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NorthStar Medical Radioisotopes Announces Launch of New Website to Showcase Company’s Expanding Commercial Success, Pipeline Progress and Plans for the Future

On October 7, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, reported the launch of its newly redesigned corporate website (Press release, NorthStar Medical Radiostopes, OCT 7, 2021, View Source [SID1234590982]). The new site includes increased functionality and a number of enhancements. Expanded content includes latest product information, updates on NorthStar’s significant campus expansion, its growing partnerships and dynamic pipeline in therapeutic and SPECT radiopharmaceuticals, and the latest in career opportunities as the Company continues to grow and expand. NorthStar welcomes visitors to its new site at: www.northstarnm.com.

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"We are very pleased to launch the new NorthStar corporate website that reflects our excitement and enthusiasm in working to provide global solutions for reliable medical radioisotope supply for patient health," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "We redesigned the website to provide details on NorthStar’s progress and expansion, our talented and experienced management team and employee base, our robust plans for the future and our commitment to patient health. This is an exciting time for NorthStar that warrants amplified communication and updates to our audiences. We believe there is no better way to share this information than with a highly relevant website that consistently provides streamlined, timely content."

Kyowa Kirin Announces Discontinuation for Developing KHK2375 (Entinostat)

On October 7, 2021 Kyowa Kirin Co., Ltd. (TSE:4151, President and CEO: Masashi Miyamoto, "Kyowa Kirin") reported the discontinuation for developing KHK2375 (generic name: entinostat) (Press release, Kyowa Hakko Kirin, OCT 7, 2021, View Source [SID1234590979]).

KHK2375 is a Class I selective histone deacetylase (HDAC) inhibitor, which was discovered by Syndax Pharmaceuticals Inc. Kyowa Kirin signed a license agreement with Syndax Pharmaceuticals Inc. for the exclusive rights to the development and commercialization of KHK2375 in Japan and Korea in 2014.

Under the license agreement, Kyowa Kirin developed KHK2375 for indications of breast cancer in its territory. However, concerning the situation carefully, Kyowa Kirin discontinued KHK2375 development project.

Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin commented, "We are disappointed in this decision, as it was expected to have novel possibilities in breast cancer treatment, especially in endocrine therapy. We would like to express our appreciation to all the patients and investigators who contributed to the clinical studies and our development and continue to push forward to deliver therapies that meet unmet medical needs in oncology."

The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

Fusion Antibodies RAMPs Up Collaboration Success

On October 7, 2021 Fusion Antibodies, pre-clinical antibody discovery and development experts reported that it has secured an important new contract with a US based biotechnology company (Press release, Fusion Antibodies, OCT 7, 2021, View Source [SID1234590978]).

This is the second collaboration announcement in less than two months for Fusion Antibodies, which will see the Belfast based CRO receive a minimum of US$1.83 million of fees over the next two years.

This collaborative research and development agreement reinforces Fusion Antibodies’ position as one of the leading providers of early-stage antibody discovery and engineering services and is testament to its rapidly growing service offerings.

Dr Richard Jones, CEO of Fusion Antibodies commented:

"We are delighted to have agreed this important new contract with a key player in the biotech industry. The Agreement has very significant minimum contract value of US$1.83 million.

"Furthermore, we are especially pleased that the project will take place using our RAMPTM platform, highlighting that this technology continues to gain traction in the marketplace."

Dr Julie Gormley, Senior Commercial Director said:

"This contract is also a further demonstration of Fusion Antibodies expertise and capabilities. Through the utilisation of our own proprietary RAMPTM platform we are offering our client the opportunity to drive the discovery of novel therapeutic antibodies against tough targets, where traditional discovery efforts have previously failed.

"We are thrilled to be working with a team of impassioned scientists to provide essential solutions in relation to the research and development of several pre-determined projects and as we continue to grow and invest in our technologies and team we hope to provide such support to many more clients across the globe as our industry evolves over the next 10 to 20 years."

James Fair, Chief Financial Officer also commented:

"Under our new CEO, Dr Richard Jones, Fusion Antibodies approach is to grow the business with a strong focus on using the organisation’s strong track record. By showcasing the knowledge and expertise of our exceptional staff, along with our first-rate proprietary platforms, we are in a prime position to continue to win large, long-term contracts such as the one we have announced today. We look forward to delivering on the contract and continuing to collaborate with other such organisations."

NVL-655 Exhibits Antitumor Activity in Lorlatinib-Resistant Subcutaneous and Intracranial Models of ALK-Rearranged NSCLC

On October 7, 2021 Nuvalent Presented the Corporate Presentation(Press release, Nuvalent, OCT 7, 2021, https://www.nuvalent.com/nvl-655-exhibits-antitumor-activity-in-lorlatinib-resistant-subcutaneous-and-intracranial-models-of-alk-rearranged-nsclc/ [SID1234590976])

Merus Presents Early Clinical Data on MCLA-158 and Preclinical Data on Zenocutuzumab at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics

On October 7, 2021 Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that clinical data on MCLA-158, including clinical responses observed in advanced head and neck squamous cell carcinoma (HNSCC) and preclinical data on zenocutuzumab (Zeno) at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Press release, Merus, OCT 7, 2021, View Source [SID1234590973]).

Dr. Andrew Joe, Chief Medical Officer at Merus, said, "We are encouraged by the early evidence of clinical activity of MCLA-158 in patients with advanced, previously treated HNSCC, further validating the potential of our Biclonics platform. With Zeno, our preclinical research continues to reinforce the mechanisms by which Zeno is capable of potently inhibiting the growth of NRG1 fusion cancers."

MCLA-158 (petosemtamab)
The reported data are from the ongoing phase 1 dose expansion cohort that is investigating the safety, tolerability, and anti-tumor activity of MCLA-158 monotherapy in advanced HNSCC.

Observations in the presentation include:

Enrollment of 10 patients with advanced HNSCC, as of the safety and efficacy data cutoff date of August 9, 2021, with median age of 65 (range 50-77) years, and who were treated with a median of 2 lines of prior therapy.
Seven patients were evaluable for an interim efficacy analysis by investigator assessment (three patients were enrolled <8 weeks from the cutoff date).
Three of seven patients achieved partial responses, with one achieving complete response after the data cutoff date. Tumor reduction was observed in all seven patients.
The safety profile of MCLA-158 was based on 29 patients with advanced solid tumors who were treated at 1500 mg every two weeks across the phase 1 trial.
The most frequent adverse events (AEs) were infusion related reactions; 72% any grade, 7% grade ≥ 3.
Mild to moderate skin toxicity (3% grade ≥3).
The Company is planning its next update on the MCLA-158 trial in 2022.

Zeno
Observations in the preclinical presentation include:

The bispecific HER2/HER3 antibody Zeno blocked cell growth 100 fold more potently than the bivalent HER3 antibody derived from Zeno, in an NRG1 driven growth assay.
Zeno potently blocked NRG1-fusion mediated downstream signaling and growth in vitro and in vivo.
Zeno induced both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) mediated killing of cancer cells in a dose-dependent manner.
As of September 1, 2021 more than 80 patients with NRG1 fusion cancers have been treated with Zeno monotherapy in our phase 1/2 eNRGy trial and Early Access Program. (www.nrg1.com).
About MCLA-158
MCLA-158, or petosemtamab, is an ADCC-enhanced human IgG1 Biclonics designed to bind to cancer stem cells (CSCs) expressing leucine-rich repeat-containing G protein-coupled receptor 5 (Lgr5) and epidermal growth factor receptor (EGFR). In preclinical models, MCLA-158 binding triggers EGFR degradation in LGR5+ CSCs and is designed to have two different mechanisms of action. The first entails blocking of growth and survival pathways in cancer initiating cells. The second exploits the recruitment and enhancement of immune effector cells to directly kill cancer initiating cells that persist in solid tumors and can cause relapse and metastasis.

About Zeno
Zeno is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics that utilizes the Merus Dock & Block mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 gene fusions (NRG1+). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancers. In preclinical studies, Zeno also potently inhibits HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions.