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US Patent and Trademark Office grants new patent for DEP® cabazitaxel, one of Starpharma’s phase 2 clinical-stage cancer treatments

On September 15, 2021 Starpharma reported that it’s DEP cabazitaxel is a proprietary nanoparticle version of leading prostate cancer drug cabazitaxel (Jevtana), which had global sales of US$536 million in 2020 (Press release, Starpharma, SEP 15, 2021, View Source [SID1234587784]). Starpharma’s DEP cabazitaxel is a water soluble, polysorbate-80 free formulation, without requirement for pre-treatment with steroids nor G-CSF to reduce the risk of severe bone marrow toxicity .

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In preclinical and clinical studies, DEP cabazitaxel has shown an improved side effect profile, notably markedly reduced bone marrow toxicity demonstrated by lower rates of severe neutropenia, thrombocytopenia, and severe anaemia, which are experienced by a significant proportion of Jevtana treated patients.

The composition of matter patent builds on Starpharma’s suite of existing international patents for DEP cabazitaxel. It specifically covers a DEP dendrimer conjugated to multiple cabazitaxel drug molecules via a particular releasable linker, with a patent term to 2039 and potential for a 5-year extension.

Starpharma CEO, Dr Jackie Fairley, commented: "The grant of this new US patent illustrates the unique and compelling benefits of Starpharma’s DEP drug delivery technology and DEP cabazitaxel. We look forward to completing the phase 2 clinical program for DEP cabazitaxel, in parallel with commercial licensing discussions."

DEP cabazitaxel is in late phase 2 clinical development, recruiting patients with solid tissue tumours, including prostate, ovarian and gastro-oesophageal cancers.

Encouraging efficacy signals have been observed in multiple tumour types, including in prostate cancer where radiological responses, significant reductions in prostate-specific antigen (PSA) and no new bone metastases were observed. These efficacy signals were observed despite patients having been heavily pre-treated with an average of 30 prior cycles of treatment, and in some cases with more than 100 cycles and up to 10 different treatment regimens. Patients treated with DEP cabazitaxel have also exhibited encouraging efficacy signals in gastro-oesophageal, ovarian, cholangiocarcinoma, lung and head and neck cancers.

DEP cabazitaxel was developed using Starpharma’s proprietary DEP drug delivery platform, used by the company and partners to create novel nanoparticle formulations of existing and new drugs to enhance their therapeutic and commercial value. DEP drug delivery is applicable to a wide range of drugs in oncology and other therapeutic areas. Starpharma has three phase 2 clinical-stage DEP assets, multiple preclinical DEP programs, and several DEP commercial partnerships with companies, including AstraZeneca, Chase Sun and Merck & Co., Inc., to develop DEP versions of their products or ADCs.

GT Biopharma Announces Updated Positive Safety Data From Phase 1 GTB-3550 Monotherapy TriKE™ Trial an Investigational Immunotherapy for Refractory Cancers to be Presented at ESMO Congress 2021

On September 15, 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 Jeffrey Miller, MD, University of Minnesota Medical School, Professor of Medicine, Division of Hematology, Oncology and Transportation will present a mini-oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 to be held virtually September 16-21 (Press release, GT Biopharma, SEP 15, 2021, View Source [SID1234587783]).

The mini-oral presentation will present updated positive Phase 1 safety data, progress, and preclinical data going beyond hematologic malignancies to solid tumors of a Phase 1 GTB-3550 TriKE trial. The Tri-Specific Killer Engager TriKE program is currently in pre-clinical and clinical development for the treatment of relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS) with solid tumor TriKE commercial manufacturing and IND enabling studies in progress.

Mini-oral Poster Presentation Details:

Title: GTB-3550 TriKE safely activates and delivers IL-15 to NK cells, but not T cells, in immune suppressed patients with advanced myeloid malignancies, a novel paradigm exportable to solid tumors expressing Her2 or B7H3 (Abstract #4068)

Speaker: Jeffrey Miller, MD

Mini-oral Session: Investigational Immunotherapy (Channel 2)

Presentation Time: September 17 at 6:10 PM EST

Mini-oral Presentation Number: 965MO

The abstract is currently available on the ESMO (Free ESMO Whitepaper) website at www.esmo.org. At the start of the mini-oral session the presentation will be available in the "Presentations" section of the Company’s website at View Source

Recent Announcement
The Company recently announced the advancement of GTB-3650 into IND-enabling studies, with which it plans to supplant the ongoing Phase 1 program with GTB-3550. GTB-3650 is a novel molecule based on camelid single-domain camelid antibody technology with advantages that build upon the strong proof-of-concept data from the Company’s first generation TriKE program, GTB-3550.

Therapeutic and commercial advantages of GTB-3650 compared to GTB-3550 include:

Based on second generation camelid single-domain antibody technology that holds several advantages over traditional IgG monoclonal antibodies
Improved potency and enhanced binding affinity
Similar preclinical safety profile
Commercial manufacturing capabilities through arrangement with Cytovance
Proprietary patented molecule, which unlike GTB-3550, is wholly owned by GT Biopharma
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).

Halozyme to Participate in the 2021 Cantor Virtual Global Healthcare Conference

On September 15, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Elaine Sun, senior vice president and chief financial officer, will present at the 2021 Cantor Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 1:20 p.m. Eastern Time / 10:20 a.m. Pacific Time (Press release, Halozyme, SEP 15, 2021, View Source [SID1234587782]).

An audio-only direct link of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 6 months following the event. To access the link, please visit Halozyme’s website approximately 10 minutes prior to the presentation to register and download any necessary audio software.

Obsidian Therapeutics To Present Preclinical Data From cytoTIL15 Program at the European Society for Medical Oncology Congress 2021

On September 15, 2021 Obsidian Therapeutics, a biotechnology company pioneering engineered cell and gene therapies, reported that the Company will present data highlighting its cytoTIL15 program at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, which will be hosted virtually September 16-21, 2021 (Press release, Obsidian Therapeutics, SEP 15, 2021, View Source [SID1234587780]).

The abstract for the poster describes how Obsidian’s cytoTIL15 product (TIL engineered with membrane-bound IL15, or mbIL15) demonstrates enhanced in vitro potency and phenotype and in vivo persistence in the absence of IL-2, paving the way for more durable efficacy and improved safety in patients with solid tumor malignancies. The abstract has been published in ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021 Abstract Book.

Details of the poster presentation:
Title: cytoTIL15: A novel TIL therapy for melanoma with superior potency and enhanced persistence without IL2 to improve safety & efficacy and expand patient eligibility
Abstract Number: 1008P
Session: Investigational Immunotherapy
Abstract Summary: Tumor-infiltrating lymphocytes (TILs) have generated promising data in clinical trials as therapy for heavily pretreated patients with solid tumor malignancies, such as metastatic melanoma. TIL therapy currently requires IL2 for in vivo maintenance of TILs, significantly limiting its application due to patient safety and eligibility hurdles. Obsidian’s cytoTIL product is comprised of TILs engineered with mbIL15 that is regulatable using a drug responsive domain (DRD) designed via our cytoDRiVE platform. Our cytoTIL15 product displays a favorable cytotoxic CD8+ T cell phenotype while maintaining TCR Vbeta repertoire diversity during manufacturing. cytoTIL15 exhibit superior in vitro anti-tumor cytotoxicity as well as polyfunctionality, compared to conventional TILs + IL2. In vivo, cytoTIL15 demonstrate greater antigen-independent expansion and persistence compared to conventional TILs treated with IL2.

Jan ter Meulen, M.D., Ph.D., Chief Scientific Officer of Obsidian, commented, "We are very excited about the superior persistence and cytotoxicity profile exhibited by cytoTIL15 in our preclinical models, and are eager to continue to advance our mission to translate these benefits to patients with metastatic melanoma and other solid tumor malignancies."

About cytoTIL15
cytoTIL15 is Obsidian’s lead cytoTIL program, currently in preclinical development for the treatment of patients with metastatic melanoma and other solid tumors. cytoTIL15 is a novel engineered tumor infiltrating lymphocyte therapy engineered with regulated membrane-bound IL15 that does not require patients to receive concomitant IL2 therapy, a toxic and costly requirement for conventional TILs. The Company expects to submit an IND for cytoTIL15 in mid-2022.

FDA Approves Tissue-Based NGS Companion Diagnostic for Takeda’s Targeted Therapy for NSCLC Patients with EGFR Exon20 Insertion Mutations

On September 15, 2021 Thermo Fisher Scientific reported that The U.S. Food and Drug Administration (FDA) has granted premarket approval to it’s Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive metastatic non-small cell lung cancer (mNSCLC) who are candidates for EXKIVITY (mobocertinib), a targeted drug developed by Takeda Pharmaceutical Company Limited ("Takeda") (Press release, Thermo Fisher Scientific, SEP 15, 2021, View Source [SID1234587776]).

EXKIVITY is a small-molecule tyrosine kinase inhibitor (TKI) designed to selectively target EGFR Exon20 insertion mutations. It received approval by the FDA on September 15, 2021 for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR Exon20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under Accelerated Approval based on overall response rate and duration of response demonstrated in the platinum-pretreated population of the Phase 1/2 trial of EXKIVITY. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

"Without proper and timely diagnoses, patients with EGFR Exon20 insertion mutations don’t have access to therapies that can most effectively treat their disease," said Dion Warren, vice president, head of U.S. Oncology Business Unit at Takeda Oncology. "We’re pleased to partner with Thermo Fisher to identify and address the unmet needs of patients with this rare cancer."

Lung cancer is the leading cause of cancer death among both men and women in the United States, and non-small cell lung cancer accounts for about 80 to 85 percent of all lung cancer cases.[i] Additionally, EGFR-positive mutations are observed in up to 18 percent of lung cancer cases in the U.S., offering an opportunity to identify and group patients based on this biomarker.[ii] While EGFR mutations are an important therapeutic target, there is a gap in therapies available for EGFR Exon20 insertion mutations,[iii] which affects approximately 1-2 percent of patients with NSCLC.[iv]

Conventional PCR methods can miss 50 percent or more of EGFR Exon20 insertion mutations[v],[vi], thus prompting diagnostic molecular testing with next-generation sequencing (NGS) technology. Testing with NGS is important for early identification and appropriate characterization of tested patients.

"EXKIVITY offers new hope to previously treated patients with mNSCLC and EGFR Exon20 insertion mutations, who usually do not respond well to other available treatments," said Garret Hampton, president, clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "FDA approval of the Oncomine Dx Target Test as a companion diagnostic for EXKIVITY will allow clinicians to identify key biomarkers in patients who could benefit from this targeted therapy. Working closely with Takeda to scale the clinical adoption of the test as a companion diagnostic for EXKIVITY is an important next step to enabling precision medicine and potentially improving outcomes of lung cancer patients."

Oncomine Dx Target Test simultaneously evaluates 23 genes associated with NSCLC. The FDA first approved the test as a CDx in 2017 and it is now approved for five targeted therapies for NSCLC and one targeted therapy for cholangiocarcinoma in the U.S. The test has also been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) as a CDx for five biomarkers – EGFR, ALK, ROS1, BRAF, and RET – associated with 10 targeted therapies for NSCLC. The test is currently approved and reimbursed by government and commercial insurers in more than 15 countries, including the U.S., multiple European nations, Japan, South Korea and the Middle East, and covering more than 550 million lives globally.