On October 5, 2022 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage T-cell reprogramming company dedicated to developing curative cell therapies for patients with solid tumors, reported that five abstracts highlighting preclinical data on its product candidates and new genetic and epigenetic reprogramming technologies were accepted for presentation at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) taking place in Boston, Nov. 8 – Nov. 12, 2022 (Press release, Lyell Immunopharma, OCT 5, 2022, View Source [SID1234621719]). The new preclinical data includes an abstract describing the effects of c-Jun overexpression in combination with NR4A3 gene knockout to enhance the functional activity of ROR1 CAR T cells. The combination of these two genetic reprogramming technologies is being incorporated in Lyell’s new product candidate, LYL119, a second generation investigational ROR1 targeting CAR T-cell therapy.

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"Our presence at SITC (Free SITC Whitepaper) includes presentations of new preclinical data from both existing and new reprogramming technologies being deployed in our growing pipeline of therapeutic candidates for solid tumors," stated Dr. Gary Lee, chief scientific officer at Lyell. "We look forward to sharing these preclinical findings on the potential of Lyell’s reprogramming technologies that are designed to address primary barriers to successful adoptive cell therapy in solid tumors in order to improve clinical responses in patients."

All the presentations describe preclinical data demonstrating that genetic and epigenetic reprogramming can ameliorate T cell exhaustion and enhance stem-like qualities and potency of T cells in various modalities, including CAR T cells, tumor-infiltrating lymphocytes (TILs) and T-cell receptor (TCR) T cells. Two presentations will feature preclinical data from LYL845, Lyell’s autologous TIL product candidate enhanced with Epi-R reprogramming technology, designed to create products with higher proportions of stem-like T cells. Lyell will also present preclinical data from its new genetic reprogramming technology designed to further limit T cell exhaustion, as well as data on its new epigenetic reprogramming technology, Stim-R, designed to generate a more potent T cell product by controlling delivery of activation molecules during T cell production.

Details on the five poster presentations are below:

NR4A3 gene editing and c-Jun overexpression synergize to limit exhaustion and enhance functional activity of ROR1 CAR T cells in vitro and in vivo

Category: Cellular therapies – Chimeric Antigen Receptors
Presentation Date, Time & Location: Thursday, Nov. 10, Poster Hall
Abstract No.: 243
Engineering potent CAR T-cell therapies by controlling T-cell activation signaling parameters using the Stim-R technology, a programmable synthetic cell-signaling platform

Category: Cellular Therapies – Chimeric Antigen Receptors
Presentation Date, Time & Location: Friday, Nov. 11, Poster Hall
Abstract No.: 252
The Epi-R technology produces a polyclonal TIL product (LYL845) with diverse tumor-reactive clones that have stem-like qualities and anti-tumor function

Category: Cellular therapies – Non-CAR adoptive cell therapies
Presentation Date, Time & Location: Friday, Nov. 11, Poster Hall
Abstract No.: 340
The Epi-R technology produces a polyclonal TIL product (LYL845) with a greater expansion success rate across hot and cold tumors, improved product phenotype, and maintenance of TCR diversity

Category: Cellular therapies – Non-CAR adoptive cell therapies
Presentation Date, Time & Location: Friday, Nov. 11, Poster Hall
Abstract No.: 370
Increased potency and functional persistence in vitro of a next-generation NY-ESO-1-specific TCR therapy incorporating Gen-R genetic reprogramming technology

Category: Cellular therapies – Non-CAR Adoptive Cell therapies
Presentation Date, Time & Location: Friday, Nov. 11, Poster Hall
Abstract No.: 232

On October 5, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported oral and poster presentations reporting clinical data and trial design for tumor infiltrating lymphocyte (TIL) cell therapies at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting in Boston, Massachusetts, November 8-12, 2022 (Press release, Iovance Biotherapeutics, OCT 5, 2022, View Source [SID1234621718]). The details of the posters and presentations are as follows:

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Title: Lifileucel TIL cell monotherapy in patients with advanced melanoma after progression on immune checkpoint inhibitors (ICI) and targeted therapy: Pooled analysis of consecutive cohorts (C-144-01 study)
Authors: A. Sarnaik, et al
Presentation Type: Rapid Oral Abstracts and Poster
Session Date and Time: November 10, 2022, Concurrent Session 105 (11:55 a.m. – 12:55 p.m. ET) and Poster Hall (1 p.m. – 9:00 p.m. ET)
Abstract ID: 789

Title: Trial in progress: A phase 1/2 open-label study (IOV-GM1-201) of TALEN-mediated PD-1–inactivated autologous tumor-infiltrating lymphocytes (TIL; IOV-4001) in patients with advanced melanoma and NSCLC
Authors: A. Betof Warner, et al
Presentation Type: Poster
Session Date and Time: November 10, 2022, 9:00 a.m. – 9:00 p.m. ET, Poster Hall
Abstract ID: 783

Iovance will host a webcast and conference call on Thursday, November 10, 2022 at 4:30 p.m. ET to discuss the pooled analysis of Cohorts 2 and 4 of the C-144-01 study of lifileucel in advanced melanoma. Iovance senior leadership will be joined by key opinion leaders and principal investigators. The live and archived webcast will be available in the Investors section of the company’s website at www.iovance.com.

On October 5, 2022 IconOVir Bio, Inc. (IconOVir), a preclinical-stage biotechnology company pioneering the next generation of oncolytic virus (OV) therapy to improve the treatment of patients with cancer, reported that it will present preclinical data on ICVB-1042 in three poster presentations at the upcoming Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2022), which is being held in Boston, MA and virtually from November 8-12, 2022 (Press release, IconOVir Bio, OCT 5, 2022, View Source [SID1234621716]).

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ICVB-1042, IconOVir’s lead product candidate, is a potent, replicative and systemically available OV. In preclinical studies, ICVB-1042 demonstrated superior potency and selectivity compared to wildtype adenovirus (Ad) and other clinical-stage Ad-based oncolytic viruses, with potent lytic replication in cancer cell lines across a broad range of tumor types. IconOVir is developing both intravenous (IV) and intratumoral (IT) formulations of ICVB-1042 and plans to advance into Phase 1 studies evaluating IV-administered ICVB-1042 in solid tumors in the first half of 2023.

Details of the poster presentations are as follows:

Abstract Title: Evaluation of the anti-tumor activity of ICVB-1042, a novel E2F-tumor selective oncolytic virus, selectively targeting tumor cells in an established human glioblastoma mouse model
Abstract Number: 1363
Session Date and Time: Thursday, November 10, 2022, 9:00 a.m. – 9:00 p.m. ET

Abstract Title: Nonclinical characterization of ICVB-1042, a novel E2F-tumor selective oncolytic virus with the potential to treat solid tumors
Abstract Number: 1362
Session Date and Time: Friday, November 11, 2022, 9:00 a.m. – 8:30 p.m. ET

Abstract Title: The chimeric Ad5/Ad34 fiber of ICVB-1042 oncolytic virus requires the CD46 cell surface receptor for efficient tumor entry
Abstract Number: 1216
Session Date and Time: Friday, November 11, 2022, 9:00 a.m. – 8:30 p.m. ET

Each abstract will become available online on the SITC (Free SITC Whitepaper) conference website beginning at 8:00 a.m. ET on Monday, November 7, 2022. For additional information, please visit the SITC (Free SITC Whitepaper) 37th Annual Meeting website, which is available at View Source

On October 5, 2022 Herantis Pharma Plc ("Herantis"), developing disease modifying therapies for Parkinson’s disease, reported that CEO Antti Vuolanto and CSO Henri Huttunen will be attending and holding 1×1 meetings at Bio-Europe 2022 between October 24th–26th, 2022 (Press release, Herantis Pharma, OCT 5, 2022, View Source,c3643277 [SID1234621715]). Additionally, CEO Antti Vuolanto will be attending, presenting, and participating in a CNS panel discussion at Redeyes’ Theme: Neurology Day on October 12th, 2022.

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Conference Details:

Redeye Theme: Neurology

Bio-Europe 2022

If you are interested in scheduling a 1×1 meeting with Herantis management you can contact the conference organizers, connect with us via the Bio-Europe 1×1 platform, and/or send an email to [email protected].

On October 5, 2022 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) approved the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody* to identify metastatic breast cancer patients with low HER2 expression for whom Enhertu (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment (Press release, Hoffmann-La Roche, OCT 5, 2022, https://diagnostics.roche.com/global/en/news-listing/2022/roche-receives-fda-approval-for-first-companion-diagnostic-to-id.html [SID1234621714]). Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

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HER2 is a receptor protein that helps cancer cells grow quickly. To determine a patient’s HER2 status, pathologists evaluate, or score, the level of HER2 receptor protein expressed in breast cancer tissue samples. If a patient’s tumour expresses high levels of HER2, the patient is identified as HER2-positive and may be considered for HER2-targeted treatment. However, half of all patients with metastatic breast cancer express low levels of HER2 which historically classified them as HER2-negative.

The PATHWAY anti-HER2 (4B5) test now includes a scoring algorithm that helps pathologists to identify "low expressors" of HER2, assigning a HER2 low status to this group of patients. With this lower cutoff, the test is able to identify patients who may benefit from Enhertu as a treatment option.

"Roche is proud to lead the way in HER2 diagnostics through critical innovations that support the identification of patients who may benefit from novel HER2-targeted therapies," said Thomas Schinecker, CEO of Roche Diagnostics. "Previously, metastatic breast cancer patients with a lower level of HER2 expression were considered to be part of the HER2-negative population and had no HER2-targeted treatment options. Now, they may be eligible for a HER2-targeted therapy, significantly increasing the number of patients who could have improved outcomes."

The PATHWAY anti-HER2 (4B5) test was used as part of the DESTINY-Breast04 trial sponsored by AstraZeneca and Daiichi Sankyo to identify patients whose tumours expressed low levels of HER2 protein. The trial reported a 50% reduction in the risk of disease recurrence or death and an overall gain of six months over standard of care in patients treated with Enhertu whose tumours had low levels of HER2 expression.

Breast cancer has surpassed lung cancer as the most commonly diagnosed cancer, with an estimated 2.3 million new cases diagnosed worldwide each year. More than 620,000 people die from breast cancer every year.4,5

The FDA approval of the new HER2 low indication expands on the intended use for Roche’s proven, on-market PATHWAY anti-HER2 (4B5) test, delivering timely, clear and confident results. The launch exemplifies Roche’s commitment to continuing to innovate integrated, high medical value solutions that help to advance personalised healthcare.

About PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Antibody

Roche’s pre-diluted PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, used in combination with the fully automated BenchMark IHC/ISH slide staining instrument, standardises all immunohistochemistry (IHC) processes from baking through staining, and reduces the possibility of human error.5 It also minimises inherent variability resulting from individual reagent dilution and other processes found in manual and semi-automated IHC methods. The Roche HER2 (4B5) clone achieves consistently high proficiency assessment scores compared to other clones6 and demonstrates high concordance with HER2 FISH7,8, empowering laboratories to employ the most widely adopted and reliable HER2-IHC primary antibody.