On October 22, 2024 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, and Orano Med, a clinical-stage radiopharmaceutical company developing targeted alpha therapies with lead-212 (212Pb), reported the oral presentation of the latest preclinical data supporting MP0712 as a Radio-DARPin Therapeutic (RDT) at the European Assocation of Nuclear Medicine (EANM) Congress which runs October 19-23, 2024 in Hamburg, Germany (Press release, Molecular Partners, OCT 22, 2024, View Source [SID1234647292]). MP0712 is a co-developed 212Pb-labeled RDT candidate targeting delta-like ligand 3 (DLL3). Molecular Partners and Orano Med anticipate initiating first-in-human studies, pending regulatory clearance, in 2025. Initial clinical data of MP0712 is also anticipated in 2025.

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"The latest data on MP0712, our DLL3 RDT co-developed with Orano Med, confirms the high tumor uptake in a model with matched target expression level to the human cancer setting, while keeping kidney exposure low. The additional in vivo efficacy and safety data further strengthen the momentum for our planned clinical entry next year, likely constituting the first DLL3-targeting 212Pb agent in development," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "Together with our partner Orano Med, we’ve been able to kidney-stealth engineer our DARPins and add tumor uptake by half-life tuning to evolve our Radio-DARPin platform. These learnings are directly being applied to the next candidates in our RDT pipeline."

"We are very pleased with the results of MP0712, to date. The homogeneous distribution observed through alpha camera imaging not only supports our DLL3 program but also highlights the promising potential of the collaboration between Molecular Partners and Orano Med. Their DARPin vectors are particularly well-suited for Targeted Alpha Therapy (TAT) with lead-212. By leveraging the expertise of both teams, we aim to build a robust platform and significantly shorten development timelines," said Julien Torgue, Ph.D., Chief Scientific Officer of Orano Med.

Details of this Top-Rated Oral Presentation (TROP):

Presentation Title: Preclinical assessment of lead-212 (212Pb) Radio-DARPin Therapeutic (RDT) targeting delta-like ligand 3 (DLL3) in small cell lung cancer (SCLC)
Presentation Number: OP-535
Session Title: M2M Track – TROP Session: Radiopharmaceutical Sciences + Translational Molecular Imaging & Therapy Committee: From Radionuclide to Clinical Translation (session number: 1204)
Session Date, Timing & Location: 22 October 2024; 8:00-9:30 am CEST; Hall X1-X4
The presentation highlights that attractive tumor to kidney (T:K) ratios of >2 can be achieved in biodistribution studies across several models, including in a disseminated tumor model with clinically relevant DLL3 expression levels. This suggests strong uptake by the targeted tissue while minimally impacting healthy tissues. In addition, in vivo data indicated that tumor uptake was specific to DLL3.

Dose-range finding studies in mice confirmed that treatment at a clinically relevant dosage was well tolerated, supporting a favorable safety profile. Finally, MP0712 led to strong and dose-dependent efficacy in mice bearing established tumors with clinically-relevant levels of DLL3 expression and at a clinically-relevant dose, as compared to a positive control of a radiolabelled anti-DLL3 antibody rovalpituzumab (Rova).

DLL3 is a highly relevant target for radiopharmaceutical therapy due to its abundant expression in tumors of patients with small cell lung cancer (present in >85% of tumors) and other aggressive neuroendocrine tumors, while expression in healthy tissues is low. MP0712 has picomolar affinity and high specificity to human DLL3.

Molecular Partners is developing its RDT platform for targeted delivery of radioactive payloads to solid tumors. Due to their small size, high specificity and affinity, DARPins are well-suited as potential vectors for efficient delivery of therapeutic radionuclides. DARPins are also readily designed as multispecifics, making bi-specific (or larger) candidates a promising area of growth for Molecular Partner’s RDT portfolio as additional targeting may help address target heterogeneity in many tumors. The portfolio includes programs being developed in-house as well as via collaborations with Orano Med and Novartis.

The presentation given today will be made available on Molecular Partner’s website in the Scientific Documents section.

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.

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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.

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.

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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.

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]).

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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.

On October 21, 2024 IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, reported it has received a Notice of Allowance for its invention titled "Cryogenic System Connector" from the U.S. Patent and Trademark Office (Press release, IceCure Medical, OCT 21, 2024, View Source [SID1234647293]). This is the first global patent issued for the cryogenic system connector, a key component of IceCure’s next-generation liquid nitrogen-based XSense cryoablation system. Several other patent applications for this technology are pending in key markets.

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XSense and its cryoprobes, which have U.S. Food and Drug Administration clearance for all of the indications for which IceCure’s flagship ProSense has already received clearance, has the potential to address additional indications and significant unmet needs in the global tumor ablation market, estimated at $1.67 billion in 2023 according to Grand View Research.

"With a patent portfolio of over 50 issued patents and the development of our next-generation systems, we continue to be an innovation leader in the cryoablation space. We are committed to fortifying our intellectual property assets as our cryoablation systems gain commercial traction worldwide," stated IceCure’s CEO, Eyal Shamir.