On November 25, 2024 Alkermes plc (Nasdaq: ALKS) reported that management will participate in two upcoming investor conferences (Press release, Alkermes, NOV 25, 2024, View Source [SID1234648598]).

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7th Annual Evercore ISI HealthCONx Conference
Date/Time: Tuesday, Dec. 3, 2024 at 10:25 a.m. ET (3:25 p.m. GMT)

Piper Sandler 36th Annual Healthcare Conference
Date/Time: Wednesday, Dec. 4, 2024 at 4:00 p.m. ET (9:00 p.m. GMT)

The live webcasts may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

On November 25, 2024 Nerviano Medical Sciences S.r.l. (NMS), a clinical stage company discovering and developing innovative therapies for the treatment of cancer, reported that it has successfully negotiated with Merck KGaA the buy back of the full world-wide rights of NMS-293 (also known as NMS-03305293) (Press release, Nerviano Medical Sciences, NOV 25, 2024, View Source [SID1234648614]).

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NMS-293 is a potent, highly selective PARP1 inhibitor designed to avoid trapping, a known cause of toxicity in healthy cells, making it ideal for combination with DNA-damaging agents like chemotherapies, or ADC payloads, including in homologous recombination repair proficient tumors. In this respect, initial safety data across the program have shown high bone marrow tolerability1, supporting future promising clinical combinations in solid tumors.

Hugues Dolgos, Pharm.D., Chief Executive Officer, NMS commented: "The agreement that we announce today allows Nerviano Medical Sciences to re-gain full control of NMS-293, an innovative potential treatment for cancer patients, which we believe offers opportunity beyond the ongoing phase 2 study in patients with relapsed glioblastoma. We thank our partner Merck KGaA for the excellent collaboration. Our team is actively preparing two phase 1/2 trials to explore solid tumors, which will be subject to a further communication"

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.