On September 27, 2023 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (referred to as "ImmuneOnco""the company’, Hong Kong Stock Exchange stock code: 01541.HK) reported that the newly developed humanized IgG1 CD24 antibody, IMM47, successfully completed the first subject enrollment and dosing in the Australian phase I clinical trial (Press release, ImmuneOnco Biopharma, SEP 27, 2023, View Source [SID1234655692]). This is another milestone achievement in the company’s rapid development.

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CD24 is widely expressed in a variety of solid tumors, including breast cancer, non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, renal cell carcinoma, ovarian cancer, and lymphoma, and is considered an important biomarker of poor prognosis in these cancers. And it appears to be great potential in clinical research.

With high specificity and high affinity binding to CD24 expressed on tumor cells, IMM47 can block immunosuppressive signals transmitted from the CD24/Siglec-10 pathway to macrophages, natural killer cells (NK) and T cells. With genetically engineered improved IgG1 Fc, IMM47can also effectively activates macrophage and natural killer cell immune responses through powerful ADCP and ADCC. In preclinical animal in vivo efficacy studies, IMM47 was shown to significantly increase the number of M1 macrophages in tumor tissues and downregulate CD24 expression in tumor cells, either alone or in combination with PD-1/PD-L1 immune checkpoint inhibitors and other drugs. Both combinations have shown encouraging abilities to inhibit tumor growth.

In addition, the IND application for IMM47 to treat solid tumors has been accepted by the National Medical Products Administration (NMPA), and we also plan to submit an application to the U.S. Food and Drug Administration (FDA) in the near future. IMM47 has obtained an authorized patent in China, an approved patent application in Japan, a pending patent application in the United States and the European Union, and a pending PCT patent that may enter multiple signatory countries in the future.

The preclinical research results of the IMM47 have been published in "Antibody Therapeutics" on September 9, 2023, in 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"

Founder and Chairman of ImmunOnco, Dr. Tian, Wenzhi said: "I am very pleased to see that our Australian phase I clinical trial of IMM47 has successfully completed the first subject enrollment and dosing. This also marks that IMM47 has officially entered the clinical research stage. IMM47 is a humanized monoclonal antibodies targeting CD24 for cancer treatment. 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. With differentiated molecular design, IMM47 can specifically bind to CD24 and effectively activate macrophages and natural killer cell immune responses. Preclinical studies have shown that IMM47 has strong anti-tumor activity with great clinical development value. We will quickly advance the clinical trial of IMM47 to benefit more patients."

Chief Medical Officer/Senior Vice President of ImmuneOnco Dr. Lu, Qiying said: "the successful completion of the first subject in the Australian Phase I clinical trial of IMM47 is of great significance for the company, marking that IMM47 officially entered the clinical research. After half year of unremitting efforts by the clinical team, ImmunOnco launched clinical trials in Australia, the first drug candidate for this target to achieve FPI globally. This is due to our first overseas deployment, thus accelerating the clinical verification of IMM47. In addition, we believe that the Australian trial will obtain valuable diverse ethnic clinical data. It will strengthen our ability to pursue collaborating opportunities with global pharmaceutical companies. We highly expect IMM47 drugable and look forward to bringing good news to cancer patients."

On September 27, 2023 KeYe Life Technologies reported under the leadership of its founder Dr. Zhang Yandong, Kaiyue Life Science has won a national patent for the application of its independently developed RNA helicase DHX33 inhibitor in the preparation of drugs for the treatment of gastric cancer (Press release, KeYe Life Technologies, SEP 27, 2023, View Source;article_id=86 [SID1234644612]).

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On September 27, 2023 Theralase reported that it has successfully completed its non-Good Laboratory Practices ("GLP") preclinical toxicology analysis of Rutherrin for Glio Blastoma Multiforme ("GBM") (Press release, Theralase, SEP 27, 2023, View Source [SID1234636145]). GBM is the most aggressive and most common type of brain cancer.

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The preclinical toxicology data collected to date has demonstrated that Theralase’s Rutherrin (RuvidarTM + human transferrin) PDC is able to be safely administered Intra Venously ("IV") into brain cancer animal models and then successfully hunt, target and significantly accumulate inside GBM cells versus healthy brain cells. When the PDC is activated by radiation therapy, such as X-ray radiation, it effectively destroys GBM tumour cells. In addition, to providing a strong cancer killing effect the technology is able to induce Immunogenic Cell Death ("ICD") and certain anti-tumour protective responses, preventing further growth of the GBM tumour cells.

Theralase is forwarding a summary of the preclinical data to Health Canada for review and response on a GLP toxicology program to be completed by the Company by 1Q2024.

Based on the successful completion of the GLP toxicology program, Theralase intends to commence a Phase Ia/Ib dose escalating clinical study in 2024 in patients diagnosed with GBM to determine the appropriate clinical dose of the drug from both a toxicity and tumour localization perspective. This phase will also look at radiation activation of a single IV dose of Rutherrin.

Following the successful completion of the Phase Ia/Ib clinical study, Theralase plans to commence a Phase IIa/IIb clinical study in Canada and the United States focused on enrolling and treating patients diagnosed with recurrent GBM, with multiple radiation activated doses of Rutherrin.

Dr. Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase stated, "Theralase’s scientific team has worked tirelessly to research and develop Rutherrin as an IV PDC that post administration is able to be activated by radiation therapy to hunt, target and destroy GBM. The GLP toxicology program that Theralase is completing will lay the groundwork for Rutherrin to be IV administered for numerous other cancers; including: Non-Small Cell Lung Cancer ("NSCLC"), pancreatic cancer, prostate cancer, kidney cancer and colorectal cancer. I look forward to commencing the clinical study program evaluation of this versatile and effective drug in 2024."

Mr. Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President and Chief Executive Officer of Theralase stated, "Dr. Mandel and his scientific team have conducted numerous in-vitro and in-vivo experiments to compile this body of preclinical work to be able to bring Rutherrin to the GLP toxicology analysis stage and then pending successful completion onto clinical development. The use of human transferrin in animal models has proven difficult to overcome, but the hard work and dedication of the Theralase team have successfully completed this work to bring Theralase to the next step."

On September 27, 2023, Kiromic BioPharma, Inc. (the "Company") issued a 25% Senior Secured Convertible Promissory Note (the "Note") to an accredited investor (Filing, Kiromic, SEP 27, 2023, View Source [SID1234635599]). The Note has a principal amount of $2,400,000, bears interest at a rate of 25% per annum (the "Stated Rate") and matures on September 27, 2024 (the "Maturity Date"), on which the principal balance and accrued but unpaid interest under the Note shall be due and payable. The Stated Rate will increase to 27% per annum or the highest rate then allowed under applicable law (whichever is lower) upon occurrence of an event of default, including the failure by the Company to make payment of principal or interest due under the Note on the Maturity Date, and any commencement by the Company of a case under any applicable bankruptcy or insolvency laws.

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The Note is convertible into shares (the "Conversion Shares") of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at an initial conversion price of $5.00 per share (the "Conversion Price"), subject to a beneficial ownership limitation equivalent to 9.99% (the "Beneficial Ownership Limitation").

The unpaid principal of and interest on the Note constitute unsubordinated obligations of the Company and are senior and preferred in right of payment to all subordinated indebtedness and equity securities of the Company outstanding as of the Issuance Date; provided, however, that the Company may incur or guarantee additional indebtedness after the Issuance Date, whether such indebtedness are senior, pari passu or junior to the obligations under the Note, which are secured by all of the Company’s right, title and interest, in and to, (i) all fixtures (as defined in the Uniform Commercial Code, the "UCC") and equipment (as defined in the UCC), and (ii) all of the Company’s intellectual property as specified in the Note, subject to certain exclusions as described in the Note.

The foregoing description of the Note is qualified in its entirety by reference to the full text of such Note, a copy of which is attached hereto as exhibit 10.1 and incorporated herein by reference.

On September 27, 2023 Accelerator Life Science Partners (ALSP), an early-stage life science accelerator and investment firm that creates and builds next-generation biotechnology companies centered on innovative science, reported the Series A financing of Automera, a new biotechnology company that focuses on the development of autophagy-targeting chimera small molecules (AUTACs) (Press release, Automera, SEP 27, 2023, View Source [SID1234635491]). Augmented with quantum chemistry and artificial intelligence (AI) enabled drug discovery tools, Automera’s AUTACs have the broad potential to rapidly generate novel therapeutic leads for a range of diseases. Automera will initially focus its product development efforts to treat cancer. The company was established by co-founders Associate Professor Michael Lazarou, Loong Wang, and Taiyang Zhang at Talo Labs Pte Ltd. in collaboration with ALSP. Automera has secured $16M in Series A funding, a co-led endeavor by ALSP and ClavystBio, with participation from Singapore-based global investor EDBI, Xora Innovation, and other undisclosed investors. Joining the Board of Directors are Loong Wang, from Automera, Dr. Alice Chen and Thong Q. Le, from ALSP, and Dr. Wen Qi Ho, from ClavystBio.

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"ALSP has long been interested in helping to drive biopharma innovation emerging in Singapore," said Alice Chen, Executive Vice President at ALSP and Automera board member. "As our first investment in Singapore, Automera exemplifies the innovative scientific and translational research ongoing in the region. We plan to leverage ALSP’s unique company-building capabilities in Singapore, and we look forward to working with the broader Singapore community to enhance the platform technologies and early-stage therapeutic programs that Automera will develop. We are honored to co-lead Automera’s Series A financing with our partners at ClavystBio and are excited about expanding Automera’s operations in the months ahead."

Automera’s AUTAC platform is a next-generation approach to realizing the potential of targeted protein degradation (TPD) as a therapeutic modality. TPD, an emerging field of novel therapeutics, catalyzes the degradation of disease-related proteins while retaining the benefits of small molecules. Automera’s AUTAC platform is designed to generate novel therapies that degrade not only disease-related proteins but also protein aggregates, organelles, and pathogens. AUTACs have the potential to provide a more flexible approach to protein degradation than existing approaches such as proteolysis-targeting chimeras (PROTACs) to trigger protein degradation.

"Automera was founded on the premise that improving health outcomes for people with serious diseases requires new technologies that make it easier, faster, and less expensive to develop safe and effective medicines," said Loong Wang, co-founder of Automera. "We believe that our AUTAC platform is one such technology, with broad potential across multiple disease indications that are difficult to treat with current therapeutic approaches. We greatly value the business and financial support that ALSP provides and are proud that leading healthcare investors are participating in Automera’s Series A financing. With these resources, Automera is well positioned to deploy our AUTAC platform toward the development of potentially transformative therapies."

Automera has assembled a distinguished scientific advisory group that includes Associate Professor Michael Lazarou, Automera’s Scientific Co-Founder at the Walter and Eliza Hall Institute of Medical Research (WEHI) and the Monash Biomedicine Discovery Institute, Dr. Nicholas Ktistakis from Babraham Institute, Dr. Gene Yeo from the University of California San Diego (UCSD) and Dr. Kendall Mohler from ALSP.

"ClavystBio is excited to be building new ventures in Singapore through partnerships with young entrepreneurs like Loong Wang and his team at Automera, and smart capital investors like ALSP," said Wen Qi Ho, Therapeutics Lead at ClavystBio. "Our mission is to accelerate the commercialization of breakthrough innovations like the AUTAC platform for health impact, and we welcome Automera and ALSP to Singapore’s growing life sciences translational community."