On October 1, 2021 T-knife Therapeutics, Inc., a biopharmaceutical company dedicated to developing novel therapeutics to fight cancer, reported that three abstracts highlighting its lead product candidate TK-8001, a T cell receptor (TCR) engineered T cell therapy (TCR-T) being developed to treat MAGE-A1 positive solid tumors, will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting taking place November 10-14, 2021 (Press release, T-Knife, OCT 1, 2021, View Source [SID1234591706]).

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"TK-8001 is a novel CD8 TCR-T targeting MAGE-A1, a tumor-specific antigen associated with aggressive cancers and poor clinical prognosis," stated Eugen Leo, Chief Medical Officer of T-knife. "The presentations at SITC (Free SITC Whitepaper) will cover important aspects of our work related with TK-8001, including favorable preclinical data comparing TK-8001 to human donor-derived TCRs, the potential benefits of MAGE-A1 as a cancer target, and the design of our forthcoming IMAG1NE Phase 1/2 study intended to evaluate the safety and efficacy of TK-8001 in select patients with MAGE-A1 expressing solid tumors."

Poster Presentation Details

Title: Optimal-affinity MAGE-A1-specific T cell receptors (TCRs) generated using the humanized TCR-transgenic mouse platform HuTCR are superior to human donor-derived TCRs
Abstract ID: 225
Date: Friday, Nov. 12, 2021
Time: 7:00 am – 5:00 pm

Title: MAGE-A1 protein expression pattern in > 5,000 tumor and healthy tissue samples: Validation of MAGE-A1 as an ideal target for TCR-based cell therapy
Abstract ID: 95
Date: Friday, Nov. 12, 2021
Time: 7:00 am – 5:00 pm

Title: A first-in-human, Phase 1/2 clinical trial of TK-8001, a MAGE-A1 directed T cell receptor in patients with advanced-stage solid tumors (The "IMAG1NE" trial)
Abstract ID: 499
Date: Friday, Nov. 12, 2021
Time: 7:00 am – 5:00 pm

About TK-8001 TCR-T
TK-8001 is a CD8 TCR-T specific for the Melanoma-associated Antigen Gene-A1, or MAGE-A1. MAGE-A1 is associated with hallmarks of aggressive cancers and poor clinical prognosis, and there is an emerging body of evidence indicating its involvement as a potential driver of tumorigenesis. MAGE-A1 represents an attractive therapeutic target given the high unmet need in MAGE-A1 expressing cancers, no reported protein expression in healthy tissues other than testis and significant consistency of expression between the primary tumor and metastases. As high affinity TCRs specific for MAGE-A1 peptides in humans are eliminated through central tolerance, we believe our HuTCR platform is a differentiated means to discover and select MAGE-A1 specific TCRs with an optimal affinity and high specificity profile.

About the IMAG1NE Phase 1/2 Trial
The IMAG1NE Phase 1/2 trial is an open-label, multi-center Phase 1/2 trial designed to evaluate the safety and efficacy of TK-8001 in patients with MAGE-A1 positive solid tumors. The Phase 1 portion of the IMAG1NE trial is planned to enroll approximately 6 to 18 patients to assess the initial safety and tolerability of ascending dose levels of TK-8001. A key outcome of the Phase 1 portion of the trial is to select a dose to be evaluated in the Phase 2 part of the study. The Phase 2 portion of the IMAG1NE trial is designed to enroll approximately 30 additional participants to assess the efficacy of TK-8001 across a range of tumor indications.

On October 1, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the permanent J-code for COSELA (trilaciclib) that was issued in July 2021 by the Centers for Medicare & Medicaid Services (CMS) is now effective for provider billing for all sites of care (Press release, G1 Therapeutics, OCT 1, 2021, View Source [SID1234590614]). The permanent J-code for COSELA, J1448 (Injection, trilaciclib, 1mg.), published online on the CMS website here (page 5).

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J-codes are permanent, product specific reimbursement codes assigned to outpatient and physician administered "buy and bill" products under Medicare Part B and are used by commercial insurers and government payers to facilitate and standardize claims submissions and reimbursements for medications like COSELA. With the permanent J-code now in effect, all hospital outpatient departments, ambulatory surgery centers and physician offices in the United States will have one consistent Healthcare Common Procedure Coding System (HCPCS) code to standardize the submission and payment of COSELA insurance claims across Medicare, Medicare Advantage, Medicaid and commercial plans.

"Given the emergent presentation of extensive-stage small cell lung cancer, and the clinical benefits of COSELA as a proactive multilineage myeloprotection drug when give prior to chemotherapy, it is absolutely essential that patients have timely access to it," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "We are pleased to receive this new permanent J-code for all sites of care as it will enable a more efficient billing process, which will ultimately help facilitate patient access to COSELA."

G1’s new technology add-on payment (NTAP) for COSELA which provides additional payment to inpatient hospitals above the standard Medicare Severity Diagnosis-Related Group (MS-DRG) payment amount also became effective for provider billing today, October 1, 2021.

About COSELA (trilaciclib) for Injection

COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.

Indication
COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

Important Safety Information
COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.

The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

This information is not comprehensive. Please click here for full Prescribing Information. View Source

On October 1, 2021 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating several investigational therapies and technologies in the company’s solid tumor product pipeline will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36thAnnual Meeting (SITC 2021), being held in Washington, DC, and virtually, November 10-14 (Press release, Genmab, OCT 1, 2021, View Source [SID1234590634]). The presentations will include a mini-oral session featuring the results of the first-in-human (FIH) phase 1/2 trial evaluating the safety and initial clinical activity of the investigational bispecific antibody, DuoBody-CD40×4-1BB (GEN1042), in patients with advanced solid tumors. Data from another FIH phase 1/2a trial, evaluating the investigational bispecific antibody, DuoBody-PD-L1×4-1BB (GEN1046) in patients with advanced solid tumors, will be presented as a poster. In addition, four posters will be presented, including one evaluating DuoBody-CD3xB7H4 (GEN1047), an investigational therapy in Genmab’s early-stage solid tumor product pipeline.

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All the abstract titles have been published on the SITC (Free SITC Whitepaper) website and may be accessed online via the SITC (Free SITC Whitepaper) Annual Meeting website. Full abstracts will be posted on November 9, 2021, at 8:00 a.m. ET.

GEN1046 and GEN1042 are being co-developed by Genmab and BioNTech (NASDAQ: BNTX) under an agreement in which the companies share all costs and future profits on a 50:50 basis.

"We are excited to present the results of these important clinical and pre-clinical studies to show the progression of the innovative technologies and investigational medicines in our antibody product pipeline and to demonstrate our commitment to delivering new therapeutic options to patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "While most of these studies have been conducted in the beginning stages of the clinical evaluation process, we are encouraged by the early results and look forward to seeing further results from ongoing clinical trials."

Abstracts accepted for presentation at SITC (Free SITC Whitepaper) 2021:

DuoBody-CD40×4-1BB (GEN1042):

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

DuoBody-PD-L1×4-1BB (GEN1046):

Peripheral and tumoral immune activity in the expansion part of the first-in human DuoBody-PD-L1×4-1BB (GEN1046) trial
Dose selection for DuoBody-PD-L1×4-1BB (GEN1046) using a semi-mechanistic pharmacokinetics/pharmacodynamics model that leverages preclinical and clinical data
DuoBody-CD3xB7H4 (GEN1047):

In vitro and in vivo studies establish DuoBody-CD3xB7H4 as a novel drug candidate for the treatment of solid cancers

New Research and Technologies:

A scalable deep learning framework for rapid automated annotation of histologic and morphologic features from large unlabeled pan-cancer H&E datasets
A translational approach to catalog pancreatic cancer heterogeneity using spatial genomics in large patient cohorts to empower target validation and rational combination selection
Molecular characterization of AXL in solid tumor malignancies using real-world data

About DuoBody-PD-L1×4-1BB (GEN1046)
DuoBody-PD-L1x4-1BB (GEN1046) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology. It targets PD-L1 and 4-1BB, selected to block the inhibitory PD1/PD-L1 axis and simultaneously conditionally activate essential co-stimulatory activity via 4-1BB using an inert DuoBody antibody format. Two clinical studies (NCT03917381, NCT04937153) in solid tumors are ongoing. DuoBody-PD-L1x4-1BB is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.

About DuoBody-CD40×4-1BB (GEN1042)
DuoBody-CD40x4-1BB (GEN1042) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology. CD40 and 4-1BB were selected as targets to enhance both dendritic cell (DC) and antigen-dependent T-cell activation, using an inert DuoBody format. A Phase 1/2 clinical study (NCT04083599) of DuoBody-CD40x4-1BB in solid tumors is ongoing. DuoBody-CD40x4-1BB is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.

On October 1, 2021 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported the acceptance of four abstracts to be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36TH Annual Meeting (SITC 2021) taking place November 10-14, 2021, at the Walter E. Washington Convention Center in Washington, D.C (Press release, Neoleukin Therapeutics, OCT 1, 2021, View Source [SID1234590657]).

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"Presentations by our scientists and collaborators at SITC (Free SITC Whitepaper) 2021 will highlight promising preclinical data with NL-201, a fully de novo IL-2/IL-15 agonist, currently in phase 1 clinical development," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. "We look forward to sharing data on the ability of NL-201 to activate the tumor microenvironment, to demonstrate antitumor activity via intratumoral administration, and to be combined with novel therapeutic candidates."

Details of the poster presentations are as follows:

Title: NL-201 Induces Inflammation in a ‘Cold’ Tumor Microenvironment through Upregulation of MHC-I, Expansion of the TCR Repertoire, and Potent Antitumor Activity when Combined with PD-1 Inhibition

Poster/Abstract Number: 716
Date/Time: Saturday, November 13, 5 a.m. to 8:30 p.m., ET

Title: Intratumoral Administration of NL-201, an Alpha-Independent IL-2/15 Receptor Agonist, Inhibits the Growth of Both Injected and Uninjected Tumors in Preclinical Models

Poster/Abstract Number: 898
Date/Time: Saturday, November 13, 5 a.m. to 8:30 p.m., ET

Title: A First-in-Human Phase 1 Study of NL-201 in Patients with Relapsed or Refractory Cancer (Trials in Progress)

Poster/Abstract: 509
Date/Time: Friday, November 12, 5 a.m. to 8:30 p.m. ET

Title: ICT01, an Anti-BTN3A Monoclonal Antibody, and NL-201, an Alpha-Independent IL-2/IL-15 Agonist, Combine to Elicit a Potent Anti-Tumor Response by Synergistically Stimulating g9d2 T Cell Activation and Proliferation

Poster/Abstract Number: 563
Date/Time: Friday, November 12, 5 a.m. to 8:30 p.m. ET

Poster presentations will be accessible in person and virtually. Onsite posters will be displayed in the SITC (Free SITC Whitepaper) Poster Hall located in Hall E of the convention center. ePosters will be available for SITC (Free SITC Whitepaper) attendees on Nov. 12 at 7 am ET and can be accessed on the SITC (Free SITC Whitepaper) virtual meeting site. All attendees will receive information on how to access the site after they have registered.

About NL-201
NL-201 is a de novo agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). Previously presented preclinical data has demonstrated the ability of NL-201 to stimulate and expand CD8+ and NK cells at low doses with minimal impact on immunosuppressive regulatory T cells. Furthermore, NL-201 has demonstrated both monotherapy and combination activity across a wide range of preclinical syngeneic tumor models.

On October 1, 2021 Immunetune, a preclinical-stage biotech developing next-generation DNA vaccines against cancer and infectious diseases, reported the upcoming presentation of data on its neoantigen DNA cancer vaccine platform at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2021 (Press release, ImmuneTune, OCT 1, 2021, View Source [SID1234590615]). The submitted abstract was selected for a poster presentation during the SITC (Free SITC Whitepaper) conference, taking place virtually and physically in Washington, D.C., from November 10 – 14, 2021.

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The selected abstract is titled "Personalized synthetic polyepitope DNA cancer vaccines encoding a novel pyroptotic adjuvant to generate effective anti-tumor T cell immunity". Abstracts can be accessed on the SITC (Free SITC Whitepaper) website once the conference begins on November 9; posters will be presented on November 12 and 13.

"It is an exciting opportunity to present our latest preclinical data at a leading international scientific and medical conference. Building upon our publication in the journal OncoImmunology in 2019, these data now include the combination of our synthetic, linear DNA cancer vaccine platform with a novel adjuvant that targets pyroptosis to elicit a potent T cell response against tumor-specific neoantigens," stated Jeroen van Bergen, CSO of Immunetune, and presenter of the poster at SITC (Free SITC Whitepaper).