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.

On June 5, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported the entry into definitive agreements to raise $2.5 million from the sale of shares of the company’s common stock priced at-market for Nasdaq purposes (Press release, Cellectar Biosciences, JUN 5, 2025, View Source [SID1234653736]). The closing of the offering is expected to occur on or about June 6, 2025, subject to satisfaction of customary closing conditions.

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Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the offering.

The agreements provide for the immediate exercise of certain outstanding warrants to purchase an aggregate of 8,301,322 shares of common stock, issued by the company on June 5, 2020, October 25, 2022 and July 21, 2024 (the "Existing Warrants"), at a reduced exercise price of $0.3041 per share. The shares of common stock issuable upon exercise of the Existing Warrants are all registered, or their resale is registered, pursuant to effective registration statements. The company did not issue any replacement warrants. The gross proceeds to the company from the exercise of the Existing Warrants are expected to be approximately $2.5 million, prior to deducting placement agent fees and offering expenses. The company intends to use the net proceeds for general corporate purposes, including working capital and operating expenses.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On June 5, 2025 Mission Bio, a leader in single-cell multi-omics solutions for precision medicine, reported the launch of its Single-Cell Genotype and Targeted Gene Expression assay, expanding the capabilities of its Tapestri Platform to become the only commercial solution that delivers simultaneous genotype and targeted gene expression profiling from over 10,000 single cells (Press release, Mission Bio, JUN 5, 2025, View Source [SID1234653751]). The assay, which can be leveraged for Phase 2 or 3 trials to home in on patients most likely to benefit from a cancer therapy, will be unveiled at the European Hematology Association (EHA) (Free EHA Whitepaper) meeting in Milan, Italy.

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Single-Cell Genotype and Targeted Gene Expression is available through Mission Bio’s Pharma Assay Development (PAD) services, where the company’s experts provide end-to-end support from custom single-cell assay design and development to data interpretation and assay transfer. The multi-modal assay has three primary applications: helping understand therapeutic resistance, designing next-generation T-cell therapies, and improving patient selection in clinical development.

In particular, the Single-Cell Genotype and Targeted Gene Expression assay addresses critical challenges in oncology drug development, where obtaining the complete picture of tumor heterogeneity and therapeutic resistance mechanisms has been hampered by limitations in existing and disparate methods. By capturing both genomic mutations and targeted gene expression changes in the same cell, the enhanced Tapestri Platform enables pharmaceutical researchers to gain a comprehensive, high-resolution view of cancer cell behavior and treatment response – allowing companies to derisk late-stage development.

"The majority of clinical failures in hematologic cancer drug development occur in Phases II and III, often due to inadequate patient response and lack of predictive biomarkers for patient stratification," said Brian Kim, CEO of Mission Bio. "We’re directly addressing the urgent need to understand which patients will respond to which drugs at what time, by adding this custom capability to our portfolio of tools. It builds on our continuing mission to offer the tools that drug developers need to understand drug impact at the single-cell level and de-risk late-stage clinical trial failures."

The new Single-Cell Genotype and Targeted Gene Expression assay also features sample multiplexing capabilities, reducing the cost of single-cell analysis by approximately 60% compared to using multiple technologies to generate similar insights. Tapestri users have previously developed bespoke capabilities to leverage targeted gene expression alongside single-cell genotype and multi-omics, an early demonstration of the value of Mission Bio’s newly integrated approach. Among multiple use cases has been the deconvolution of clonal architecture and tracking resistant subclones under therapeutic pressure in AML. In the future, Mission Bio’s PAD team will enable true multi-omics by adding immunophenotyping to the Single-Cell Genotype and Targeted Gene Expression assay.

Mission Bio and Partners Presenting at EHA (Free EHA Whitepaper)

EHA will feature two oral presentations from Mission Bio’s academic partners featuring use of the Tapestri Platform.

Interrogating clonal evolution of NPM1-mutant AML through genetic and genomic approaches

Dr. Linde Miles, assistant professor at Cincinnati Children’s Hospital Medical Center
Friday, 13 June, 15:45 – 16:15 CEST
Amber Hall 7+8
Session 3 Keynote lecture: Cell fate and cell plasticity in normal and malignant hematopoiesis

Dr. Lars Velten, Centre for Genomic Regulation (CRG) Barcelona, Spain
Saturday, 14 June, 14:00 – 14:20 CEST
Brown Hall 2
Both Dr. Miles and Dr. Velton will also present at Mission Bio’s EHA (Free EHA Whitepaper) evening event, The Power of One: A Night of Multi-Omics Discovery @ EHA (Free EHA Whitepaper) 2025, Friday, June 13, 2025 at 7:00 PM.

Late-Breaking Oral Session: INCA33989 is a Novel, First In Class, Mutant Calreticulin-Specific Monoclonal Antibody that Demonstrates Safety and Efficacy in Patients with Essential Thrombocythemia (ET)

Dr. John Mascarenhas, Icahn School of Medicine at Mount Sinai
Sunday, June 15, 2025, 09:15 CEST
Location TBD
Mission Bio will also be presenting six posters at EHA (Free EHA Whitepaper) in Poster Hall, beginning on Saturday, 14 June, 18:30 CEST.

CXCR4 Expression In Aml Blasts And Its Impact On CXCR4 Inhibitor Efficacy During Consolidation Therapy: Results From The Sal Blast Trial
Dr. Enise Ceran (Heidelberg, Germany)
Single Cell Multi-omic Analysis Uncovers Molecular And Clonal Events Associated With Ruxolitinib Treatment Response In Myelofibrosis
Dr. Sebastiano Rontauroli (Modena, Italy)
Characterization Of CD9 As A Novel Marker For Disease-Propagating Stem Cells In Myelofibrosis
Dr. Lara Tavernari (Modena, Italy)
Deciphering Clonal Heterogeneity In Aml Npm1 Through Single-Cell Multi-Omic
Dr. Wencke Walter (Munich, Germany)
Three Patterns Of Molecular Minimal Residual Disease Kinetics In Venetoclax + Azacitidine (V+A) Treated Acute Myeloid Leukemia (AML) Patients
Dr. Jiří Mayer (Brno, Czechia)
High-Throughput And Highly Sensitive Single Cell Genotyping With Simultaneous Chromatin Accessibility Profiling In Myeloid Precursor Conditions
Dr. Masanori Motomura (Kyoto, Japan)
For more information about Mission Bio’s Targeted Single-Cell Gene Expression assay and Pharma Assay Development services, please visit missionbio.com.

Visit Mission Bio at EHA (Free EHA Whitepaper) at booth M.10.

On June 4, 2025 Niagen Bioscience, Inc. (NASDAQ: NAGE) (formerly ChromaDex Corp.), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, reported that its Chief Executive Officer, Rob Fried, and Chief Financial Officer, Ozan Pamir, will participate in Oppenheimer’s 25th Annual Consumer Growth and E-Commerce Conference (Press release, ChromaDex, JUN 4, 2025, View Source [SID1234653705]).

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Mr. Fried is scheduled to participate in a fireside chat on Monday, Jun 9, from 2:15 p.m. to 2:50 p.m. Eastern Time (11:15 a.m. Pacific Time). To register for the Niagen Bioscience fireside chat webcast, please visit www.wsw.com.

Mr. Fried and Mr. Pamir will also hold one-on-one meetings with institutional investors throughout the day.

A replay of the webcast will be available following the event on the Niagen Bioscience Investor Relations website, www.investors.niagenbioscience.com. For additional information on Niagen Bioscience, visit www.niagenbioscience.com.

On June 4, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the National Medical Products Administration (NMPA) has approved the company’s first- in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, for the first-line treatment of persistent, recurrent, or metastatic cervical cancer, in combination with platinum-based chemotherapy, with or without bevacizumab (Press release, Akeso Biopharma, JUN 4, 2025, View Source [SID1234653721]). The NMPA approval marks the third approved indication for cadonilimab.

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With the approval for first-line cervical cancer, cadonilimab has achieved comprehensive coverage for the treatment of advanced cervical cancer, offering an innovative treatment option for patients across all stages of advanced cervical cancer. This approval addresses the critical unmet need for immune-based therapies for first-line cervical cancer patients in China and represents a significant step forward in the treatment of this disease. In addition to the treatment for first-line cervical cancer, cadonilimab is also approved for first-line treatment of advanced gastric cancer, and for the treatment of relapsed or metastatic cervical cancer who progressed on or after platinum-based chemotherapy.

The approval for cadonilimab’s use in combination with chemotherapy (with or without bevacizumab) in first-line cervical cancer is based on the clinical data from the Phase III COMPASSION-16 (AK104-303) study. In COMPASSION-16, the cadonilimab combination regimen showed a notable efficacy benefit in patients with tumors that have a negative PD-L1 expression (CPS <1), comprising 27.9% of the population in the treatment group, compared to 24.2% in the control group. The study met both progression-free survival (PFS) and overall survival (OS) endpoints, demonstrating significant improvements in both endpoints for patients treated with the cadonilimab regimen compared to standard therapies in the first-line setting for cervical cancer.

Subgroup analyses from COMPASSION-16 study indicated that both PD-L1-positive and PD-L1-negative populations, regardless of bevacizumab inclusion, benefited from the treatment. The results of the COMPASSION-16 trial were presented as a Late-Breaking Abstract (LBA) at the 2024 International Gynecologic Cancer Society (IGCS) Global Meeting, and were subsequently published in The Lancet and later reported again in Nature Reviews Clinical Oncology.

Cervical cancer remains one of the most prevalent and deadly cancers among women, with a 5-year survival rate of approximately 17.0% for patients in the advanced stages. In 2022, China reported 150,700 new cervical cancer cases, resulting in the second-largest burden of cervical cancer worldwide.

Professor Wu Xiaohua, the principal investigator of COMPASSION-16 and a professor at the Fudan University Shanghai Cancer Center, stated, "COMPASSION-16 is the first Phase III study focused on first-line cervical cancer patients in China, with internationally recognized data. We’ve seen cadonilimab’s breakthrough efficacy in both recurrent and metastatic cervical cancer, showing high effectiveness, low toxicity, and strong anti-tumor activity regardless of PD-L1 expression. This first-line combination therapy sets a new standard in cancer treatment and is expected to accelerate the clinical adoption of cadonilimab, benefiting more patients."

Dr. Xia Yu, founder, chairwoman, president, and CEO of Akeso, commented, "Cadonilimab has demonstrated significant survival benefit for cervical cancer patients across all-comer populations in both clinical trials and real-world settings. For patients who respond to PD-1/L1 monotherapy, cadonilimab offers superior therapeutic outcomes over PD-1/PD-L1 therapies. For patients with low PD-L1 expression or those who are resistant to PD-1 monotherapy, cadonilimab provides significant clinical benefits over current treatment options. Cadonilimab takes advantage of the synergistic anti-tumor effect of two immune checkpoint targets, PD-1 and CTLA-4, while producing a meaningfully lower immune side effects than the combination of PD-1 and CTLA-4 antibody therapies. This approval represents another advancement of immunotherapy 2.0 in cervical cancer therapy, offering clinically meaningful improvements in disease treatment and in patient quality of life. This achievement reflects Akeso’s robust innovation capabilities and commitment to cancer patient outcomes, and it also aligns with our corporate vision to become a global leader in developing next-generation therapeutic antibodies for patients worldwide. "

Currently, cadonilimab is included in 16 authoritative clinical treatment guidelines and consensus documents across multiple oncology indications, including gastric cancer, gynecological cancers, liver cancer, esophageal cancer, and nasopharyngeal cancer. Beyond the three approved indications, cadonilimab is also currently in over 30 Phase II and III clinical trials for other cancer types, which includes different stages of disease progression as well as different cancer sub-types. These include clinical studies on gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer.