Candel Therapeutics Announces Participation in Upcoming Scientific Conferences Related to Oncolytic Viral Immunotherapies

On October 1, 2021 Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported that its President and Chief Executive Officer, Paul Peter Tak, MD, PhD, FMedSci, and E. Antonio Chiocca, MD, PhD, FAANS, an investigator on Candel’s clinical trials in brain cancer, will present data and overviews pertaining to oncolytic viral immunotherapies for glioblastoma and other solid tumors at the following upcoming scientific conferences (Press release, Candel Therapeutics, OCT 1, 2021, View Source [SID1234590650]).

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Cambridge Healthtech Institute’s 9th Annual Immuno-Oncology Summit Conference Program: Oncolytic Virus Immunotherapy
Date and Time: Wednesday, Oct. 6, 2021
Presenter: Paul Peter Tak, MD, PhD, FMedSci
Presentation Title: Novel Oncolytic Viral Immunotherapies for Solid Tumors
Hanson Wade’s 6th Annual Oncolytic Virotherapy Summit
Date and Time: Wednesday, Oct. 27, 2021
Presenter: Paul Peter Tak, MD, PhD, FMedSci
Presentation Title: Novel Oncolytic Viral Immunotherapies to Immunize Against the Patient’s Own Tumor Neo-antigens: CAN-2409 and CAN-3110
Hanson Wade’s 6th Annual Oncolytic Virotherapy Summit
Date and Time: Wednesday, Oct. 27, 2021
Presenter: E. Antonio Chiocca, MD, PhD, FAANS
Presentation Title: Improving Oncolytic HSV1 for Glioblastoma Therapy
Details from the presentations will be available on the Candel website at View Source

About CAN-2409

CAN-2409, Candel’s most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the local release of tumor-specific neo-antigens. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity.

Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, CAN-2409 presents a favorable tolerability profile; more than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in localized, non-metastatic prostate cancer, non-small cell lung cancer, high-grade glioma, and pancreatic cancer in ongoing clinical trials.

About CAN-3110

CAN-3110 is an HSV replication-competent oncolytic virus engineered to enhance selective killing of cancer cells while sparing neighboring healthy cells. CAN-3110 selectively expresses ICP34.5, a key gene in HSV replication, in tumor cells that overexpress nestin, a cytoskeletal protein. Nestin is highly expressed in high-grade glioma cells and other tumor tissues, but it is absent in the healthy adult brain.

Candel is evaluating the effects of treatment with CAN-3110 in recurrent high-grade glioma. Encouraging clinical results of the ongoing phase 1 clinical trial were recently presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Agenus to Present AGEN1181 Clinical Data at SITC

On October 1, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported acceptance of its abstract describing updated Phase 1 clinical trial results for AGEN1181 (Fc-enhanced anti-CTLA-4) alone and in combination with balstilimab (anti-PD-1) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting, to be held November 10-14, 2021 (Press release, Agenus, OCT 1, 2021, View Source [SID1234590649]).

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Presentation Details:

Abstract Title: AGEN1181, an Fc-enhanced anti-CTLA-4 antibody, alone and in combination with balstilimab (anti-PD-1) in patients with advanced solid tumors: Initial phase I results (NCT03860272)
Abstract Number: 479
Presenting Author: Dr. Anthony El-Khoueiry

The full abstract will be released on Tuesday, November 9, 2021. The updated data will be presented at the conference and will become available in the investor section of our website at View Source following the presentation on November 12, 2021.

Iovance Biotherapeutics to Present Clinical Data for Tumor Infiltrating Lymphocyte (TIL) Cell Therapies Across Multiple Solid Tumors and Treatment Settings at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting

On October 1, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported oral and poster presentations of clinical and non-clinical data for tumor infiltrating lymphocyte (TIL) cell therapies in multiple solid tumors will be presented at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Iovance Biotherapeutics, OCT 1, 2021, View Source [SID1234590647]). The SITC (Free SITC Whitepaper) 36th Annual Meeting will be held from November 12-14, 2021 in Washington, D.C. and virtually. Details of the oral presentation and posters are as follows:

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Title: Phase 2 efficacy and safety of autologous tumor-infiltrating lymphocyte (TIL) cell therapy in combination with pembrolizumab in immune checkpoint inhibitor-naïve patients with advanced cancers
Authors: D O’Malley, et al.
Presentation Type: Oral Presentation
Date and Time: Saturday, November 13, 2021
Abstract ID: 492

Title: First phase 2 results of autologous tumor-infiltrating lymphocyte (TIL; LN-145) monotherapy in patients with advanced, immune checkpoint inhibitor-treated, non-small cell lung cancer (NSCLC)
Authors: A Schoenfeld, et al.
Presentation Type: Poster (available beginning on Friday, November 12, 2021 at 7 a.m. ET)
Abstract ID: 458

Title: Successful generation of tumor-infiltrating lymphocyte (TIL) product from renal cell carcinoma (RCC) tumors for adoptive cell therapy
Authors: B Halbert, et al.
Presentation Type: Poster (available beginning on Friday, November 12, 2021 at 7 a.m. ET)
Abstract ID: 176

Title: Expansion of tumor-infiltrating lymphocytes (TIL) using static bag for the clinical manufacturing rapid expansion protocol (REP) process
Authors: K Onimus, et al.
Presentation Type: Poster (available beginning on Friday, November 12, 2021 at 7 a.m. ET)
Abstract ID: 101

Anixa Biosciences Announces Notice of Allowance for Additional Patent on its CAR-T Cancer Therapy

On October 1, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX) ("Anixa"), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance broadening protection of Anixa’s novel Chimeric Antigen Receptor-T cell (CAR-T) cancer treatment technology, known as its Chimeric Endocrine Receptor T-cell, or CER-T approach, or more specifically, "Follicle Stimulating Hormone Receptor-Mediated CAR-T technology," which has been licensed from The Wistar Institute and is being developed in partnership with Moffitt Cancer Center (Press release, Anixa Biosciences, OCT 1, 2021, View Source [SID1234590645]).

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The patent is titled, "Methods and Compositions for Treating Cancer," and the inventors are Drs. Jose Conejo-Garcia and Alfredo Perales-Puchalt, both formerly of The Wistar Institute. Dr. Conejo-Garcia is Chair of the Department of Immunology at Moffitt Cancer Center and Dr. Perales-Puchalt is Vice President of R&D at Geneos Therapeutics. The patent is assigned to The Wistar Institute and Anixa Biosciences’ majority-owned subsidiary, Certainty Therapeutics, Inc. is the exclusive, world-wide licensee. This patent is in the family of the originally granted patent, and it covers additional intellectual property related to Anixa’s CAR-T technology.

Dr. Amit Kumar, President and CEO of Anixa Biosciences, stated, "We are pleased to receive this notice from the USPTO, confirming additional protection of our novel CAR-T cancer treatment technology. This technology takes advantage of specific hormone-to-hormone receptor biology to address malignancies and holds promise to be the first successful CAR-T therapy against solid tumors. While our initial focus is the treatment of ovarian cancer—with clinical trials expected to begin before year-end—the technology covered by the patent is broad and may have applicability in treating other solid tumors by exploiting an anti-angiogenesis mechanism of action."

About Anixa’s CER-T approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa’s Chimeric Antigen Receptor-T cell (CAR-T) Technology approach, known as "Follicle Stimulating Hormone Receptor (FSHR)-mediated CAR-T technology," is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone receptor, and the target-binding domain is derived from its natural ligand, this technology is also known as CER-T (Chimeric Endocrine Receptor T-cell) therapy, a new type of CAR-T.
The therapy based on this technology was recently authorized by the U.S. Food and Drug Administration (FDA) for Phase 1 clinical testing.

BioNTech to Present New Clinical and Preclinical Data Across Multiple Immuno-Oncology Programs at 36th SITC Annual Meeting

On October 1, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company"), a next generation immunotherapy company pioneering novel therapies for cancer and infectious diseases, reported that new clinical and preclinical data will be presented in six posters and one presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held both in person and virtually from November 10 – 14, 2021 (Press release, BioNTech, OCT 1, 2021, View Source [SID1234590644]). The presentations will include new data from multiple programs across various drug classes along with first-in-human data for three programs. This is the largest data collection the company will present at a scientific meeting, showcasing BioNTech’s diversified oncology pipeline.

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"The data we will be presenting at SITC (Free SITC Whitepaper) 2021 is indicative of our continued pursuit of pathbreaking science and the development of our platform technologies that tailor anti-cancer therapies to individual patient needs," said Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "We are encouraged by the considerable progress within our oncology portfolio seeing multiple programs now coming to fruition. They represent critical steps for us towards bringing cancer immunotherapy into the next generation and we are looking forward to sharing the data with the scientific community at a key conference."

Presentation Details:

Antibodies, Next-Generation Checkpoint Immunomodulators

Program: BNT312
Presentation Title: First-in-human phase 1/2 trial to evaluate the safety and initial clinical activity of DuoBody-CD40×4-1BB (GEN1042) in patients with advanced solid tumors
Session Title: Concurrent Rapid Oral Abstract Presentation Session 206: Clinical
Speaker: Melissa L. Johnson, M.D., Lead Investigator, Associate Director, Lung Cancer Research, Sarah Cannon Cancer Institute, TriStar Centennial Medical Center
Abstract Number: 493
Date & Time: Saturday, November 13, 2021, 12:45 pm – 1:45 pm ET

This product candidate GEN1042 (BNT312) is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future profits on a 50:50 basis.

Poster Details:

All data presented in poster presentations at the poster hall will be made available as virtual ePosters throughout the SITC (Free SITC Whitepaper) 36th Virtual Annual Meeting.

mRNA Therapeutics, FixVac

Program: BNT111
Poster Title: An RNA lipoplex (RNA-LPX) vaccine demonstrates strong immunogenicity and promising clinical activity in a Phase I trial in cutaneous melanoma patients with no evidence of disease at trial inclusion
Abstract Number: 15965
Date & Time: Friday, November 12, 2021, 7:00 am – 8:30 pm ET

Program: BNT112
Poster Title: A first-in-human (FIH) Phase I/IIa clinical trial assessing a ribonucleic acid lipoplex (RNA-LPX) encoding shared tumor antigens for immunotherapy of prostate cancer; preliminary analysis of PRO-MERIT
Abstract Number: 15941
Date & Time: Friday, November 12, 2021, 7:00 am – 8:30 pm ET

Engineered Cell Therapies, NEO-STIM

Program: BNT221
Poster Title: BNT221, an autologous neoantigen-specific T-cell product for adoptive cell therapy of metastatic ovarian cancer
Abstract Number: 201
Date & Time: Friday, November 12, 2021, 7:00 am – 8:30 pm ET

Antibodies, Next-Generation Checkpoint Immunomodulators

Program: BNT311
Short Presentation Title: Peripheral and tumoral immune activity in the expansion part of the first-in-
human DuoBody-PD-L1×4-1BB (GEN1046) trial
Abstract Number: 516
Date & Time: Saturday, November 13, 2021, 7:00 am – 8:30 pm ET

The product candidate GEN1046 (BNT311) is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future profits on a 50:50 basis.

Program: BNT311
Short Presentation Title: Dose selection for DuoBody-PD-L1×4-1BB (GEN1046) using a semimechanistic
pharmacokinetics/pharmacodynamics model that leverages preclinical and clinical data
Abstract Number: 786
Date & Time: Saturday, November 13, 2021, 7:00 am – 8:30 pm ET

The product candidate GEN1046 (BNT311) is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future profits on a 50:50 basis.

Small Molecule Immunomodulators, Toll-like Receptor (TLR) Binding platform

Program: BNT411
Short Presentation Title: Preliminary safety, PK/PD and efficacy results from a first-in-human phase I/IIa clinical trial of BNT411, a systemic Toll-like receptor 7 agonist in patients with solid tumors
Abstract Number: 525
Date & Time: Friday, November 12, 2021, 7:00 am – 8:30 pm ET