On October 1, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies for patients with unmet needs, reported that two abstracts featuring targeted radiotherapies in combination with CD47 antibody immunotherapy for solid tumor and hematologic indications have been accepted for presentation at the 36th Annual Meeting of the Society for Immunotherapy for Cancer (SITC 2021) (Press release, Actinium Pharmaceuticals, OCT 1, 2021, View Source [SID1234590656]). Actinium’s abstract titles and presentation logistics are as follows:

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Title: Enhancement of the anti-tumor effects of CD47 blockade in solid tumors by combination with targeted radioimmunotherapy

Poster Number: 589

Location: Poster Hall

Dates and Times: 11/12/2021 – 11/14/2021, 7:00 am – 5:00 pm

Title: Anti-CD33 actinium-225 targeted radioimmunotherapy enhances the biologic activity of anti-CD47 antibody immunotherapy in preclinical models of acute myeloid leukemia

Poster Number: 590

Location: Poster Hall

Dates and Times: 11/12/2021 – 11/14/2021, 7:00 am – 5:00 pm

Sandesh Seth, Actinium’s Chairman and CEO, said, "We are excited to highlight our latest R&D efforts focused on combinations of actinium-225 based targeted radiotherapies with CD47 immunotherapies, which has emerged as one of the most active targets in immunotherapy drug development of late, in solid tumors and blood cancers. We are thrilled that our abstracts, which are a product of our enhanced R&D capabilities, have been accepted at SITC (Free SITC Whitepaper). This body of work stemmed from our AWE technology platform, R&D capabilities in immuno-oncology and new laboratory facilities. We’ve highlighted our intention to move into solid tumor indications and immunotherapy combinations outside of the solid tumor work we are doing with our partner Astellas, so it is incredibly exciting to unveil our first initiatives in these areas at SITC (Free SITC Whitepaper). We look forward to presenting data from our work at the conference and continuing to be at the front lines of targeted radiotherapy development leveraging our deep technical knowledge, supply chain and clinical capabilities."

SITC is being held November 10 – 14, 2021 at the Walter E. Washington Convention Center in Washington, D.C. The full posters will be made available on the presentations page of Actinium’s website after the embargo is lifted at 8 AM ET on November 9, 2021.

On October 1, 2021 BioNTech SE (BNTX) reported the first colorectal cancer patient has been treated with its individualized mRNA cancer vaccine BNT122 (autogene cevumeran, RO7198457) in a phase 2 trial (Press release, BioNTech, OCT 1, 2021, View Source [SID1234590695]). It is planned to enroll about 200 patients to evaluate the efficacy of BNT122 compared to watchful waiting after surgery and chemotherapy. The trial has been initiated in the United States, Germany, Spain and Belgium.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Özlem Türeci, Chief Medical Officer of BioNTech, said: "Many cancers progress in such a way that the patient initially appears tumor-free after surgery, but after some time tumor foci that were initially invisible grow and form metastases. In this clinical trial in patients with colorectal cancer, we aim to identify high-risk patients with a blood test and investigate whether an individualized mRNA vaccine can prevent such relapses."

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).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"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.