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."

On September 27, 2023 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported presentations on POSLUMA (flotufolastat F 18) injection (formerly known as 18F-rhPSMA-7.3) at the upcoming American Society for Therapeutic Radiology and Oncology (ASTRO) 2023 Annual Meeting, to be held in San Diego, Calif., from October 1 to 4, 2023 (Press release, Blue Earth Diagnostics, SEP 27, 2023, View Source [SID1234635490]). POSLUMA is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

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"PET imaging with POSLUMA reveals clinical information crucial to decision-making for men with prostate cancer, and we are excited to share further information with the radiation oncology community at ASTRO 2023," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. "Phase 3 results from the SPOTLIGHT trial demonstrated the ability of POSLUMA to detect recurrent disease even at low prostate specific antigen (PSA) levels, and Dr. Ashesh Jani’s oral presentation will detail further information about its diagnostic performance at PSA levels <1 ng/mL. Dr. Phillip Kuo will present additional results from the Phase 3 LIGHTHOUSE trial that evaluated POSLUMA performance in newly diagnosed patients having high/very high risk prostate cancer and negative results with conventional imaging. Blue Earth Diagnostics will also host an Industry-Expert Theater event, ‘POSLUMA: Precision PET Imaging that is Truly Revealing’."

Details of selected oral and poster presentations by Blue Earth Diagnostics and its collaborators are listed below.

HIGHLIGHTED SCIENTIFIC PRESENTATIONS

Monday, October 2, 2023

Oral presentation

Title:

Detection Rate of 18F-rhPSMA-7.3 PET in Patients with Suspected Prostate Cancer Recurrence at PSA Levels <1 ng/mL: Data from the Phase 3 SPOTLIGHT Study

Presenter:

Ashesh B. Jani, MD, FASTRO, Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, Ga., for the SPOTLIGHT Study Group

Session Type:

Oral

Session Title:

SS11 – GU 3 Novel Prognostication Techniques for Prostate Cancer

Presentation Time:

3:30 – 3:37 PM PT

Location:

Room 6 D/E

Presentation No.:

160

Tuesday, October 3, 2023

Poster presentation

Title:

Diagnostic Performance of 18F-rhPSMA-7.3 PET in Men with Newly Diagnosed High-risk Prostate Cancer and Negative Conventional Imaging

Presenter:

Phillip H. Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering, University of Arizona, Tucson, Ariz., on behalf of Gary A. Ulaner, MD, Ph.D., Hoag Family Cancer Institute, Irvine, Calif. and University of Southern California, Los Angeles, Calif., for the LIGHTHOUSE Study Group

Session Title:

PQ 06 – Poster Q&A 06 – Session 06 – Genitourinary Cancer, Patient Safety and Nursing

Presentation Time:

2:30 – 3:45 PM PT

Location:

Hall B1

Presentation No.:

2972

Blue Earth Diagnostics invites participants at the 2023 ASTRO Annual Meeting to attend the presentations above and visit the company at Exhibit Booth 2223. Blue Earth Diagnostics is hosting an Industry-Expert Theater event, "POSLUMA: Precision PET Imaging that is Truly Revealing," with invited speaker Dr. Nicholas Zouain, Radiation Oncologist, Medical Director of West Florida Radiation Therapy, US Oncology Network, Clearwater, Fla. The event will be held on Sunday, October 1, 2023, from 12:00 PM to 1:00 PM PT, in Theater 1 of the San Diego Convention Center. For full session details and scientific presentation listings, please see the ASTRO online program here.

Indication and Important Safety Information About POSLUMA

INDICATION
POSLUMA (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

with suspected metastasis who are candidates for initial definitive therapy
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.
To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf.