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 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.

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]).

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"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.

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.