On April 27, 2022 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that four abstracts with clinical trial designs and clinical data of its innate cell engagers (ICE) have been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 3-7, 2022 in Chicago, IL (Press release, Affimed, APR 27, 2022, View Source [SID1234613158]).

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The events include an oral presentation by Yago Nieto, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center with an update of the study that evaluates AFM13 pre-complexed with NK cells in patients with relapsed/refractory CD30-positive lymphomas. In addition, three "Trial in Progress" posters will be presented to provide background information and introduce the study design of the three ongoing AFM24 studies in which patients with EGFR-positive solid tumors are treated with AFM24 monotherapy or combinations with either Roche’s checkpoint inhibitor atezolizumab or NKGen Biotech’s NK cell product SNK01.

Oral presentation details:
Title: Innate cell engager (ICE) AFM13 combined with preactivated and expanded cord blood (CB)-derived NK cells for patients with refractory/relapsed CD30+ lymphoma
Authors: Yago Nieto, Pinaki Banerjee, Indreshpal Kaur, Roland Bassett, Lucila Kerbauy, Rafet Basar, Mecit Kaplan, Lori Griffin, Daniel Esqueda, Christina Ganesh, Melissa Barnett, Amin Alousi, Chitra Hosing, Jeremy Ramdial, Neeraj Saini, Samer Srour, Sairah Ahmed, Swaminathan Iyer, Hun Lee, Ranjit Nair, Raphael Steiner, Karenza Alexis, Andreas Harstrick, Elizabeth J Shpall, Katayoun Rezvani
Oral session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia, Friday, June 3, 2022, 1:00 – 4.00 p.m. CDT

Poster details:
Title: A phase 1/2a open label, multicenter study to assess the safety, tolerability, pharmacokinetics, and efficacy of AFM24 in patients with advanced solid cancers: Study design and rationale.
Authors: Omar Saavedra Santa Gadea, Elena Garralda, Juanita Suzanne Lopez, Mark M. Awad, Jacob Stephen Thomas, Crescens Diane Tiu, Daniela Morales-Espinosa, Christa Raab, Bettina Rehbein, Gabriele Hintzen, Kerstin Pietzko, Paulien Ravenstijn, Michael Emig, Anthony B. El-Khoueiry

Poster details:
Title: AFM24 in combination with atezolizumab in patients with advanced EGFR-expressing solid tumors: Phase 1/2a study design and rationale.
Authors: Omar Saavedra Santa Gadea, Eric Christenson, Anthony B. El-Khoueiry, Andres Cervantes, Christa Raab, Ulrike Gaertner, Kerstin Pietzko, Gabriele Hintzen, Paulien Ravenstijn, Daniela Morales-Espinosa, Juanita Suzanne Lopez

Poster details:
Title: The combination of CD16A/EGFR innate cell engager, AFM24, with SNK01 autologous natural killer cells in patients with advanced solid tumors.
Authors: Anthony B. El-Khoueiry, Paul Y. Song, Jennifer Rubel, Dorna Y. Pourang, Christa Raab, Gabriele Hintzen, Michael Emig, Pilar Nava-Parada

Poster session for all posters: Developmental Therapeutics – Immunotherapy, Sunday, June 5, 2022, 8:00 – 11:00 a.m. CDT

Abstract release: The full abstracts will become public at 5:00 p.m. EDT on Friday, May 26.

More details about the programs for the ASCO (Free ASCO Whitepaper) Annual Meetings are available online at www.asco.org

About AFM13
AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimed’s most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT, NCT04101331). In addition, The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-sponsored phase 1/2 trial in combination with cord blood-derived allogeneic NK cells in patients with relapsed/refractory CD30-positive lymphomas (NCT04074746).

About AFM24
AFM24 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
Affimed is evaluating AFM24 in patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies as monotherapy and in combinations with other cancer treatments. AFM24-101, a monotherapy, first-in-human phase 1/2a open-label, is a non-randomized, multi-center, multiple ascending dose escalation and expansion study. Additional details may be found at www.clinicaltrials.gov using the identifier NCT04259450. Furthermore, AFM24 is being evaluated in a phase 1/2a study in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab (AFM24-102, NCT05109442). Affimed and NKGen Biotech have initiated a phase 1/2a study (AFM24-103), investigating AFM24 in combination with SNK01, NKGen Biotech’s NK cell product (NCT05099549).

On April 27, 2022 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies for the treatment of hard to treat cancers, reported that it has entered into exclusive license and sublicense agreements with CLS Therapeutics ("CLS") to develop its interventional DNase based oncology platform, which is aimed at improving outcomes of existing treatments, including immunotherapies (Press release, Xenetic Biosciences, APR 27, 2022, View Source [SID1234613017]). Xenetic will host a conference call and webcast, today, April 27, 2022, at 8:30 a.m. ET (details below).

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Xenetic Biosciences, Inc., Tuesday, April 26, 2022, Press release picture
Under the terms of the agreements, Xenetic has an exclusive license to CLS’ intellectual property, for uses of DNases in cancer, including systemic co-administration of DNases along with standard therapies, including chemotherapy, radiation and checkpoint inhibitors, or along with conventional chimeric antigen receptor (CAR) T therapies. In addition, the licenses cover "DNase-armored" CAR T therapies in which novel CAR T products are engineered to secrete DNases into the tumor microenvironment to potentially improve T-cell infiltration, activity and persistence. As part of the agreements, Xenetic will make an upfront payment of $500,000 in cash and issue 875,000 shares of common stock, and will make future payments based on the achievement of certain clinical and regulatory milestones of up to $13 million per program, as well as issue up to an additional 950,000 shares of common stock based on the achievement of certain milestones. Additionally, Xenetic will pay tiered royalty payments ranging from mid-single to low-double digits on any potential future sales, as well as a percentage share of certain consideration received by Xenetic from sublicensees.

The licensed DNase platform is designed to target Neutrophil Extracellular Traps ("NETs"), which are weblike structures composed of extracellular chromatin coated with histones and other proteins. NETs are expelled by activated neutrophils, in response to microbial or pro-inflammatory challenges. However, excessive production or reduced clearance of NETs can lead to aggravated inflammatory and autoimmune pathologies, as well as creation of pro-tumorigenic niches in the case of cancer growth and metastasis.

A substantial amount of scientific literature has implicated NETs in the context of cancer pathogenesis and resistance to cancer therapies (including chemo, radio, and immunotherapies such as checkpoint inhibitors and cell therapies). In published reports, elevated levels of NETs have been a biomarker associated with poor prognosis in patients with a variety of cancers.

In addition, resistance to existing therapeutic agents can involve the release of immunosuppressive signaling factors from NETs, or physical barriers created by NETs which can impede the infiltration, activity, and survival of cytotoxic T cells in the tumor microenvironment.

Published pre-clinical models have demonstrated the effectiveness of systemically administered DNase, alone or in combination with other agents, for the elimination of NETs and prevention of tumor growth and metastasis.

"We are excited to in-license this oncology platform. Based on the compelling pre-clinical efficacy data seen to date, we believe the DNase-based oncology platform has the potential to improve the outcomes of chemotherapy and immunotherapy treatments in multiple solid tumor indications," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "This transaction provides Xenetic with near term opportunities for value-driving milestones, and an anticipated timeline to clinic that now positions us as an emerging clinical-stage company. This gives us the confidence to focus our capital and human resources on advancing the DNase pipeline. Our primary efforts are now aimed at advancing the systemic DNase program into the clinic as an adjunctive therapy for locally advanced or metastatic cancers. Our goal is to provide solutions in the treatment of solid tumors by improving response and overcoming resistance to checkpoint inhibitors or chemotherapy. Ultimately, we expect these programs to drive value for shareholders in the near and long term."

Adoptive transfer of CAR T cells has emerged as one of the most promising advances in cancer immunotherapy. Engineered CAR T cells, designed to recognize cancer-associated antigens, are capable of sustained and selective killing of tumor cells, with substantial reduction of tumor burden. CAR T therapies have exhibited remarkable clinical success against hematological malignancies but thus far have failed to demonstrate success in the context of solid tumors. Published evidence suggests that in addition to immunosuppressive factors, mechanical barriers formed by NETs can impede T-cell penetration and occlude T-cell contact with tumor cells.

"To successfully treat solid tumors, CAR T cells must be able to infiltrate, persist, and maintain anti-tumor function in a hostile tumor microenvironment that is itself adept at immunosuppression and conducive to tumor cell survival. Recent approaches to CAR T design include "armored" CAR-T cells, so named because they can express additional factors to resist immunosuppression or degrade physical components of the tumor’s extracellular matrix, including NETs. We intend to conduct pre-clinical research with the goal of demonstrating that armoring CAR T cells to secrete DNase can support depth and durability of response against solid tumor indications," said Curtis Lockshin, Chief Scientific Officer of Xenetic.

Conference Call and Webcast

Xenetic management will host a conference call and webcast presentation for investors, analysts, and other interested parties to discuss the in-licensing today, April 27, 2022, at 8:30 AM ET.

Interested participants and investors may access the conference call by dialing (877) 407-9708 (domestic) or (201) 689-8259 (international). The live webcast will be accessible on the Events page of the Investors section of the Xenetic website, xeneticbio.com, and will be archived for 90 days.

On April 27, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T-cell activating technologies, reported the titles of two abstracts accepted for poster presentations during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held from June 3-7, 2022 (Press release, PDS Biotechnology, APR 27, 2022, View Source [SID1234613035]).

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Abstract # 6041 poster presentation summarizes updates to the preliminary efficacy and safety data from the PDS Biotechnology sponsored VERSATILE-002 Phase 2 clinical trial, which is studying PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer. This trial is designed to treat both checkpoint inhibitor (CPI) naïve and refractory patients. PDS Biotech previously announced that the trial had achieved its preliminary efficacy milestone in the CPI naive arm earlier this year and presented detailed preliminary safety data at the 2022 Multidisciplinary Head and Neck Cancers Symposium.

Abstract Number: 6041
Abstract Title: PDS0101 a novel type 1 interferon and CD8+ T-cell activating immunotherapy in combination with pembrolizumab in subjects with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC)
Presenting Author: Jared Weiss, M.D., Section Chief of Thoracic and Head and Neck Oncology at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, who serves as the Lead Principal Investigator for VERSATILE-002
Session Title: Head and Neck Cancer
Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT

Abstract # 2518 poster discussion presentation summarizes findings from the ongoing National Cancer Institute (NCI)-led Phase 2 clinical trial, which studies PDS0101 in combination with two investigational immune-modulating agents. This news follows the achievement of the enrollment objective of 30 patients in the CPI refractory arm announced in March. The NCI will continue to enroll both CPI refractory and naive patients until the 56-patient enrollment objective is achieved.

Confidential
Abstract Number: 2518
Abstract Title: Phase II evaluation of the combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16+ malignancies.
Presenting Author: James Gulley, Ph.D., National Cancer Institute
Session Title: Poster discussion Session / Developmental Therapeutics —Immunotherapy
Session Date and Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM; 11:30 AM-1:00 PM CDT

For patients interested in enrolling in the NCI-led clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email [email protected], and/or visit the website: View Source

The abstracts will be available on Thursday, May 26, 2022 at 5:00 PM EDT on ASCO (Free ASCO Whitepaper).org.

"We are excited about the opportunity to provide updates on two of our PDS0101 clinical programs at this year’s ASCO (Free ASCO Whitepaper) annual meeting," commented Dr. Lauren V. Wood, M.D., Chief Medical Officer at PDS Biotech. "ASCO offers PDS Biotech a unique opportunity to update the scientific community on our ongoing Phase 2 trials and the potential of the Versamune platform in immuno-oncology."

KEYTRUDA is a registered trademark of Merck Sharp and Dohme Corp. a subsidiary of Meck & Co., Inc. Kenilworth, NJ USA.

On April 27, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, reported updated one-year post-transplant data presented on omidubicel at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings (TCT), being held in Salt Lake City, UT, April 23-26, 2022 (Press release, Gamida Cell, APR 27, 2022, View Source [SID1234613068]).

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In an oral presentation titled "Allogeneic Hematopoietic Stem Cell (allo-HSCT) Transplant with Omidubicel Demonstrates Sustained Clinical Improvement Versus Standard Myeloablative Umbilical Cord Blood Transplantation (UCBT): Final Results of a Phase III Randomized, Multicenter Study," Mitchell Horwitz, M.D., Professor of Medicine, Duke Cancer Institute, shared one-year post-transplant follow up data from the omidubicel Phase 3 trial. The data showed sustained clinical benefits in the first-year post-transplant with omidubicel, as demonstrated by significant reduction in infectious complications. Results also showed reduction in non-relapse mortality and no significant increase in relapse rates with omidubicel, compared to UCBT (23% vs. 18%). It was concluded that HSCT with omidubicel results in rapid hematopoietic recovery, reduced rates of infections and no increase in GvHD rates compared with standard UCB. There was a continued trend toward improved OS in favor of the omidubicel arm over time (73% vs. 60%). The overall and sustained clinical benefit of omidubicel makes it an important addition to the options for allogeneic HSCT.

"In allo-HSCT, early engraftment and lower infections are the key predictors of long-term success for patients," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell, "We are encouraged by the continuous positive and sustained results from patients involved in the Phase 3 trial of omidubicel, now one-year out from treatment. These results provide promising rationale that omidubicel could become a compelling treatment option for patients in need of an allo-HSCT transplant."

Gamida Cell initiated a rolling Biologics License Application (BLA) submission for omidubicel in the first quarter of 2022 and is on-track to complete submission of all modules of the BLA in the second quarter of 2022.

In total, Gamida Cell is presenting two oral and six poster presentations at TCT 2022, including an oral presentation that was selected as a TCT Best Abstract. All poster presentations are publicly available at www.ASTCT.org.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status and orphan drug designation by the FDA. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). For more information on clinical trials of omidubicel, please visit the Gamida Cell website.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About NAM Technology

Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we are able to enhance, expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. This allows us to administer a therapeutic dose of cells that may help cancer patients live longer better lives.

On April 27, 2022 DURECT Corporation (Nasdaq: DRRX) reported that it will report its first quarter 2022 financial results and host a conference call after the market close on Wednesday, May 4, 2022 (Press release, DURECT, APR 27, 2022, https://investors.durect.com/news-releases/news-release-details/durect-corporation-announce-first-quarter-2022-financial-results [SID1234613159]).

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