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.

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!

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.

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.

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!

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."

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]).

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’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.

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.

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 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.

On August 7, 2025 aTyr Pharma, Inc. (Nasdaq: ATYR) ("aTyr" or the "Company"), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported second quarter 2025 results and provided a corporate update (Press release, aTyr Pharma, AUG 7, 2025, View Source [SID1234655006]).

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!

"With the recent completion of the last patient visit in our Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD), we are on track to report topline data in mid-September," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "This upcoming readout represents a major inflection point for aTyr, our clinical program for efzofitimod in ILD, and the broader sarcoidosis community, and we look forward to sharing the results."

Second Quarter 2025 and Subsequent Period Highlights

Completed the last patient visit in the global pivotal Phase 3 EFZO-FIT study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. Topline data from the study are expected in mid-September 2025. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo administered intravenously monthly for a total of 12 doses. The study enrolled 268 patients with pulmonary sarcoidosis across 85 centers in nine countries. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction measured as the absolute change from baseline to week 48. Secondary endpoints include measures of sarcoidosis symptoms and lung function. Patients who complete the study and wish to receive treatment with efzofitimod outside of the clinical trial are eligible to participate in an Individual Patient Expanded Access Program.

Announced interim data from the ongoing Phase 2 EFZO-CONNECT study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with limited or diffuse systemic sclerosis (SSc, or scleroderma)-related ILD (SSc-ILD). This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo administered intravenously monthly for a total of six doses. Enrollment in the study is ongoing, and the study intends to enroll up to 25 patients at multiple centers in the United States. The interim analysis evaluated skin assessments and serum biomarkers at baseline and week 12 for efzofitimod and placebo patients. Eight patients were evaluated, including five with diffuse and three with limited SSc-ILD. Key findings for efzofitimod-treated patients to date included:

Stable or improved modified Rodnan Skin Score (mRSS), a key measure of skin fibrosis, for all patients and an improvement of 4 points or greater for three out of four efzofitimod-treated patients with diffuse SSc-ILD, where the minimal clinically important difference (MCID) is a 4 to 6 point improvement at 12 months

Preliminary signals of improvement for inflammatory biomarkers including interferon gamma (IFN-γ) and monocyte chemoattractant protein-1 (MCP-1) and disease biomarkers Krebs von den Lungen-6 (KL-6) and surfactant protein-D (SP-D)

Efzofitimod was generally safe and well tolerated at all doses, with no treatment related serious adverse events

Advanced ATYR0101 to investigational new drug (IND) candidate stage for pulmonary fibrosis. ATYR0101 is a fusion protein derived from a proprietary extracellular domain of aspartyl-tRNA synthetase (DARS) that binds to latent transforming growth factor beta binding protein 1 (LTBP-1) to induce cell death of myofibroblasts, which are key cells responsible for driving the progression of fibrosis. The Company anticipates filing an IND application in the second half of 2026.

Preclinical data generated to date demonstrating ATYR0101’s unique anti-fibrotic mechanism through LTBP-1 were presented in an oral presentation at the American Thoracic Society 2025 Respiratory Innovation Summit

Announced that the Company was added to the Russell 2000 Index and broad market Russell 3000 Index. These additions were a part of the 2025 Russell U.S. Indexes annual reconstitution.

Second Quarter 2025 Financial Highlights and Cash Position

Cash & Investment Position: Cash, cash equivalents, restricted cash and available-for-sale investments as of June 30, 2025, were $83.2 million. Subsequent to the end of the second quarter 2025, the Company raised approximately $30.7 million in gross proceeds from its at-the-market (ATM) offering with Jefferies LLC. The Company believes its cash runway will be sufficient to fund its operations for a period of one year following the Phase 3 EFZO-FIT readout.

R&D Expenses: Research and development expenses were $15.4 million for the second quarter 2025, which consisted primarily of clinical trial costs for the Phase 3 EFZO-FIT and Phase 2 EFZO-CONNECT studies, manufacturing costs for the efzofitimod program and research and development costs for the efzofitimod and discovery programs.

G&A Expenses: General and administrative expenses were $4.9 million for the second quarter 2025.

About Efzofitimod

Efzofitimod is a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. aTyr is currently investigating efzofitimod in the global Phase 3 EFZO-FIT study in patients with pulmonary sarcoidosis, a major form of ILD, and in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.