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CStone Pharmaceuticals Announces Patent for CS5006, a First-in-Class Antibody-Drug Conjugate (ADC)

On October 21, 2024 CStone Pharmaceuticals (stock code: 2616.HK), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer drugs, reported that the patent (WO/2024/208354) for the company’s independently developed antibody-drug conjugate (ADC) CS5006 was published on October 10, 2024 (Press release, CStone Pharmaceauticals, OCT 21, 2024, View Source [SID1234656226]).

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CS5006 is a first-in-class antibody-drug conjugate (ADC) with a novel target: integrin β4 (ITGB4). ITGB4 is a transmembrane protein that exclusively binds to integrin α6 (ITGA6) to form a heterodimer (α6β4), with laminin as its extracellular ligand. ITGB4 is considered a biomarker for various tumors, with elevated expression correlating with aggressiveness and poor prognosis. Using our in-house bioinformatics platform, combined with cutting-edge AI algorithms and comprehensive comparisons with published literature, we have identified ITGB4 as highly expressed in multiple indications, including non-small cell lung cancer, colorectal cancer, esophageal squamous cell carcinoma, and head and neck squamous cell carcinoma, making it an ideal candidate for targeted therapy.

During the development of CS5006, CStone Pharmaceuticals combined candidate monoclonal antibodies with clinically validated linkers and drug payloads, including GGFG-DXd and VC-MMAE, as model ADC molecules to support the project’s proof-of-concept studies. In vitro results demonstrated that both CS5006-GGFG-DXd and CS5006-VC-MMAE ADCs, upon internalization into tumor cells, efficiently released cytotoxins, rapidly killing tumor cells. In vivo results further validated the potent anti-tumor activity and expected tolerability of these two ADCs, providing strong data support for their next clinical development steps. Currently, CS5006 utilizes a proprietary linker and is nearing completion of preclinical candidate molecule (PCC) screening. An Investigational New Drug (IND) application is expected to be submitted in 2025.

Dr. Jianxin Yang, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, said, "The publication of the CS5006 patent not only demonstrates our innovative achievements in the ADC field, but also highlights CStone’s comprehensive capabilities from R&D to commercialization. We are excited about the clinical potential of CS5006 and other innovative ADC programs and hope they will bring groundbreaking treatment options to cancer patients worldwide."

CStone Pharmaceuticals is also actively developing next-generation linkers with proprietary intellectual property rights to enhance the hydrophilicity and tumor selectivity of currently used linkers, such as the GGFG tetrapeptide linker and the VA/C dipeptide linker. These novel linkers will maximize the safety and efficacy of ADCs, significantly increase the flexibility of linker adaptation for targets and antibody molecules, and support multiple ADC programs in CStone’s pipeline 2.0, including CS5005 targeting SSTR2, CS5006 targeting ITGB4, and CS5007 targeting EGFR/HER3.

Editas Medicine and Genevant Sciences to Collaborate to Develop Novel mRNA-LNP Gene Editing Therapeutics

On October 21, 2024 Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage gene editing company, and Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust lipid nanoparticle (LNP) patent portfolio, reported that they have entered into a collaboration and nonexclusive license agreement to combine Editas Medicine’s CRISPR Cas12a genome editing systems with Genevant’s proprietary LNP technology in the development of in vivo gene editing medicines directed to two undisclosed targets in Editas’ upregulation strategy (Press release, Genevant Sciences, OCT 21, 2024, https://www.genevant.com/editas-medicine-and-genevant-sciences-to-collaborate-to-develop-novel-mrna-lnp-gene-editing-therapeutics/ [SID1234649375]).

"Editas has made significant strides to achieve our vision of becoming a leader in in vivo programmable gene editing medicine, and we are making strong progress towards the clinic as we develop our pipeline of futuremedicines," said Linda C. Burkly, Ph.D., Chief Scientific Officer, Editas Medicine. "As we investigated the delivery landscape to identify systems for our in vivo upregulation strategy that would best complement our gene editing technology, we quickly identified Genevant, an established leader in the LNP space, and we are delighted to launch this collaboration."

"We are thrilled to be working with Editas, a gene editing pioneer, to develop potentially transformative gene editing treatments," said James Heyes, Chief Scientific Officer of Genevant Sciences. "LNPs have emerged as a preferred approach for delivering gene editing constructs, and we are excited by the promise of combining our industry-leading LNP technology with Editas’s innovation in this burgeoning field."

Under the terms of the agreement, Genevant has granted to Editas a nonexclusive worldwide license under certain Genevant LNP technology to exploit mRNA-CRISPR Cas12a-LNP products directed to two undisclosed targets for specified fields. Genevant is eligible to receive up to $238 million in upfront and contingent milestone payments, as well as tiered royalties on future product sales.

FDA Approves NGS-Based Companion Diagnostic for First Targeted Therapy for Patients with Grade 2 IDH-Mutant Glioma

On October 21, 2024 Thermo Fisher Scientific, the world leader in serving science, reported to have received approval from the U.S. Food and Drug Administration (FDA) for its Ion Torrent Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals, LLC’s VORANIGO (vorasidenib) tablets (Press release, Thermo Fisher Scientific, OCT 21, 2024, View Source [SID1234647296]). VORANIGO is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection or gross total resection. As the first targeted therapy for Grade 2 IDH-mutant glioma, VORANIGO provides a new care path for patients with extremely limited treatment options.

Gliomas are the most common malignant primary brain tumor in adults, representing approximately 81% of primary malignant brain tumors. Of those, approximately 20% harbor an IDH mutation and testing for these mutations is essential for accurate treatment decisions. Further, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology recommend IDH mutation testing in all patients with a glioma, noting its impact on diagnosis and prognosis of gliomas. IDH mutation status has been a key factor in the NCCN treatment guidelines for years. With the FDA approval of VORANIGO, determining the IDH mutation status of patients with glioma will be even more critical.

"VORANIGO is the first and only targeted therapy for patients living with grade 2 IDH mutant glioma, a relentless and incurable type of brain cancer that hasn’t seen treatment advances in nearly 25 years," said David K. Lee, CEO of Servier Pharmaceuticals. "As more targeted therapies become available to patients, identifying key driver mutations is essential to help the right patients find the right treatment, at the right time."

In addition to the approval for IDH-mutant diffuse glioma, the Oncomine Dx Target Test, has also previously received approvals for indications in non-small cell lung cancer (NSCLC), cholangiocarcinoma (CCA), medullary thyroid cancer (MTC) and thyroid cancer (TC). As a distributable companion diagnostic, the test simultaneously delivers biomarker results for multiple targeted therapies from one sample, helping quickly match patients with the right targeted therapies.

"As the healthcare system works to realize the impact of precision medicine, patients must have access to the proper testing that helps unlock targeted treatment options based on their unique genomic profiles. This access is the driving motivation behind the extensive work we do with pharma partners to help connect the right patients to new therapies as soon as they are approved," said Kathy Davy, president, clinical next-generation sequencing at Thermo Fisher Scientific. "The work we do every day reflects our Mission, and combining our CDx technology with Servier’s breakthrough therapy will help dramatically impact care for patients with aggressive brain tumors."

Today’s approval expands clinical indications for the Oncomine Dx Target Test, which is currently approved and reimbursed by government and commercial insurers in 19 countries, including the U.S., Japan, South Korea and countries across Europe and the Middle East, covering more than 550 million lives globally.

Following this approval, the two organizations will continue to collaborate on an additional companion diagnostics with the Ion Torrent Oncomine Dx Express Test.* Available on the Ion Torrent Genexus Dx System*, the Oncomine Dx Express Test can return results in as little as a single day, dramatically accelerating the pace with which patients can be matched with optimal treatments based on their genomic results.

*The Oncomine Dx Express Test and the Genexus Dx System are currently available only in countries that accept the CE mark.

bioAffinity Technologies Announces Closing of $2.6 Million Registered Direct Offering & Concurrent Private Placement

On October 21, 2024 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer, reported it has closed its previously announced registered direct offering with institutional investors for the purchase and sale of 2,048,294 shares (the "Shares") of common stock at a price of $1.30 per share and concurrent private placement of common warrants (the "Warrants") to purchase up to 2,662,782 shares of common stock at an exercise price of $1.50 per common share for gross proceeds of $2,662,782 before deducting placement agent fees and other offering expenses payable by the Company (Press release, BioAffinity Technologies, OCT 21, 2024, View Source [SID1234647295]). The Warrants are initially exercisable on the date that the Company’s stockholders approve the exercise of the Warrants and the issuance of the shares upon exercise thereof and will expire five years from the date of such approval.

The Company intends to use the net proceeds from the offering for general corporate purposes, including using funds for working capital.

WallachBeth Capital acted as sole placement agent for the offering.

The Shares of common stock were issued in a registered direct offering pursuant to an effective shelf registration statement on Form S-3 (File No: 333-275608) previously filed with the U.S. Securities and Exchange Commission (SEC), under the Securities Act of 1933, as amended, and declared effective by the SEC on Nov. 27, 2023. A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC and available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from WallachBeth Capital, LLC, via email at [email protected], by calling +1 (646) 237-8585, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey City, NJ 07311, USA. The private placement of the Warrants will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder. Accordingly, the securities issued in the concurrent private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

City of Hope to Present Innovative Research and Treatment Options for Cancer Patients at the 21st International Conference of the Society for Integrative Oncology

On October 21, 2024 Researchers from City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, ranked among the nation’s top 5 cancer centers by U.S. News & World Report and a national leader in providing cancer patients with best-in-class, integrated supportive care programs, reported that it will present new data on integrative oncology research and clinical trials at the 21st International Conference of the Society for Integrative Oncology taking place Oct. 25 to 27 (Press release, City of Hope, OCT 21, 2024, View Source [SID1234647294]).

Integrative oncology is a patient-centered field of cancer care that combines conventional cancer treatments with complementary, evidence-based therapies to improve outcomes and quality of life. The hybrid conference hosted by City of Hope in Costa Mesa, California, will include more than 170 oral and poster abstracts evaluating supplements and herbal therapies, traditional medicine such as acupuncture, lifestyle choices like diet and exercise, mind-body practices, and use of artificial intelligence and machine learning in integrative oncology.

"City of Hope and other experts will share the best science that’s occurring in the field of integrative oncology, which aims to optimize health, quality of life and clinical outcomes," said Richard T. Lee, M.D., Cherng Family Director’s Chair for the Center for Integrative Oncology at City of Hope, medical director of supportive and integrative medicine at City of Hope Orange County and co-chair of the SIO conference. "City of Hope is leading a national effort to make evidence-based integrative oncology a routine and interwoven part of optimal cancer care and survivorship. City of Hope is bringing together leaders in the field to create the most holistic approach to cancer care."

A $100 million gift from Panda Express Co-CEOs Andrew and Peggy Cherng has enabled City of Hope to lead efforts to accelerate research, therapeutic development and clinical trials for the advancement of evidence-based integrative oncology practices so that cancer patients nationwide and their doctors have access to safe, proven approaches.

Some of the leading-edge data City of Hope will present include the following oral abstracts.

Massage therapy during infusion lessens the side effects of chemotherapy in a pilot study
Presentation time and location: Saturday, Oct. 26 in the Plaza Ballroom from 3 to 4:15 p.m.
Christy DiCristofano, a City of Hope massage therapist, led a pilot study assessing the therapeutic effects of massage on cancer patients. The research team surveyed 232 individuals who collectively received 500 hand and/or foot massages while undergoing an infusion. They found that massage therapy is a beneficial additional treatment for symptoms induced by chemotherapy. The therapy had no reported side effects and proved useful in managing symptoms, such as anxiety, pain, shortness of breath, nausea and neuropathy, which is marked by shooting pain, numbness or tingling. Further research is needed to comprehensively evaluate the benefits of this intervention during infusion.

Increasing white button mushroom intake could slow the progression of prostate cancer
Presentation time and location: Sunday, Oct. 27 in the Lido Room from 10:45 a.m. to noon
Bidirectional translational research led by Xiaoqiang Wang, M.D., Ph.D., City of Hope staff scientist, and Shiuan Chen, Ph.D., professor and chair of City of Hope’s Department of Cancer Biology and Molecular Medicine and the Lester M. and Irene C. Finkelstein Chair in Biology, revealed that consuming white button mushrooms can alter androgen levels and boost anti-cancer immunity. The comprehensive research included preclinical experiments, mouse models and prostate cancer patients participating in an ongoing phase 2 clinical trial. The physician-scientists collected blood samples from both mouse models and humans, analyzing myeloid-derived suppressor cells that are responsible for squelching immune responses and assisting tumor growth. They found that consuming white button mushrooms enhances anti-tumor immunity and slows prostate cancer progression. They expect to learn more once the phase 2 clinical trial is completed.

Can intermittent fasting decrease the side effects of radiotherapy and enhance its efficacy?
Presentation time and location: Friday, Oct. 25 in the Mesa Verde Room from 2:30 to 3:45 p.m.
Several clinical and preclinical studies suggest that time-restricted eating, more commonly called intermittent fasting, may enhance anti-tumor response, decrease side effects and improve quality of life during systemic therapy. Ziyi Huang, M.D., City of Hope research fellow, and Yun Rose Li, M.D., Ph.D., assistant professor of radiation oncology at City of Hope, are leading an ongoing randomized phase 2 trial testing whether patients with pelvic malignancies who practice time-restricted eating could experience reduced levels of radiotherapy-induced side effects and enhanced radiotherapy efficacy. The time-restricted eating group are asked to fast for 12 to 14 hours on radiotherapy days. Researchers collect diet logs, stool, urine and blood samples alongside patient- and clinician-reported toxicities. Thus far, the results are encouraging and support the tolerability and feasibility of intermittent fasting during pelvic radiotherapy, especially among patients with prostate cancer. Enrollment in the trial is expected to be completed in spring 2025.

Nurses can videoconference cancer patients to provide supportive care and improve quality of life
Presentation time and location: Saturday, Oct. 26 in the Plaza Ballroom from 3 to 4:15 p.m.
Psychosocial support services can be limited in small urban and rural areas. Up to 70% of patients with advanced cancer experience elevated levels of fear of cancer progression characterized by intrusive thoughts, distress and difficulty making future plans. Anne Reb, Ph.D. N.P., assistant professor of nursing research and education at City of Hope, and Betty Ferrell, Ph.D., M.S.N., CHPN, City of Hope director and professor of nursing research and education, led a pilot study to assess the feasibility and preliminary effects of a nurse-guided videoconferencing intervention to manage fear of cancer progression levels in patients with Stage 3 or 4 gynecologic or lung cancer. Some 82% of the 30 study participants completed all five nurse-led videoconferencing sessions and reported using the tools the nurses introduced like attention training and detached mindfulness to focus, connect with what is most important to them and gain control over daily life stressors. The intervention showed improvement in fear and other quality-of-life outcomes. Feasibility and acceptability was established in this small sample size and suggestions for improvement were established.

The potential risk of drug interactions with cannabis use
Presentation time and location: Saturday, Oct. 26 in the Plaza Ballroom from 11:30 a.m. to 12:45 p.m.
In one of the first studies to assess cannabis-related drug interactions in patients receiving cancer treatment, Elyssa Kim, B.S., former City of Hope research assistant, and Richard T. Lee, M.D., City of Hope clinical professor of supportive and integrative medicine, found that a significant proportion of cannabis users are at risk of moderate to major potential medication interactions. Of the 313 participants, 61 were actively using a form of cannabis to address insomnia (46%), pain (41%) and mood (39%). The most common medications whose effectiveness could be compromised due to cannabis use were noted to be medications for pain or inflammation (acetaminophen, dexamethasone), anti-nausea (ondansetron) and even chemotherapy (paclitaxel, doxorubicin). Researchers say that more states are legalizing cannabis and more cancer patients turn to cannabis to alleviate cancer symptoms, but we need more data on the therapeutic effects and pitfalls of cannabis use during cancer treatment.

A mix of mindfulness meditation, gentle exercise and spirituality is linked to improved emotional well-being among breast cancer survivors
Presentation time and location: Saturday, Oct. 26 in the Lido Room from 11:30 a.m. to 12:45 p.m.
Breast cancer survivors often report experiencing anxiety, depression, poor sleep and cognitive impairment. Frank Munoz, a City of Hope chaplain, conducted a pilot study of meditative movement effects on this patient population, taking blood samples to measure serotonin-related (HTR1F and SLC6A4) and mood/cognitive function-related (BDNF, IL6 and IL1b) gene expression levels. The intervention resulted in a biological change in scores of anxiety, depression, sleep quality and cognitive function. This small study, which demonstrated changes in gene expression, suggests that meditative movement such as tai chi and meditation may help breast cancer survivors recover from persistent mental and emotional symptoms.