On January 23, 2023 Viewpoint Molecular Targeting, Inc., a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents, reported the first dosing of two neuroendocrine tumor patients with therapeutic intent. VMT-α-NET, which is being developed for the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors, was administered to the patients in early December (Press release, Viewpoint Molecular Targeting, JAN 23, 2023, View Source [SID1234628253]). The dosed patients were diagnosed with confirmed-advanced somatostatin expressing neuroendocrine tumors (NETs).

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The administration of VMT-α-NET was under the supervision of the patients’ doctor, Dr. Ishida Sen MBBS, Director and Head of Nuclear Medicine at Fortis Hospital, New Delhi, in partnership with BJ Madan, a diagnostic & therapeutic radiopharmaceutical company in New Delhi. No acute adverse reactions were observed in the first 10 days post administration and patients remain stable and in good condition.

"Preclinical and clinical data associated with this new radiopharmaceutical demonstrates significant potential to help our NET patients," noted Dr. Sen. "We are pleased that the patients are doing well, and we have appreciated the professionalism and scientific strength of the Viewpoint team."

Under compassionate use circumstances, VMT-α-NET may be made available to qualified doctors in some countries. In this circumstance, Viewpoint supplied drug precursors and isotopes for the local production of its proprietary radiotherapeutic, VMT-α-NET.

"We are highly committed to the rapid development of alpha-particle radionuclide therapy for cancer," said Viewpoint CEO Thijs Spoor. "We are pleased to support Dr Sen’s team in making this product available for her patients."

The progress of these patients will be followed by Dr. Sen and her team over the coming months. The safety and effectiveness of the treatments will be evaluated by Dr. Sen’s team with laboratory testing, observation of NET-associated symptoms, and repeat medical imaging.

In the U.S., VMT-α-NET will imminently enter a Phase 1 imaging and therapy study, to be conducted at various hospitals and clinics. VMT-α-NET, is categorized as an investigational new drug by the U.S. Food and Drug Association and the administration of VMT-α-NET for compassionate use is completely independent from and not within the scope of the Company’s Phase 1 trial.

On January 23, 2023 Swiss Rockets, a Basel-based incubator and accelerator of start-up companies in oncology and infectiology, reported that it acquired all assets and intellectual property of Piqur and transferred them to Torqur (Press release, Torqur, JAN 23, 2023, View Source [SID1234627671]). Torqur is a platform for the discovery and efficient development of innovative anti-cancer therapies targeting the metabolic PI3K/mTOR intracellular signalling pathway.

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Piqur Therapeutics AG, a biotech spin-off company of the University of Basel, was co-founded by Dr. Vladimir Cmiljanovic in 2011 to develop bimiralisib, a potent and balanced pan-PI3K/mTOR inhibitor, discovered by Vladimir and his sister Dr. Natasa Cmiljanovic during their Ph.D. studies at the University of Basel. Since 2018 Vladimir and Natasa have been working together to further develop bimiralisib and a pipeline of next-generation PI3K/mTOR inhibitors under Swiss Rockets’ expertise.

The PI3K/mTOR intracellular signalling pathway is often abnormally activated and has a significant role in cancer formation. The lead candidate bimiralisib is a balanced pan-PI3K/mTOR inhibitor formulated for oral and topical administration. Promising early clinical activity has been demonstrated in multiple phase 1/2 studies allowing further development towards proof-of-concept studies in various oncology and dermatology indications.

Over 10 years, Piqur received funding of CHF 100+ million. Dr. Vladimir Cmiljanovic explains: "With these assets in our hands, we founded Torqur, which is now in possession of a drug candidate in clinical phase II for different solid tumours with potential to be further developed for various additional indications such as lymphomas, skin cancers and brain tumours." Torqur also has a pipeline of additional molecules which have already entered initial stages of development and is strengthening its pipeline by investing in the development of next-generation PI3K/mTOR inhibitors to form a robust portfolio of therapeutic areas in oncology and beyond.

Torqur is committed to providing next-generation potent PI3K/mTOR inhibitors for targeted cancer therapies to support patients’ quality of life and extended survival. With the company’s know-how, extensive drug development experience, and a broad network of internationally recognized experts and partners, Torqur believes it can deliver the best treatment and most promising outcomes to patients.

On January 23, 2023 NovAccess Global Inc., a Colorado corporation ("NovAccess" or the "company"), reported previously entered into three securities purchase agreements dated August 20, 2021, February 15, 2022, and May 5, 2022 (collectively, the "Agreements"), with AJB Capital Investments, LLC ("AJB") (Filing, 8-K, NovAccess Global, JAN 23, 2023, View Source [SID1234626477]). Pursuant to the Agreements, NovAccess issued promissory notes to AJB representing loans provided by AJB to the company totaling $1.75 million. Also pursuant to the Agreements, NovAccess paid AJB commitment fees totaling 1,575,000 unregistered shares of the company’s common stock (the "commitment fee shares"). If AJB is unable to sell the commitment fee shares for amounts specified in the Agreements, then AJB may require NovAccess to issue additional shares or pay cash in the amount of the shortfall (the "make-whole rights"). However, AJB may only exercise its make-whole rights within time frames following the loan dates specified in the Agreements (the August 20, 2021 and February 15, 2022 make-whole rights each have a term of 18 months and the May 5, 2022 make-whole rights have a term of 36 months). The August 20, 2021 make-whole rights expire on February 20 of this year. To avoid forcing AJB to sell the commitment fee shares in order to take advantage of its make-whole rights, on January 20, 2023 NovAccess entered into a letter agreement with AJB extending the exercise period for the make whole-rights to 72 months. As amended by the letter agreement, the make-whole rights now expire on August 20, 2027, February 15, 2028, and May 5, 2028. The letter agreement makes additional less material revisions to AJB’s make-whole rights and harmonizes the make-whole rights among the Agreements.

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The letter agreement with AJB is filed as an exhibit to this Current Report on Form 8-K. The description above is qualified in its entirety by reference to the full text of the agreement.

On January 23, 2023 TME Pharma N.V. (Euronext Growth Paris: ALTME) (Paris:ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported a clinical update on survival of first-line glioblastoma patients in the GLORIA expansion arm evaluating NOX-A12, the CXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab (Press release, TME Pharma, JAN 23, 2023, View Source [SID1234626476]).

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With a median follow-up to date of 10 months in this arm of the trial median overall survival (mOS) has not yet been reached, and five of six patients (83%) remain alive. The 10-month timepoint is an important landmark for assessment since this is the expected survival for patients with MGMT unmethylated tumors and incomplete resection1.

"The data presented in November 2022 at the SNO conference demonstrated the ability of NOX-A12 in combination with radiotherapy and bevacizumab to durably shrink brain tumors in glioblastoma patients with 100% radiographic response and an 83% rate of mRANO response, which is twice as high as the mRANO response rate reported from comparable studies with bevacizumab and standard of care2," said Aram Mangasarian, CEO of TME Pharma. "We are pleased to see the data continuing to support our approach with each update, and we are keen to understand the extent of survival benefit that these patients will obtain. We will continue to provide clinical updates as the data mature."

On January 23, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that the Company’s medical director, Matthew Goldberg, M.D., F.A.A.D., board-certified dermatologist and dermatopathologist, will present at the Precision Medicine World Conference (PMWC) 2023, being held Jan. 25-27 in Santa Clara, California (Press release, Castle Biosciences, JAN 23, 2023, View Source [SID1234626475]).

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Dr. Goldberg’s presentation, titled "Using Molecular Diagnostics to Inform Cancer Management Decisions," will take place on Wednesday, Jan. 25, at 2:30 p.m. Pacific time as part of Track 3: Diagnostics and Molecular Profiling in the Clinic. Dr. Goldberg will highlight several tests within Castle’s skin cancer and gastroenterology portfolios, including DecisionDx-Melanoma, DecisionDx-SCC and the TissueCypher Barrett’s Esophagus test, and demonstrate how the personalized information the tests provide can help clinicians make more informed treatment decisions in the care of their patients to potentially improve patient outcomes.

"Castle Biosciences is a leading company in the precision medicine space that is committed to transforming disease management for skin cancers and Barrett’s esophagus," said Dr. Goldberg. "By focusing on disease states with significant unmet clinical need, we leverage our innovative in-house testing platforms to provide meaningful improvements to diagnostic or risk stratification approaches across the various disease states where we offer molecular testing.

"While there is much discussion about the promise of personalized medicine, Castle’s tests have the potential to improve patient outcomes and reduce costs to the healthcare system. I am looking forward to sharing concrete examples during my discussion of how molecular testing technologies can be clinically accessed for the benefit of patient care today."

Dr. Goldberg has served as Castle’s medical director since 2020 and supports Castle’s commercialized and pipeline tests. He graduated summa cum laude from Princeton University and received his medical degree from the Icahn School of Medicine at Mount Sinai. Dr. Goldberg completed his dermatology residency at the University of California, San Francisco, and completed a dermatopathology fellowship at the University of Texas Southwestern.

Conference presentation content will be available to registered attendees only. Visit View Source for more information and registration details.

About Precision Medicine World Conference

PMWC, the "Precision Medicine World Conference," is the largest and original annual conference dedicated to precision medicine. PMWC’s mission is to bring together recognized leaders, top global researchers and medical professionals, and innovators across healthcare and biotechnology sectors to showcase practical content that helps close the knowledge gap between different sectors, thereby catalyzing cross-functional fertilization and collaboration in an effort to accelerate the development and spread of precision medicine.

Since 2009, PMWC has been recognized as a vital cornerstone for all constituents of the health care and biotechnology community, providing an exceptional forum for the exchange of information about the latest advances in technology, in clinical implementation, research and in all aspects related to the regulatory and reimbursement sectors.