On July 11, 2023 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported the completion and data maturity of its Phase 1 dose escalation study of CM24, a first-in-class anti-CEACAM1 monoclonal antibody addressing multiple tumor types (Press release, Purple Biotech, JUL 11, 2023, View Source [SID1234633173]).

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In the dose escalation part of the study, 11 refractory, pancreatic ductal adenocarcinoma (PDAC) patients whose cancer progressed following two lines of prior therapies were treated with CM24 at 10, 15 and 20mg/kg once every two weeks (q2w) and nivolumab at 480mg once every four weeks (q4w).

The investigational immunotherapy combination was well tolerated across all dose levels with no recorded Drug Limiting Toxicities (DLTs). Grade 3 adverse events were reported in 6 of the patients and none was considered related to the study drugs. No Grade 4 or deaths were reported.

Overall Survival (OS) data across all dose levels from this study with Purple’s chemo free CM24 in combination with nivolumab, demonstrated comparable OS rate in comparison to historical data of third line patients treated with chemotherapy, which demonstrate an OS median rate in a range of 3 to 4 months1.

Among the patients who demonstrated a response or disease control from the CM24 + nivolumab treatment, one third line patient has survived for 14.6 months. The patient had Microsatellite Stable (MSS) and PDL-1 IHC 2+ and 5% staining, features not expected to respond to immuno-oncology therapy.

Based on the study’s safety, tolerability, efficacy, pharmacokinetic and pharmacodynamic data, the recommended Phase 2 dose of CM24 in combination with nivolumab was determined to be 20mg/kg. We believe that these encouraging and confirmed final results provide additional support to the rationale for conducting the already initiated Phase 2 randomized study of CM24 in combination with nivolumab and standard of care chemotherapy vs. standard of care chemotherapy alone, in the second line PDAC setting. This randomized Phase 2 study (NCT04731467) is being conducted as part of Purple Biotech’s clinical collaboration with Bristol Myers Squibb.

"We are highly encouraged by these latest Phase 1 data and plan to provide further details from this study at an upcoming medical conference," said Isaac Israel, Purple Biotech’s Acting Chief Executive Officer. "As we continue the Phase 2, which is enrolling as planned across multiple sites in the U.S., Europe, and Israel, we expect to share initial Phase 2 data by the end of 2023 and topline results later in 2024."

Efficacy of the third-line chemotherapy in patients with advanced pancreatic cancer.

Bomi Kim, Jinwoo Ahn, Jae Hyup Jung, Kwangrok Jung, Jong-Chan Lee, Jin-Hyeok Hwang, and Jaihwan Kim, Journal of Clinical Oncology 2023 41:4_suppl, 711-711

On July 11, 2023 PharmaMar (MSE:PHM) reported that its licensing partner, Lotus Pharmaceutical CO., Ltd. (TWSE:1795), has received accelerated marketing approval for Zepzelca (lurbinectedin) by the Taiwan Food and Drug Administration (TFDA), for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy (Press release, PharmaMar, JUL 11, 2023, View Source [SID1234633172]). It had been more than 10 years since a drug had been approved in Taiwan for this therapeutic indication.

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This new approval of lurbinectedin is based on the data from the open-label, multi-center, single-arm monotherapy clinical trial in 105 adult patients with relapsed SCLC (including patients with platinum-sensitive and platinum-resistant disease), that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the US.

In November 2021, PharmaMar and Lotus Pharmaceutical signed a licensing agreement for lurbinectedin in Taiwan. Under the terms of the agreement PharmaMar will retain production rights and will sell the product to Lotus for its clinical and commercial use, while Lotus will pursue the marketing approval in Taiwan and have the right to market the compound exclusively.

The approval is subject to confirmation with a Phase III clinical trial. With this approval in Taiwan, lurbinectedin is now approved in 12 countries around the world.

About 15% of all lung cancers are Small Cell Lung Cancer (SCLC). This type of lung cancer tends to grow and spread faster than Non Small Cell Lung Cancer. In most people with SCLC, the cancer has already spread beyond the lungs at the time it is diagnosed.

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.

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.

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.