On August 22, 2022 Alpha Tau Medical Ltd. (Nasdaq: DRTS) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, and MIM Software Inc. ("MIM Software"), a leading global provider of medical imaging software, reported a collaboration between the two companies to provide treatment planning software for clinical sites using the Alpha DaRT therapy (Press release, Alpha Tau Medical, AUG 22, 2022, View Source [SID1234618536]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, the parties will collaborate on the use of MIM’s software suite, including MIM Symphony and MIMcloud, for development of new features and support for the Alpha DaRT across multiple potential indications, integration into all clinical trials involving the Alpha DaRT, and bundling the MIM software with the Alpha DaRT for future commercial sales in territories where the Alpha DaRT and MIM’s software are both approved.

The MIM Symphony treatment planning software guides clinicians through an easy step-by-step process to place Alpha DaRT sources precisely and create a patient-personalized treatment plan. MIM’s proprietary image manipulation capabilities, including MIM ReSlicer, and process and data management with MIM Workflows and MIMcloud, allow MIM Symphony to support treatment planning flexibly across multiple disease sites. Versatile guidance capabilities, including the ability to create custom 3D-printed access devices, assist in Alpha DaRT placement for challenging targets.

"We are thrilled to be taking this next step in our longstanding relationship with MIM," noted Uzi Sofer, CEO of Alpha Tau. "While working with MIM for the past few years, we have seen this software’s ability to make treatment planning simpler and more powerful for the clinicians using the Alpha DaRT, and we are very excited to integrate our technologies and deliver the best therapeutic care for cancer patients. We continue to see increasing response rates in our clinical trials, culminating in our most recent data release from our U.S. pilot study treating cutaneous cancers, where we observed a 100% complete response rates at 12 and 24 weeks after treatment. We believe that our improved treatment planning capabilities, including those developed with our colleagues at MIM, have played an important part in that achievement." Alpha Tau Chief Operating Officer, Amnon Gat, added "Our experience with the MIM team has been fantastic, and has instilled confidence that we can continue to develop together new treatment planning methods and workflows for our pipeline indications such as cancers of the brain, pancreas and liver."

"Our collaboration with Alpha Tau is an excellent opportunity for MIM to impact radiotherapy and patient outcomes" said Andy Nelson, CEO of MIM Software. "We are very pleased with the response rates and are excited to be involved in providing an enhanced patient experience with Alpha DaRT." MIM Software Chief Scientific Officer, Jon Piper, added "It’s been wonderful working together with Alpha Tau towards improving outcomes for patients whose options are limited today. We are hopeful that the planning, quality assurance, and standardization that MIM provides will allow clinicians to realize the potential of this transformational modality."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On August 22, 2022 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported it will report its financial results for the first half of 2022 on August 24, 2022 before market open and subsequently host a webcast presentation at 4 p.m. CET / 10 a.m. ET (Press release, Nykode Therapeutics, AUG 22, 2022, View Source [SID1234618534]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website: View Source

On August 22, 2022 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that BVF Partners L.P. and RA Capital Management have exercised their remaining tranche 1 warrants issued in connection with the Company’s November 2021 financing, resulting in proceeds of $20.9 million to the Company (Press release, Concert Pharmaceuticals, AUG 22, 2022, View Source [SID1234618533]). Concert has the potential to receive an additional $49.2 million if the tranche 2 warrants issued to BVF and RA Capital in connection with the same financing are exercised in full by their October 31, 2022 expiration date. If the tranche 2 warrants are fully exercised, under its current operating plan, Concert would expect its cash, cash equivalents and investments to fund the Company beyond the anticipated submission of its New Drug Application (NDA) for CTP-543, which is expected in the first half of 2023.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The exercise period of the tranche 1 and tranche 2 warrants was tied to the clinical success of the Company’s CTP-543 THRIVE-AA1 and THRIVE-AA2 Phase 3 trials for alopecia areata. Concert reported positive topline results from the THRIVE-AA1 and THRIVE-AA2 trials in May 2022 and August 2022, respectively. In June 2022, Concert received $18.9 million from the partial exercise of the tranche 1 warrants issued to BVF and RA Capital.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.