On September 14, 2023 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that a patient with advanced inoperable pancreatic cancer has been treated in a clinical trial at Hadassah Medical Center in Jerusalem, Israel (Press release, Alpha Tau Medical, SEP 14, 2023, View Source [SID1234635159]). The trial is designed for a broad range of solid tumor patients who do not qualify for participation in other existing trials or who do not have other treatment options according to the treating physician.

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!

"We are dedicated to improving the lives and giving hope to cancer patients and their families, and we believe that Alpha DaRT has the potential to transform the treatment landscape for malignant tumors worldwide," said Alpha Tau CEO Uzi Sofer. "Treating this patient with advanced inoperable pancreatic cancer, who may not have had other life-saving options at this stage, is very encouraging as we continue to execute on our unwavering mission to reach those patients with high unmet need. We are pursuing our objective of establishing Alpha DaRT as a treatment option for this terrible illness with our ongoing studies of pancreatic cancer in Israel and Montreal."

"The Department of Gastroenterology of Hadassah University Medical Center, in conjunction with all our multidisciplinary partners, was privileged to utilize the groundbreaking Israeli technology of endoscopic ultrasound-guided implantable alpha radiation to treat a patient with pancreatic cancer," noted Dr. Harold Jacob, Head of the Advanced Endoscopic Unit, Hadassah Medical Center, who, together with Dr. Ari Benson and Dr. Julia Epstein, treated the patient. "The procedure was smooth, straightforward, and incredibly quick, thanks to the support of the Alpha Tau team. The Alpha DaRT treatment holds promise and gives hope for pancreatic cancer patients and their families."

"Pancreatic cancer is particularly devastating, with an estimated 5-year survival rate of less than 5%," commented Alpha Tau CMO Dr. Robert Den. "Alpha DaRT might offer hope to patients who otherwise may not have available efficacious treatments. I am heartened that we have been able to treat our first pancreatic cancer patient in Israel, and I look forward to gaining further insight into the safety and efficacy profile of Alpha DaRT from our ongoing studies."

On September 13, 2023 AimedBio reported to have received equity investment from the "Life Science Fund", an investment fund created by Samsung Biologics, Samsung C&T, and Samsung Bioepis.

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!

– It is Samsung’s fourth investment through the "Life Science Fund", but the first case as domestic investment.

– They will be collaborating on ADC toolbox co-development and CDO business of AMB001, a KDDF grant-receiving platform.

(Press release, AimedBio, SEP 13, 2023, View Source;s_keyword=&s_where=&start=10 [SID1234656920])

On September 13, 2023 ImmuneOnco Biopharmaceuticals reported the preclinical research results of IMM47 under the tittle of IMM47, a humanized monoclonal antibody that targets CD24, exhibits exceptional anti-tumor efficacy by blocking the CD24/Siglec-10 interaction and can be used as monotherapy or in combination with anti-PD1 antibodies for cancer immunotherapy " in the journal "Antibody Therapeutics" (Press release, ImmuneOnco Biopharma, SEP 13, 2023, View Source [SID1234655691]).

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!

CD24 widely expresses in a variety of solid tumors, including breast cancer, non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, renal cell carcinoma, and ovarian cancer. It is well accepted that CD24 is an important biomarker of poor prognosis in these cancers and focused in clinical R&D.

The paper explains the mechanism of IMM47 on destroying tumor cells and its powerful ability to inhibit tumor growth by a serial in vitro and in vivo experiments. With high specificity and binding ability to CD24 expressed on tumor cells, IMM47 can block immunosuppressive signals transmitted via the CD24/Siglec-10 pathway to macrophages, natural killer cells (NK) and T cells. With genetically engineered IgG1-Fc, IMM47 effectively activates macrophage and natural killer cell via powerful ADCP and ADCC. Li, song and Chen, Dianze share the first author. In the in vivo efficacy studies on model animals, IMM47 significantly increases the number of M1 macrophages in tumor tissues and downregulates CD24 expression in tumor cells, either alone or in combination with PD-1/PD-L1 immune checkpoint inhibitors and other drugs. By using both combinations, it also demonstrates encouraging abilities to inhibit tumor growth.

With these promising results, the IND application for IMM47 to treat solid tumors was accepted by the National Medical Products Administration (NMPA). It is also ready to submit the application to the U.S. Food and Drug Administration (FDA) in the near future.

The corresponding author, Dr. Tian, Wenzhi ( founder and chairman of ImmuneOnco), said: "I am very pleased to see the preclinical research results of our IMM47 published in Antibody Therapeutics. IMM47 is a humanized monoclonal antibody targeting CD24 for cancer therapy. The antibody screening for CD24 was quite challenge due to its small size of extracellular domain which exhibits weaker immunogenicity. We persevered through the accumulation of a lot of trivial work and finally got the IMM47 molecule with high affinity and specificity. IMM47 can specifically bind to CD24 and effectively activate macrophages and natural killer cell to regain immune response. Preclinical studies support the conclusion that IMM47 has powerful anti-tumor activity with great clinical value. We will quickly advance the clinical research of the IMM47 to benefit more subjects sooner."

On September 13, 2023 Titan Pharmaceuticals, Inc. ("Titan" or the "Company") reported to have entered into a Securities Purchase Agreement (the "Purchase Agreement") with The Sire Group Ltd. ("Sire Group" or the "Investor"), pursuant to which the Company has agreed to issue 950,000 shares of Series AA Convertible Preferred Stock, par value $0.001 per share (the "Series AA Preferred Stock") to the Investor at a price of $10.00 per share, for an aggregate purchase price of $9,500,000 (the "Private Placement"). The purchase price consists of (i) $5 million in cash at closing and (ii) $4.5 million in the form of a promissory note from Sire Group, personally guaranteed by a principal of Sire Group, due and payable on September 23, 2023, subject to two 10-day extensions which include additional payments of $50,000 for each extension. The terms, rights, obligations and preferences of the Series AA Preferred Stock are set forth in a Certificate of Designations, Preferences and Rights of Series AA Convertible Preferred Stock of the Company (the "Certificate of Designations"), filed with the Secretary of State of the State of Delaware on September 13, 2023. Copies of the form of Purchase Agreement and the Certificate of Designations are attached hereto as Exhibits 10.1 and 4.1, respectively, and are incorporated herein by reference.

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 Certificate of Designations, each share of Series AA Preferred Stock will be convertible, at the holder’s option at any time, into shares of the Company’s common stock at a conversion rate equal to the quotient of (i) the stated value of such share divided by (ii) the initial conversion price of $0.466, subject to specified adjustments as set forth in the Certificate of Designations. Based on the initial conversion rate, approximately 20,386,266 shares of the Company’s common stock would be issuable upon conversion of all the shares of Series AA Preferred Stock, when issued, assuming the absence of in-kind dividends. The Series AA Preferred Stock will contain limitations that prevent the Investor from acquiring the lower of either (i) the maximum percentage of common stock permissible under the rules and regulations of The Nasdaq Stock Market ("Nasdaq") without first obtaining shareholder approval or (ii) 19.99% of the Company’s outstanding common stock.

The holder of the Series AA Preferred Stock is entitled to receive dividends on shares of the Series AA Preferred Stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends actually paid on shares of the common stock. No other dividends will be paid on shares of the Series AA Preferred Stock. Any shares of Series AA Preferred Stock may, at the option of the holder, be converted at any time into that number of shares of common stock at the conversion price set forth above. The Series AA Preferred Stock does not have any voting rights. In the event of any liquidation, dissolution or winding up of the Company, the holder of the Series AA Preferred Stock will be entitled to receive out of the assets, whether capital or surplus, of the Company the same amount that a holder of common stock would receive if the Series AA Preferred Stock were fully converted to common stock, which amounts shall be paid pari passu with all holders of common stock. The foregoing description provides a summary of certain material terms of the Series AA Preferred Stock issued pursuant to the Purchase Agreement, as set forth in Certificate of Designations, which is filed as Exhibit 4.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The shares sold in the Private Placement do not involve a public offering and have not been registered under the Securities Act of 1933, as amended, in reliance on Regulation S thereunder.

Registration Rights Agreement

In connection with the Private Placement, the Company entered into a registration rights agreement with the Investor (the "Registration Rights Agreement") pursuant to which the Company has agreed to provide certain registration rights upon the occurrence of certain events set forth in the Registration Rights Agreement. The foregoing description of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by the full text of the Registration Rights Agreement, which is filed as Exhibit 10.2 to this Current Report on Form 8-K and is incorporated herein by reference.

On September 13, 2023 Bioneer reported that The Innovation Fund has invested approximately DKK 12.3 million in a research project aimed at developing a biological drug candidate that represents a completely new concept in cancer treatment (Press release, Bioneer, SEP 13, 2023, View Source;utm_medium=rss&utm_campaign=the-innovation-fund-invests-in-the-development-of-cym-001-an-innovative-bispecific-antibody-to-treat-metastatic-castration-resistant-prostate-cancer-bampc [SID1234635201]). The molecule, CYM-001, owned by Cymab ApS, is a bispecific antibody that stimulates the body’s own immune system to fight cancer cells.

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 the past decade, immune therapy biologics, known as checkpoint inhibitors, have revolutionized cancer treatment. They are becoming more widely used, with an estimated global market of $22 billion in 2023. However, with the expansion of checkpoint inhibitors, it has become clear that there are limitations, and there are large patient groups who cannot benefit from the treatment as their tumors are non-immunogenic, as is the case with certain types of advanced-stage prostate cancer.

Non-immunogenic tumors in mCRPC are the initial target for CYM-001. Each year, about 1300 men in Denmark die from prostate cancer, with a mortality rate that has remained largely unchanged for decades (Association of The Nordic Cancer Registries). Both in Denmark and the USA, prostate cancer is the second most common cancer-related cause of death in men, surpassed only by lung cancer. Existing treatment options for late stages of prostate cancer are currently limited and are not curative for several patient subgroups, including mCRPC. Existing treatment options also often have severe side effects. Impotence and incontinence are frequent consequences, resulting in reduced quality of life for patients.

The goal of the project is initially to develop a treatment for non-immunogenic tumors within metastatic prostate cancer, but it is expected to be applicable to several cancer types. The project is based on experiences with approved drugs combined with new scientific discoveries. Laboratory testing of various molecular prototypes has been ongoing for the past two years.

The project will aim to achieve crucial preclinical and CMC development, as well as clarify the clinical development for CYM-001 into a product for the treatment of metastatic prostate cancer. CYM-001 has the potential to be the first product of a new class of biological drugs that increase the quantity and effectiveness of immune cells in the tumor and are thus effective for cancer treatment where existing immune therapy falls short.

The project is a collaboration between the University of Southern Denmark, Research Unit for Clinical Physiology and Nuclear Medicine, Bioneer A/S, and Cymab ApS. At the University of Southern Denmark, Mikael Palner, Head of the Preclinical Imaging Core Facility and Associate Professor, and Christina Baun, Radiographer, will be responsible for translational pharmacological studies to characterize CYM-001. At Bioneer A/S, Christian Clausen, CSO, and Alexandra Baer, R&D Manager Upstream Development Mammalian Cells, will be responsible for cell line and Master Cell Bank development of CYM-001. Together, the partners have extensive experience in drug development, from molecular design and preclinical testing to the development of production methods that enable clinical testing.

Johan Faber, CEO, Cymab ApS. "By both stimulating the body’s own immune cells and directing them directly towards the tumor, the treatment is expected to be effective against cancer types that are not responsive to existing immune therapy. This provides doctors with an entirely new tool in the fight against so-called non-immunogenic or ‘cold’ tumors, unlike today, where there are essentially no effective treatments. The original field of potential drug candidates has now been narrowed down to one, and the new investment from the Innovation Fund enables the crucial development towards the ultimate goal of bringing new treatment options to an area of cancer treatment where nothing currently exists. It’s fantastic."

Hans Wandall, Prof. MD and Chairman, Cymab ApS. "The lack of recruitment of the body’s immune cells in non-immunogenic tumors is observed in several other cancer types besides prostate cancer. By targeting the binding of the molecule to these cancer types, the concept has broad potential as a new treatment paradigm."

Stine Kjellev, CSO, Cymab ApS. "We will be able to offer a better and more targeted treatment with fewer side effects for the types of cancer where the body’s own immune cells do not effectively collaborate with the existing treatment. Our therapy, which we call Targeted Immune Stimulation, abbreviated as TIMS, has the potential to ensure that the same revolutionary effect delivered by checkpoint inhibitors can now also be offered to patient groups with non-immunogenic tumors."

Mikael Palner, Head of the Preclinical Imaging Core Facility and Associate Professor, University of Southern Denmark. "At the Research Unit for Clinical Physiology and Nuclear Medicine, we are at the forefront of diagnostics and are developing groundbreaking methods to improve patients’ quality of life. Therefore, it is truly exciting to be part of this project, which has the potential to revolutionize current treatment options and make a huge difference for the affected patients."

Christian Clausen, CSO, Bioneer A/S. "Bioneer develops cell lines that can be used for the production of new biological drugs. We are working on new methods to improve cell lines to produce more efficiently, as well as to produce more complex proteins. We look forward to collaborating on this new type of prostate cancer treatment project."