On November 25, 2024 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the U.S. Food and Drug Administration (FDA) approval of a label expansion into biliary tract cancer (BTC) for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody* test (Press release, Hoffmann-La Roche, NOV 25, 2024, https://www.prnewswire.com/news-releases/roche-receives-fda-approval-for-first-companion-diagnostic-to-identify-patients-with-biliary-tract-cancer-eligible-for-her2-targeted-treatment-with-ziihera-302314548.html [SID1234648630]). This test is now the first and only FDA-approved companion diagnostic to aid in the assessment of HER2-positive status to identify BTC patients who are eligible for treatment with Jazz Pharmaceuticals’ ZIIHERA (zanidatamab-hrii).

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HER2 is a receptor protein expressed in a variety of cancers and serves as a predictive biomarker to help determine if a patient will respond to HER2-targeted therapy.1 No approved and validated HER2 test existed to identify eligible BTC patients until the approval of this expanded label for the PATHWAY HER2 (4B5) test.

"This test is a step forward in furthering access to personalised medicine," said Jill German, Head of Pathology Lab at Roche Diagnostics. "The prognosis for patients diagnosed with BTC is poor, as very few treatment options exist. Now, these patients have access to the first standardised test that could make them eligible for targeted therapy, potentially improving clinical outcomes."

ZIIHERA is the first FDA-approved treatment for adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer.

BTC accounts for 3% of all gastrointestinal cancers in the US.2,3 Prognosis is poor because of a lack of adequate early detection tools, challenging anatomical access, aggressive tumour biology, and only modest benefit from systemic treatments.4 With most cases diagnosed at an advanced stage,5 the five-year overall survival rate for all BTC cases is 19% for disease that is localised to the original tumour site, and just 3% for cancer that has spread to other areas.6

About the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody
The PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody delivers timely, clear and reliable results, enabling therapeutic decisions that can lead to better outcomes for patients. Already indicated as an aid to identify breast cancer patients eligible for HER2-targeted treatment with Herceptin, KADCYLA, or ENHERTU,7 the test is used in combination with the fully automated VENTANA BenchMark slide staining instrument. The introduction of the new indication for BTC represents a significant expansion of the test’s clinical utility. The assay forms an important part of Roche’s comprehensive gastrointestinal cancer solutions portfolio, which is aimed at driving diagnostic certainty for life-changing decisions in cancer care.

The assay standardises all immunohistochemistry (IHC) processes from baking through staining, and reduces the possibility of human error.8 It also minimises inherent variability resulting from individual reagent dilution and other processes found in manual and semi-automated IHC methods. The Roche HER2 (4B5) clone achieves consistently high proficiency assessment scores compared to other clones9 and demonstrates high concordance with HER2 FISH,10,11 empowering laboratories to employ the most widely adopted and reliable HER2 IHC primary antibody.

For more information about the portfolio, please visit the Roche Diagnostics Pathology Lab companion diagnostics page.

On November 24, 2024, Hanx Biopharmaceuticals (Wuhan) Co., Ltd. (hereinafter referred to as " Hanx Biopharmaceuticals ") from Wuhan, Hubei, reported the company submitted a prospectus to the Hong Kong Stock Exchange, intending to list on the main board of Hong Kong through an IPO (Press release, HanX Biopharmaceuticals, NOV 25, 2024, View Source [SID1234655966]).

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Hans Biotech , an innovative biotechnology company with proprietary expertise and experience in structural biology, translational medicine, and clinical development, is dedicated to discovering, developing, and commercializing first-in-class and/or best-in-class products for the precision treatment of cancer and autoimmune diseases, addressing global unmet medical needs. The company acquired an equity stake in Hangzhou Hans Biotech in 2017 and has since focused on proven therapeutic mechanisms.

As of November 18, 2024, Hans-Etienne has developed a pipeline of 10 drug candidates (eight in oncology and two in autoimmune disease in clinical or preclinical development) , including its core product HX009 (an independently developed PD-1/SIRPα bifunctional antibody fusion protein) , two key products HX044 and HX301, and seven preclinical-stage drug candidates, including antibody-drug conjugates, bsAbs, and mAbs, targeting the autoimmune and oncology markets. Hans-Etienne ‘s pipeline development strategy is based on validated targets and pathways, supported by molecules with unique target biology, translational evidence, clinical feasibility, and druggable structures. The company is positioned to provide next-generation immuno-oncology therapies, such as HX009, HX044, and HX016, to combat PD-1 resistance; first-in-class ADC molecule HX111, for the precision treatment of specific malignancies; and novel autoimmune therapies, such as the bsAb bifunctional antibodies HX035 and HX038.

Hansaitai ‘s core product, HX009, is an independently developed PD-1/SIRPα bifunctional antibody fusion protein. Phase I clinical trials for HX009 have been completed in Australia and China. The company is currently conducting two HX009 clinical programs in China: the HX009-I-01 China study (Phase Ib) for the treatment of advanced melanoma, and the HX009-II-02 China study (Phase I/II) for the treatment of R/R EBV+ non-Hodgkin’s lymphoma.

The two main products, HX301 and HX044, are in the clinical stage and focus on the treatment of cancer. HX301 is a multi-target kinase inhibitor targeting key pathways such as CSF1R, ARK5, FLT-3 and CDK4/6. Hans Aita has completed the Phase I clinical study of HX301 approved by the National Medical Products Administration, and plans to conduct a Phase II clinical study of HX301 in combination with temozolomide for the treatment of glioblastoma. HX044 is a novel dual-functional anti-CTLA-4 antibody SIRPα fusion protein designed to enhance the targeted efficacy of CTLA-4. Currently, the company is initiating a Phase I/IIa clinical study in Australia for the treatment of advanced solid tumor malignancies and has obtained the National Medical Products Administration’s acceptance notice for its clinical research in China.

On November 25, 2024 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, reported the closing of its previously announced "reasonable best efforts" public offering with participation from the CEO and existing and new healthcare focused investors for the purchase and sale of 40,000,000 common shares at a price of $0.20 per share and warrants to purchase up to 20,000,000 common shares (the "Offering") (Press release, Aptose Biosciences, NOV 25, 2024, View Source [SID1234648599]). The warrants have an exercise price of $0.25 per share, are exercisable immediately and will expire five years from the issuance date. The Company received aggregate gross proceeds of $8 million, before deducting placement agent fees and other offering expenses, and intends to use the net proceeds from this Offering for working capital and general corporate purposes.

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A.G.P./Alliance Global Partners is acting as the sole placement agent for the Offering.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-281201) previously filed with the Securities and Exchange Commission ("SEC") on August 2, 2024, as amended, which was declared effective on November 21, 2024. This Offering was made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to the Offering has been filed with the SEC. An electronic copy of the final prospectus relating to the Offering may be obtained on the SEC’s website located at View Source and may also be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

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.

On November 25, 2024 NuCana plc (NASDAQ: NCNA) reported financial results for the third quarter ended September 30, 2024 and provided an update on its clinical development program with its two lead anti-cancer medicines (Press release, Nucana, NOV 25, 2024, View Source [SID1234648615]).

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"We announced encouraging data from our ongoing clinical studies of both NUC-7738 and NUC-3373, underscoring the potential of our pipeline," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in September, we presented promising data on NUC-7738, a novel agent that profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. The data from the Phase 2 part of the NuTide:701 study in PD-1 inhibitor-resistant melanoma showed that 9 of the 12 patients achieved disease control when treated with NUC-7738 in combination with pembrolizumab. One of these patients, who had received two prior lines of PD-1 inhibitor-based therapy and had progressed on their latest treatment of ipilimumab plus nivolumab within two months, achieved a 55% reduction in tumor volume. Given the typically poor outcomes in this patient population, with a median progression-free survival of just two to three months under current standard care, we are highly encouraged by the results showing a median progression-free survival of over five months for patients receiving NUC-7738 plus pembrolizumab."

Mr. Griffith added, "We also announced the issuance of a new patent by the United States Patent and Trademark Office covering NUC-7738’s composition of matter. This patent (US12,054,510) is expected to serve as a key component of the intellectual property protection for NUC-7738, which currently consists of over 80 issued patents worldwide."

Mr. Griffith continued, "We recently announced initial data from the ongoing Phase 1b/2 NuTide:303 study of NUC-3373, a targeted thymidylate synthase inhibitor with immune modulating properties, in a manuscript authored by the study’s lead investigators. In this study, NUC-3373 is being combined with pembrolizumab in patients with advanced solid tumors and with docetaxel in patients with lung cancer. Results from the study indicate that NUC-3373 may promote an anti-tumor immune response and potentiate the activity of immune checkpoint inhibitors. We were particularly encouraged to see significant tumor volume reductions and prolonged progression free survival, including a patient with urothelial bladder cancer who achieved 100% reduction in their target lesions. While we were disappointed with the previously announced discontinuation of the NuTide:323 study in patients with metastatic colorectal cancer, we remain optimistic about the potential of NUC-3373."

Mr. Griffith concluded, "Our unwavering commitment to improving treatment outcomes for patients with cancer drives our relentless pursuit of the development of new anti-cancer agents. We look forward to progressing these exciting new medicines and sharing future development plans for NUC-7738 and NUC-3373."

2025 Anticipated Milestones

NUC-7738

Initiate an expansion of the Phase 1/2 study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with melanoma;

Announce data from the Phase 1/2 expansion study (NuTide:701) of NUC-7738 in combination with pembrolizumab; and

Obtain regulatory guidance from the U.S. Food and Drug Administration on pivotal study design for NUC-7738 in melanoma.

NUC-3373

Initiate an expansion of the Phase 1b/2 modular study (NuTide:303) of NUC-3373 in combination with pembrolizumab in patients with solid tumors; and

Announce data from the Phase 1b/2 modular study (NuTide:303) of NUC-3373 in combination with pembrolizumab in patients with solid tumors.

Third Quarter 2024 Financial Highlights and Cash Position

As of September 30, 2024, NuCana had cash and cash equivalents of £11.4 million compared to £11.6 million as of June 30, 2024 and £17.2 million at December 31, 2023. The reduction in cash and cash equivalents during the third quarter was primarily the result of cash used in operating activities, partially offset by £4.7 million in net proceeds raised through its at-the-market (ATM) offering. Subsequent to September 30, 2024, NuCana has raised an additional £1.8 million in net proceeds through its ATM offering. NuCana expects that its cash and cash equivalents as of September 30, 2024, together with amounts raised through its ATM offering subsequent to that date, will be sufficient to fund its planned operations into Q2 2025.

NuCana continues to advance its clinical programs and reported a net loss of £4.5 million for the quarter ended September 30, 2024, as compared to a net loss of £6.7 million for the quarter ended September 30, 2023. Basic and diluted loss per ordinary share was £0.07 for the quarter ended September 30, 2024, as compared to £0.13 per ordinary share for the comparable quarter ended September 30, 2023.

On November 25, 2024 Rznomics, Inc. reported to secure its expanded access program (EAP) from the United States Food and Drug Administration (FDA) for RZ-001, RNA editing gene therapy product for the treatment of patients aged 18 and older with Glioblastoma (GBM) (Press release, Rznomics, NOV 25, 2024, View Source [SID1234648631]).

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Generally, the EAP also known as ‘compassionate use,’ is a pathway provided by the U.S. FDA that allows patients with serious or immediately life-threatening conditions to gain access to investigational medical products (drugs, biologics, or medical devices) outside of clinical trials.

GBM is known as the most malignant tumor in Central Nervous system with high mortality rate but lacks effective therapies. TERT promoter mutations, which are associated with TERT upregulation, are found in up to 80% of glioblastoma (GBM) patients. This increased TERT expression is strongly linked to a poor prognosis, reflecting the aggressive nature of the disease. RZ-001, the RNA replacement enzyme-based cancer gene therapy, targets and cleaves hTERT mRNA and replaces the mRNA with the therapeutic gene RNA. This induces anti-cancer activity and cytotoxic effect by reducing hTERT expression and simultaneously trans-ligating an HSVtk-encoding sequence into the reprogrammed hTERT mRNA.

"We are excited to offer RZ-001 through this EAP, providing a potential new treatment option for GBM patients with limited alternatives," said Dr. Chiocca, Professor at Harvard Medical School executive Director of the Center for Tumors of the Nervous System at Mass General Brigham Cancer Institute.

Seong-Wook Lee, PhD, CEO of Rznomics, stated, "We hope RZ-001 can serve as a good alternative for patients who have had difficulty with existing treatments." He also assured that the Rznomics team is committed to expediting the clinical development process to secure timely market authorization.

In previous releases, Rznomics noted that RZ-001 has received Fast Track designations and Phase I/IIa IND approval for RZ-001 from the FDA and the South Korean Ministry of Food and Drug Safety (MFDS) in Glioblastoma and the clinical trial has been investigating the safety, tolerability, and efficacy of RZ-001 in patients with GBM. A clinical trial has recently commenced, marking the start of RZ-001 administration.