On April 22, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that its global first-in-class PD-1/VEGF bispecific antibody, ivonescimab, in combination with chemotherapy, has demonstrated strongly positive results in the Phase III clinical trial (AK112-306/HARMONi-6) for first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC) (Press release, Akeso Biopharma, APR 22, 2025, View Source [SID1234652021]). The Independent Data Monitoring Committee (IDMC) declared that the study had met its primary endpoint of progression-free survival (PFS) at the first pre-specified interim analysis. The results of HARMONi-6 study are both statistically significant and clinically meaningful.

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Detailed results from the HARMONi-6 study will be presented at an upcoming medical conference later this year.

Data from the HARMONi-6 study show that, in the intention-to-treat (ITT) population, ivonescimab plus chemotherapy decisively beat tislelizumab plus chemotherapy in terms of progression-free survival (PFS)
The ivonescimab combination showed clinically meaningful PFS benefits in both PD-L1-positive and PD-L1-negative populations
The trial enrolled a total of 532 patients, approximately 63% of whom had centrally located squamous cell carcinoma, a distribution consistent with real-world patient populations
Ivonescimab demonstrated a favorable safety profile, with no new safety signals identified. The incidence of treatment related serious adverse events and the incidence of bleeding events of grade 3 or higher were comparable to those of the control group
The HARMONi-6 study is ivonescimab’s third Phase III clinical trial with positive results in lung cancer, highlighting that treatment with ivonescimab can overcome the limitations of bevacizumab in treating squamous-NSCLC.

The HARMONi-6 study is also ivonescimab’s second Phase III clinical trial with positive results in lung cancer in head-to-head comparisons vs. PD-1 inhibitors, further establishing ivonescimab as a comprehensive treatment option for both first-line and later-line NSCLC. This result further positions ivonescimab to improve upon and replace the current standard of care for the treatment of NSCLC. The study was conducted at 66 clinical research centers across China.

Professor Lu Shun, Director of Shanghai lung cancer, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine and principal investigator of the AK112-306 / HARMONi-6 study, commented:

"It is a great honor for us to witness ivonescimab once again successfully challenge the optimal standard of care. This breakthrough not only advances the treatment of non-small cell lung cancer but also marks a significant milestone in global oncology immunotherapy."

"The interim analysis results from the HARMONi-6 study show that ivonescimab in combination with chemotherapy significantly prolonged progression-free survival (PFS) compared to tislelizumab with chemotherapy. In patients with up to 63% central squamous carcinoma, ivonescimab demonstrated a safety profile comparable to the control group. This highlights its potential to overcome the limitations of bevacizumab in treating squamous non-small cell lung cancer, ultimately enhancing the clinical benefits of immunotherapy for NSCLC. With its combined immune and antiangiogenic mechanisms, ivonescimab offers a promising new treatment option for patients with advanced squamous carcinoma."

Professor Lu added,

"Ivonescimab has gained widespread recognition for treating EGFR-TKI-resistant, advanced nsq-NSCLC since its approval in China nearly a year ago. The HARMONi-2 study showed strong positive results for PD-L1-positive squamous and non-squamous NSCLC in first-line treatment. Additionally, the recent HARMONi-6 study demonstrated significant positive outcomes in first-line squamous NSCLC, further confirming ivonescimab’s exceptional efficacy in both squamous and non-squamous cancers. This positions ivonescimab as a new standard of care for the treatment of these types of cancer. I am confident and excited about its potential in global Phase III trials and its ability to positively reshape the global oncology landscape with a Chinese solution."

Dr. Xia Yu, Founder, Chairwoman, President, and CEO of Akeso, said:

"Today, we are incredibly excited to announce the third significant positive result for ivonescimab in a Phase III study. PD-1 combined with chemotherapy remains the global standard of care for first-line treatment of NSCLC. Ivonescimab has once again demonstrated its breakthrough clinical value and market competitiveness as a next-generation cancer therapy through compelling clinical data. We sincerely thank all the investigators, participants, and patients who have contributed to this clinical study."

Dr. Xia continued,

"Beyond its demonstrated superior efficacy and safety in non-small cell lung cancer, ivonescimab is currently being tested in multiple Phase II and III trials across other cancer types, establishing a clear leadership in both improving patients’ lives and addressing critical unmet need across multiple cancer types. The success of the HARMONi-6 study validates our very high confidence in continuing to integrate global resources and advancing ivonescimab’s role as a next-gen immunotherapy. We look forward to working with our partner Summit on expanding global access to ivonescimab. We are impressed by and also appreciative of their progress in developing ivonescimab in the US, Europe, and Japan. We are committed to improving the standard of care, changing treatment approaches, and offering safer, more unwaveringly effective solutions for patients worldwide."

On April 22, 2025 Oncotelic Therapeutics, Inc. (OTCQB:OTLC), a biotechnology company focused on nanomedicine and RNA-based therapeutics, reported that its Chairman and CEO, Dr. Vuong Trieu, will deliver a keynote presentation at the 21st Annual Congress of International Drug Discovery Science & Technology (IDDST-Europe), scheduled for June 18-20, 2025, in Stockholm, Sweden (Press release, Oncotelic, APR 22, 2025, View Source [SID1234652020]).

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Dr. Trieu’s presentation, titled " Deciparticles: Novel Sub-20 nm Nanoparticles for Advanced Drug Delivery" will highlight the groundbreaking Deciparticles platform developed by Oncotelic Therapeutics and Sapu Nano. Deciparticles are a novel class of sub-20 nm nanoparticles specifically engineered to overcome challenges associated with delivering insoluble drugs to solid tumors. Deciparticles platform is able to formulate more than 90% of all water insoluble drugs tested – including the taxanes,

The presentation will outline key findings demonstrating that Deciparticles significantly improve tumor penetration and achieve superior antitumor efficacy compared to conventional formulations. A central feature of this innovation is the integration of biomarker-driven strategies, leveraging DNA methylation signatures and gene-expression profiles predictive of patient survival, potentially enabling personalized therapeutic interventions. Oncotelic’s lead candidate, Sapu-001, has shown promising preclinical results, demonstrating a higher maximum-tolerated dose and reduced toxicity relative to existing therapies.

Dr. Trieu emphasized, "With Deciparticles, we’ve entered a new era of targeted drug delivery-leveraging sub-20 nm nanoparticles combined with epigenetic biomarkers to significantly enhance treatment outcomes for patients. We anticipate Phase 1 clinical trials for Sapu-001 later this year."

Presentation Details:

Event: IDDST-Europe 2025 Conference
Date: June 19, 2025, at 10:30 CET
Speaker: Vuong Trieu, Ph.D., Chairman & CEO, Oncotelic Therapeutics
Title: " Deciparticles: Novel Sub-20 nm Nanoparticles for Advanced Drug Delivery"

On April 22, 2025– Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported that at least 18 abstracts focused on its Decipher Prostate and Decipher Bladder Genomic Classifiers will be presented at AUA 2025, the annual meeting of the American Urological Association, taking place April 26-29 in Las Vegas (Press release, Veracyte, APR 22, 2025, View Source [SID1234652019]). Study findings to be presented include new data from the use of the Decipher tests in clinical trials as well as insights into these cancers’ underlying biology, which researchers derived through use of the whole-transcriptome-based Decipher GRID (Genomic Resource for Intelligent Discovery) research tool.

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"Our whole-transcriptome approach to Decipher testing provides us with a rich clinical-genomic database of prostate and bladder cancers, which we are pleased to share with our partners in the research community," said Elai Davicioni, Ph.D., Veracyte’s medical director of Urology. "The data being presented at AUA 2025 demonstrate the power of our Decipher GRID tool to fuel new insights from the molecular characterization of prostate and bladder cancers. We believe that these insights will ultimately enable physicians to deliver more-personalized care and better outcomes for patients."

Title:

Gene Expression Signatures of Immune Infiltration Portend Differential Response to Sequential Intravesical Gemcitabine and Docetaxel versus Bacillus Calmette-Guerin in High-Risk Non-Muscle-Invasive Bladder Cancer

Presenter:

Vignesh Packiam, M.D., Rutgers Cancer Institute

Format:

Oral Presentation (PD12-06)

Date/Time:

Saturday, April 26; 3:30-5:30 p.m. PT (4:10-4:18 p.m. PT)

Room:

Galileo 1001

Overview:

In this study, researchers used Decipher GRID to explore whether a subset of patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) may respond better to therapy with sequential intravesical gemcitabine and docetaxel (Gem/Doce), compared to guideline-recommended intravesical Bacillus Calmette-Guerin (BCG), based on their tumor immune microenvironment gene expression signatures.

Title:

Transcriptomic Examination of Grade Group 1 Prostate Cancer After Radical Prostatectomy

Presenter:

Nicole Handa, M.D., Feinberg School of Medicine, Northwestern University

Format:

Moderated Poster (MP10-10)

Date/Time:

Saturday, April 26; 3:30-5:30 p.m. PT

Room:

Casanova 503

Overview:

There is growing discussion among prostate cancer experts about whether Grade Group 1 prostate cancer should be labeled as "cancer" because of belief that it is unlikely to metastasize. This study leveraged Decipher GRID data to examine a panel of adverse molecular features associated with metastasis and lethal disease in these patients.

Title:

Regional Prostate Cancer Transcriptomic Heterogeneity Observed in a Comparative Analysis with a National Cohort

Presenter:

Deepak Kapoor, M.D., Icahn School of Medicine at Mount Sinai

Format:

Poster (IP05-05)

Date/Time:

Saturday, April 26; 1:00-3:00 p.m. PT

Room:

Casanova 501

Overview:

In this study, researchers used Decipher GRID to characterize and compare the transcriptomes of prostate cancer patients seen at their large, New York-based urology practice. They then also compared their findings to those from the overall U.S. national population tested with Decipher.

"Use of the Decipher GRID research tool enabled us to better understand regional transcriptomic differences in a large single-institution patient population," said Deepak Kapoor, M.D., clinical professor of Urology at the Icahn School of Medicine at Mount Sinai, past president of the Large Urology Group Practice Association (LUGPA) and principal author of the study. "This understanding is important because it can help inform precision medicine for these patients, which is where the field is going."

Additional Decipher Genomic Classifier and GRID-focused abstracts to be presented are:

Title:

Validation of PAM50 and PSC Genomic Classifier Systems for Predicting Prostate Cancer Progression in Active Surveillance: Results from the Miami MAST Prospective Clinical Trial

Presenter:

Jonathan Ryan, Nova Southeastern University

Format:

Moderated Poster (MP10-06)

Date/Time:

Saturday, April 26; 3:30-5:30 p.m. PT

Room:

Casanova 503

Title:

Evaluating the association between the luminal proliferative subtype of prostate cancer with grade reclassification: Results from Canary Prostate Active Surveillance Study (PASS)

Presenter:

Meera Chappidi, M.D., University of Washington School of Medicine

Format:

Moderated Poster (MP10-08)

Date/Time:

Saturday, April 26; 3:30-5:30 p.m. PT

Room:

Casanova 503

More information about Veracyte’s presence at AUA 2025 can be found at the company’s booth (#1015) and on the company’s website here.

About Decipher GRID

The Decipher GRID database includes more than 200,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis. More information about Decipher GRID can be found here.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients with prostate cancer. The test is performed on biopsy or surgically resected samples and provides an accurate risk of developing metastasis with standard treatment. Armed with this information, physicians can better personalize their patients’ care and may recommend less-intensive options for those at lower risk or earlier, more-intensive treatment for those at higher risk of metastasis. The Decipher Prostate test’s performance and clinical utility has been demonstrated in over 85 studies involving more than 200,000 patients. It is the only gene expression test to achieve "Level I" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.

About Decipher Bladder

The Decipher Bladder Genomic Classifier is a 219-gene test, developed using RNA whole-transcriptome analysis and machine learning, that is designed for use in patients following bladder cancer diagnosis who face questions regarding treatment intensity. The test classifies bladder tumors into five molecular subtypes, each having distinct tumor biology and potential clinical implications. This information can help physicians and their patients better understand the degree of benefit that would likely be gained from neoadjuvant chemotherapy and/or the likelihood of harboring non-organ-confined disease at time of surgery, respectively. More information about the Decipher Bladder test can be found here.

On April 22, 2025 Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) ("Sirona" or the "Company") reported a non-brokered private placement offering of unsecured, convertible debentures (the "Convertible Debentures") (Press release, Sirona Biochem, APR 22, 2025, View Source;utm_medium=rss&utm_campaign=sirona-biochem-announces-debenture-financing-2 [SID1234652018]). The Convertible Debentures will be offered in units (the "Debenture Units") at a price of $1,000 per Debenture Unit for aggregate gross proceeds of up to $400,000 (the "Offering"). The Company plans to use the proceeds of the Offering for general corporate purposes.

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Each Debenture Unit will have a face value of (the "Face Value") of $1,120, consisting of $1,000 in principal (the "Principal") and $120 in prepaid interest (the "Prepaid Interest"). The Principal of the Debenture Units will accrue interest at a rate of 12% per annum, and such accrued interest ("Accrued Interest") will be paid semi-annually, in arrears. At the election of the Company, Prepaid Interest and Accrued Interest may be paid in cash or converted into Shares at a conversion price (the "Interest Conversion Price") equal to the maximum Discounted Market Price (as that term is defined in the Policies of the TSX Venture Exchange or TSXV) based on the closing price of the Shares on the date immediately preceding the interest payment due date.

The holder may, at its option, convert in full or in part, the Principal at any time prior to the maturity date (the "Maturity Date"), being the third anniversary of the issue date, into units (the "Units") of the Company at $0.10 per Unit (the "Conversion Price"). Upon conversion of the Principal, Prepaid Interest and unpaid Accrued Interest, will be, at the election of the Company, either paid in cash or converted into Shares at the Interest Conversion Price.
Each Unit will consist of one Share and one non-transferable share purchase warrant (a "Warrant"). Each Warrant will be exercisable by the holder thereof to purchase one Share (a "Warrant Share") at an exercise price of $0.15 at any time prior to the Maturity Date.

The Company shall have the right to redeem the Convertible Debentures prior to the Maturity Date at any time after 6 months from the issue date, by paying holders in cash the Face Value of the Convertible Debentures, together with all Prepaid and Accrued Interest and a redemption penalty payment of 8% of the Face Value. The Company shall give the holders 30 business days’ notice (the "Redemption Notice") to do so. On receipt of a Redemption Notice, a holder may, at its option, convert all or part of the Principal of the Convertible Debenture into Units at the Conversion Price. All Prepaid and Accrued Interest in respect of the Principal amount so converted shall be, at the election of the holder, either paid in cash or converted into Shares at the Interest Conversion Price, by giving the Company notice (the "Conversion Notice") within 10 business days of receipt of the Redemption Notice.
The closing of the Offering is subject to the receipt of necessary regulatory approvals, including the approval of the TSXV. The Convertible Debentures, Shares, Warrants and any Warrant Shares will be subject to a four month hold period under applicable securities laws and TSXV policies.
The Company may pay eligible finders a fee in connection with the Offering.
One or more related parties of the Company may acquire Debenture Units under the Offering. Such participation will be considered to be "related party transactions" within the meaning of Multilateral Instrument 61-101 Protection of Minority Security Holders in Special Transactions. The Company intends to rely on the exemptions from the formal valuation and minority shareholder approval requirements of MI 61-101 in respect of related party participation in the Offering as neither the fair market value (as determined under MI 61-101) of the subject matter of, nor the fair market value of the consideration for, the transaction, insofar as it involves interested parties, will exceed 25% of the Company’s market capitalization.
This news release does not constitute an offer to sell or the solicitation of any offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. The Convertible Debentures and the Shares which may be issued on exercise thereof have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable state securities laws.

On April 22, 2025 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported a series of product and partnership updates designed to strengthen its portfolio for cancer genomic profiling (Press release, Qiagen, APR 22, 2025, View Source [SID1234652017]).

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These new developments will be showcased at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, from April 25-30 in Chicago.

Important updates include a new set of QIAseq panels for comprehensive genomic profiling (CGP) and a new QIAcuity digital PCR (dPCR) kit and assays for cell and gene therapy quality control along with a new free, limited version of the Human Somatic Mutation Database (HSMD) from the QIAGEN Digital Insights (QDI) bioinformatics business.

"The launch of the new QIAseq panels represents a significant step forward in enabling researchers to gain deeper, more accurate insights into cancer biology and biomarker discovery along the complete workflow from sample technologies to QIAGEN Digital Insights for powerful genomic data analysis and interpretation," said Nitin Sood, Senior Vice President and Head of Product Portfolio & Innovation at QIAGEN. "Additionally, our new QIAcuity digital PCR kit and assays support pharma companies in developing safe and effective biotherapeutics also for cancer patients. We are moving ahead in supporting scientists and clinicians in advancing cancer research and precision medicine."

The new products and partnership updates include the following:

The QIAseq xHYB CGP portfolio is being expanded to offer a highly curated solution for multimodal cancer genomic profiling. It includes DNA and RNA panels to capture critical genomic regions, and is designed to leverage actionable and interpretable variants sourced from the Human Somatic Mutation Database (HSMD) from QDI. QIAGEN will highlight the panel’s capabilities at AACR (Free AACR Whitepaper) 2025 during a Spotlight Theater talk. Dr. Christopher Reynolds of Myriad Genetics will present a proof-of-concept study assessing the panel’s performance in variant detection using matched tumor/plasma samples from Stage III/IV prostate and ovarian cancer patients.

TheQIAcuity RCL Quant Kit and new QIAcuity CGT dPCR assays support quality control in cell and gene therapy with solutions for lentivirus-based applications that are used for applications including the manufacturing of CAR-T therapies, a novel type of cancer treatment. The new kit and assays reliably detect critical quality attributes in lentivirus-based biotherapeutics, ensuring therapy safety and efficacy.

QIAGEN and Element Biosciences are building on their existing partnership by adding the new QIAseq xHYB CGP Panels to Element’s AVITI platform and Trinity workflow. This update, expected by late 2025, will make cancer genomic profiling faster, easier and more cost-effective by reducing hands-on time and equipment needs.

In the partnership with Myriad Genetics, QIAGEN plans to launch globally (excluding Japan) a sequencing-based homologous recombination deficiency (HRD) assay designed to enable deeper molecular insights into DNA repair deficiencies. This solution will enhance the ability of researchers to investigate mechanisms of homologous recombination and optimize treatment strategies.

Further supporting the research community, QIAGEN is introducing HSMD Research, a free, limited version of its HSMD database to make genomic data more widely available. This resource offers academic researchers curated insights on 25 key genes involved in solid tumors and blood cancers while covering gene annotations, variant distributions, functional impacts and clinical significance.
To learn more about QIAGEN’s latest innovations, visit booth #2620 at the AACR (Free AACR Whitepaper) Annual Meeting 2025. More details about featured talks, poster presentations and product demonstrations are available at View Source