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K36 Therapeutics Receives FDA Clearance of Investigational New Drug (IND) Application for KTX-2001 in Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Announces Clinical Trial Collaboration with Bayer for Supply of Darolutamide

On August 7, 2025 K36 Therapeutics, Inc. ("K36"), a privately held clinical-stage biotechnology company developing novel, targeted therapies for cancers with unmet medical need, reported the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) Application for KTX-2001, a selective, oral inhibitor of NSD2 (nuclear receptor-binding SET domain protein 2), a histone methyltransferase and oncogene that activates gene expression in some cancers (Press release, K36 Therapeutics, AUG 7, 2025, View Source [SID1234655011]).

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With this clearance, KTX-2001 becomes the second NSD2 inhibitor from K36 to advance into clinical development. This Phase 1 program will evaluate KTX-2001 both as a monotherapy and in combination with Bayer’s androgen receptor inhibitor, darolutamide, for metastatic castration-resistant prostate cancer (mCRPC) NCT07103018.

"We are proud to announce the FDA cleared the IND for our second clinical program, KTX-2001, on July 3rd. This achievement demonstrates our team’s efficiency and focus on advancing KTX-2001 and positively impacting the lives of patients with mCRPC," said Terry Connolly, Ph.D., President and Chief Executive Officer of K36. "Along with this significant milestone, I am delighted to announce the Company has entered into a clinical trial collaboration agreement with Bayer for supply of darolutamide for the combination with KTX-2001 in our trial."

Under the terms of the agreement, K36 will conduct and sponsor the trial and Bayer will supply darolutamide. K36 maintains development and commercial rights to KTX-2001. KTX-2001 is a highly potent and selective inhibitor of NSD2 that is being developed for the treatment of solid tumors, initially mCRPC, and compliments K36’s first clinical candidate, KTX-1001, that is being developed for the treatment of relapsed and/or refractory multiple myeloma patients with genetic translocation t(4;14).

Separately, K36 announced it has selected the Prostate Cancer Clinical Trials Consortium (PCCTC) as the Contract Research Organization (CRO) who will operationalize the KTX-2001 clinical program, STRIKE-001. "We are pleased to partner with K36 as its CRO. PCCTC has established a robust network of academic and community sites, and has significant expertise in managing innovative, multisite prostate cancer clinical trials and are uniquely positioned to support the efficient launch and execution of the STRIKE-001 trial," said Jake Vinson, CEO of the PCCTC.

Jason Redman, MD, Senior Medical Director at K36 Therapeutics and leader of the KTX-2001 prostate cancer program stated, "Targeting NSD2 inhibition as a first-in-class, oral therapy represents a fundamentally new approach to treating prostate cancer by modulating the epigenetic drivers of tumor progression. This novel mechanism is distinct from other epigenetic therapies and addresses the underlying biology in a new way. The STRIKE-001 Phase 1 trial marks an important step forward, bringing a promising new option to patients with limited treatment alternatives."

About KTX-2001

KTX-2001 is a small molecule, specific inhibitor of the nuclear receptor binding SET domain protein 2 (NSD2) (also known as multiple myeloma [MM] SET domain-containing protein [MMSET]/Wolf-Hirschhorn syndrome candidate 1 protein [WHSC1]). Both KTX-1001 and KTX-2001 specifically inhibit NSD2 methylation of histone H3 at lysine 36 (H3K36) and disrupts aberrant NSD2-dependent oncogenic pathways.

About the KTX-2001 Phase 1 Clinical Trial

The Phase 1 clinical trial STRIKE-001 NCT07103018 is a multi-center, open label dose escalation of KTX-2001 single agent (Part A) and KTX-2001 combination with darolutamide (Part B). Part A will evaluate the safety and tolerability, maximum tolerated dose and recommended phase 2 dose(s) of KTX-2001 monotherapy in participants with mCRPC. Part B will study the safety and tolerability of KTX-2001+darolutamide to determine the recommended Phase 2 dose(s) of KTX-2001+darolutamide in participants with mCRPC. Additionally, objectives for Parts A and B include pharmacokinetics, pharmacodynamics and preliminary clinical activity. K36 expects to enroll approximately 140 participants with mCRPC who have progressed on a second generation or later androgen receptor inhibitor (AR) targeted therapy/androgen biosynthesis inhibitor starting in 2H2025.

US NCI Sponsors Senhwa Biosciences’ Second Program-IND Submitted for Clinical Trial Targeting MYC-Aberrant Lymphoma

On August 7, 2025 Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported that US National Cancer Institute (NCI) sponsors Senhwa’s second program IND has been submitted to US FDA for clinical trial targeting MYC-aberrant lymphoma (Press release, Senhwa Biosciences, AUG 7, 2025, View Source [SID1234655010]). Following the initiation of the first trial using CX-5461 as a monotherapy in advanced solid tumors, the IND-submission of the second trial marks a milestone in the development of CX-5461.

With sponsorship from the NCI, this program significantly reduces Senhwa’s clinical development expenditures, easing its R&D financial demands while enhancing the overall project value and commercialization potential—a major positive for the company’s future growth.

A Globally Innovative G4-Targeting Mechanism Against Hard-to-Treat MYC-Driven Lymphomas – 30% of Cancers Involve MYC Mutation

MYC is a critical oncogene, with approximately 28% of cancer patients exhibiting gene amplification or mutation, including in lung, breast, liver cancers, and lymphomas. The MYC protein drives cell proliferation, angiogenesis, and apoptosis suppression, playing a key role in multiple malignancies. CX-5461, developed by Senhwa, precisely stabilizes the G-quadruplex (G4) structures in DNA within cancer cells, suppressing MYC gene expression and effectively disrupting tumor growth pathways.

Preclinical research has demonstrated that CX-5461 exhibits strong inhibitory effects against MYC-overexpressing tumors, highlighting its potential as a next-generation targeted cancer therapy—especially promising for difficult-to-treat lymphomas.

With NCI Sponsorship Significantly Reduces R&D Costs

The clinical trial program is fully led and partially funded by the NCI, covering clinical trial design, operational personnel, trial sites, regulatory, and data management resources. According to Senhwa’s internal estimates, this sponsorship could reduce Senhwa’s clinical development expenditures, easing its R&D financial costs, enhancing development efficiency and accelerating commercialization progress.

Substantial Market Potential for B-cell Lymphomas – Global Annual Sales Expected to Surpass USD 10 Billion

According to BioSpace market data, global sales of B-cell lymphoma therapies reached USD 4.9 billion in 2024 and are projected to grow to USD 8.9 billion by 2035, with a steady compound annual growth rate (CAGR) of 5.79%. There is particularly strong demand for novel targeted therapies for relapsed and refractory lymphoma patients, revealing a significant market gap.

With its unique mechanism and precision medicine potential, Senhwa’s CX-5461 is well-positioned to enter the high-value niche market upon successful progression into late-stage clinical trials and potential regulatory approval, offering substantial commercial value.

CX-5461: The World’s First and Most Advanced G4-Quadruplex Stabilizer for Cancer Treatment

CX-5461 is the world’s first and most advanced anti-cancer investigational drug targeting G-quadruplex DNA structures. It specifically modulates the expression of key oncogenes like MYC, thereby inhibiting cancer cell proliferation and survival. The upcoming NCI-sponsored will evaluate CX-5461 dose optimization and treatment efficacy in Patients with MYC-aberrant, specific subtypes of aggressive B-cell non-Hodgkin lymphoma who have received at least one prior line of therapy and have no other available treatment options, aiming to address critical unmet medical needs with a potentially breakthrough therapeutic solution.

Minghui Pharmaceutical Announces USD 131 Million Pre-IPO Financing to Advance Late-Stage Pipeline and Global Expansion

On August 7, 2025 Minghui Pharmaceutical ("Minghui"), a late-stage clinical biopharmaceutical company, reported the closing of a USD 131 million Pre-IPO financing led by new investors OrbiMed and co-led by Qiming Venture Partners (Press release, Minghui Pharmaceutical, AUG 7, 2025, View Source [SID1234655009]). Further support came from existing investor TF Capital, and seven new investors, including including BioTrack Capital, 5Y Capital, New Day Fund, and Wider Link Enterprise Investment limited. Representatives from OrbiMed and Qiming Venture Partners will join the company’s Board of Directors.

Proceeds will be used to advance the company’s clinical programs, with a particular focus on its PD-1/VEGF bispecific antibody and combination strategies with antibody-drug conjugates (ADCs). The funds will also support the planned commercial launch of its topical JAK inhibitor in China.

"This financing marks an important milestone as we continue to advance a globally competitive pipeline and enter our next stage of growth," said Dr. Guoqing Cao, Chief Executive Officer of Minghui. "We’re grateful for the confidence and support of our investors and remain committed to delivering innovative medicines that improve outcomes for patients worldwide."

"We have been impressed by Minghui’s scientific rigor, execution capabilities, and differentiated pipeline," said Dr. David Wang, Partner and Senior Managing Director at OrbiMed Asia. "We’re excited to support the company as it transitions towards commercialization and expands its global footprint."

"Minghui has built a compelling portfolio of novel drug candidates targeting critical unmet medical needs," said Dr. Kan Chen, Partner and Co-lead of Healthcare at Qiming Venture Partners. "We are pleased to support its continued growth and help bring transformative therapies to patients around the world."

Whitehawk Therapeutics Reports Second Quarter 2025 Financial Results and Recent Highlights

On August 7, 2025 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved ADC cancer treatments, reported financial results for the second quarter ended June 30, 2025, and provided recent corporate progress (Press release, Whitehawk Therapeutics, AUG 7, 2025, View Source [SID1234655008]).

"We’re pleased with the progress made in Q2 to advance our ADC portfolio and remain on track to file INDs for our first two programs – HWK-007 and HWK-016 – by year-end 2025, with the third program, HWK-206, to follow in mid-2026," said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. "We believe we are well-positioned to advance our pipeline and generate key clinical data across the portfolio with our existing cash position."

Recent Operational Highlights:

On track to bring all three assets to IND by mid-2026. IND submissions are planned by year-end 2025 for HWK-007 and HWK-016. An IND for HWK-206 is expected by mid-2026.

Focused execution and capital efficiency support anticipated runway into 2028. Based on current plans, cash position enables initial clinical data readouts across the portfolio.
Second Quarter 2025 Financial Results:

Cash, cash equivalents and short-term investments as of June 30, 2025, were $177.2 million as compared to $47.2 million as of December 31, 2024. Cash is anticipated to fund operations into 2028 based on current plans.

Net loss for the three months ended June 30, 2025, was $52.6 million as compared to $14.6 million for the three months ended June 30, 2024. This includes the remaining portion of the upfront payment of $38.0 million under the Wuxi ADC agreement.

Helix and Veracyte Partner to Expand Access to Clinically Actionable Genomic Insights in Prostate Cancer Care

On August 7, 2025 Helix, a leader in precision health, reported a partnership with leading cancer diagnostics company Veracyte that will make it easier for urologists to add comprehensive germline testing for patients with high-risk localized and metastatic prostate cancer (Press release, Veracyte, AUG 7, 2025, View Source [SID1234655007]). Through this collaboration, Helix’s whole-exome based hereditary cancer test will be available alongside Veracyte’s Decipher Prostate test, enabling a more complete view of each patient’s cancer biology and inherited risk.

The partnership was also highlighted during Veracyte’s earnings call, reinforcing the shared commitment to expanding access to clinically actionable genomic insights in prostate cancer care.

The National Comprehensive Cancer Network (NCCN) guidelines recommend germline genetic testing for patients with metastatic and high-risk localized prostate cancer. Germline findings can influence therapeutic decision-making, including the use of targeted therapies like PARP inhibitors. The integration of Helix’s hereditary cancer test into the Decipher ordering workflow gives physicians a convenient way to access this important information and deliver more personalized care.

"Patients diagnosed with cancer deserve seamless access to genomic insights that can improve their care – not just in academic centers, but wherever they’re treated," said James Lu, M.D., Ph.D., CEO and co-founder of Helix. "Through our work with Veracyte, we’re helping expand access to both germline and transcriptomic insights in a single clinical workflow, so physicians can more easily align care decisions with the latest clinical guidelines."

Understanding a patient’s inherited predisposition to cancer offers a number of benefits. It can inform treatment choices, identify risk for additional cancers, and provide actionable information to at-risk family members. When paired with pharmacogenomic (PGx) testing, providers can also better match treatments to each patient’s genetic profile to improve safety and efficacy.

This collaboration is part of Helix’s broader mission to make precision medicine more accessible and impactful for all patients. Helix currently runs the Helix Research Network, the largest and fastest growing precision clinical research network in the world, where several of their partners have begun launching universal cancer screening programs for patients diagnosed with cancer. With its proprietary Exome+ assay and Sequence Once, Query Often model, Helix delivers high-quality genomic insights at scale, enabling ongoing clinical value that may reduce the need for repeat testing.