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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"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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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 15, 2021 Illumina, Inc. (NASDAQ: ILMN) reported that it has selected seven new genomics companies to join the third global funding cycle of Illumina Accelerator (Press release, NewStem, SEP 15, 2021, View Source [SID1234590974]). The global company creation engine, focused on partnering with entrepreneurs to build breakthrough genomics startups, invested in four companies for the 3rd funding cycle of Illumina Accelerator Cambridge, UK and three companies for the 13th funding cycle of Illumina Accelerator San Francisco Bay Area.

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"The global reach of Illumina Accelerator is demonstrated by our investment in these seven diverse startups from six countries," said Amanda Cashin, PhD, co-founder and Global Head of Illumina For Startups. "This diversity is testament to the strength and breadth of the talented entrepreneurs around the world focused on unlocking the power of the genome to improve human health and beyond."

During two, six-month funding cycles per year, Illumina Accelerator provides the selected startups with access to seed investment, access to Illumina sequencing systems and reagents, as well as business guidance, genomics expertise, and fully operational lab space adjacent to Illumina’s campuses in Cambridge, UK or the San Francisco Bay Area. The newest companies to join Illumina Accelerator’s portfolio of genomics startups include:

Illumina Accelerator Cambridge

BIXBIO LIMITED , a genomics startup from South Africa, is focused on unlocking the potential of diverse genetic data in Africa to transform the field of precision medicine.
EpiCombi.AI Limited , a genomics signature-driven therapeutics spinout from Oxford University, is overcoming epigenetic barriers in cancer complexity through the creation of AI-derived, network-acting multi-targeted drugs.
Genegoggle Sp. z o.o. , a biotech company from Poland, leverages multi-dimensional genomic and epigenetic elements to discover novel therapeutics and intelligent systems to improve human health.
NewStem Ltd. , a cancer therapeutics and diagnostics company from Israel, is developing genetic-based products utilizing a proprietary haploid human embryonic stem cells library of mutations.
Illumina Accelerator SF Bay Area

ImYoo Inc. , a direct-to-consumer single-cell transcriptomics company from the California Institute of Technology, aims to deliver personalized, biology-driven health insights by connecting people with similar immune profiles to share their health journeys.
Solena Ag, Inc. , an agriculture biotech company from Mexico, is commercializing innovative methods and proprietary biological solutions tailored to each farm, soil or region to improve crop profitability and soil health.
Yali Biosciences Inc. , a food tech company from San Francisco Bay Area, uses synthetic biology and genomics tools to make climate-smart, sustainable foods.
"Our newest investments demonstrate the depth and breadth of genomics applications across the globe," said Alex Aravanis, MD, PhD, Chief Technology Officer, Head of Research and Product Development at Illumina. "These seven genomics startups are focused on discovering breakthrough therapeutics, diagnostics, and direct to consumer applications to transform human health and beyond."

Illumina Accelerator is accepting applications for the next global funding cycle, which are due by October 1, 2021. Through a single, global application process, Illumina Accelerator will select up to five companies in each location. To learn more and apply, please visit our website.

About Illumina For Startups

Illumina for Startups is focused solely on creating an innovation ecosystem for the genomics industry by partnering with leading venture capital investors and entrepreneurs to create, launch, and grow genomics startups. Illumina for Startups initiatives include Illumina Accelerator, founded in 2014, and Sequoia Capital China Intelligent Healthcare Genomics Incubator, Powered by Illumina, launching Fall 2021. Illumina Accelerator is a company creation engine co-located with Illumina research and development sites in San Francisco Bay Area and Cambridge, UK. Illumina Accelerator has invested in 61 genomics startups from across the globe, which have collectively raised over $1 billion in venture capital funding. For more information, visit our website.

On September 15, 2021 PsiOxus Therapeutics, Ltd. (PsiOxus), a tumor re-engineering company, reported that they will present key safety and translational data from their first-in-human phase 1 FORTITUDE clinical study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 this week. Data from the completed monotherapy dose-escalation part of the FORTITUDE study, initiated in 2019 to assess the safety and tolerability of the NG-350A T-SIGn vector, will be presented on Friday 16th September 2021, with the poster available in full at www.psioxus.com shortly afterwards.

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NG-350A is a T-SIGn vector designed to re-engineer cancers by selectively expressing a CD40 agonist monoclonal antibody, a potent activator of immuno-inflammatory responses, within the tumour microenvironment. PsiOxus is developing this agent as one of several products within its T-SIGn portfolio of vectors that combine systemic delivery with localized production of powerful transgene payloads to allow the selective re-engineering of both primary and metastatic tumors.

The data to be presented at the ESMO (Free ESMO Whitepaper) Congress show that IV delivery of NG-350A results in sustained elevations of inflammatory cytokines in the phase 1 FORTITUDE trial. In particular, marked and persistent dose-dependent increases in both IL-12 and IFNγ were observed after a single 1-week course of NG-350A, indicative of robust activation of antigen presenting cells via CD40 agonism generated within the tumor. Expansion of new T cell clones, a high proportion of which were new clones, was also observed following a single cycle of NG-350A. Safety data from the 25 patients treated with NG-350A as part of the now completed monotherapy dose-escalation part of FORTITUDE demonstrated that NG‑350A was well-tolerated, with few of the adverse events associated with systemic delivery of anti-CD40 agonists observed.

Together, these data suggest NG-350A contributes to the re-programming of the tumour microenvironment while avoiding the toxicity associated with systemic non-localized dosing of anti-CD40 antibodies.

"The headline data shared at the ESMO (Free ESMO Whitepaper) Congress confirms previous findings that our T-SIGn vector replicates selectively in primary tumor cells and metastases and persists for several months after intravenous delivery. Even more importantly, the biomarker data indicates that ongoing vector replication in tumors effectively translates into sustained production of the transgene payload, in this case a CD40 agonistic antibody. This translational data is a first in class demonstration of a downstream effect of tumor re-engineering, using T-SIGn vectors to turn the patient’s tumor cells into small drug factories," said Tom Lille, M.D., Ph.D., Chief Medical Officer, PsiOxus.

Based on these highly promising data, NG-350A will be assessed in combination with an anti–PD-1 checkpoint inhibitor in Part B of FORTITUDE.