On May 22, 2023 Hanx Biopharmaceuticals, Inc. (HanxBio), reported that the company has received Investigational New Drug (IND) approval to start clinical trial of the potentially first-in-class recombinant anti-CD47/PD-1 bispecific antibody (BsAb), HX009, in Patients with relapsed/refractory Lymphoma (Press release, HanX Biopharmaceuticals, MAY 22, 2023, View Source [SID1234631928]). This is a Phase IB/II clinical study to be conducted in the United States to evaluate HX009 in the treatment of lymphoma patients who have failed standard therapy.

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This is another important milestone of HX009 development as well as in the company’s drug development program. HX009 has been studied in Australia and China in both solid tumor and lymphoma indications. The approval by FDA to start clinical trial in US strengthens the development of HX009 globally, and enhances the company’s position in the field of bispecific antibody research.

Dr. Lei Zhang, CMO of HanxBio, said: "We are very pleased that our HX009 program has received clinical trial research approval from the US FDA. Although immune checkpoint inhibitors (ICIs) have shown great promises in a wide range of oncology indications, there still remains many challenges including in lymphoma. Therefore, it is of great value to develop the next generation of ICIs, including BsAb, such as dual targeting CD47 and PD-1 BsAb like HX009. We look forward to rapidly advancing the clinical development of HX009, bringing new treatment options to patients to meet unmet medical needs."

On May 22, 2023 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported that six abstracts have been accepted for oral and poster presentation at the upcoming Society for Nuclear Medicine & Molecular Imaging (SNMMI) 2023 Annual Meeting, which will be held in Chicago, June 24-27, 2023 (Press release, Actinium Pharmaceuticals, MAY 22, 2023, View Source [SID1234631927]). These abstracts exhibit the breadth of Actinium’s technological and clinical endeavors over the past year that are now culminating in targeted radiotherapies that improve the outcomes of cancer patients.

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Details of the SNMMI oral presentation:

Presentation Title: Machine learning applications to optimize dosimetric imaging of I131-apamistamab for bone marrow conditioning in relapsed/refractory acute myeloid leukemia (R/R AML)
Session Type/Title: Oral / New developments in radiopharmaceutical therapy
Date and Time: June 25, 5:00pm – 6:15pm ET

Details of the SNMMI poster presentations:

All posters will be accessible for viewing for the entirety of the conference. The general session is Science Pavilion – Meet the Authors Session: June 26, 5:15pm – 6:15pm

Abstract Title: Relative biological effectiveness of antibody radioconjugates (ARCs): In vitro dosimetric evaluation to streamline pre-clinical decision-making
ID: P86
Track: Oncology, Basic and Translational

Abstract Title: Streamlining personalized dosimetry for I131-apamistamab using a Co-57 sheet source to circumvent the need for radionuclide-specific attenuation correction
ID: P715
Track: Molecular Targeting Probes-Radioactive & Nonradioactive

Abstract Title: Organ-specific dosimetry to estimate potential toxicity thresholds of Actimab-A (lintuzumab-Ac225) used in combination with venetoclax in relapsed/refractory AML
ID: P88
Track: Oncology, Basic and Translational

Abstract Title: Individualized dosing for high-dose targeted radiation of hematopoietic cells with Iomab-B (I131-apamistamab) prior to HCT in relapsed/refractory acute myeloid leukemia (R/R AML): Safety and efficacy results from the pivotal phase 3 SIERRA trial
ID: P685
Track: Oncology Clinical Diagnosis & Therapy

Abstract Title: Administration and radiation safety of high-dose Iomab-B (I131-apamistamab) demonstrated in multiple clinical settings: Experience from the large multicenter phase 3 SIERRA trial for targeted conditioning of patients with relapsed/refractory AML
ID: P730
Track: Oncology Clinical Diagnosis & Therapy

On May 22, 2023 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it will hold an analyst call to highlight data at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from the Pivotal Phase 2 FELIX study of obe-cel data in adult r/r B-ALL (Press release, Autolus, MAY 22, 2023, View Source [SID1234631926]). The event will be held on June 2 at 4.00 pm ET/9.00 pm BST. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call.

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A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website.

ASCO Oral Presentation, abstract #7000:

Title: Safety and efficacy of Obecabtagene autoleucel (obe-cel, AUTO1), a fast-off rate CD19CAR in relapsed/refractory adult B-Cell acute lymphoblastic leukemia (r/r B-ALL): Topline results of the pivotal FELIX study

Session Title: Hematologic Malignancies — Leukemia, Myelodysplastic Syndromes, and Allotransplant
Session date and time: Friday, June 2, 2023, 14:00 – 17:00 EDT, 19:00 – 22:00 BST
Presenting Author: Dr. Claire Roddie, MD, PhD, FRCPath, Consultant Haematologist and Honorary Senior Lecturer, Cancer Institute, University College London (UCL)

On May 22, 2023 VerImmune Inc ("VerImmune"), an early-stage biotechnology company specializing in the development of innovative products based on a novel Virus-inspired Particle (ViP) technology platform, reported the successful completion of a Type B pre-IND meeting with the US Food and Drug Administration (FDA) for its groundbreaking VERI-101 immuno-oncology lead product for the treatment of multiple solid tumors (Press release, VerImmune, MAY 22, 2023, View Source [SID1234631923]).

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The primary objective of the pre-IND meeting was to seek FDA concurrence on VerImmune’s manufacturing, control strategies and development plans, the design of non-clinical IND-enabling studies, and guidance on the proposed first-in-human clinical trial in cancer patients for VERI-101. The FDA provided clear and constructive feedback in the form of written responses to the Pre-IND package and questions submitted by VerImmune. This feedback from the FDA on the overall development strategy empowers VerImmune to advance towards the IND preparation and submission of VERI-101.

Joshua Wang, Ph.D., Founder and CEO of VerImmune Inc., commented, "This milestone for our startup is of paramount importance as it provides regulatory clarity, paving the way for our new ViP-based modality as well as our highly novel immunotherapy approach to advance to clinical trials. We are thrilled by the positive and valuable feedback received from the FDA, which enables us to efficiently execute the necessary steps for IND approval. I want to express my gratitude to our exceptional team and dedicated advisors who have worked tirelessly to reach this stage."

VerImmune’s primary focus lies in the field of Oncology, wherein the ViP technology enables a pioneering first-in-class cancer immunotherapy approach known as Anti-tumor Immune Redirection (AIR). This innovative method harnesses the body’s pre-existing immune system, specifically by leveraging the immune memory from past infections or childhood vaccination to combat cancer. By taking a highly orthogonal approach, VerImmune’s technology holds immense potential to revolutionize the Immuno-Oncology market, offering new treatment possibilities for patients facing limited options or resistance to current cancer therapies.

On May 22, 2023 TransCode Therapeutics, Inc. (NASDAQ: RNAZ) ("TransCode" or the "Company"), the RNA Oncology Company committed to more effectively treating cancer using RNA therapeutics, reported that its Board of Directors approved a 1-for-20 reverse stock split, to be effective 4:05 p.m. Eastern Time today, May 22, 2023 (Press release, TransCode Therapeutics, MAY 22, 2023, View Source [SID1234631922]). TransCode common stock is expected to begin trading on a split-adjusted basis on the Nasdaq Capital Market on Tuesday, May 23, 2023, under the current trading symbol, "RNAZ." The reverse stock split was approved by TransCode’s stockholders on May 10, 2023, and is intended to increase the per share trading price of the Company’s common stock to enable the Company to satisfy the minimum bid price requirement for continued listing on the Nasdaq Capital Market.

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The 1-for-20 reverse stock split will automatically convert 20 current shares of TransCode’s common stock into one new share of common stock. No fractional shares will be issued in connection with the reverse stock split. Stockholders of record who would otherwise hold a fractional share of TransCode’s common stock will receive a cash payment in lieu thereof at a price equal to that fraction of a share to which the stockholder would otherwise be entitled multiplied by the closing price of TransCode’s common stock on the Nasdaq Capital Market on May 22, 2023. The reverse split will reduce the number of shares of outstanding common stock from approximately 16,998,534 shares to approximately 849,926 shares. Proportional adjustments also will be made to the exercise prices of TransCode’s outstanding stock options and warrants, and to the number of shares issued and issuable under TransCode’s stock incentive plans.

Vstock Transfer LLC will act as the exchange agent for the reverse stock split. Stockholders of record are not required to take any action to receive post-split shares in book-entry. Stockholders owning shares through a bank, broker, custodian or other nominee will have their positions automatically adjusted to reflect the reverse stock split, subject to the holding entity’s particular processes; such stockholders will not be required to take any action in connection with the reverse stock split. However, these banks, brokers, custodians or other nominees may have different procedures than registered stockholders for processing the reverse stock split and making payment for fractional shares. If a stockholder holds shares of common stock with a bank, broker, custodian or other nominee and has any questions in this regard, stockholders are encouraged to contact their bank, broker, custodian or other nominee for more information.

In connection with the reverse stock split, the Company’s CUSIP number will change to 89357L 204 as of 4:05 pm on Monday, May 22, 2023.