On November 30, 2021 QSAM Biosciences, Inc. (the "Company"), through its wholly-owned subsidiary, QSAM Therapeutics Inc. (the "Subsidiary"),reported that it entered into a patent and technology license agreement (the "License Agreement") and trademark assignment with IGL Pharma, Inc. ("IGL") to secure the exclusive, worldwide rights to the radiopharmaceutical drug candidate, CycloSam (Filing, 8-K, QSAM Biosciences, NOV 30, 2021, View Source [SID1234596310]). The License Agreement stipulated milestone-based payments to IGL tied to successful completion of clinical trial phases, royalty fees on net sales, and commissions from sublicensing or sale of the product among other things. On November 24, 2021, the Company and IGL entered into a first amendment to the License Agreement to effect certain changes to the commercial arrangement between the parties. We have summarized the key terms of the amendment below (the "Amended License Agreement"):

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(i)The Company had previously agreed to issue a 5% equity interest in the Subsidiary to IGL upon satisfaction of certain conditions. Pursuant to the Amended License Agreement, we have agreed to issue 500,000 restricted common shares of the Company to IGL in lieu of equity interest in the Subsidiary;
(ii)The License Agreement stipulated a payment to IGL of up to 50% of any sublicense fees received by the Company in the event of a grant of rights to CycloSam to a third party. This fee has been materially reduced to a fixed payment of 5% of any sublicense fee, which includes the sale of the technology or sale of our Subsidiary that holds the Amended License Agreement to a third party;
(iii)Milestone payments tied to phases of clinical trials were increased from a total of $150,000 to a total of $410,000, which are expected to be paid over the following two to three years, and our payment upon the first commercial sale of CycloSam to third parties was increased from $1,500,000 to $2,000,000;
(iv)We have agreed to provide IGL the right to observe and participate in any board of directors meeting of the Company in which any scheduled agenda item may reasonably affect the rights of IGL under the Amended License Agreement

On November 30 2021 Redx Pharma (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that Lisa Anson, Chief Executive Officer, and Peter Collum, Chief Financial Officer, will be participating at the Piper Sandler 33rd Annual Virtual Healthcare Conference, 30 November to 2 December (Press release, Redx Pharma, NOV 30, 2021, View Source [SID1234596309]). A pre-recorded presentation by Lisa Anson can be accessed via the following link: https://bit.ly/3CSvvSV

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On November 30, 2021 Akoya Biosciences, Inc., (Nasdaq: AKYA), The Spatial Biology Company, reported that its Advanced Biopharma Solutions (ABS) laboratory, located in Marlborough, Massachusetts, has received its Certificate of Registration from the Clinical Laboratory Improvement Amendments (CLIA) program, following the receipt of a Massachusetts Department of Public Health clinical laboratory license (Press release, Akoya Biosciences, NOV 30, 2021, View Source [SID1234596308]). This certification enables Akoya’s ABS lab to support later stage clinical trial studies with its biopharmaceutical partners.

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CLIA certification affirms that Akoya’s ABS lab processes and services operate under high quality standards and provides a framework for assay development and validation that consistently meets guidelines for accuracy, precision, specificity, sensitivity, and reproducibility. This milestone is an important step towards advancing the company’s platforms toward clinical use. It further positions Akoya Biosciences as an attractive partner for biopharmaceutical companies seeking to incorporate its ground-breaking spatial biology technologies into their clinical research, most notably in the expanding field of cancer immunotherapy.

"Securing CLIA certification for ABS demonstrates our commitment to meeting the highest quality standards," said Brian McKelligon, Chief Executive Officer of Akoya Biosciences. "This is an important step in support of our effort to work with our biopharmaceutical partners to identify biomarkers that lead to better clinical decision making and improved patient outcomes."

Spatial biology, a rapidly emerging field of science, allows researchers to discover and validate biomarker signatures that map the interactions of tumor and immune cells across an entire tumor tissue section by retaining the spatial context. Published studies have demonstrated that spatial phenotypic signatures, based on Akoya’s platform, are more accurate at predicting response to immunotherapy than biomarkers currently being used in the clinic.

The certification will enable Akoya to expand its collaborations with key partners like AstraZeneca and other biopharmaceutical companies working with Akoya’s ABS Program. The goal of this program is to enable biopharma partners to leverage Akoya’s deep spatial biology expertise and technological innovations from the early stages of clinical trials, potentially, through full companion diagnostic approval.

The CLIA certification is the latest milestone in Akoya’s ongoing efforts to ensure consistency and standardization of its laboratory processes and results. Important prior milestones include a recent publication in the Journal of Immunotherapy for Cancer on the MITRE Study, demonstrating for the first time a spatial biology workflow with the throughput, accuracy and reproducibility required to serve the translational and clinical markets.

On November 30, 2021 Walgreens Boots Alliance (Nasdaq: WBA) and McKesson Corporation (NYSE: MCK) reported that they have reached an agreement for WBA to acquire the remaining 30% share of their GEHE Pharma Handel (GEHE) and Alliance Healthcare Deutschland (AHD) joint venture (Press release, McKesson, NOV 30, 2021, View Source [SID1234596307]). Following this transaction, WBA will become the 100% owner of the combined GEHE and Alliance Healthcare businesses in Germany.

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GEHE and AHD successfully combined their operations in the German pharmaceutical market on November 1, 2020. In that transaction WBA became the 70% owner of the joint venture with McKesson holding the remaining 30%. Today’s announcement follows McKesson’s announcement in July 2021 of the sale of certain European businesses and its intention to exit the European region fully.

"We are very pleased to have reached agreement with McKesson to take full control of our joint German pharmaceutical wholesaling operations. This new, exciting step enables Walgreens Boots Alliance to further strengthen its position as a leading pharmaceutical wholesaler in Germany," said Ornella Barra, Chief Operating Officer, International, Walgreens Boots Alliance. "We thank McKesson for their partnership in forming and developing our joint venture and look forward to further improving our innovative services to manufacturers and pharmacists in Germany."

Brian Tyler, chief executive officer, McKesson: "The sale of our minority stake in the GEHE-Alliance Healthcare joint venture in Germany is part of our stated intention to exit the European market to reinvest in strategic growth opportunities elsewhere. We believe that WBA is an excellent parent company for the GEHE-Alliance Healthcare businesses in Germany and wish our colleagues all the best under their full ownership."

The transaction is subject to standard regulatory clearance by the relevant local authorities. Financial terms of the transaction have not been disclosed.

On November 30, 2021 ABM Therapeutics (ABM), a clinical-stage biopharmaceutical company with a focus on treating brain cancers and cancer metastases, reported that its IND application for ABM-1310, a new-generation BRAF inhibitor, has been approved by the National Medical Products Administration (NMPA) to conduct Phase 1 clinical trials in patients of advanced solid tumors with BRAF mutation in China (Press release, ABM Therapeutics, NOV 30, 2021, View Source [SID1234596305]). This is the first clinical candidate and IND approval obtained by ABM Therapeutics in China.

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ABM-1310 is a brain-penetrant BRAF inhibitor. Due to its high selectivity and optimal physicochemical properties, as well as superior efficacies and high margin of safety in preclinical models, it is expected to solve issues, such as brain metastasis, that are associated with marketed drugs.

The Phase 1 trials will be a multi-center, open-label study to assess safety, tolerability, pharmacokinetics, and preliminary efficacy. The primary goal of the study is to determine the optimal dose for Phase 1b/2 studies. The company started an ongoing Phase 1 safety trial in the United States in June of 2020.

"This is excellent progress for ABM. I really appreciate the team, including members from our supporting CRO, for all their highly efficient and superbly executed hard work. This first IND approval in China is another milestone in the development of ABM-1310, which further validates ABM’s capabilities of independent R&D innovation and technological excellence," said Dr. Chen Chen, founder and CEO of ABM Therapeutics. "Due to the blood-brain barrier (BBB), most anti-cancer drugs have poor brain penetration, resulting in limited efficacy on the brain lesion. It is an indisputable fact that many cancer patients are affected by brain metastases, but current treatment options are rare. It is a challenge to develop brain-penetrant anti-cancer drugs, but there is certainly a highly unmet medical need. ABM-1310 is a novel small molecule with high water solubility, cell permeability, and selectivity. We will begin clinical development at full throttle in China with the hope of bringing the potential therapeutic benefits to patients in the near future."

As a leading company with an emphasis on small molecules with good cell/brain permeability to address cancer metastases, particularly brain metastases, ABM has a broad and robust proprietary pipeline based on its brain medicine R&D platform. The company looks forward to further collaboration with investigators, clinical sites, big pharma and biotech companies.