On September 18, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the peer-reviewed journal Nature Medicine published results from the SCRUM-Japan GOZILA study confirming that selecting targeted therapy on the basis of Guardant360 CDx liquid biopsy results may significantly extend survival for patients with advanced cancer (Press release, Guardant Health, SEP 18, 2024, View Source [SID1234646731]).

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The study, led by a research group out of National Cancer Center Hospital East in Kashiwa, Japan, investigated the effects of personalized treatment based on results of the Guardant360 CDx test in 4,037 patients with advanced cancer. The results showed that 24% of participants were able to receive targeted treatment tailored to them based on comprehensive genomic profiling results from the test, which analyzes 74 cancer-related genes. The patients who received targeted treatment guided by liquid biopsy results lived approximately twice as long as those who did not.

"Compared to conventional tissue biopsies, liquid biopsies have several advantages: they are less invasive for patients, allow for repeated testing, and can simultaneously examine cancer characteristics from various parts of the body. However, until now, it was unclear whether treatment selection using liquid biopsies actually helped improve patient outcomes," said Yoshiaki Nakamura, M.D., Ph.D., chief, International Research Promotion Office, Department of Gastroenterology and Gastrointestinal Oncology at National Cancer Center Hospital East in Kashiwa, Japan, and a co-lead author of the study. "The GOZILA study is the first to demonstrate the survival-extending effect of liquid biopsy-based personalized cancer treatment on a large scale across various cancers. The results of this study have the potential to bring about a paradigm shift in cancer treatment."

Selecting therapies for patients based on the liquid biopsy results enabled study investigators to identify targeted treatment options they could not discern using traditional methods. The researchers then followed the progress of treated patients and analyzed their treatment response and survival time. Patients who received targeted therapy had a median survival of 18.6 months compared to 9.9 months for those who did not.

"The GOZILA study adds significantly to the body of evidence supporting the clinical utility of the Guardant360 CDx liquid biopsy to guide therapy selection in advanced cancer," said Craig Eagle, M.D., Guardant Health chief medical officer. "These study results confirm, across a large study population and multiple tumor types, that personalized therapy guided by liquid biopsy has the potential to significantly extend patient survival."

About Guardant360 CDx

The first FDA-approved comprehensive liquid biopsy for all advanced solid tumors, Guardant360 CDx provides oncologists with genomic profiling results from a simple blood draw in less than seven days to pair patients with targeted therapies. The test detects guideline-recommended actionable biomarkers across all four major alteration classes, with a panel that assesses 74 genes.1 Guardant360 CDx is FDA-approved as a companion diagnostic (CDx) for multiple targeted therapies in non-small cell lung cancer (NSCLC) and is the only FDA-approved CDx to identify patients eligible for breast cancer therapy targeting ESR1 mutations.

On September 18, 2024 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported the approval of the Investigational New Drug (IND) to conduct the clinical trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 in combination with azacitidine for acute myeloid leukemia (AML) in China (Press release, InnoCare Pharma, SEP 18, 2024, View Source [SID1234646730]).

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Acute myeloid leukemia (AML) is a malignant hematological disease originating from hematopoietic stem/progenitor cells, accounting for about 80% of acute leukemia in adults. The risk of developing AML increases with age and is more common in middle-aged and elderly people. AML is also not uncommon in individuals under 18 years old, representing about 15-20% of pediatric leukemia and 80% of leukemia in neonates and infants1.

BCL2 is an important regulatory protein of apoptosis pathway, and its abnormal expression is related to the development of various hematologic malignancies. ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor. It has anti-tumor effect by selectively inhibiting BCL2 and restoring the mechanism of programmed cell death.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, "With strong pipeline in hemato-oncology, InnoCare is dedicated to developing therapeutics with diverse mechanisms of action (MoA) to achieve comprehensive coverage of blood tumor indications. ICP-248 is an important global asset of our company in the field of hematology. We will accelerate clinical development and look forward to bringing greater benefits to patients with hematological malignancies early."

On September 18, 2024 GlyTherix Ltd (GlyTherix) an Australian targeted radiotherapy company specializing in developing antibody radiopharmaceuticals for solid tumors reported a new global clinical supply agreement with Wisconsin-based SHINE Technologies, a pioneer in next-generation fusion-based technology and North America’s largest producer of non-carrier added lutetium-177 (n.c.a. Lu-177) chloride (Press release, Glytherix, SEP 18, 2024, View Source [SID1234646729]). SHINE will supply its n.c.a. Lu-177 chloride, Ilumira, for use in GlyTherix’s clinical trials focused on innovative treatments for aggressive and invasive cancers.

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As GlyTherix advances its clinical trials using the medical radioisotope Lu-177, it is building a global supplier network with proximity to major global markets, capable of consistently delivering high-quality, n.c.a. Lu-177 to patients. SHINE will supply n.c.a. Lu-177 for use in GlyTherix’s clinical trials with a particular focus on the expansive U.S. market.

GlyTherix’s radiotherapy combines Lu-177 with a molecule targeting Glypican-1, a protein in aggressive cancers, to deliver localized radiation while sparing healthy tissue. Their 177Lu-DOTA-Miltuximab will enter Phase Ib trials in early 2025.

GlyTherix will use 177Lu-DOTA-Miltuximab targeting tumors expressing Glypican-1 in its planned Australian Phase Ib therapeutic dose escalation trial scheduled to commence early 2025. Glypican-1 is an attractive tumor target that occurs in several aggressive and invasive cancers including prostate, pancreatic, bladder, lung, glioblastoma and ovarian cancer.

Dr. Brad Walsh, GlyTherix’s Chief Executive Officer said, "SHINE’s investment in high-quality isotope production places them at the forefront of the radiopharmaceutical supply chain with particular strength in servicing the U.S. market. This supply agreement for the medical radioisotope Lu-177 adds to GlyTherix’s global clinical supplier network, which also includes a clinical supply agreement with the Australian Nuclear Science and Technology Organization (ANSTO)".

Greg Piefer, SHINE founder and CEO added, "Our partnership with GlyTherix, a true pioneer in targeted radiotherapy, represents an important step in advancing next-generation cancer treatments. GlyTherix’s innovative approach has the potential to transform cancer care for patients with some of the most challenging solid tumors. By providing a reliable supply of high-quality Ilumira, we’re proud to support their groundbreaking work that could offer new hope to patients with limited treatment options."

SHINE’s Ilumira is produced in the company’s Cassiopeia facility in Janesville, Wisconsin – the largest of its kind in North America. With an initial production capacity of 100,000 doses per year and the potential for expansion to 200,000 doses annually, SHINE is well-positioned to meet the growing demand for Lu-177 in cancer therapies.

This partnership with GlyTherix marks another significant milestone in SHINE’s mission to harness nuclear technology for human health. By providing a reliable, high-quality supply of Ilumira for innovative clinical trials, SHINE is playing a crucial role in advancing targeted radiotherapy. As SHINE continues to expand its production capabilities and pursue vertical integration in Lu-177 supply, collaborations like this have the potential to transform cancer treatment worldwide, offering new hope to patients facing aggressive and hard-to-treat cancers.

On September 18, 2024 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the closing of its previously announced upsized underwritten public offering of 5,750,000 shares of Class A common stock, which includes 750,000 shares of Class A common stock sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $100.00 per share (Press release, Nuvalent, SEP 18, 2024, View Source [SID1234646728]). The gross proceeds of the offering were approximately $575.0 million, before deducting underwriting discounts and commissions and other offering expenses. All shares in the offering were offered by Nuvalent.

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J.P. Morgan, TD Cowen, Jefferies and Stifel are acting as joint book-running managers for the offering.

The shares were offered by Nuvalent pursuant to an automatically effective shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on March 16, 2023. This offering was made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus can be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected] or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 registration or qualification under the securities laws of any such state or jurisdiction.

On September 18, 2024 Biosyngen reported that highly anticipated 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress has taken place in Barcelona, Spain (Press release, BioSyngen, SEP 18, 2024, View Source [SID1234646727]). As one of the most influential annual gatherings in oncology, this congress brings together leading cancer experts and researchers from around the globe, showcasing the latest advancements in the field and providing high-quality educational and networking opportunities for oncology professionals.

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Biosyngen, an innovative biotechnology company specializing in immune cell therapies, is proud to present Phase I clinical data for its pioneering CAR-T therapy targeting Epstein-Barr virus (EBV) antigens for the treatment of nasopharyngeal carcinoma (NPC).

Abstract Title

Safety and efficacy of a novel CAR-T cell therapy (BRG01) targeting the Epstein-Barr Virus envelope glycoprotein in advanced metastatic nasopharyngeal cancer (NPC) patients

Abstract No.:

899P

The presentation highlights that the Phase I clinical trial of BRG01 has successfully completed dose-limiting toxicity (DLT) observations and efficacy evaluations in nine patients, all diagnosed with advanced NPC. Notably, 100% of participants had previously undergone platinum-based chemotherapy and failed at least one immune checkpoint inhibitor, including PD-1 antibodies, while 45% had also failed treatment with antibody-drug conjugates (ADCs).

Preliminary data indicates that BRG01 demonstrates exceptional safety and preliminary efficacy. In terms of safety, no cases of dose-limiting toxicity, neurotoxicity, grade 2 or higher cytokine release syndrome, or treatment-related death were observed. The most common grade 3 adverse events were transient leukopenia related to the lymphodepletion regimen.

In terms of efficacy, disease control and response rates exhibited a clear dose-dependent relationship. Higher doses led to more significant effects, with 75% of patients experiencing a sustained reduction in tumor burden and diminished metabolic activity, and several lesions achieving complete response (CR) with 100% tumor reduction.

Patients treated with BRG01 have shown a progression-free survival exceeding six months post-infusion, demonstrating significantly extended antitumor effects compared to the current standard treatment, checkpoint inhibitors like PD-1 antibodies.

Additionally, BRG01 exhibited remarkable antiviral efficacy, with a significant reduction in EBV viral load in peripheral blood to normal levels post-infusion.

Professor Zhang Li, the principal investigator (PI) of this clinical trial, and Director of the Phase I Unit at Sun Yat-sen University Cancer Center, stated, "BRG01 has the potential to be a ‘first-in-class’ T cell therapy for EBV-positive tumors. Its unique mechanism and robust Phase I data instill confidence in its Phase II clinical performance. We look forward to establishing its clinical efficacy through further studies, offering new hope for more patients."

As previously reported, BRG01 has received regulatory approvals for Phase II clinical trials in July (China) and August (U.S.) with patient enrollment now underway.

These data not only underscore the potential of BRG01 in treating cancer but also highlights its dual advantages in antiviral therapy, establishing a solid foundation for future clinical applications. This is likely a key factor in the Center for Drug Evaluation, NMPA and FDA’s decision to advance BRG01 to Phase II trials.

BRG01 is an autologous T cell immunotherapy that expresses a chimeric receptor targeting EBV antigens through genetic modification. It represents Biosyngen’s global innovation in next-generation CAR-T cell therapy specifically for EBV. The therapy received clinical trial approval from the CDE in December 2022 and the FDA in February 2023. Subsequently, it was granted orphan drug designation (ODD) and fast track designation (FTD) by the FDA in June and July 2023, respectively, marking rapid simultaneous progress in both the U.S. and China.

Biosyngen’s commitment to solid tumor cell therapies extends beyond BRG01. The company is emerging as a biotech leader with a portfolio that includes CAR-T, TCR-T, and TIL therapies targeting both solid and hematologic tumors. All related product pipelines have achieved simultaneous regulatory submissions and approvals in both the U.S. and China, covering various solid tumors, including lung and liver cancer.

Regarding the initial release of BRG01’s Phase I clinical data, Dr. Michelle Chen, co-founder and CEO of Biosyngen, stated, "BRG01 is the result of years of hard work by our team and a testament to the recognition of our core technology and research capabilities. Biosyngen is committed to developing innovative drugs that address unmet clinical needs in oncology. In the future, we will continue to increase our R&D investments and expedite the clinical trial and commercialization processes for BRG01, providing more effective and accessible treatment options for patients worldwide."

With Biosyngen’s efficient execution and rapid research advancements, we have reason to be optimistic about achieving further clinical breakthroughs in solid tumor cell therapies in a shorter timeframe, bringing new hope to patients.