved agents are possible. We look forward to the clinical efficacy results from the ongoing Phase 2 portion of the trial. In this phase, we may begin to see benefits driven by the unique properties of the rhPSMA molecule. Additionally, the novel dosing regimen, which is designed to deliver higher cumulative doses of radioactivity with front-loading in the early treatment cycles, could provide further therapeutic advantage."

About metastatic prostate cancer
In 2025 it is estimated that there will be 50,055 new cases of metastatic prostate cancer in the United States (de novo diagnoses plus recurrence from earlier stage diagnoses).1 Five-year survival for newly diagnosed metastatic prostate cancer is low, 36.6%.2 While death rates from prostate cancer have declined over the past three decades2, there is still considerable room to improve patient outcomes.

About Radiohybrid Prostate–Specific Membrane Antigen (rhPSMA)
rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses four distinct domains. The first consists of a Prostate–Specific Membrane Antigen–targeted receptor ligand. It is attached to two labelling moieties which may be radiolabeled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics.