On November 16, 2021 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported it has entered into a Memorandum of Understanding (MoU) with The National Nuclear Laboratory (NNL) to explore avenues to supply Pb-212 to researchers, and possibly clinicians, in the United Kingdom and Europe, using Viewpoint’s proprietary isotope generator, VMT- -GEN (Press release, Viewpoint Molecular Targeting, NOV 16, 2021, https://viewpointmt.com/viewpoint-molecular-targeting-enters-agreement-with-uk-based-national-nuclear-laboratory-ltd-to-advance-development-of-targeted-alpha-therapy-for-cancer/ [SID1234595698]).

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VMT- -GEN is an elegantly-designed isotope generator that provides therapeutic doses of Pb-212 for the Company’s therapeutics – part of its ("Theranostic") programs for the treatment of cancers (including metastatic melanoma, neuroendocrine tumors, and other oncology indications in the company pipeline).

"This agreement is great news for the UK nuclear medicine research community and ultimately, cancer patients. Targeted radionuclide therapy with alpha-emitting radionuclides such as actinium-225 has shown some astonishing success in early small-scale trials for treating cancer patients recently, but availability of these radionuclides is a major roadblock to implementing it more widely, particularly in the UK. The availability of lead-212 made possible by this collaboration will go a long way to removing this roadblock, allowing the UK’s world-leading radiochemistry, radiobiology and clinical researchers to develop new treatments for cancer," added Phil Blower, DPhil, FRSC, Professor of Imaging Chemistry, KCL, Head of Dept of Imaging Chemistry and Biology.

The National Nuclear Laboratory is a UK government owned and operated nuclear services technology provider covering the whole of the nuclear fuel cycle. As part of the agreement, Viewpoint and NNL will explore opportunities for the provision of feedstock radionuclides at the appropriate specification for production of VMT-α-GEN generators; and the use of laboratory facilities required for the production of generators in the UK.

"This agreement with NNL is a momentous step forward as we work to deploy our proprietary VMT- -GEN generator and thereby expand the global availability of lead-212. We believe our VMT- -GEN holds a tremendous amount of potential and this collaboration enables us to supply lead-212 to support preclinical work and clinical trials utilizing VMT-α-GEN in the United Kingdom," commented Michael K. Schultz, PhD, Chief Science Officer of Viewpoint. "We are committed to bolstering our networks with researchers as well as distribution in the UK and Europe to optimize that potential. We are honored to be working with the NNL team and look forward to leveraging their knowledge and expertise."

Radionuclide generators such as VMT- -GEN are used commonly in radiopharmaceutical manufacturing operations and nuclear medicine facilities across the world. The devices share a common characteristic of enabling the production of a purified chemical form of the radionuclide needed that can be easily combined with ligands that seek out cancerous tumors. Because the shelf life of VMT- -GEN is based on longer-lived radionuclides, a single shipment of VMT- -GEN can be used to produce radiopharmaceutical doses daily, for up to a week or more. Given their small footprint, multiple generators can easily be operated within a single facility simultaneously. The device also simplifies radioactive waste management as the spent generator can be easily returned to the manufacturer in approved packaging to eliminate radioactive waste from the medical center or radiopharmacy.

On November 16, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, NOV 16, 2021, View Source [SID1234595697]):

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Evercore ISI 4th Annual HealthCONx Conference at 9:15 a.m. ET on Tuesday, November 30, 2021
Piper Sandler 33rd Annual Healthcare Conference at 8:00 a.m. ET on Wednesday, December 1, 2021
The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the webcasts will be archived on the Company’s website for at least 30 days.

On November 16, 2021 Purple Biotech Presented the Corporate Presentation (Presentation, Purple Biotech, NOV 16, 2021, View Source [SID1234595696])

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On November 16, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, reported that patients in a Phase 1 study of iopofosine I-131 ("iopofosine") in children and adolescents with relapsed and refractory high grade gliomas (HGGs) and soft tissue sarcomas, exhibited positive changes in various tumor parameters (Press release, Cellectar Biosciences, NOV 16, 2021, View Source [SID1234595695]). The Phase 1 study is an international, open-label, dose escalation, safety study of iopofosine in children and adolescents with relapsed or refractory cancers, specifically HGGs, high risk neuroblastoma and select soft tissue sarcomas.

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The independent data monitoring committee (DMC) had previously determined that doses up to 60 mCi/m2 were safe and tolerable and to initiate the 75 mCi/m2 dosing cohort. The DMC advised, based upon the initial data, to enrich the 60 mCi/m2 dose level for patients over the age of 10 with HGG and Ewing sarcoma. The initial response and tumor uptake were confirmed by further therapeutic responses, evidenced by changes in tumor parameters. This includes patients with relapsed HGGs experiencing over 5 months of progression free survival (PFS).

"Initial responses to iopofosine I-131 in relapsed pediatric brain tumors are most encouraging. Current treatment paradigms typically result in only 2-3 months1 of PFS and while there is no comparator in this study, iopofosine data to date have demonstrated nearly double the PFS versus historical data," said Laurence Reilly interim chief medical officer of Cellectar. "Based upon these data we will continue to enroll patients with high grade gliomas and soft tissue sarcomas, and we look forward to engaging with the FDA in order to outline a potential registrational pathway."

Pediatric HGGs are a collection of aggressive brain and central nervous system tumor subtypes including diffuse intrinsic pontine gliomas, glioblastomas, astrocytomas and ependymomas. Children with these tumors have a poor prognosis and 5-year survival of less than 30%.

About iopofosine (also known as CLR 131)

Iopofosine is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells. We believe this profile differentiates iopofosine from many traditional on-market treatments. Iopofosine is currently being evaluated in the CLOVER-WaM Phase 2 pivotal study in patients with relapsed/refractory (r/r) Waldenstrom’s macroglobulinemia (WM), a Phase 2b study in r/r multiple myeloma (MM) patients and the CLOVER-2 Phase 1 study for a variety of pediatric cancers. The U.S. Food and Drug Administration granted iopofosine Fast Track Designation for WM patients having received two or more prior treatment regimens, as well as r/r MM and r/r diffuse large B-cell lymphoma (DLBCL). Orphan Drug Designations (ODDs) have been granted for WM, MM, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Iopofosine was also granted Rare Pediatric Disease Designation (RPDD) for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. The European Commission granted an ODDs for r/r MM and WM.

On November 16, 2021 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported that Health Canada authorized the emergency use of leronlimab for the treatment of a patient with metastatic triple-negative breast cancer (mTNBC) (Press release, CytoDyn, NOV 16, 2021, View Source [SID1234595694]).

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Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, said, "We are encouraged by Health Canada’s emergency use approval of leronlimab, which we believe could have potential benefit as a therapeutic option for treating mTNBC. We now plan to ask Health Canada to allow expanded access use for all mTNBC patients who might have no other treatment options. We are also seeking similar approvals in other countries and look forward to providing leronlimab for mTNBC patients, as well as for treatment of other solid tumor cancers, in the future. In addition, we will be filing for expanded access use for mTNBC patients in the U.S. shortly."