On September 15, 2021 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, reported that it will be participating at upcoming conferences (Press release, Mannkind, SEP 15, 2021, View Source [SID1234587742]). Presenting from the Company will be its Chief Executive Officer, Michael Castagna, PharmD.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Oppenheimer Fall Healthcare Life Sciences & MedTech Summit – Wednesday, September 22, 2021 at 2:55 pm – 3:35 pm (ET)
2021 Cantor Global Virtual Healthcare Conference – Monday, September 27, 2021 at 11:20 am – 11:50 am (ET)
Interested parties can access a link to the live webcast of the presentations from the Events & Presentations section of the Company’s website at View Source The webcast replay may be accessed at the same location for 14 days following the live presentation.

On September 15, 2021 Guardant Health, Inc. (Nasdaq: GH), along with leading academic institutions and pharmaceutical companies, reported that share data highlighting molecular targets of importance, treatment resistance patterns, and advantages of using the Guardant360 liquid biopsy test to help improve the management of advanced solid cancers at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 virtual congress on September 16-21 (Press release, Guardant Health, SEP 15, 2021, View Source [SID1234587760]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"While precision oncology has made a meaningful difference in improving clinical outcomes for highly prevalent cancers, such as non-small cell lung, colorectal, and breast, there remains a subset of patients who don’t respond to currently available treatments," said Craig Eagle, MD, Guardant Health Chief Medical Officer. "It is gratifying to be able to work with the oncology community to analyze the molecular information generated from our liquid biopsy tests to continue to increase our understanding of possible new targets and more personalized treatments which can potentially improve overall survival of these hard-to-treat cancers in a more meaningful way."

Guardant INFORM Liquid Biopsy Dataset Shows No Clear Standard of Care and Unmet Need for Patients with HER2+ Metastatic Colorectal Cancer

Title

ePoster

Presenter

Characteristics and treatment patterns among patients with HER2-amplified advanced/metastatic colorectal cancer (mCRC): A clinical-genomic database study

439P

John Strickler

Guardant360 Liquid Biopsy Reveals Molecular Insights Impacting Outcomes in Patients with Unresectable and Early-Onset (<50 years) Metastatic Colorectal Cancer

Title

ePoster

Presenter

Molecular features in liquid biopsy of early (EO) and late-onset colorectal cancer (LO)

500P

Julia Alcaide-Garcia

Mutational landscape in synchronous unresectable metastatic colorectal cancer (mCRC) according to upfront primary tumour resection (UPTR)

503P

Manuel Benavides

Guardant360 Liquid Biopsy Reveals Treatment Resistance Patterns and Therapeutic Targets for the Management of Advanced Cancers Including Non-Small Cell Lung and Pancreatic

Title

ePoster

Presenter

First-results of the CLIMB360 study, a prospective molecular screening program across multiple cancer types based on circulating tumor DNA (ctDNA)

92P

Javier Garcia-Corbacho

Pre-existing and acquired mechanisms of resistance to lorlatinib in previously treated patients (pts) with ALK+ advanced non-small cell lung cancer (NSCLC)

1196P

Ben J. Solomon

Cell-free DNA dominant clone allele frequency associates with poor outcomes in advanced pancreatic cancer

1483P

Pedro Uson Junior

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]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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).

On September 14, 2021 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported that the Company will host a virtual Key Opinion Leader event on radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer on Thursday, September 23 at 11:00 a.m. ET (Press release, Galera Therapeutics, SEP 14, 2021, View Source [SID1234587659]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Dr. Carryn Anderson, Clinical Associate Professor of Radiation Oncology at the University of Iowa, will provide a review of the current clinical treatment paradigm for patients with locally advanced head and neck cancer, including the use of intensity-modulated radiation therapy.

Dr. Anderson’s presentation will be followed by a video from a head and neck cancer survivor on his experience with SOM and a presentation from Galera’s President and CEO, Mel Sorensen, M.D., with an overview of the SOM market in patients with head and neck cancer.

The live audio webcast of the event will be accessible from the News & Events section of the Investors page of Galera’s website at investors.galeratx.com. Individuals can participate in an interactive Q&A session by submitting questions via the webcast platform.

An archived version of the webcast will be available for 30 days following the event.

On September 14, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that its Decipher Prostate RP genomic classifier is uniquely recommended in the 2022 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Oncology to guide treatment decisions for men with prostate cancer (Press release, Veracyte, SEP 14, 2021, View Source [SID1234587678]). The new guidelines specifically recommend Decipher Prostate RP after radical prostatectomy and that men with high-risk scores (>0.6) should be strongly considered for salvage radiotherapy with the addition of concurrent hormone therapy, when early radiation therapy is missed.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are thrilled that Decipher Prostate RP is now recommended by the NCCN to guide specific treatment decisions," said Elai Davicioni, Ph.D., Veracyte’s senior vice president, scientific and clinical operations, urologic cancers. "The NCCN’s designation is unique to Decipher Prostate RP and underscores the extensive clinical validation and clinical utility data behind the test. We believe this recommendation will ultimately enable more men to receive the treatment they need, while reducing unnecessary therapy."

The new NCCN recommendations are based on results of the NRG Oncology Phase 3 randomized controlled trial, RTOG 96-01. This study, which followed patients for a median of 12 years, demonstrated that Decipher risk results were associated with hormone therapy benefit, with Decipher high-risk men receiving greater absolute benefit from hormone therapy compared to Decipher low-risk men. In the subset of patients who received hormone therapy in addition to early salvage radiotherapy, Decipher high-risk men experienced improvements in distant metastasis, prostate cancer-specific mortality and overall survival, while Decipher low-risk men had good oncologic outcomes without hormone therapy.

The Decipher Prostate genomic classifier is currently being investigated in seven National Cancer Institute-sponsored, Phase 3, prospective, randomized controlled clinical trials; 13 Phase 2/3 prospective trials; and more than 20 retrospective studies of Phase 3 randomized controlled trials. Many of these trials require Decipher Prostate testing for study inclusion.

About Decipher Prostate

Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) is a 22-gene, whole-transcriptome-developed genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.