Affimed Announces Acceptance of Three Abstracts with Preclinical Data on Its Innate Cell Engagers at the 36th Annual Meeting of the Society for Immunotherapy of Cancer

On October 1, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that three abstracts with preclinical data of its innate cell engagers have been accepted for poster presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), which will be held on November 10-14, 2021 (Press release, Affimed, OCT 1, 2021, View Source [SID1234590655]).

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Abstract details:
Title: Tetravalent, bispecific innate cell engager AFM24 enhances macrophage mediated tumor cell phagocytosis
Abstract ID: 880
Authors: Sheena Pinto, Susanne Wingert, Jens Pahl, Armin Beez, Sabrina Purr, Uwe Reusch, Arndt Schottelius and Joachim Koch

Title: Enhanced antibody-mediated phagocytosis and antibody-mediated cell cytotoxicity using tetravalent, bispecific innate cell engagers (ICE) in 3D spheroids
Abstract ID: 881
Authors: Sheena Pinto, Savannah Jackson, Julia Knoch, Christian Breunig, Arndt Schottelius and Joachim Koch

Title: The bispecific innate cell engagers AFM13 (CD30/CD16A) and AFM24 (EGFR/CD16A) increase the fraction of tumor target-responsive NK cells and boost serial killing
Abstract ID: 894
Authors: Chiara Zambarda, Karolin Guldevall, Christian Breunig, Damien Toullec, Jacopo Fontana, Sheena Pinto, Jens Pahl, Susanne Wingert, Joachim Koch and Björn Önfelt

The full abstracts will be released on November 9, 2021 at 8 a.m. EST.
For more details about the SITC (Free SITC Whitepaper) Virtual Annual Meeting please visit: View Source

Selecting Drugs with Patient’s Cancer Tissue is Future of Pancreatic Cancer Treatment

On October 1, 2021 Nagourney Cancer Institute reported that According to a presentation on September 30th by scientists from New South Wales Australia at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pancreatic Cancer, tumor samples removed from each patient hold the key to selecting the most effective cancer treatments (Press release, Nagourney Cancer Institute, OCT 1, 2021, View Source [SID1234590692]).

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The session entitled "The KPC model has helped advance pancreatic cancer therapy: Agree or disagree?" debated the role of mouse models for the development of cancer treatments and provided participants the opportunity to see the very real importance of human cancer tissue studies for drug selection.

"We are very pleased to see that the research community has come to appreciate the role of tumor tissue removed from each patient for the selection of chemotherapy drugs and combinations" said Dr. Robert Nagourney, who participated in the symposium and is director at the Nagourney Cancer Institute, where his group pioneered these human tumor tests over the past two decades.

With more than 10,000 human cancer studies to date, Dr. Nagourney has one of the largest databases in the world and has published extensively with results of clinical trials using these techniques in breast, ovarian, lung and other cancers. With a 2-fold improvement in clinical response reported and improved one-year survival in over 2500 published patient outcomes, the ex vivo analysis of programmed cell death (EVA/PCD) platform offers real hope for patients with advanced and hard to treat cancers like pancreatic.

"We have conducted over 200 pancreatic cancer patient studies and have improved the outcome for many patients who were deemed untreatable," said Nagourney. "One such patient recently rounded 11 years in remission after he presented with widely metastatic pancreatic cancer in April of 2009."

"Animal models and standard protocols can’t possibly provide those kinds of results in diseases like metastatic pancreatic cancer" he added.

Pancreatic cancer is the 3rd leading cause of cancer death in the United States with annual incidence that has risen dramatically in the past 2 decades. With only a 10% five-year survival, pancreatic cancer represents one of the greatest unmet needs in modern medical oncology.

Juntendo University and Astellas Establish "Direct Reprogramming Regenerative Medicine Course" for Scientific Breakthroughs

On October 1, 2021 Juntendo University (President: Hajime Arai, M.D., Ph.D.) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that the parties have established, inside Juntendo University Graduate School of Medicine, a joint research course entitled, "Direct Reprogramming Regenerative Medicine Course" (Professor & Director, Diagnostics and Therapeutics of Interactable Diseases, Intractable Disease Research Center, Genome Medical Center: Yasushi Okazaki M.D., Ph.D., Specially Appointed Professor: Masahito Matsumoto, Ph.D.) (Press release, Astellas, OCT 1, 2021, View Source [SID1234590612]). The course will be retained for a term of three years from October 2021.

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This joint research course aims to create a new modality that maximizes the therapeutic effect for diseases with high unmet medical needs, such as type 1 diabetes, by direct reprogramming using the K factor*1 . Itwill also conduct research to expand this modality to other diseases. Juntendo University Graduate School of Medicine will be acquiring the basic data including the study of the optimal combination of direct reprogramming factors that include the K factor, and Astellas will be conducting the applied research for disease treatment by gene therapy using this factor and selection of the optimal modality.

Direct reprogramming is a biology that directly converts the fate of cells without passing through the pluripotent state. The technology that enables direct reprogramming in vivo has attracted attention as a new regenerative medicine technology. Unlike conventional therapies, direct reprogramming not only removes unwanted cells or replenishes necessary cells; it also converts unnecessary cells into necessary cells. It is therefore expected to show high efficacy against intractable diseases that have been thought to be incurable.

Juntendo University and Astellas have been conducting joint research collaboration on the establishment of differentiation methods for therapeutic cells by direct reprogramming based on the agreement executed in 2018. This time, as part of this joint research collaboration, the two parties have established this joint research course to further strengthen the partnership and progressively conduct research on direct reprogramming as a new therapeutic paradigm.

Through this joint research course, Juntendo University and Astellas will take on the challenge of drug discovery based on direct reprogramming technology, with the aim of providing patients with new treatment options.

Entry into a Material Definitive Agreement

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").

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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.

Actinium Announces Two Abstracts Highlighting Combinations of CD47 Targeting Immunotherapy with Targeted Radiotherapies in Solid Tumors and Blood Cancers Accepted for Presentation at Society for Immunotherapy for Cancer (SITC) Conference

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:

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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.