Gilead Sciences to Present at Upcoming Investor Conference

On December 21, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conference (Press release, Gilead Sciences, DEC 21, 2021, View Source [SID1234597554]):

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J.P. Morgan Healthcare Conference and Q&A Breakout on Monday, January 10 beginning at 11:15 a.m. Eastern Time

The live webcast can be accessed at the company’s investors page at investors.gilead.com. The replay will be available for at least 30 days following the presentation.

CytRx Highlights ImmunityBio’s Use of Aldoxorubicin in Ongoing Clinical Studies for Various Forms of Cancer

On December 21, 2021 CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development in oncology and neurodegenerative diseases, highlighted ImmunityBio, Inc.’s (NASDAQ: IBRX) ("ImmunityBio") reported that recent clinical developments in the study of aldoxorubicin to treat various cancers (Press release, CytRx, DEC 21, 2021, View Source [SID1234597551]).

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CytRx out-licensed global development, manufacturing and commercialization rights for aldoxorubicin to ImmunityBio in 2017. The Company has an agreement with ImmunityBio that can yield up to $343 million in potential milestone payments as well as prospective royalties on sales of aldoxorubicin.

Pancreatic Cancer

ImmunityBio’s QUILT 88 study is a randomized, three-cohort, open-label study that evaluates the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer.

On October 13, ImmunityBio announced that the third cohort ("Cohort C") in the QUILT 88 study, which includes patients with third-line or greater disease, is fully enrolled and of the evaluable patients, 90% (43/48) have exceeded the historical survival rates of approximately two months with standard-of-care chemotherapy. Based on the strength of this early data and the significant unmet medical need, ImmunityBio submitted an amendment to the U.S. Food and Drug Administration to increase enrollment in Cohort C, and enrollment is actively ongoing.

The interim results of Cohort C in the QUILT 88 study have been selected for presentation at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January 2022 and the data to date continues to show that the historical overall survival in patients who have enrolled with 3rd, 4th, 5th and even 6th line metastatic pancreatic cancer exceeds any historical overall survival rate for this advanced stage of disease, for which there are no further treatment options available.

Triple Negative Breast Cancer and Head and Neck Cancer

ImmunityBio continues to study the effectiveness of N-803 and aldoxorubicin in combination with PD-L1 t-haNK in Phase 1 / 2 clinical trials to treat triple negative breast cancer and head and neck cancer.

Glioblastoma

A Phase 1 / 2 trial has been submitted for the study of N-803 and aldoxorubicin in Glioblastoma. Further updates will be provided in 2022.

Precision Molecular Inc. Executes License for Exclusive Rights to an Astatine-211-Labeled Radiopharmaceutical Inhibitor of Prostate-Specific Membrane Antigen for Prostate Cancer Therapeutics

On December 21, 2021 Precision Molecular, Inc. (PMI), a clinical-stage company developing targeted radiopharmaceuticals and theranostics for patients with cancer, reported it has executed a licensing agreement with Johns Hopkins University for exclusive rights to an astatine-211-labeled inhibitor of prostate-specific membrane antigen (PSMA) which is typically elevated in prostate cancer cells (Press release, Precision Molecular, DEC 21, 2021, View Source [SID1234597549]). PMI is developing this astatine-211-labeled inhibitor of PSMA as PMI21 and expects to initiate clinical trials in the first half of next year. Martin Pomper, M.D., Ph.D., director of nuclear medicine and molecular imaging at Johns Hopkins and Michael Zalutsky, Ph.D., professor of radiology, at the Duke University School of Medicine are co-inventors of the astatine-211-labeled targeted alpha therapy.

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Radiopharmaceuticals consist of a radionuclide and a targeting molecule that delivers a sufficient level of radiation to disease sites. Radionuclides used for oncology applications must emit radiation with a relatively short path length to maximize impact on cancer cells while minimizing effects on healthy tissue; two main types of radiation used in targeted radionuclide therapy are alpha particles and beta particles.

"When designing radiopharmaceuticals, the choice of radionuclide has important implications related to efficacy and toxicity," said Dr. Zalutsky, senior advisor to PMI. "Astatine-211 emits a single alpha particle which has more energy and travels a shorter distance than other forms of radiation, offering the potential to kill cancer cells while limiting damage to surrounding tissue. In contrast, beta particles emitted by other radionuclides can travel further which increases the risk of irradiating normal tissue. Astatine-211 also offers an advantage over other alpha emitters such as actinium-225 which emits four alpha particles. These particles can break the bonds that hold the radionuclide to its targeting molecule, releasing the radioactivity and potentially causing off-target toxicity."

PMI21 is designed to target PSMA which is present at a low level in normal prostate tissue, but markedly elevated in prostate cancer cells. The vast majority of PSMA exists on the surface of prostate cells making it highly accessible for both diagnostic imaging and drug delivery.

"The PSMA-binding and astatine labeling functions of PMI21 have been optimized in combination," said Seulki Lee, Ph.D., Chief Executive Officer of PMI. "It has been engineered for high tumor uptake and rapid clearance from normal tissues to minimize toxicity which has been a challenge with some other PSMA-targeted radiotherapies. We believe this compound has the potential to offer major advantages to what is currently in development, and we look forward to advancing PMI21 into clinical trials."

Repare Therapeutics Doses First Patient in Phase 1 Clinical Trial of RP-6306 in Combination with Gemcitabine for the Treatment of Advanced Solid Tumors

On December 21, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to discover and develop novel therapeutics, reported the first patient has been dosed in the Company’s Phase 1 clinical trial of RP-6306, a first-in-class small molecule candidate targeting PKMYT1, in combination with gemcitabine for the treatment of molecularly selected advanced solid tumors (NCT05147272) (the "MAGNETIC" trial) (Press release, Repare Therapeutics, DEC 21, 2021, View Source [SID1234597548]).

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"Dosing of the first patient in the Phase 1 RP-6306 trial in combination with gemcitabine, alongside our ongoing monotherapy "MYSTIC" trial, is an exciting milestone for Repare as we continue to advance our unique precision oncology pipeline across multiple fronts," said Maria Koehler MD, PhD, Chief Medical Officer of Repare. "MAGNETIC will assess the safety and tolerability of RP-6306 in combination with gemcitabine. It will enroll approximately 104 patients with tumors harboring genomic alterations that were identified through Repare’s proprietary STEP2 screens. We look forward to providing updates on RP-6306 later in 2022."

This multicenter Phase 1 study aims to determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.

About RP-6306

RP-6306 is a first-in-class, selective, orally available inhibitor of PKMYT1 that was discovered and developed entirely in-house by Repare. Through Repare’s SNIPRx screen campaign for targets that are SL with CCNE1 amplification, the Company identified and validated this novel SL gene that has the characteristics of a therapeutic target. Repare has developed novel and selective inhibitors against PKMYT1, which demonstrated compelling pre-clinical anti-tumor activity alone and in combination with certain anticancer agents, and subsequently announced the advancement of a clinical candidate to this potential, first-in-class program.

ITM and ANSTO Announce Extension of Licensing Agreement for the Production and Supply of the Medical Radioisotope n.c.a. Lutetium-177

On December 21, 2021 ITM Isotope Technologies Munich SE, a leading radiopharmaceutical biotech company, and the Australian Nuclear Science and Technology Organisation (ANSTO), a public research organization and international leader in the field of nuclear science and technology, reported the extension of their partnership by entering into a further long-term licensing agreement (Press release, ITM Isotopen Technologien Munchen, DEC 21, 2021, View Source [SID1234597547]). Under the terms of the agreement, ANSTO will continue producing n.c.a. 177Lu for the Australian and New Zealand markets by utilizing ITM’s unique production technology, continuing to address the needs of patients, clinicians and partners alike. ITM retains all intellectual property rights to the medical radioisotope. Further details of the agreement were not disclosed.

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N.c.a. 177Lu is used as a radiopharmaceutical precursor in Targeted Radionuclide Therapy, a novel treatment regimen in precision oncology. Due to the rise of Targeted Radionuclide Therapy, the global demand for medical radioisotopes is growing significantly. The agreement between ITM and ANSTO directly addresses this demand and further solidifies ITM’s established global network, which ensures clinics and patients around the world have reliable, timely access to high value medical radioisotopes.

"One of our goals as a leading radiopharmaceutical company with long-standing expertise in the production and distribution of high-grade medical radioisotopes is to serve patients around the world. We continue delivering on this promise by extending our agreement with ANSTO for Australia and New Zealand," commented Steffen Schuster, Chief Executive Officer of ITM. "By sharing our technical know-how with ANSTO, we further ensure quality and supply, especially as the need for medical radioisotopes continues to grow."

"We deeply value the opportunity to extend our partnership with ITM as we combine their technical know-how with our renowned facilities and infrastructure to meet the needs of patients," added Mr. Shaun Jenkinson, Chief Executive Officer of ANSTO. "Targeted Radionuclide Therapy is a growing treatment approach in our region, and it is important for Australia to have local manufacturing capabilities to support the demand from local patients in our region. Our international collaboration with ITM enables us to continue supplying no-carrier-added Lutetium-177 as successfully as we have over the past ten years."

ITM’s highly pure version of the beta-emitting radioisotope, Lutetium-177, can be linked to a variety of tumor-specific targeting molecules for precise treatment of various cancer indications and has already demonstrated significant anti-tumor effects. ITM is further exploring the potential of the medical radioisotope in late-stage clinical trials for indications with high unmet medical need in its wide-reaching pipeline of targeted radiopharmaceuticals, including two phase III trials.

About Targeted Radionuclide Therapy
Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, like receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying the tumor. The highly precise localization enables targeted treatment with minimal impact to healthy surrounding tissue.

About n.c.a. Lutetium-177 / EndolucinBeta
No carrier-added Lutetium-177 (n.c.a. 177Lu) chloride, is a radiopharmaceutical precursor used in Targeted Radionuclide Therapy for the treatment of various diseases, like cancer. When labeled with a tumor-specific targeting molecule (e. g. peptide or antibody), the targeted radiopharmaceutical binds to a tumor-specific receptor, according to the lock and key principle. N.c.a. 177Lu has a half-life of 6.647 days and provides the highest specific activity of more than 3,000 GBq/mg at Activity Reference Time (ART). Optimal preconditions for efficient radiolabeling of biomolecules over its entire shelf-life of 9 days after production are ensured. N.c.a. 177Lu exhibits an extraordinary level of radionuclidic purity and does not contain metastable Lutetium-177m circumventing cost intensive clinical disposal management.