On November 30, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that the VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma multiforme (GBM) has been activated at its first Canadian site, Sunnybrook Health Sciences Centre in Toronto (Press release, Kintara Therapeutics, NOV 30, 2021, View Source [SID1234596281]).

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The Kintara treatment arm is also currently actively recruiting at 30 U.S. sites as of November 24, 2021.

The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), is a patient-centered, Phase 2/3 adaptive platform trial evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. Since January 2021, GCAR has accelerated the pace of clinical site activation with increased awareness in the medical community of Kintara’s arm of the study. GCAR plans to enroll 150-200 patients in the Kintara arm of the study at over 40 sites in the U.S. and Canada with potential to increase this total to 65 clinical trial centers worldwide.

"The Kintara treatment arm joined the GBM AGILE study in January of this year, and is already active at 31 sites in the US and Canada," stated Timothy Cloughesy, M.D., Professor of the Neurology and Molecular and Medical Pharmacology program at the University of California, Los Angeles and Principal Investigator for the GBM AGILE study. "This international clinical site, which we expect to be the first of many international sites, demonstrates the ability of GCAR’s GBM AGILE platform trial to materially accelerate the clinical development timelines for the company."

"The entire Kintara team remains excited by the pace at which our treatment arm is being executed in the study," commented Robert E. Hoffman, Kintara’s Chief Executive Officer. "With 31 sites already active, including our first international site, we are delighted to witness GCAR’s exceptional clinical trial execution capabilities that drew us to participate in this exciting and highly efficient registrational study."

GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with GBM through response adaptive randomization and a seamless Phase 2/3 design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol allowing multiple therapies, or combinations of therapies, from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, data from GBM AGILE may be used as the foundation for a new drug application and biologics license application submissions and registrations to the FDA and other health authorities.

On November 30, 2021 Nektar Therapeutics (NASDAQ: NKTR) reported that it will present data at two upcoming medical meetings for two of its cytokine immuno-oncology programs: IL-2 agonist, bempegaldesleukin (BEMPEG), and IL-15 agonist, NKTR-255 (Press release, Nektar Therapeutics, NOV 30, 2021, View Source [SID1234596299]). The company will be presenting clinical data for BEMPEG from the ongoing PROPEL study in patients with non-small cell lung cancer (NSCLC) at the 2021 European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress in Geneva, Switzerland from December 8 to December 11, 2021. In addition, two clinical data presentations for NKTR-255 in patients with relapsed/refractory hematologic malignancies will be presented during the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta, Georgia from December 11 to December 14, 2021.

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Presentation at 2021 ESMO (Free ESMO Whitepaper)-IO:

Abstract #140P: "Preliminary results from PROPEL: A phase 1/2 study of bempegaldesleukin (BEMPEG: NKTR-214) plus pembrolizumab (PEMBRO) with or without chemotherapy in patients with metastatic NSCLC," Felip, E., et al.

ePoster will be on display on the ESMO (Free ESMO Whitepaper)-IO 2021 virtual meeting platform on Monday, December 6, 2021, at 12:00 pm GMT (7:00 a.m. ET)
Presentations at ASH (Free ASH Whitepaper)

Abstract #3134: "Safety, Tolerability, PK/PD, and Preliminary Efficacy of NKTR-255, a Novel IL-15 Receptor Agonist, in Patients with Relapsed/Refractory Hematologic Malignancies," Shah, N., et al.

Presenter: Nina Shah, M.D.
Session 203: Lymphocytes and Acquired or Congenital Immunodeficiency Disorders: Poster III
ePoster will be on display on the ASH (Free ASH Whitepaper) 2021 virtual meeting platform on Monday, December 13, 2021, at 6:00 a.m. ET
Abstract #2815: "Pharmacodynamic Analysis of CAR-T Cell Persistence in Patients with Hematologic Malignancies Treated with NKTR-255, an IL-15 Receptor Agonist That Enhances CD8+ T cells: Preliminary results from a Phase 1 Study," Turtle, C., et al.

Presenter: Alexandre Hirayama, M.D.
Session 704: Cellular Immunotherapies: Clinical: Poster II
ePoster will be on display on the ASH (Free ASH Whitepaper) 2021 virtual meeting platform on Sunday, December 12, 2021, at 6:00 a.m. ET
Company to Host Webcast Analyst and Investor Conference Call During ESMO (Free ESMO Whitepaper)-IO Congress 2021

The company will host a conference call and webcast for analysts and investors on Monday, December 6, 2021, at 1:00 p.m. GMT (8:00 a.m. ET) during the 2021 ESMO (Free ESMO Whitepaper)-IO Congress. The call will include Dr. Daniel Johnson, medical oncologist at the Gayle and Tom Benson Cancer Center and Deputy Director, Precision Cancer Therapies (Phase I) Research Program at Ochsner Medical Center, and Dr. Mehmet Altan, Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center.

The event will follow the publication of the NKTR-214 (BEMPEG) PROPEL poster (Abstract #140P) on Monday, December 6, 2021.

Analyst Call:

Date and Time: Monday, December 6, 2021, at 1:00 p.m. GMT (8:00 a.m. ET)

Dial-in: 877-881-2183 (toll-free) or 970-315-0453 (enter access code 7797059)

Investors and analysts can also view slides and listen to the live audio webcast of the presentation at View Source The event will also be available for replay for two weeks on the company’s website, www.nektar.com.

Biography for Daniel Johnson, M.D.

Daniel Johnson, M.D. is a medical oncologist at Ochsner Medical Center who specializes in treating patients with melanoma, lung cancer, and head and neck cancer. His specific research interests include strategies to overcome immunotherapy resistance and prevent immunotherapy related toxicities. He has published multiple peer-reviewed articles and presentations at national meetings pertaining to the management and underlying mechanisms of immune toxicity. Dr. Johnson is also a clinical investigator focusing on designing and implementing clinical trials intended to optimize the safety and efficacy of immune checkpoint inhibitors. Dr. Johnson received his M.D. from Louisiana State University (LSU) School of Medicine. He completed his internship and residency at LSU Internal Medicine Residency Program and completed his fellowship in hematology and medical oncology at the University of Texas MD Anderson Cancer Center. Dr. Johnson is board-certified in medical oncology and hematology by American Board of Internal Medicine.

Biography for Mehmet Altan, M.D.

Mehmet Altan, M.D., is an Assistant Professor in the Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. His current research areas include identification of mechanisms for primary and secondary resistance to immunotherapies and predictive markers for immunotherapy toxicities. He also works on translational research projects for identification of spatiotemporal dynamics of the tumor microenvironment in response to immunotherapy to define potential therapeutic targets.

On November 30, 2021 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy, reported the opening of a new clinical study in collaboration with Dr. Duane Mitchell at the University of Florida (Press release, Immunomic Therapeutics, NOV 30, 2021, View Source [SID1234596263]). RENEW (NCT04963413) is designed to evaluate the ability to generate pp65 Lysosomal Associated Mediated Protein (LAMP) RNA-pulsed dendritic cells in patients who have completed standard external beam radiation and concomitant temozolomide and who are receiving adjuvant temozolomide chemotherapy at the time of enrollment.

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This is an extension of the Phase 2 ATTAC-II study (NCT02465268) where eligibility is limited to those patients who have had surgery but have not yet received chemoradiation. The RENEW pilot study will enroll adult patients with newly diagnosed WHO Grade IV glioma (GBM) who have completed standard of care surgery and chemoradiation and who are currently receiving adjuvant temozolomide chemotherapy.

"The RENEW pilot study’s expansion of the eligibility criteria allow a number of untreated patients with GBM to participate in a clinical study that includes our novel dendritic cell vaccine," said Dr. Bill Hearl, Chief Executive Officer at Immunomic Therapeutics, Inc. "We look forward to continued evaluation of ITI’s platform in both the ongoing ATTAC-II and the RENEW studies in an effort to address this clear and pressing unmet medical need."

ITI is developing several dendritic cell vaccines for the treatment of cancer, including ITI-1000 for glioblastoma multiforme (GBM), with key opinion leaders in cancer immunotherapy for brain tumors, John Sampson, M.D., Ph.D. from Duke University and Duane Mitchell, M.D., Ph.D. from the University of Florida. ITI’s dendritic cell vaccine is designed to target the pp65 viral antigen of Cytomegalovirus (CMV) that is expressed in GBM, but not in normal brain cells. In the ATTAC studies, the GBM patients’ white blood cells are removed, matured into dendritic cells (DCs), and modified to generate a vaccine to the pp65 viral protein when fused to the Lysosomal Associated Membrane Protein 1 (LAMP1) protein for antigen presentation. This dendritic cell vaccine is then returned to the patient. As observed in the ATTAC studies (ATTAC-GM: NCT00693639), ITI believes this approach may harness the body’s immune system to recognize, attack and destroy tumor cells that express CMV in GBM and potentially other cancers.

About Glioblastoma (GBM)

According to the American Association of Neurological Surgeons, GBM is an aggressive brain cancer that often results in death within 15 months of diagnosis. GBM develops from glial cells (astrocytes and oligodendrocytes), grows rapidly, and commonly spreads into nearby brain tissue. GBM is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that GBM represents about 15% of all primary brain tumors and approximately 10,000 cases of GBM are diagnosed each year in the U.S.

About ITI-1000 and the Phase 2 (ATTAC-II) Study

ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase II clinical trial (ATTAC-II) for the treatment of GBM. ITI-1000 was developed using Immunomic’s proprietary investigational lysosomal targeting technology, UNITE, in the context of cell therapy. In May 2017, Immunomic exclusively licensed a patent portfolio from Annias Immunotherapeutics for use in combination with UNITE and ITI-1000, allowing Immunomic to combine UNITE with a patented and proprietary CMV immunotherapy platform. The ATTAC-II study (NCT02465268) is a Phase II randomized, placebo-controlled clinical trial enrolling patients with newly diagnosed GBM that will explore whether dendritic cell (DC) vaccines, including ITI-1000, targeting the CMV antigen pp65 improves survival. This study is enrolling up to 120 subjects at three clinical sites in the United States. For more information on the ATTAC-II study, please visit (NCT02465268).

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein 1 (LAMP1), an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach puts UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in a Phase II clinical trial as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On November 30, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported the pricing of its previously announced initial public offering (STAR Offering) on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange (SSE) (Press release, BeiGene, NOV 30, 2021, View Source [SID1234596282]). The total number of shares being offered in the STAR Offering is 115,055,260 ordinary shares, par value $0.0001 per share, which represents 8.62% of BeiGene’s total outstanding ordinary shares as of October 31, 2021, after giving effect to the shares being offered. The shares offered in the STAR Offering will be issued to and subscribed for by permitted investors in the People’s Republic of China (PRC) and listed and traded on the STAR Market in Renminbi (RMB Shares).

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The public offering price of the RMB Shares is RMB192.60 per ordinary share, which equates to HK$234.89 per ordinary share and US$391.68 per American Depositary Share (ADS), based on an assumed exchange rate of RMB0.81996 to HK$1.00 and RMB6.3924 to US$1.00. Each ADS represents 13 ordinary shares.

The gross proceeds to BeiGene from the STAR Offering, before deducting underwriting commissions and other estimated offering expenses, are expected to be approximately RMB22.2 billion, or approximately US$3.5 billion, based on an assumed exchange rate of RMB6.3924 to US$1.00.

Subject to customary closing conditions, BeiGene expects to deliver the RMB Shares against payment on or about December 9, 2021 and the RMB Shares are expected to begin trading on the STAR Market on or about December 15, 2021 under the stock code "688235."

China International Capital Corporation Limited and Goldman Sachs Gao Hua Securities Co. Ltd. are acting as joint sponsors and joint bookrunners for the STAR Offering. J.P. Morgan Securities (China) Company Limited, CITIC Securities Co., Ltd. and Guotai Junan Securities Co., Ltd. are acting as joint bookrunners for the STAR Offering.

BeiGene has granted China International Capital Corporation Limited a 30-day overallotment option for up to 17,258,000 additional RMB Shares. If the over-allotment option is fully exercised, the total number of shares being offered in the STAR Offering will be 132,313,260 Shares, which represents 9.79% of BeiGene’s total outstanding ordinary shares as of October 31, 2021, after giving effect to the shares being offered.

BeiGene expects to use the net proceeds from the STAR Offering to fund its research and clinical development, construction of its research and development centers and a manufacturing plant in China, sales and marketing force expansion in China, and for working capital and general corporate purposes.

In accordance with applicable PRC laws and regulations, the STAR Offering is being conducted solely within the PRC and only to permitted investors who are eligible to participate in the STAR Offering in accordance with applicable PRC securities laws and regulations, and rules promulgated by the SSE and the China Securities Regulatory Commission (CSRC). The STAR Offering is being conducted pursuant to a prospectus and other offering materials prepared by BeiGene in Chinese language and as approved by and registered with the SSE and the CSRC, which are only permitted to be used within the PRC. No part of the STAR Offering is intended to involve a public offering or sale of the RMB Shares into or in the United States or any other jurisdiction outside of the PRC. In addition, although the RMB Shares are of the same class and have the same rights as the Company’s existing ordinary shares listed on the Hong Kong Stock Exchange (HKEx), the RMB Shares will not be fungible with the ordinary shares listed on the HKEx or the Company’s ADSs representing its ordinary shares listed on the NASDAQ Global Select Market (NASDAQ), and in no event will any RMB Shares be able to be converted into ordinary shares listed on the HKEx or ADSs listed on NASDAQ, or vice versa.

An automatically effective shelf registration statement on Form S-3 was filed with the Securities and Exchange Commission (SEC) on May 11, 2020. A preliminary prospectus supplement relating to and describing the key terms of the STAR Offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. The final terms of the STAR Offering will be disclosed in a final prospectus supplement to be filed with the SEC. The purpose of the prospectus supplement is to register all RMB Shares offered in the STAR Offering under the Securities Act of 1933, as amended (Securities Act) to ensure that the offer and sale of the RMB Shares, if any, to permitted investors who are U.S. persons (as defined in Regulation S under the Securities Act) in transactions outside the United States will not violate the registration requirements under Section 5 of the Securities Act.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. This press release is being issued pursuant to, and in accordance with, Rule 134 under the Securities Act.

On November 30, 2021 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE protein biologic technology platform, reported that an abstract was accepted for presentation at the upcoming European Society for Medical Oncology ("ESMO") Immuno-Oncology ("IO") Congress 2021 to be held December 8-11, 2021 in Geneva Switzerland (Press release, GT Life Sciences, NOV 30, 2021, View Source [SID1234596300]).

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ESMO IO 2021 presentation details:

e-Poster Display Title (#126P): Novel B7-H3 targeting dual nanobody NK cell engagers display robust activity against a broad spectrum of solid and hematologic malignancies

ESMO-IO will publish full abstracts on their website on Thursday, December 2 at 12:00 pm CET. GT Biopharma will post its poster on the company’s website in the "Presentations" section during the conference.

For abstract and event details please visit: View Source

About Camelid Antibodies

Camelid antibodies are single domain antibodies (sdAbs) from the Camelidae family of mammals that include llamas, camels, and alpacas. These animals produce 2 main types of antibodies. One type of antibody camelids produce is the conventional antibody that is made up of 2 heavy chains and 2 light chains. They also produce another type of antibody that is made up of only 2 heavy chains and no light chain. This is known as heavy chain IgG (hcIgG). While these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also known as single domain antibodies, contain only the VHH region from the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity (equivalent to conventional antibodies), high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of genetic engineering, format flexibility or modularity, low immunogenicity, and a higher penetration rate into tissues.

About GTB-3650

GTB-3650 is the Company’s lead second-generation Tri-Specific Killer Engager TriKE program currently in preclinical development for the treatment of relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS).