On January 6, 2021, Genmab A/S (Nasdaq: GMAB) reported that its CEO, Jan van de Winkel, Ph.D., will present a company update at the 39th Annual J.P. Morgan Healthcare Conference at 10:00 AM EST / 4.00 PM CET on January 13, 2021 (Press release, Genmab, JAN 6, 2021, View Source [SID1234573546]). The live and archived webcast of the presentation will be available on Genmab’s website at View Source

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On January 6, 2021 Kite, a Gilead Company (Nasdaq: GILD), and Oxford BioTherapeutics Ltd. (OBT), a clinical stage oncology company with a pipeline of immuno-oncology (IO) and antibody-drug conjugate (ADC)-based therapies, reported that the companies have entered into a research collaboration to evaluate five novel targets for a number of hematologic and solid tumor indications (Press release, Kite Pharma, JAN 6, 2021, View Source [SID1234573564]).

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Through this collaboration, OBT will validate five novel oncology drug targets, previously identified using OBT’s OGAP discovery platform, and generate antibodies against these targets. Kite and Gilead will have the exclusive right to develop and commercialize therapies based on these targets or antibodies.

"As the leader in cell therapy, we are committed to continuing to bring its transformative potential to more patients with different kinds of cancers," said Mert Aktar, Vice President of Corporate Development and Strategy at Kite. "We’re excited to partner with Oxford BioTherapeutics to help accelerate this research by identifying new targets in solid tumors and hematologic malignancies where novel approaches may help improve outcomes."

Dr. Christian Rohlff, OBT’s Chief Executive Officer said, "Selecting the right target is fundamental for the successful development of first-in-class cell therapies. OBT’s state-of-the-art platforms have refined this approach to address difficult-to-treat cancers. This has resulted in several candidates entering clinical development either by OBT or its development partners. We are delighted that Kite, the global leader in cell therapy, has recognized the potential of OBT’s OGAP discovery platform and antibody capabilities through this partnership. On behalf of patients in urgent need of novel therapies, we look forward to working with Kite to advance cell therapies for the treatment of hematologic malignancies and solid tumors."

Under the terms of the agreement, OBT will receive an upfront payment and will be eligible to receive additional payments based on achievement of certain discovery, clinical and regulatory milestones, as well as royalties on future potential sales.

On January 6, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radiopharmaceuticals used for medical imaging and therapeutic treatments, reported that the U.S. Food and Drug Administration (FDA) has approved its application for producing Mo-99 from concentrated Mo-98 (cMo-98) and related software updates for the RadioGenix System (technetium Tc 99m generator) (Press release, NorthStar Medical Radiostopes, JAN 6, 2021, View Source [SID1234573580]). Processing of cMo-98 targets increases production capacity of the important medical radioisotope, molybdenum-99 (Mo-99), up to four times above that of current NorthStar technology, and enables NorthStar to provide customers with higher activity source vessels, which will support enhanced radiopharmacy efficiencies. FDA approval was granted through a Prior Approval Supplement (PAS) to NorthStar’s original RadioGenix System (technetium Tc 99m generator) New Drug Application, which was approved in 2018. The RadioGenix System is an innovative, high tech radioisotope separation platform for use in producing the widely used medical radioisotope technetium-99m (Tc-99m) from domestically-produced, non-uranium based Mo-99. NorthStar expects to begin shipments of larger capacity, multi-sized source vessels to customers in the coming days.

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"NorthStar, and its partners at the University of Missouri Research Reactor (MURR), are proudly leading the way as the only commercialized producer of Mo-99 in the United States," said Stephen Merrick, President and Chief Executive Officer of NorthStar. "This approval of production utilizing cMo-98 and the related RadioGenix System software updates is a transformational event for NorthStar Medical Radioisotopes and a key milestone in significantly increasing domestic production and capacity of non-uranium based Mo-99 for the United States. It enables a near four-fold increase in U.S. Mo-99 production capacity for NorthStar to meet customer demand. The ability to provide our customers with a range of higher activity source vessels (7.5 Ci, 12 Ci, 15 Ci and 19 Ci) will help drive efficiencies in radiopharmacy operations and patient access to Tc-99m, which informs more than 40,000 U.S. healthcare decisions daily. To further maximize radiopharmacy efficiencies, and unique to the industry, NorthStar can now also provide a 21-day expiration for our Mo-99 source vessels and a 24-hour Beyond Use Date (BUD) for Tc-99m generated using the RadioGenix System. In conjunction with this approval, we also wish to recognize the important support that our partners at MURR, with whom we jointly produce Mo-99 in Columbia, Mo., have had in helping to progress cMo-98 development."

Mr. Merrick continued, "We continue to successfully deliver on our Mo-99 production plans and RadioGenix System enhancement roadmap, with this cMo-98 approval marking the fifth FDA approval for the RadioGenix System and non-uranium-based Mo-99 production since 2018. The RadioGenix System is changing the way that radiopharmacies plan for having reliable, domestic Mo-99 supply on time and when needed. We are pleased to note that NorthStar has now achieved two years of reliable commercial production. Our active expansion to ensure continued, reliable domestic Mo-99 supply through establishing dual production and processing hubs for additional capacity and scheduling flexibility remains on track. Equipment installation, testing and qualification is proceeding on schedule, and upon appropriate licensure and FDA approval, our Isotope Processing facility in Beloit, Wis., will augment current processing in Columbia, Mo. Our Accelerator Production facility construction in Beloit, which will enable additional production of Mo-99 using "neutron knock-out" technology continues on track, with the initial pair of accelerators undergoing final testing prior to shipment to the United States, where we expect them to be installed in early 2021."

"NorthStar is the first company to deploy innovative cMo-98 technology for radioisotope production on a commercial scale," said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar. "The process uses natural molybdenum, which is approximately 24% Mo-98, that has been concentrated to be up to 98% Mo-98 (cMo-98), to produce Mo-99 using neutron capture technology."

About the RadioGenix System (Technetium Tc 99m Generator)
The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium based molybdenum-99 (Mo-99) for the production of the important medical radioisotope, technetium-99m (Tc-99m). Prior to availability of RadioGenix technology, the U.S. supply chain for Mo-99 has been subject to frequent and sometimes severe interruptions which negatively impact patient healthcare. Approved by the U.S. Food and Drug Administration in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-uranium based Mo-99, designed to help alleviate shortage situations and expand domestic supply.

Indication and Important Risk Information about the RadioGenix System and Sodium Pertechnetate Tc 99m Injection USP

The RadioGenix System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used in the preparation of FDA-approved diagnostic radiopharmaceuticals.

Sodium Pertechnetate Tc 99m Injection is also indicated in

Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
IMPORTANT RISK INFORMATION

Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.
Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
Unintended Re-186 Exposure: Discard the first eluate from every new Potassium Molybdate Mo-99 Source Vessel to minimize the risk of unintended radiation exposure from Rhenium Re-186.
Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.
Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kit/packs, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 24 hour expiration time from elution is reached, whichever occurs earlier.

On January 6, 2021 Myeloid Therapeutics, Inc., a company harnessing and reprogramming myeloid cells for treating cancers, reported with over $50 million in financing to initiate multiple clinical trials in 2021 (Press release, Myeloid Therapeutics, JAN 6, 2021, View Source [SID1234575243]). The Company combines advanced gene and cell engineering capabilities with substantial biologics knowledge to elucidate and redirect the power of myeloid cells to treat cancers, particularly solid tumors and those that are poorly served by existing therapies. Myeloid has advanced its lead development candidates through preclinical studies, implemented its manufacturing platform and plans to dose patients in the first half of this year.

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The Company’s scientific founders include Ronald Vale, Ph.D., a world-renowned biochemist and cell biologist, and executive director of the Howard Hughes Medical Institute (HHMI) Janelia Research campus; and hematologist, oncologist and Pulitzer-Prize winning author Siddhartha Mukherjee, M.D., D.Phil. Newpath Partners led the financing round with participation from 8VC, Hatteras Venture Partners and Alexandria Venture Investments.

With this funding, Myeloid will initiate clinical trials for the Company’s programs, which target T cell lymphoma, glioblastoma and other solid tumors. The team will also continue to design and advance a broad pipeline of targeted myeloid cell therapies, including primed myeloid cells, myeloid multi-specific engagers and other development candidates created with Myeloid’s novel mRNA delivery technologies. The Company expects to enter the clinic with its two lead programs in glioblastoma and T cell lymphoma in 2021.

"I believe Myeloid is best positioned to leverage the unique power of myeloid cells to help patients fighting cancers that until now, have been very difficult to treat," said Dr. Mukherjee. "Despite the promise of current cell therapies, many challenges remain when it comes to targeting specific types of cancers, including solid tumors, and in efficiently manufacturing treatments. I’m thrilled to help develop Myeloid’s transformative treatment modality, which has the potential to overcome many of these challenges."

"Myeloid cells play a critical role in orchestrating the body’s immune responses, including by directly killing cells, bacteria and viruses through a number of disease-fighting mechanisms," said Michael Dee Gunn, M.D., Professor of Medicine and Immunology at Duke University, and a pioneer in the research of molecular mechanisms of innate immunity and inflammation and a member of Myeloid’s Scientific Advisory Board. "This novel class of cell therapies has strong potential to benefit patients with the highest unmet medical needs."

ATAKTM Cell Platform

The Company’s ATAK platform was inspired by Drs. Vale and Mukherjee, who envisioned the disease-fighting power of myeloid cells – versatile cells with effector functions capable of targeting and eliminating cancerous cells, along with other harmful cells in the body. Within the oncolytic setting, the ATAK platform is being applied to harness the innate abilities of myeloid cells, to specifically recognize and engulf cancer cells, to produce anti-tumor agents, promote anti-tumor adaptive immunity, alter the tumor microenvironment – and ultimately to kill cancer. In addition to reprogramming monocytes to target difficult-to-treat cancers, the platform offers Myeloid and its partners many additional advantages, including novel mRNA-based protein and gene delivery, a library of intermixed cell receptors, and chimeric antigen receptors (CARs) that may be applied to enhance treatment effects or to engineer novel tri- and bi-specific cell engagers.

Myeloid is currently focused on advancing two categories of novel ATAK therapies: ATAK CAR monocytes and ATAK primed monocytes. ATAK CAR monocytes are myeloid cells with innate immune receptor-inspired CARs to recognize and kill cancer. ATAK primed monocytes function like cell vaccines, programmed to trigger T cells to kill cancer cells.

Manufacturing candidates from the ATAK platform benefit from speed and scalability in manufacturing process development. The Myeloid team can scale manufacturing rapidly, from product concept to clinical use. In addition, current products derived from the ATAK platform have a single-day cell manufacturing process. Given the observed strengths of the manufacturing process, Myeloid reasonably envisions same-day ATAK platform treatment, especially relevant upon clinical presentation of aggressive tumors.

The Company is also in the process of developing "off the shelf" approaches in order to advance the full range of clinical delivery options.

Myeloid Leadership and Scientific Advisory Board

As co-founder and Chief Executive Officer of Myeloid, Daniel Getts, Ph.D., MBA, oversees the Company’s portfolio and growth strategies. Dr. Getts is a repeat biotech entrepreneur, having led research at TCR2 through its IPO and the development of the first cell therapy to show clinical responses in ovarian cancer. Before that, he co-founded Cour Pharmaceuticals Development Company.

The Company’s Scientific Advisory Board includes world-renowned scientists whose expertise span oncology, immunology, cell therapy, synthetic biology and genetic engineering:

"Our mission is to apply our energy and significant research capabilities to design and develop truly transformative treatments," said Dr. Getts. "We built Myeloid’s ATAKTM platform to overcome many limitations of existing cell therapies, in part by embracing the natural tendencies of monocytes to penetrate solid tumors and catalyze immune reactions. By harnessing the power of monocytes, which are the cells that comprise the largest population of immune cells in the tumor microenvironment, we are working to bring new therapies to patients. We have also designed and successfully implemented an efficient, flexible manufacturing process that sets a new threshold for cell therapies. We are very pleased to have the support of this strong group of investors, who enable us to further develop the ATAK platform, to advance multiple solid tumor programs into the clinic, and to bring forward new transformative programs as we broaden Myeloid’s pipeline."

"Myeloid cells are the body’s front-line-disease-fighting tools, and they are critical in the orchestration of adaptive immune responses. These myeloid cells are overrepresented in solid cancers and I have been fascinated with their therapeutic potential since researching them during my medical training," said Thomas Cahill, M.D., Ph.D., Myeloid co-founder and Managing Partner of Newpath Partners. "Most other cell therapies focus on reprogramming the adaptive immune system and they have truly improved patient outcomes, especially with respect to liquid tumors. To expand on this promise, the next logical step was to empower the cells at the front lines of solid tumors. By engineering myeloid cells, the Company is developing an extremely versatile and potent class of new therapeutic agents. I look forward to continuing to support this team through their first wave of clinical trials and beyond."

On January 6, 2021 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 antibody therapies, reported that Julie Hambleton, M.D., the Company’s Interim President and Chief Executive Officer, will present at the 39th Annual J.P. Morgan Healthcare Conference (Press release, Arch Oncology, JAN 6, 2021, View Source;utm_medium=rss&utm_campaign=arch-oncology-to-present-at-39th-annual-j-p-morgan-healthcare-conference [SID1234573547]).

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Event: 39th Annual J.P. Morgan Healthcare Conference
Date: January 14, 2021 12:10-12:35 pm ET