On September 28, 2023 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that new data from the ongoing OPTIMIZE-1 Phase 2 study of the company’s lead asset mitazalimab, a best-in-class CD40 mAb agonist, will be presented in oral and poster presentations at the AACR (Free AACR Whitepaper) (American Association for Cancer Research) Special Conference on Pancreatic Cancer, being held in Boston September 27-30, 2023 (Press release, Alligator Bioscience, SEP 28, 2023, View Source [SID1234635496]). Preclinical mitazalimab data were also recently presented in a poster presentation at the International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (CICON), held in Milan September 20-23, 2023.

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"The data reported in these three presentations add to the growing clinical evidence demonstrating that mitazalimab induces relevant activation of the immune system leading to enhanced anti-tumor responses to chemotherapy and provides durable benefits to patients with metastatic pancreatic cancer," said Søren Bregenholt, CEO of Alligator Bioscience. "We are very pleased to share these important developments at two of the year’s most important oncology conferences, which have allowed us to update the scientific community on the great clinical progress we are making with mitazalimab in the OPTIMIZE-1 study, ahead of the topline readout in early Q1 next year."
Oral presentation at AACR (Free AACR Whitepaper): "CD40 agonist mitazalimab in combination with mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Interim efficacy results of the OPTIMIZE phase 1b/2 study"

Date/Time: Thursday 28 September, 2023, 2.15 – 4.40 pm EDT
Session: Plenary Session 3: Clinical Updates
Presenter: Teresa Macarulla, Vall d’Hebrón University Hospital, Barcelona, Spain

Interim efficacy analysis of 57 evaluable patients from the OPTIMIZE-1 study (NCT04888312) that were announced in June 2023
Overall response rate per RECIST v1.1 was 43.9% (25 patients with partial response); an additional 19 patients achieved stable disease, resulting in a 77.2% disease control rate
Median time to response was 2.2 months and median duration of response was 8.7 months
Results demonstrated encouraging anti-tumor activity in mPDAC with good durability of responses, meriting continued development, possibly in a randomized setting
The OPTIMIZE-1 study continues to progress and remains on track for top-line readout in early Q1 2024.

Poster presentation at AACR (Free AACR Whitepaper): "Interim pharmacodynamic analyses of mitazalimab in combination with FOLFIRINOX in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) identify CD4 effector T cells as a correlate of treatment outcomes"

Date/Time: Friday 29 September, 2023, 4.40 – 6.40 pm EDT
Session: Poster Session C
Presenter: Dr. Gregory Beatty, Abramson Cancer Center & Division of Hematology-Oncology, University of Pennsylvania

Interim pharmacodynamic analyses and their association with outcomes from the OPTIMIZE-1 study, demonstrating that mitazalimab and mFOLFIRINOX induce distinct immune responses in pancreatic cancer patients
Analyses demonstrated that the desired activation of the immune system after mitazalimab exposure was achieved revalidating its mechanism of action
Analyses also demonstrated that increases in CD4 effector T cells correlate with treatment outcomes and suggest a mitazalimab-specific contribution to tumor responses in patients with metastatic pancreatic cancer
Poster presentation at CICON: "Efficacy and pharmacodynamic biomarkers of mitazalimab in combination with chemotherapy in preclinical mouse models"

Details of anti-tumor efficacy of mitazalimab and FOLFIRINOX in a preclinical tumor model and pharmacodynamic biomarkers in peripheral blood, induced at early time points after treatment
Preclinical data demonstrated that mitazalimab synergizes effectively with FOLFIRINOX, inducing long-term survival in a preclinical tumor model
The pharmacodynamic biomarkers identified in these preclinical data are in agreement with data from a Phase 1 dose escalation study of mitazalimab in patients with advanced solid stage tumors (NCT02829099)
Together, these preclinical tumor model data support mitazalimab’s mechanism of action as also observed in the ongoing OPTIMIZE-1 study

On September 27, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that the US Food and Drug Administration (FDA) has transferred the Investigational New Drug (IND) Application for its allogeneic CD19 CAR T azer-cel from Precision Biosciences Inc. (NASDAQ GS: DTIL) to Imugene, following the exclusive worldwide license acquired in August (Press release, Imugene, SEP 28, 2023, View Source [SID1234635467]).

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Imugene MD & CEO, Ms Leslie Chong said, "We are actively progressing the ongoing multi-centre Phase 1b (ClinicalTrials.gov ID NCT03666000) study using the recommended Phase 2 regimen of azer-cel as we prepare for the start of a potential Phase 2 registrational study at the earliest opportunity, and we expect the Clinicaltrials.gov ID will be updated to reflect Imugene being the sponsor imminently."

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.