On January 12, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune T-cell activating technology, reported that it has been granted U.S Patent Application No. 15,724,818 titled "Novel HPV16 Non HLA-Restricted T-cell Vaccines, Composition and Methods of Use Thereof" by the United States Patent and Trademark Office (USPTO) (Press release, PDS Biotechnology, JAN 12, 2022, View Source [SID1234598617]).

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The newly issued patent covers the PDS0101 immunotherapy which consists of a combination of the Versamune technology platform with a unique mixture of short protein fragments derived from the cancer-causing virus, HPV16. The composition promotes the induction of killer (CD8+) T-cells by the immune system that recognize, and attack cancers caused by infection with HPV16 irrespective of the patients’ genetic makeup.

HPV16 is the most oncogenic or cancer-causing type of HPV, and is by far the most prevalent in patients with advanced HPV-associated cancers, including anal, cervical, head and neck, penile, vaginal and vulvar cancers. More than 40,500 patients are diagnosed with HPV16-associated cancers each year according to the International Journal of Cancer. Some of these cancers have been reported to be increasing in incidence over the last few years.

"We remain excited about the promising early efficacy and safety data from our ongoing phase 2 clinical trials. The early clinical data coupled with the recent grant of the PDS0101 patent that runs into late 2037 puts PDS Biotech in a strong position to progress commercialization of the product to address a significant unmet need for more effective treatment of advanced HPV-associated cancers," stated Frank Bedu-Addo, Chief Executive Officer of PDS Biotech.

In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA in a Phase 2 study (NCT04260126) in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. PDS Biotech is also conducting a Phase 2 clinical study in both second- and third-line treatment of multiple advanced HPV-associated cancers with the National Cancer Institute (NCI). A third Phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center.

On January 12, 2022 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported promising new preclinical data regarding PTX-35 has been accepted for publication in the American Journal of Transplantation and is available at: View Source (Press release, Heat Biologics, JAN 12, 2022, View Source [SID1234598616]).

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Key Findings:

·A single dose of the preclinical version of PTX-35 (mPTX-35), was able to expand regulatory T cells (Tregs) and significantly improve disease and graft survival outcomes.
·Chemically induced pancreatic failure (a model for type-1 diabetes) could be partially reversed when mice were transplanted with beta-cell islet allografts and treated with mPTX-35.
·Disease protection in preclinical models was correlated with a significant expansion of Tregs and protection of the allograft, resulting in euglycemia and a graft survival benefit.
·Long-term surviving grafts showed a marked increase in Treg infiltration which directly correlated with mPTX-35 agonist activity.

PTX-35 is a novel, potential first-in-class antibody immunomodulator of TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells and can be manipulated to expand regulatory T-cell subsets. PTX-35 is the Company’s first antibody-based product, currently in a Phase 1 clinical trial for the treatment of patients with solid tumors.

Dr. James Shapiro, Professor in the Department of Surgery and Clinical Islet Transplant Program at the University of Alberta, Edmonton, Canada, commented, "The study demonstrated that a single dose of PTX-35 enabled prolonged graft survival in a mouse model of pancreatic islet allotransplantation. Additionally, PTX-35 could contribute to achieving lasting immunological tolerance in organ transplantation."

Jeff Wolf, Chief Executive Officer of Heat, commented, "We are very encouraged by these results showing pronounced Treg expansion and significantly prolonged graft survival compared to control. PTX-35 has the potential to modulate immunological responses and may facilitate minimization of post-transplant immunosuppression, which supports further clinical evaluation in the context of inflammatory disease. Similar preclinical results have also been previously demonstrated for bone marrow, corneal and cardiac transplantation using these and other TNFRSF25 agonists."

Mr. Wolf further noted, "We are also making significant progress with HS-110 and expect to file for an End of Phase 2 meeting with the FDA this quarter. Our goal for this meeting is to discuss potential Phase 3 registration pathways for HS-110. Although this submission is taking longer than expected, we believe we have prepared a very comprehensive package and look forward to the FDA’s feedback."

On January 12, 2022 Denovicon reported to be participating in BIO Partnering at JPM 2022 (Press release, Denovicon Therapeutics, JAN 12, 2022, View Source [SID1234598615]). Reach out to us there, if you’re interested in learning more about our AI/machine learning/molecular modeling platform and current molecular assets.

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On January 12, 2022 Apollomics Inc. an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, reported that the management team will host two upcoming webcasts to accommodate participants from the U.S. and China (Press release, Apollomics, JAN 12, 2022, View Source [SID1234598613]). Co-Founder, Chairman and Chief Executive Officer, Guo-Liang Yu, PhD, will be joined by Sanjeev Redkar, PhD, Co-Founder and President, K. Peony Yu, M.D., Chief Medical Officer, and Wilson W. Cheung, CPA, Chief Financial Officer, to provide a strategic overview and an update on the Company’s pipeline programs.

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Session Dates/Times:

Session U.S. Pacific U.S. Eastern China Europe
English January 26th
11:00 a.m.

January 26th
2:00 p.m.

January 27th
3:00 a.m.

January 26th
8:00 p.m.

Chinese January 26th
7:00 p.m.

January 26th 10:00 p.m. January 27th 11:00 a.m. January 27th 4:00 a.m.
All are invited to listen to the event and view the presentation via webcast on the Apollomics website under the News/Events section: Events and Presentations. An archive of the webcast will be available for three months.

On January 11, 2022 Allogene Therapeutics, Inc., a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and Antion Biosciences, a Swiss cell and gene engineering company, reported that they have entered into an exclusive collaboration and global license agreement for Antion’s miRNA technology (miCAR) to advance multiplex gene silencing as an additional tool to develop next generation allogeneic CAR T products (Press release, Antion Biosciences, JAN 11, 2022, View Source [SID1234629137]).

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Antion is an early-stage research company with foundational miRNA technology. In preclinical studies, Antion has demonstrated proof-of-concept for multiplex gene silencing in an allogeneic CAR T cell model. These studies demonstrated the ability of miCARTM technology to silence multiple gene targets in a single step and indicate this technology has broad application within cell and gene engineering. Allogene plans to deploy miCARTM with other technologies to develop next-generation strategies for immune evasion and other advances in allogeneic CAR T therapy.

"We believe that Antion has one of the few technology options capable of delivering multiplex gene silencing with a high degree of specificity and potency," said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "We are excited to be working with Antion to explore how their miCAR technology may advance and accelerate Allogene’s research efforts aimed at creating best in class allogeneic cell therapies."

As part of this agreement, Antion will exclusively collaborate with Allogene on oncology products for a defined period. Allogene will also have exclusive worldwide rights to commercialize products incorporating Antion technology developed during the collaboration. Allogene will provide Antion an upfront cash payment and a preferred equity investment. Allogene will pay Antion developmental and commercial milestones and a single-digit royalty on any product sales. Allogene will also take a seat on Antion’s Board of Directors.

"This collaboration represents an exciting validation of the power and flexibility of our miCAR platform." said Sven Kili, M.D., Chief Executive Officer. "We are extremely enthusiastic to be working with Allogene, as the world leader in Allogeneic CAR T therapies to bring next-generation life changing therapies to patients"