On October 1, 2021, Cue Biopharma, Inc., a Delaware corporation (the "Company"), reported that it entered into an Open Market Sale Agreement (the "Sales Agreement") with Jefferies LLC, as agent (the "Agent"), pursuant to which the Company may offer and sell shares of its common stock, $0.001 par value per share, having an aggregate offering price of up to $80,000,000 (the "Shares") from time to time through the Agent (the "Offering") (Filing, 8-K, Cue Biopharma, OCT 1, 2021, View Source [SID1234590633]). The Company is filing a prospectus supplement with the Securities and Exchange Commission (the "SEC") in connection with the Offering (the "Prospectus Supplement") under the Company’s existing shelf Registration Statement on Form S-3 (File No. 333-239357), as amended by Post-Effective Amendment No. 3, which became effective on May 21, 2021 (the "Registration Statement").

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!

Upon delivery of a placement notice to the Agent and subject to the terms and conditions of the Sales Agreement, the Agent may sell the Shares by any method that is deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including sales made directly on or through the Nasdaq Capital Market or on any other existing trading market for the Company’s common stock.

The Company or the Agent may suspend or terminate the offering of Shares upon notice to the other party, subject to certain conditions. The Agent will act as sales agent on a commercially reasonable efforts basis consistent with its normal sales and trading practices.

The Company has agreed to pay the Agent commissions for its services of acting as agent of 3.0% of the gross proceeds from the sale of the Shares pursuant to the Sales Agreement. The Company has also agreed to provide the Agent with customary indemnification and contribution rights.

A copy of the Sales Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the material terms of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to such exhibit.

Wilmer Cutler Pickering Hale and Dorr LLP, counsel to the Company, has issued a legal opinion relating to the Shares. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

The Shares will be sold pursuant to the Registration Statement, and offerings of the Shares will be made only by means of the Prospectus Supplement. This Current Report on Form 8-K shall not constitute an offer to sell or solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such state or jurisdiction.

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 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]).

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!

"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).

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