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MAIA Biotechnology Announces New Responder in Non-Small Cell Lung Cancer Phase 2 Clinical Trial

On June 5, 2025 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported a new partial response (PR) was identified in a patient after 20 months of treatment in its Phase 2 THIO-101 clinical trial evaluating ateganosine (THIO), sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo) in patients with advanced non-small cell lung cancer (NSCLC) who are resistant to immune therapy and chemotherapy (Press release, MAIA Biotechnology, JUN 5, 2025, View Source [SID1234653750]). A partial response is defined as a decrease in tumor size of at least 30%.

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"The patient remained on treatment and we observed stable disease for more than twenty months before the partial response was identified, highlighting the efficacy, safety and low toxicity of the treatment. Extended-term responses like this are not often seen in heavily pretreated patients in hard-to-treat diseases such as NSCLC, where the prognosis for the advanced-stage of the disease is typically poor," said MAIA Chairman and CEO Vlad Vitoc, M.D. "We confirmed this response with a second scan, and we are highly confident that ateganosine could become an outstanding therapeutic alternative for third-line NSCLC patients."

THIO-101 third line (3L) data cutoff from May 15, 2025, showed median overall survival (OS) of 17.8 months for the 22 NSCLC patients who received at least one dose of ateganosine in parts A and B of the trial. At the data cutoff, the patient with the longest survival in the trial had completed 32 cycles of therapy and had 24.3 months survival. Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months.1

MAIA has announced the trial design for an expansion of its THIO-101 pivotal Phase 2 trial in NSCLC to assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous CPI treatment and chemotherapy.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

Tracer Biotechnologies Announces Strategic Partnership with QIAGEN to Advance Blood-Based MRD Testing for Solid Tumors

On June 5, 2025 Tracer Biotechnologies, a leader in blood-based molecular diagnostics for cancer, reported a strategic partnership with QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) to co-develop and commercialize minimal residual disease (MRD) assays for solid tumors on QIAGEN’s QIAcuity digital PCR platform (Press release, Qiagen, JUN 5, 2025, View Source [SID1234653749]).

This collaboration aims to deliver highly sensitive, cost-effective, and decentralized MRD testing solutions that enable oncologists to monitor cancer recurrence and guide personalized treatment decisions using minimally invasive blood samples.

"Partnering with QIAGEN enables Tracer to bring our solid tumor MRD expertise to a broader market using a robust digital PCR platform in QIAcuity," said Mark Kaganovich, CEO of Tracer Biotechnologies. "With QIAcuity’s sensitivity and scalability, we can deliver high-quality companion diagnostics that integrate seamlessly into clinical workflows and offer new options to oncologists and patients."

Tracer offers two complementary MRD solutions:

Tracer dPCR, a tumor-informed, multiplexed digital PCR assay that allows institutions to run bespoke MRD tests internally using their own digital PCR instruments;
Tracer WGS, an AI-powered whole-genome ctDNA platform that enables ultra-sensitive tumor-agnostic detection and tracking with no need for prior tissue.
"This new partnership represents an important step in further establishing QIAGEN’s major role in oncology. We are bringing innovative MRD technologies into drug development through our companion diagnostic partnerships," said Jonathan Arnold, Vice President, Head of Partnering for Precision Diagnostics at QIAGEN. "In particular, we want to strengthen our scalable, cost-effective solutions based on our QIAcuity digital PCR system and enable our pharmaceutical partners to use MRD insights for guiding personalized treatment decisions for cancer patients."

Tracer’s mission is to turn every digital PCR machine and next-generation sequencer into a sensitive MRD assay—empowering institutions, pharmaceutical companies, and clinicians with the tools to decentralize testing, accelerate treatment decisions, and personalize cancer care.

Kelun-Biotech Announces Approximately US$250 Million Placement

On June 5, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported the placement of 5,918,000 H shares under its general mandate, representing approximately 2.54% of the enlarged share capital of the Company post the placement (Press release, Kelun, JUN 5, 2025, View Source [SID1234653748]). The shares were placed at HK$331.8 per share, raising net proceeds of approximately US$250 million.

Highlights of the placement include:

The offering was widely recognized by a broad-based investors including domestic and international institutional investors. The transaction was multiple times oversubscribed with robust participation from high-quality investors including global long only funds, sovereign wealth funds, and healthcare specialist funds;
Due to the robust booking demand, the deal size was upsized from the initially targeted US$200 million at launch to US$250 million, making it the largest follow-on offering in the biopharma industry in the Hong Kong market over the past 12 months;
The final offer price represents a 7.58% discount to the last closing price and a 0.89% premium to the average closing price over the past five trading days.
The Company primarily intends to use the net proceeds of the placing (i) for the research and development, clinical trials, registration filings, manufacturing and commercialization of its products; (ii) to enhance its internal research and development technology capabilities, strengthen external collaboration, and expand its product pipeline portfolio.

Dr. Michael Ge, CEO of Kelun-Biotech, commented: "We are pleased to see continued support from our key existing shareholders, alongside the addition of new, high-profile investors. This reflects the strong recognition of Kelun-Biotech’s long-term investment value by international capital markets and specialist investors. With the support of this financing, we aim to further strengthen our pipeline strategy and accelerate global clinical development. This will enable us to unlock the potential of cutting-edge therapies and deliver innovative treatments to benefit more cancer patients."

Hengrui Pharma Showcases Global Impact at the 2025 ASCO: 72 Study Results Highlight Chinese Cancer Innovation

On June 5, 2025 Hengrui Pharma reported a strong international presence, featuring 15 innovative drugs and 72 research outcomes at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting successfully concluded in Chicago on June 3 (local time) (Press release, Hengrui Pharmaceuticals, JUN 5, 2025, View Source [SID1234653747]). These included 4 oral presentations, 5 rapid oral presentations, 27 poster presentations, and 36 online publications. Multiple groundbreaking research advances has elicited widespread discussion among global experts.

In the field of breast cancer, results from 19 studies evaluating the company’s innovative drugs—pyrotinib, dalpiciclib, camrelizumab, apatinib, adebrelimab, Trastuzumab rezetecan (SHR-A1811), and SHR-2017, either in combination with each other or with chemotherapies, were presented at ASCO (Free ASCO Whitepaper) 2025. Notably, 7 studies involving pyrotinib and 6 studies involving dalpiciclib were selected, with both agents consistently demonstrating promising efficacy, reinforcing their established roles in breast cancer treatment. Furthermore, studies evaluating SHR-A1811 and adebrelimab were selected for rapid oral presentations, attracting considerable attention from the industry.

In the field of gastrointestinal cancers, drugs such as camrelizumab, apatinib, adebrelimab, and SHR-8068 were featured in a total of 30 accepted studies. Notably, camrelizumab was included in 21 of these studies, demonstrating its broad therapeutic profile and potential while reinforcing its position as a key focus at ASCO (Free ASCO Whitepaper). This further solidifies the achievements of China-developed PD-1 inhibitors on the global stage. Additionally, adebrelimab, which has achieved significant breakthroughs in lung cancer in recent years, is actively expanding into new indications. At this year’s ASCO (Free ASCO Whitepaper), five related studies exploring adebrelimab’s efficacy in indications such as hepatocellular carcinoma (HCC), cholangiocarcinoma (CCA) , and pancreatic cancer were presented. The ongoing emergence of cutting-edge research on both established and emerging agents holds promise for improving clinical outcomes for patients with gastrointestinal tumors.

Across a wide range of disease areas—including lung cancer, gynecologic cancers, lymphoma, bladder cancer, head and neck cancer, melanoma, sarcoma, nasopharyngeal carcinoma, chordoma, salivary gland cancer, thymic cancer, desmoid tumors, and salivary duct carcinoma—Hengrui Pharma’s innovative oncology portfolio (camrelizumab, apatinib, adebrelimab, pyrotinib, dalpiciclib, fluzoparib, famitinib, SHR-A1811, SHR-1501, SHR-1701, SHR-1826, SHR-A1912, and SHR-A2102) was featured in 22 research presentations at ASCO (Free ASCO Whitepaper) 2025. These comprised 4 oral presentations, 2 rapid oral presentations, 12 poster presentations, and 4 online publications, collectively demonstrating the company’s robust R&D capabilities. Additionally, one online publication highlighted ondansetron oral soluble film, underscoring its favorable efficacy in preventing and treating chemotherapy-induced nausea and vomiting (CINV).

For 15 consecutive years, Hengrui Pharma has consistently presented its cutting-edge research at the ASCO (Free ASCO Whitepaper) Annual Meeting, highlighting the company’s global leadership in oncology drug research and development while showcasing China’s robust pharmaceutical innovation capabilities to the international academic community. The inclusion of 70 Hengrui-sponsored studies at this year’s meeting reflects the strong foundation laid by the company’s portfolio of 23 marketed innovative drugs and a robust pipeline of over 90 candidates currently in development. Looking ahead, Hengrui will remain committed to its patient-centric approach, striving to develop advanced therapeutics that support the "Healthy China" initiative and enhance clinical outcomes for patients globally.