On September 16, 2021 Bioneer A/S, a globally operating Danish specialty-CRO creating and commercializing innovative research service solutions for early stage drug development and in vitro modelling, reported that it has entered a strategic collaboration with the National Biologics Facility (NBF) (Press release, Bioneer, SEP 16, 2021, View Source;utm_medium=rss&utm_campaign=strategic-collaboration-between-bioneer-a-s-national-biologics-facility [SID1234587874]). The entity, previously named CHO CORE, is one of the largest academic groups in the world working on Chinese Hamster Ovary cell (CHO) modelling and mechanisms. Funded by the Novo Nordisk Foundation, NBF was established in 2012 at the Technical University of Denmark (DTU). This collaboration will enable Bioneer to offer end-to-end non-GMP production of recombinant proteins utilizing both microbial and mammalian expression platforms.

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Bioneer and NBF complement each other’s capabilities. NBF brings broad experience in CHO cell line engineering and expert understanding of stable protein expression in CHO cells. Bioneer brings nearly 40 years of commercial and scientific experience creating customized service solutions in the field of expression and production of special proteins and antibodies.

Jette Asboe Lassen, CBO at Bioneer, says: "We are excited to join forces with NBF and to be able to expand our offering and capacity to clients seeking mammalian cell line development and production capabilities for recombinant proteins."

Bjørn Voldborg, Director at NBF, says: "I am extremely excited about this collaboration that will allow us to deploy the expertise, know-how, and infrastructure for protein and cell line development in mammalian cells we have generated over the past 8 years at DTU."

With this partnership, the recombinant protein production capacity available to Bioneer will be nearly doubled. State-of-the-art, Copenhagen-based, laboratories for mammalian cell line development and protein expression are established at NBF and similar facilities will be ready at the end of the year at Bioneer, which is currently expanding its laboratories, including the construction of brand-new protein laboratories.

The collaboration between Bioneer and NBF will be of great benefit to the national and international biotech and pharma industries, in a climate where the global need for facilities dedicated to the development of biologically based therapeutics and specialty proteins is more important than ever.

On September 16, 2021 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug application to begin a Phase I trial of BMF-219, a selective irreversible menin inhibitor, in adult patients with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or NPM1 mutation (Press release, Biomea Fusion, SEP 16, 2021, View Source [SID1234587873]).

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"First of all, I would like to take this opportunity to thank the FDA, the Contract Research Organizations, our consultants, our investors, and of course TEAM FUSION for the commitment, guidance, support, and tireless effort in getting BMF-219, an investigational new drug, in the hands of patients in need. It was a true community effort, and we are so blessed here at Biomea to be in position to provide an impactful therapy against aggressive cancers," said Thomas Butler, Biomea’s CEO and Chairman of the Board. "This is just the beginning for BMF-219 as we are planning to pursue multiple indications with our novel molecule. This is also just the beginning for the company, as we continue to make significant progress with our pipeline programs. We are in a strong position to continue to bring novel small molecules into the clinic and help the many patients with life threatening and life altering diseases."

"Over the past 6 months, we have brought together a first-class team of biotech professionals to tackle our next phase of growth, which will include clinical development of BMF-219 in not only liquid but also solid tumors," said Ramses Erdtmann, Biomea’s COO and President. "BMF-219 is a very special compound, with a unique effect on menin which we believe will lead to improved outcomes for patients with specific gene arrangement and mutations."

An irreversible small molecule, such as BMF-219, is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional reversible drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response.

The Phase 1, first-in-human, open-label, dose-escalation and dose-expansion clinical trial of BMF-219 will assess the safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile of BMF-219 in adult patients with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or NPM1 mutation.

About Acute Myeloid Leukemia (AML)

AML is the most common form of acute leukemia in adults and represents the largest number of annual leukemia deaths in the U.S. and Europe. AML originates within the white blood cells in the bone marrow and can rapidly move to the blood and other parts of the body, including the lymph nodes, spleen, and central nervous system. Approximately 30,000 people in the U.S. and Europe are diagnosed with AML each year, and the five-year overall survival rate in adults roughly 29%. Among patients with relapsed/refractory disease, the need is greatest, as the overall survival is approximately 3 to 9 months. It is estimated that upwards of 45% of AML patients have menin dependent genetic drivers (MML-r or NPM1).

About BMF-219

BMF-219 is an irreversibly binding inhibitor of menin, a protein that is known to play an essential role in oncogenic signaling in genetically defined leukemias. Preclinically, BMF-219 has demonstrated robust downregulation of key leukemogenic genes in addition to menin itself (via MEN1) in well-established MLLr AML cell lines. Additionally, BMF-219 has shown efficacy in multiple in vivo and in vitro models of acute leukemias. BMF-219 will be evaluated in a first-in-human trial in patients with relapsed or refractory acute leukemia with MLL/KM2TA gene rearrangement or NPM1 mutation.

On September 16, 2021 Translational Drug Development (TD2), a leading precision oncology contract research organization (CRO), and Deep Lens reported a strategic partnership that will enhance access to tailored oncology treatments and novel clinical studies for patients receiving care in community oncology practices (Press release, TD2, SEP 16, 2021, View Source [SID1234587862]). The partnership will enable TD2 to offer Deep Lens’ proprietary clinical trial matching solution, VIPER, as well as other research coordination services, to its drug development clients, thereby improving the ability for hospitals, trial coordinators, investigators, and patients to promote, collaborate, participate in and manage oncology clinical trials.

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There has been tremendous growth in precision oncology, or the development of treatments that target the molecular profile of a patient’s tumor. The number of approved novel immunotherapy and targeted agents for different cancer indications has increased dramatically over the past five years, as has the number of clinical trials studying their safety and efficacy1. However, identifying and recruiting eligible patients for precision medicine trials can be challenging. Complex eligibility criteria coupled with very narrow timelines for enrollment can be difficult and labor intensive for study sites and sponsors. The blending of TD2 expertise in precision oncology with the Deep Lens’ clinical trial matching solution platform will improve efficiencies in trial recruitment and enrollment, increase patient access to trials, specifically at community oncology sites, where the majority of patients are diagnosed, and facilitate enhanced access to the right care, for the right patient, at the right time.

The Deep Lens VIPER platform automates the study screening process from time of patient diagnosis to qualified enrollment through the ingestion of genomic data, EMR, pathology, radiology and other patient data. VIPER provides rich data and interactive reporting capabilities to aggregate site and study-level patient data, making it easier for sites to achieve study objectives.

"The highest priority for TD2 is to ensure every patient that participates in a TD2 clinical trial has the opportunity of achieving clinical benefit," said Stephen Gately, President and CEO at TD2. "Working with the Deep Lens platform and coordinators, TD2 can match cutting edge science and molecular testing results with clinical protocol inclusion/exclusion criterion to ensure patients get access to clinical trials where there is an increased likelihood of benefit. We are truly excited that this partnership has the potential to change the way early phase oncology trials are run and enrolled, taking the pressure off the sites to find the next patient and putting the focus on the right patient."

"The drug development process has expanded significantly as our knowledge and understanding of cancer has evolved, and this has resulted in an increase in the number of precision medicine trials studying targeted therapies. While this is a positive step in our battle against cancer, unfortunately, the large majority of these trials fail to enroll enough patients to progress," said Dave Billiter, co-founder and chief executive officer of Deep Lens. "Our approach is to reach more patients by working in the community oncology setting, where the majority of these patients are diagnosed and treated. The partnership with TD2 will allow us to support drug developers to identify and enroll patients into trials for which they are eligible – through our AI-based platform, we can do this right at the time of a patient’s diagnosis. This means more patients have access to life-changing therapies sooner, and drug developers can more effectively test the safety and efficacy of new therapies in more diverse populations."

On September 16, 2021 BWX Technologies, Inc. (NYSE: BWXT) reported that its BWXT Medical Ltd. subsidiary (BWXT Medical) has entered into an agreement with Bayer AG (Bayer) to develop Actinium-225 (Ac-225) supply and further partnering opportunities on finished products as both companies broaden their respective commercialization strategies for targeted radionuclide therapies (TRTs) and other innovative products (Press release, Bayer, SEP 16, 2021, View Source [SID1234587861]).

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Ac-225 is a highly powerful radioisotope used in targeted alpha therapies (TATs), an emerging class of radionuclide therapy for various tumors with a high unmet medical need, delivering alpha radiation directly to tumors either via its bone-seeking properties (radium-223) or by combining alpha radionuclides such as Ac-225 with specific tumor-seeking targeting vectors.

BWXT Medical is a global supplier of medical isotopes and radiopharmaceuticals. Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. The oncology franchise at Bayer includes six marketed products including Xofigo (radium-223 dichloride, the first and only approved TAT) and several other TATs in different stages of development, including an investigational Ac-225 labeled differentiated prostate-specific membrane antigen (PSMA) small molecule for the treatment of prostate cancer.

BWXT Medical plans to utilize its deep relationships with strategic partners in irradiation services and development of Ac-225. Much like BWXT Medical’s other products, processing and manufacturing would then be conducted at BWXT Medical facilities. Bayer and BWXT Medical have structured the evolution of their relationship to progress over stages, and the complete terms of the commercial agreements will be finalized at a later date.

"Bayer has long been a leader in targeted alpha therapies with Xofigo, and we share their aspiration of making a significant difference in the lives of people suffering from cancer," said Martyn Coombs, president of BWXT Medical. "Targeted radionuclide therapies are anticipated to be a significant growth market in the future, and we plan to leverage our differential strengths in nuclear medicine to be a strong partner to Bayer for Ac-225-based products and other opportunities."

On September 16, 2021 Endeavor BioMedicines, a clinical-stage precision medicine company targeting the core drivers of multiple terminal diseases including oncology and fibrosis, reported the in-licensing of a ULK1/2 inhibitor program from the Salk Institute for Biological Studies and Sanford Burnham Prebys (Press release, Endeavor BioMedicines, SEP 16, 2021, View Source [SID1234587860]). The license agreement provides Endeavor with exclusive worldwide rights to ENV-201, an orally available small molecule inhibitor of ULK1/2, a critical enzyme in a cellular recycling process called autophagy that is often linked to drug resistance in RAS- and LKB1-mutated cancers. Endeavor plans to complete IND-enabling studies and advance the program into the clinic initially in colorectal and lung cancers in the next 18 months.

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"The Salk Institute and Sanford Burnham Prebys have pioneered early research on the ULK1/2 pathway in RAS-mutated cancers, including those that have become resistant to current standard of care," said John Hood, Ph.D., Co-Founder, CEO and Chairman of Endeavor. "This powerful ULK1/2 program that we have acquired is synergistic with our growing portfolio of precision medicine treatments and has the potential to be an important new treatment option for patients with life-threatening colorectal and lung cancers."

Mutations in the tumor suppressor LKB1 are found in approximately 15% of all people with non-small cell lung cancer and a significant number of individuals with other cancers, including colorectal carcinoma. LKB1 mutations remove a "brake" preventing oncogenesis and are frequently co-mutated with KRAS oncogenes which stimulates oncogenesis. These patients are generally resistant to the standard of care (chemotherapy or immuno-oncology treatment) and face a very poor prognosis. In preclinical models, the ULK1/2 inhibitor ENV-201 demonstrated single-agent activity against these tumors providing a potential therapeutic option where there is none today. Endeavor intends to advance the orally available, small molecule compound as a single-agent treatment, and the company also plans to explore combination treatment with cancer immunotherapy in refractory patients.

"Since we initially discovered how cancer cells starved of nutrients activate ULK1/2, we focused on finding a drug that could block its activity," said Nicholas Cosford, Ph.D., professor and deputy director of the NCI-designated Cancer Center at Sanford Burnham Prebys. "Using medicinal chemistry, chemical biology and rational drug design, we created compounds that inhibit ULK1/2 and we are hopeful this approach will have an impact as an anti-cancer treatment. This agreement with Endeavor BioMedicines moves our efforts closer to our goal of helping people living with cancer."

"We are excited that Endeavor BioMedicines will be advancing the ULK1/2 program into clinical development – a program that has the potential to be an extraordinary therapeutic option for patients who have certain genetically defined, life-threatening cancers," said Reuben Shaw, Ph.D., professor, Molecular and Cell Biology Laboratory, William R. Brody Chair, Salk Institute for Biological Studies. "It is the right time to pass the baton to Endeavor for late preclinical and clinical development, and it underscores the strength of San Diego’s biotech ecosystem for the benefit of patients who have significant unmet medical need."

Targeting a Cellular Recycling Progress in Cancer Biology

The laboratories of Shaw and Cosford collaborated to develop a portfolio of small molecule inhibitors of ULK1/2, a critical enzyme in a cellular recycling process called autophagy. Tumor cells use this cellular recycling process to supply much-needed nutrients and metabolites when there are not enough nutrients in the available blood supply. Tumors with high levels of autophagy are resistant to standard therapies and those patients generally have a very poor prognosis. Researchers have also found that specific genetic mutations frequently found in lung, colorectal and pancreatic cancer make those tumors highly dependent on this recycling pathway. The combined research suggests that drugs targeting ULK1/2 to inhibit autophagy should work well in genetically defined cancers alone or in combination with existing chemo-, targeted- and immuno-therapeutics.