On August 22, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) and Noile-Immune Biotech Inc. reported that the companies entered into a license agreement for Noile-Immune’s proprietary PRIME (Proliferation-Inducing and Migration-Enhancing) CAR-T technology (Press release, Chugai, AUG 22, 2022, View Source [SID1234618532]).

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In recent years, cancer immunotherapy has been widely recognized as a new approach to cancer treatment by enhancing the immune system to attack cancer cells. Chimeric antigen receptor T cell (CAR-T cell) therapy is a type of cancer immunotherapy, in which a patient’s immune cells (T cells) are collected, transfected with a gene for an artificial chimeric antigen receptor (CAR), which recognizes a cancer antigen, expanded in large numbers and returned to the patient’s body. The therapy is currently used as a new treatment for hematologic cancers. Noile-Immune’s PRIME technology is expected to open up the possibility of CAR-T cell therapy not only for hematologic cancers but also for solid tumors. PRIME technology is a platform designed to enhance the function of immune cells through the expression of the cytokine*1 IL-7 and the chemokine*2 CCL19 from CAR-T cells, exerting anti-tumor effects.1,2 Preclinical studies (mouse, in vivo) have shown that the PRIME technology increases the expression of IL-7 and CCL19 and boosts the proliferation and migration into solid tumors of both CAR-T cells as well as the patient’s own immune cells.

*1 Cytokine is a bioactive substance secreted from cells, and mainly controls the proliferative activity, function, survival, etc. of immune cells.
*2 Chemokine is a type of a bioactive substance that control the migration of immune cells, including white blood cells, into tissues.
The agreement is based on the evaluation results for PRIME technology under the previous technology assessment agreement between Chugai and Noile-Immune in June 2020. Under the newly executed license agreement, Noile-Immune grants Chugai the rights to use PRIME technology for the creation and research of PRIME CAR-T cells, as well as the rights to develop, manufacture and commercialize PRIME CAR-T cell products for certain targets. Chugai will pay Noile-Immune an upfront payment and technology transfer fees. Also, Chugai may potentially pay over ¥20 billion in total if predetermined development or sales milestones are achieved. If Chugai successfully launch a product using PRIME technology, it will also pay royalties on sales in addition to the aforementioned sales milestones.

"Chugai is focusing efforts to establish new modalities following small molecules, antibodies and mid-size molecules under its multi-modality drug discovery strategy. We will challenge ourselves to make an innovative modality available for solid tumors by combining Noile-Immune’s PRIME technology and Chugai’s scientific and technical capabilities," said Dr. Osamu Okuda, Chugai’s President and CEO.

"I am very pleased that the evaluation for our PRIME technology, which was initiated in 2020, resulted in this license agreement. We hope that this agreement will accelerate the development of safe and effective cancer immunotherapies for solid tumors, deliver new treatment options to patients suffering from cancer worldwide as soon as possible, and lead to the creation of a society that can overcome cancer," said Koji Tamada, M.D., Ph.D, Noile-Immune’s President & CEO and scientific founder.

On August 22, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it has transferred common shares in an amount equal to approximately 38.6% of the issued and outstanding shares of Bausch + Lomb Corporation ("Bausch + Lomb") to an existing wholly-owned unrestricted subsidiary of the Company (the "Internal Transfer") (Press release, Bausch Health, AUG 22, 2022, View Source [SID1234618531]).

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Common shares in an amount equal to approximately 50.1% of Bausch + Lomb continue to be held by a wholly-owned restricted subsidiary of the Company, and Bausch + Lomb itself remains a restricted subsidiary of the Company. The Company, through its subsidiaries, continues to hold the same number of shares of Bausch + Lomb as it did prior to the Internal Transfer, which in the aggregate comprises approximately 88.7% of the issued and outstanding shares of Bausch + Lomb.

The Internal Transfer is consistent with the Company’s commitment to the separation of Bausch + Lomb and provides the Company with strategic flexibility while it evaluates all relevant factors and considerations relating to the separation of Bausch + Lomb. Further, the Company has engaged Houlihan Lokey and White & Case LLP as financial and legal advisors, respectively, to assist the Company in evaluating potential strategic alternatives.

The separation of Bausch + Lomb is contingent on the expiry of customary lockups related to the initial public offering of Bausch + Lomb, the achievement of targeted debt leverage ratios and the receipt of applicable shareholder and other necessary approvals.

On August 22, 2022 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, AUG 22, 2022, View Source [SID1234618529]).

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The share buy-back program is expected to be completed no later than August 31, 2022 and comprises up to 370,000 shares.

The following transactions were executed under the program from August 15, 2022 to August 19, 2022:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 521,883 shares as treasury shares, corresponding to 0.79% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 22 dated June 17, 2022.

On August 22, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that the diagnostic 64Cu SAR-Bombesin trial (BOP) for patients with prostate cancer is open for recruitment in Australia (Press release, Clarity Pharmaceuticals, AUG 22, 2022, View Source [SID1234618524]).

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BOP (Copper-64 SAR Bombesin in PSMA negative Prostate Cancer (BOP) is a Phase II investigator-initiated trial (IIT) in up to 30 patients led by Prof Louise Emmett at St Vincent’s Hospital Sydney. The BOP trial will be assessing the safety of 64Cu-SAR-Bombesin as well as looking at the diagnostic potential for men with negative prostate specific membrane antigen (PSMA) positron emission tomography (PET) or low PSMA expression disease in patients with suspected biochemical recurrence (BCR) of their prostate cancer and patients with metastatic castrate resistant prostate cancer (mCRPC) who are not eligible for PSMA therapy. The trial will be imaging with 64Cu SAR-Bombesin on the day of administration as well as at later timepoints.

Approximately 20% of prostate cancers with BCR are PSMA-PET negative1-4. These patients are therefore unlikely to respond to therapeutic PSMA-targeted products and currently have few treatment options available to them. Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment. The SAR-Bombesin product targets the Gastrin Releasing Peptide receptor (GRPr) found on up to 100% of prostate cancers5-9 as well as many other cancers. As such, the product could offer valuable imaging and therapeutic options for not only PSMA negative patients, but also the large number of patients that have the target receptor on their cancers.

BOP builds on the data generated in PSMA-negative prostate cancer patients at St Vincent’s Hospital imaged under TGA SAS as well as from pilot diagnostic IIT of SAR-Bombesin in breast cancer patients, the C-BOBCAT trial, which was recently presented at the prestigious American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting.

Prof Louise Emmett (St Vincent’s Hospital Sydney), Principal Investigator in the BOP trial, commented, "The data we acquired to date for SAR-Bombesin through SAS, published as a case study10, has demonstrated diagnostic imaging potential in PSMA-negative prostate cancer and highlighted potential utility of the product as a theranostic agent. At St Vincent’s Hospital we imaged four men with 64Cu SAR-Bombesin under SAS. They had rising PSA levels but no detectable disease using currently available imaging techniques. SAR-Bombesin was able to detect disease in these patients which successfully led to changes in management of the patient and their disease.

"We are excited by the prospect of making SAR-Bombesin available to a larger pool of patients under clinical trial conditions so that we can carefully analyse the role of this product in the better management of patients. In addition, the central manufacture of these products enables more flexibility in administering the product and has the potential to improve scheduling due to a longer shelf-life in comparison to commonly used diagnostic isotopes such as 68Ga and 18F.

"I am very pleased to be working with Clarity on the Targeted Copper Theranostic (TCT) platform of products. The BOP trial investigating 64Cu SAR-Bombesin is our third trial using Clarity’s TCTs range of products," said Prof Emmett.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "The early data we are generating on our SAR-Bombesin product is already changing the lives of patients with cancer. We are looking forward to progressing the development of this product in Australia and the US for diagnostic and therapeutic applications, hoping that it will provide new options for cancer patients who have few treatment options available to them at present. We believe that SAR-Bombesin has potential to provide large patient populations with accurate and precise detection and treatment of cancers that express the target and deliver clinical, environmental and logistical benefits enabled by the copper isotope pairing."

"BOP is yet another part of our collaboration with St Vincent’s Hospital and Prof Louise Emmett and we look forward to continuing our work on the development of TCTs with the mutual goal of improving treatment outcomes for children and adults with cancer" said Dr Taylor.

Clarity’s Prostate Cancer clinical trial program overview

About SAR-Bombesin
SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the gastrin-releasing peptide receptor (GRPr) present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPr is found in approximately 75-100% of prostate cancers, including prostate cancers that don’t express PSMA (PSMA-negative)5-9. The product utilises Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu for therapy).

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide11. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease12.

On August 21, 2022 BroadenBio reported the company received the official letter of acceptance (Study May Proceed Letter) from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1 clinical trial of Class I investigational new drug BB102 for advanced solid tumors (Press release, BroadenBio, AUG 21, 2022, View Source [SID1234640201]). The project has previously been approved for clinical study by the Center of Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in July 2022, and a first-in-human Phase 1 clinical trial for patients with advanced solid tumors will soon be initiated in China.

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BB102 is an innovative small molecule kinase inhibitor discovered and being developed by BroadenBio for the treatment of advanced solid tumors driven by abnormal oncogenic genes. Besides its novel mechanism of action, high selectivity, good safety, and over advantages, BB102 shows promising efficacy to mutation-driven tumors, and is expected to benefit more cancer patients.