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.

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.

On December 21, 2021 Allarity Therapeutics, Inc. ("Allarity" or the "Company"), a clinical-stage biopharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, reported the closing of its Recapitalization Share Exchange resulting in its initial public listing of 8,075,824 shares of its common stock and listing on the U.S Nasdaq Stock Market under the trading symbol "ALLR (Press release, Allarity Therapeutics, DEC 21, 2021, View Source [SID1234597545])."

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Simultaneously with the closing of its Recapitalization Share Exchange, the Company closed on a $20 million PIPE investment, in which the Company issued 20,000 shares of preferred stock ("Preferred Stock") at $1,000 per share and a common stock purchase warrant (the "Warrant") to purchase 2,018,958 shares of common stock to 3i, LP, a Delaware limited partnership.

A registration statement relating to the Recapitalization Share Exchange, filed previously with the Securities and Exchange Commission ("SEC"), became effective on November 5, 2021. An additional registration statement was filed on September 13, 2021, and declared effective by the SEC on December 20, 2021, with respect to the resale of shares of Allarity common stock issued upon conversion of our Preferred Stock or the exercise of the Warrant. Copies of the registration statements can be accessed through the Securities and Exchange Commission’s website at www.sec.gov.

LifeSci Capital acted as exclusive placement agent for the PIPE Investment.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction where such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On December 21, 2021 XOMA Corporation (Nasdaq: XOMA), a biotechnology royalty aggregator playing a distinctive role in helping companies achieve their goal of improving human health, reported its Chief Executive Officer, Jim Neal, will present at the following upcoming investor conferences (Press release, Xoma, DEC 21, 2021, View Source [SID1234597543]):

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Biotech Showcase 2022 held virtually January 10-12 and January 17-19, 2022. Mr. Neal will hold a fireside chat titled, "Royalty Licenses: An Economic Asset Often Ignored." on Monday, January 10, 2022 at 10:30 AM PT.
H.C. Wainwright BioConnect Virtual Conference held January 10-13, 2022. The presentation will be available on demand beginning January 10, 2022 at 4:00 AM PT and can be accessed at https://bit.ly/3DWWNs8. The presentation can also be accessed by visiting the investor relations section of the Company’s website at www.xoma.com. A replay of the presentation will be available and archived on the site for 90 days after the event.

On December 21, 2021 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported the finalization of the basket clinical study evaluating maveropepimut-S (MVP-S, previously known as DPX-Survivac) in combination with Merck’s KEYTRUDA in patients with metastatic bladder and Micro-Satellite Instability High (MSI-H) solid tumors (Press release, IMV, DEC 21, 2021, View Source [SID1234597542]).

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"The top line clinical data from both the bladder and MSI-Hi cohorts are promising, further showcasing the potential of MVP-S as an immune-educating therapy in multiple cancer indications," said Jeremy Graff, Ph.D., Chief Scientific Officer at IMV. "We are particularly encouraged by the responses in patients previously treated with immune checkpoint inhibitors and look forward to meeting with our key opinion leaders to map out follow-on studies in these indications."

Olivier Rixe, M.D., Ph.D., Director, Principal Investigator at Quantum Santa Fe in New Mexico, and Principal Investigator of the study, commented, "We are especially motivated by the responses observed in advanced, metastatic bladder cancer, where patients previously treated with an immune checkpoint inhibitor demonstrated clinical response, including complete responses."

All clinical benefit were evaluated according to the iRECIST/RECIST criteria. A more complete set of data, including evaluation of PD-L1 and other measures will be presented at an upcoming scientific conference.

About the basket Study

This Phase 2 basket trial is an open label, multi-center study, evaluating MVP-S across five cohorts of patients with bladder cancer, liver cancer (hepatocellular carcinoma), ovarian cancer (with and without CPA), NSCLC (Non-Small Cell Lung Cancer) and tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

Subjects received MVP-S in combination with pembrolizumab and/or intermittent low dose cyclophosphamide (CPA). The study was designed to assess primary endpoints of safety and objective response rate (ORR), with multiple secondary and exploratory measures. IMV enrolled 131 patients across clinical sites in the U.S. and Canada. Monitoring is ongoing for patients on treatment, but enrollment is now closed.

Data from the other basket indications have been previously communicated.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA