PDS Biotech Strengthens Intellectual Property Portfolio Governing A Combination of Versamune® and PDS0301

On July 11, 2023 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported the Canadian Intellectual Property Office has allowed patent number 2,876,656 titled, "Cationic Lipid Vaccine Combinations and Methods of Use," governing composition of matter and uses for Versamune (R-DOTAP) in combination with PDS0301 (Press release, PDS Biotechnology, JUL 11, 2023, View Source [SID1234633170]). The intellectual property provides broad protection for treatments utilizing Versamune based therapies, including PDS0101, in combination with PDS0301 as a potential treatment for cancer. This patent expands PDS Biotech’s market coverage and adds to the world-wide patent portfolio including the patent granted by the United States Patent and Trademark Office (USPTO), U.S. Patent No. 11,401,306, covering the combination of Versamune and cytokines including Interleukin 12 (IL-12).

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The Canadian patent will protect the capability of the composition of Versamune and PDS0301 to reduce the population of a well-documented population of cells called myeloid derived suppressor cells (MDSC) that enable the cancer to escape attack by T cells. The composition, when administered with a tumor antigen, enhances the Versamune induced anti-tumor response. Suppression of anti-tumor immune responses is a major mechanism by which tumor cells escape attack by T cells. MDSCs are reported to be the key immunosuppressive cells present in the tumor that protect the cancer’s ability to grow and are a major obstacle to effective cancer immunotherapy.

"This newly allowed patent adds to the intellectual property governing Versamune based therapies in combination with PDS0301, which we believe represent a potentially transformative treatment approach for advanced cancer patients," said Dr. Frank Bedu-Addo, CEO of PDS Biotech. "Possessing multilayered IP for our immunotherapies is an important value driver for PDS Biotech and is a key component of our business strategy. We anticipate that Canada will constitute an important market as we begin our commercialization and partnership strategies."

In December 2022, PDS Biotech provided an update on the National Cancer Institute led study of a combination of PDS0101, PDS0301 and an immune checkpoint inhibitor (ICI) in patients with various types of human papillomavirus (HPV) 16-positive cancers who had failed all prior treatments including ICI therapy. These patients have a historical median overall survival (OS) of 3-4 months on ICI therapy. This combination achieved a median overall survival of 21 months reported in 29 patients. In the patients who had not received prior ICI therapy, median OS had not yet been reached at 27 months, and an objective response rate of 88% (7/8) and complete response in 38% (3/8) of patients was reported. In similar ICI naïve patients on a combination of ICI therapy and chemotherapy, the published median OS is approximately 13 months and objective response is approximately 35%. Similar results with the combination of PDS0101, PDS0301 and an ICI were seen in all types of HPV-positive advanced cancers including anal, cervical, head and neck, vaginal and vulvar.

PDS Biotech’s exclusive rights to the combination of PDS0101 and PDS0301 permits it to design compositions and methods that overcome tumor immune suppression utilizing a different mechanism from checkpoint inhibitors.

About Versamune
Versamune is a novel investigational T cell activating platform which effectively stimulates a precise immune system response to a cancer-specific protein. Versamune based investigational immunotherapies promote a potent targeted T cell attack against cancers expressing the protein. They are given by subcutaneous injection and can be combined with standard of care treatments. Clinical data suggest that Versamune based investigational immunotherapies, such as PDS0101, demonstrate meaningful disease control by reducing and shrinking tumors, delaying disease progression and/or prolonging survival. Versamune based immunotherapies have demonstrated minimal toxicity to date that may allow them to be safely combined with other treatments. We believe Versamune based investigational immunotherapies represent a transformative treatment approach for cancer patients to provide improved efficacy, safety and tolerability.

About PDS0101
PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically effective immune responses and the combination of PDS0101with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression, and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About PDS0301
PDS0301 is a novel investigational tumor-targeting antibody-conjugated Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. PDS0301 is given by a subcutaneous injection. PDS0301 is designed to improve the safety profile of IL-12 and to enhance the anti-tumor response.

Neurocrine Biosciences Announces Conference Call and Webcast of Second Quarter 2023 Financial Results

On July 11, 2023 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it has scheduled its second quarter 2023 financial results conference call and webcast for 5:00 a.m. Pacific Time (8:00 a.m. Eastern Time) on August 1, 2023 (Press release, Neurocrine Biosciences, JUL 11, 2023, View Source [SID1234633169]).

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The schedule for the press release and conference call / webcast is as follows:

• Q2 2023 Press Release:

August 1, 2023 at 4:00 a.m. PT / 7:00 a.m. ET

• Q2 2023 Conference Call:

August 1, 2023 at 5:00 a.m. PT / 8:00 a.m. ET

• Domestic Dial-In Number:

800-895-3361

• International Dial-In Number:

785-424-1062

• Conference ID:

NBIX

The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

Termination of a Material Definitive Agreement

As previously disclosed, on May 17, 2023, Mustang Bio, Inc. (the "Company") reported to have terminated the Amended and Restated Exclusive License Agreement (the "PSCA Technology License"), dated as of August 13, 2021, by and between the Company and City of Hope ("COH") as a result of its determination to discontinue development of its MB-105 (PSCA) program (Filing, 8-K, Mustang Bio, JUL 11, 2023, View Source [SID1234633167]). In connection with the discontinuation of the Company’s MB-105 (PSCA) program and the termination of the PSCA Technology License, on July 10, 2023, the Company terminated the Exclusive License Agreement, dated as of March 17, 2017, by and between the Company and the Regents of the University of California (the "UCLA License Agreement"). Under the UCLA License Agreement, the Company received an exclusive license for the use of prostate stem cell antigen ("PSCA") chimeric antigen receptor ("CAR") engineered T cell ("CAR T") technology, which is being applied in the treatment of prostate cancer, pancreatic cancer and other solid tumors.

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The Company will not incur any early termination penalties in connection with the termination of the UCLA License Agreement. The termination of the UCLA License Agreement is effective 30 days from the date of the notice of termination. The foregoing summary is qualified in its entirety by reference to the UCLA License Agreement, filed as an Exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2017, filed with the Securities and Exchange Commission on August 14, 2017.

Monopar Announces MNPR-101 Radiopharma Collaboration Agreement with National University of Singapore

On July 11, 2023 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer, reported a collaboration with the Cancer Science Institute of Singapore (CSI Singapore) at the National University of Singapore (NUS) to evaluate radiopharmaceutical versions of MNPR-101 in several aggressive cancers (Press release, Monopar Therapeutics, JUL 11, 2023, View Source [SID1234633165]). MNPR-101 is a novel, first-in-class humanized monoclonal antibody to the urokinase Plasminogen Activator Receptor (uPAR).

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Dr. Anand Jeyasekharan, MBBS MRCP (UK) PhD, of CSI Singapore, NUS, will be the Principal Investigator on the collaboration. Dr. Jeyasekharan is a physician-scientist who runs a research laboratory investigating the molecular and biological responses of cancer cells to oncology drugs, as well as treats cancer patients and leads early phase oncology clinical trials at NUS.

In this collaboration, Dr. Jeyasekharan will initially investigate uPAR expression levels in tissue samples from patients with various subtypes of advanced soft tissue sarcoma (ASTS). Studies have shown uPAR to be a promising target for ASTS, which is a cancer Dr. Jeyasekharan specializes in treating. He plans to assess retrospective patient samples to identify which subtypes of ASTS have the highest expression of uPAR, thus making them the most promising to pursue in a human clinical trial.

"uPAR is an exciting target for ASTS, and a radiopharmaceutical approach using MNPR-101 has the potential to combine personalized medicine with precision oncology," said Dr. Jeyasekharan. "We have the chance here to use immunohistochemistry on patient tissue samples to identify high uPAR expressing cancers, to then work with our colleagues in radiology and nuclear medicine to radiolabel MNPR-101 for a subsequent clinical imaging study. For patients with positive scans, a therapeutic isotope such as Lu-177 or Ac-225 may provide an interesting option for a clinical trial."

"It is exciting what Dr. Jeyasekharan and NUS are aiming to do here," said Chandler Robinson, MD, CEO of Monopar. "They are seeing if we can select patients most likely to respond at the time of tissue biopsy. And from there, if you can see it on PET/SPECT imaging with a radiopharmaceutical version of MNPR-101, you can treat it. Dr. Jeyasekharan is uniquely equipped to undertake this endeavor, too, as he can oversee both the preclinical work as well as the overall management of patients under standard Phase 1 protocols."

First Patient Dosed in SAR’514 / IPH6401 Phase 1/2 Clinical Trial in Relapsed/Refractory Multiple Myeloma

On July 11, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that the first patient was dosed in a Sanofi-sponsored Phase 1/2 clinical trial (NCT05839626), evaluating SAR’514 / IPH6401 in relapsed/refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA) (Press release, Innate Pharma, JUL 11, 2023, View Source [SID1234633164]).

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SAR’514 is a trifunctional anti-BCMA NKp46xCD16 NK cell engager, using Sanofi’s proprietary CROSSODILE multi-functional platform, which comprises the Cross-Over-Dual-Variable-Domain (CODV) format. It induces a dual targeting of the NK activating receptors, NKp46 and CD16, for an optimized NK cell activation, based on Innate’s ANKET (Antibody-based NK cell Engager Therapeutics) proprietary platform.

The purpose of the dose escalation and dose expansion study is to evaluate the safety, pharmacokinetics and preliminary efficacy of SAR’514 in monotherapy in patients with RRMM and RRLCA.

Joyson Karakunnel, MD, MSc, FACP, Chief Medical Officer at Innate Pharma "We are pleased to see a second molecule from our ANKET platform reaching the clinic. In addition to the targeting of the tumor antigen BCMA, SAR’514 / IPH6401 co-engages the two activating receptors NKp46 and CD16 to leverage the advantages of harnessing NK cell effector functions against cancer cells and thus has the potential to be a new innovative option for patients living with Relapsed/Refractory Multiple Myeloma or Light-chain Amyloidosis."

Peter Adamson, MD, Global Development Head, Oncology, Sanofi "We are excited to see our collaboration with Innate Pharma continue to move forward, leveraging scientific advances in our understanding of the potential of NK cells to impact cancer. Our first patient dosed with SAR’514 / IPH6401 is indeed welcome news. We look forward to data as it emerges, with the goal of improving the outcome for patients with relapsed/refractory multiple myeloma (RRMM) or relapsed/refractory light-chain amyloidosis (RRLCA)."

The start of the trial has triggered a milestone payment from Sanofi to Innate, which is part of a previously announced research collaboration with Sanofi.

More information about the Phase 1/2 trial can be found on clinicaltrials.gov.

About ANKET

ANKET (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer.

This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.