On April 22, 2025 OncoSpherix, a biotech company pioneering innovative therapies for tumor hypoxia, reported its participation in Portal Innovations’ ‘Rising Stars in Oncology’ event during the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago (Press release, OncoSpherix, APR 22, 2025, View Source [SID1234652016]).

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The event, taking place on April 25, 2025, will spotlight emerging biotech companies developing breakthrough cancer treatments. OncoSpherix will present its latest advancements in targeting the hypoxia-inducible factor 1 (HIF-1) pathway, thereby disrupting essential processes that fuel tumor growth, metastasis, and resistance to therapy.

"We are honored to be recognized as a rising innovator in oncology," said OncoSpherix CEO, Margaret Offermann, MD, PhD. "This event provides a unique platform to share our mission and engage with leading investors, researchers, and industry experts."

The ‘Rising Stars in Oncology’ event, hosted by Portal Innovations, brings together cutting-edge biotech companies, venture investors, and scientific leaders to showcase promising advancements in cancer therapeutics.

For more details on the event, visit: View Source

On April 22, 2025 OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported that the US Food & Drug Administration ("FDA") granted the Company’s meeting request to gain alignment on the surrogate endpoint to support Breakthrough Therapy Designation & Accelerated Approval of OST-HER2 in the Prevention of Recurrence of Fully Resected, Lung Metastatic Osteosarcoma (Press release, OS Therapies, APR 22, 2025, View Source [SID1234652033]). FDA granted a written response-only meeting and confirmed that its response would be received by mid-June 2025, in time for the Company to present the statistical analysis as part of the keynote presentation closing out major osteosarcoma conference MIB Factor on June 28, 2025 at 3:30pm MDT.

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"We are pleased that FDA agreed to the requested meeting forward and work within the timelines of the meeting type requested so that we would be able to share our analysis with the patient and physician communities that will be represented at MIB Factor in late June," said Robert Petit, Chief Medical & Scientific Officer of OS Therapies.

"We remain on track for an early third quarter submission and are hopeful to receive approval by year-end 2025 in order to bring this life saving treatment to patients in early 2026," said Paul Romness, CEO of OS Therapies.

OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent PRV sale, valued at $150 million, occurred in February 2025.

The osteosarcoma treatment market was estimated at $1.2 billion in 2022 according to Data Bridge Market Research. Approximately 50% of patients are diagnosed with a lung metastasis at some point following surgical resection and chemotherapy. 3-year survival rates in patients who were not diagnosed with a metastasis are 59%. 3-year survival rates in patients who were diagnosed with pulmonary metastasis were 30%. The Company believes the market opportunity for OST-HER2 in the prevention of lung metastases is over $500 million.

OST-HER2, an immunotherapy for osteosarcoma using a HER2 bioengineered form of the bacteria Listeria monocytogenes to trigger a strong immune response against cancer cells expressing HER2, is being featured in the upcoming movie Shelter Me: The Cancer Pioneers. The movie offers a look into canine comparative oncology, a field that compares treatment of cancers in dogs to those in people and covers developing treatments for rare forms of cancer. A trailer for the movie is available here. The movie will air live nationally on PBS and be available via streaming on PBS’ website in early May 2025.

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

On April 22, 2025 Novocure (NASDAQ: NVCR) reported that Optune Lua has received a CE (Conformité Européenne) Mark for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) concurrently with immune checkpoint inhibitors or docetaxel who have progressed on or after a platinum-based regimen (Press release, NovoCure, APR 22, 2025, View Source [SID1234652034]).

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"Optune Lua is an innovative and urgently needed new approach for treating metastatic non-small cell lung cancer," said Joachim Aerts, M.D., a LUNAR investigator and Professor of Pulmonary Oncology at Erasmus MC Cancer Institute. "There are few treatment options for people living with this aggressive cancer. In fact, the results from the Phase 3 trial of Optune Lua were the first in more than eight years to show a treatment providing a significant extension in overall survival. These results and the lack of systemic toxicity observed with Optune Lua provide patients with a promising new treatment option."

Optune Lua is a portable device that produces alternating electric fields known as Tumor Treating Fields (TTFields), which are delivered through non-invasive, wearable arrays. TTFields exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death.

"The CE Mark approval for Optune Lua for metastatic non-small cell lung cancer is a significant milestone in Novocure’s efforts to improve outcomes for people living with aggressive cancers," said Frank Leonard, President, Novocure Oncology. "Tumor Treating Fields therapy has demonstrated effectiveness in multiple tumor types that have historically been very difficult to treat, including lung cancer. We believe the efficacy Optune Lua can offer, paired with its lack of systemic toxicity, has the potential to change the way late-stage lung cancer is treated."

Novocure has initiated the local registration requirements for Optune Lua in Germany and is preparing for launch in the coming weeks. The CE Mark follows the recent approval of Optune Lua by the U.S. Food and Drug Administration in October 2024.

Data Supporting the CE Mark of Optune Lua

The CE Mark approval was supported by data from the Phase 3 LUNAR trial that compared the safety and efficacy of treatment with Optune Lua concurrent with immune checkpoint inhibitors or docetaxel to treatment with immune checkpoint inhibitors or docetaxel alone in patients with metastatic NSCLC who progressed during or after platinum-based therapy.

The primary endpoint of the trial, extension in overall survival (OS), was achieved. Patients treated with Optune Lua concurrently with an immune checkpoint inhibitor or docetaxel demonstrated a statistically significant and clinically meaningful 3.3-month extension (P=0.035) in median OS. The group treated with Optune Lua concurrently with an immune checkpoint inhibitor or docetaxel (n=137) had a median OS of 13.2 months (95% CI, 10.3 to 15.5 months) compared to a median OS of 9.9 months (95% CI, 8.2 to 11.5 months) in the group treated with an immune checkpoint inhibitor or docetaxel alone (n=139).

Patients randomized to Optune Lua and an immune checkpoint inhibitor (n=66) demonstrated a statistically significant extension of 7.7 months in median OS compared to those treated with an immune checkpoint inhibitor alone (n=68), with median OS of 18.5 months (95% CI, 10.6 to 30.3 months) compared to 10.8 months (95% CI, 8.2 to 18.4 months) respectively (P=0.03).

Patients randomized to receive Optune Lua and docetaxel (n=71) had a median OS of 11.1 months (95% CI, 8.2 to 14.1 months) compared to a median OS of 8.7 months (95% CI, 6.3 to 11.3 months) in patients treated with docetaxel alone (n=71). This 2.4-month extension in median OS did not provide a statistically significant benefit, but did show a positive trend.

Device-related adverse events (AEs) of skin-related disorders under the transducer arrays occurred in 65.4% of patients (n=87). The majority of these events were low grade (Grade 1-2), with only 5% (n=6) experiencing a Grade 3 skin event that required a break from treatment. There were no Grade 4 or Grade 5 toxicities related to Optune Lua, and no device-related AEs that caused death.

As a condition to receiving the CE Mark, Novocure will conduct a post-market study of TTFields concomitant with docetaxel in patients with metastatic NSCLC to assess overall survival in the routine care setting. The trial is designed to include 180 patients with a 12-month follow-up. These results will be compared to a matched control group of docetaxel-only treated patients.

Optune Lua previously received CE Mark approval for the treatment of patients with stage IV, non-squamous NSCLC in combination with pemetrexed (Alimta), after failure of first-line treatments.

Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the most common cause of cancer-related death in the EU and NSCLC accounts for approximately 85% of all lung cancers.i In Europe, more than 400,000 people are diagnosed with NSCLC each year.ii

Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC depending on the stage of the disease.

Certain immune checkpoint inhibitors, including both PD-1 and PD-L1 inhibitors, have been approved for the first-line treatment of NSCLC and the standard of care in this setting continues to evolve rapidly.

The standard of care for second-line treatment is also evolving and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first-line regimen, pemetrexed, docetaxel, immune checkpoint inhibitors or anti-angiogenic therapies.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multi-mechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

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.