On July 6, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported a clinical collaboration with Novartis to evaluate the combination of tipifarnib and alpelisib in patients with head and neck squamous cell carcinoma (HNSCC) whose tumors have HRAS overexpression or PIK3CA mutation and/or amplification. Tipifarnib is Kura’s farnesyl transferase inhibitor drug candidate currently in a registration-directed trial as a monotherapy in patients with HRAS mutant HNSCC. Novartis’ alpelisib is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against the PI3Kα isoform.

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"Our preclinical data suggest that HRAS and PI3Kα are co-dependent pathways involved in the development and maintenance of HNSCC in certain patient populations. Combining tipifarnib with alpelisib has the potential to provide a clinically meaningful increase in anti-tumor activity compared to when inhibiting either pathway alone," said Stephen Dale, M.D., Chief Medical Officer of Kura Oncology. "We believe this clinical collaboration will enable us to potentially expand the use of tipifarnib to a significantly higher percentage of patients with advanced HNSCC. We look forward to initiating the combination trial in the second half of 2021."

The Phase 1/2 KURRENT trial is a biomarker-defined cohort study designed to evaluate the safety, determine the recommended combination dosing and assess early anti-tumor activity of tipifarnib and alpelisib for the treatment of HNSCC patients whose tumors are dependent on HRAS and/or PI3Kα pathways, which is approximately 50% of HSNCC patients, according to The Cancer Genome Atlas (TCGA).

Under the collaboration, Kura maintains global development and commercial rights to tipifarnib.

About HNSCC

Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide, accounting for more than 500,000 new cases each year. Despite advances in immunotherapy, the prognosis for advanced HNSCC patients remains poor, with an estimated median overall survival of 13-15 months in patients when stratified by PD-L1 expression. Although the anti-epidermal growth factor receptor (EGFR) antibody, cetuximab, was approved more than a decade ago, development of biomarker-directed therapies in HNSCC has been stymied by the limited number of druggable targets in the genomic landscape and the challenge of managing drug refractory recurrent/metastatic HNSCC.

About Tipifarnib

Tipifarnib, is a potent, selective and orally bioavailable inhibitor of farnesyl transferase, which has been granted Breakthrough Therapy and Fast Track Designations by the FDA for the treatment of patients with HRAS mutant HNSCC. In addition to HNSCC, tipifarnib has demonstrated encouraging clinical activity in multiple additional genetically defined tumor types. Kura has received multiple issued patents for tipifarnib, providing patent exclusivity in the U.S. and foreign countries.

On July 6, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") reported that it will release its second-quarter 2021 financial results on Tuesday, Aug. 3, 2021 (Press release, Bausch Health, JUL 6, 2021, View Source [SID1234584634]). Bausch Health will host a conference call and live web cast at 8:00 a.m. EDT to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.

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On July 6, 2021 Cleveland BioLabs, Inc. (NASDAQ: CBLI), an innovative biopharmaceutical company developing novel approaches to activate the immune system, reported that the Company and Cytocom Inc., a leading biopharmaceutical company developing next generation therapeutics that target immune restoration and homeostasis, will host an investor call and live webcast on Wednesday, July 7 at 8:30 a.m. ET (Press release, Cytocom, JUL 6, 2021, https://www.cytocom.com/2021/07/06/cleveland-biolabs-inc-and-cytocom-inc-announce-call-to-discuss-stockholder-meeting-vote-results-and-proposed-merger/?utm_source=rss&utm_medium=rss&utm_campaign=cleveland-biolabs-inc-and-cytocom-inc-announce-call-to-discuss-stockholder-meeting-vote-results-and-proposed-merger [SID1234584652]).

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During the call, Michael K. Handley, President and Chief Executive Officer of Cytocom, and members of the Cleveland BioLabs Board of Directors will discuss the results of the vote on the merger transaction, scheduled to take place July 6, 2021, during a Special Meeting of Cleveland BioLabs shareholders. Mr. Handley will also discuss the strategic vision for the combined companies including the opportunities in COVID-19, Crohn’s disease, pancreatic cancer, hematology, and acute radiation syndrome. The company is developing therapies and plans to launch therapies into the $48.7 billion gastrointestinal market, the $84.3 billion therapeutic oncology market, the $82.5 billion hematology market and the $125.0 billion autoimmune market. The combined company could have the broadest Toll-like receptor therapeutic platform in the industry, allowing it to potentially treat a multitude of immune-related diseases and significantly expand the size of its total addressable markets.

Conference Call Information:

Investors and interested participants may access the conference call or live webcast via the following:

An archive of the audio webcast will remain available for 90 days beginning at approximately 11:30 a.m. ET on July 7, 2021. The recording can be accessed at View Source

On July 5, 2021 Prescient Therapeutics Limited (ASX: PTX), the clinical stage oncology company developing personalised medicine approaches to cancer, reported excellent results from in silico immunogenicity testing of OmniCAR’s key binding components, SpyTag and SpyCatcher (Press release, Prescient Therapeutics, JUL 5, 2021, file:///C:/Users/komal/Downloads/PTX_PTX_successful_immunogenicity_testing_of_OmniCAR%20(1).pdf [SID1234584601]). These results substantially de-risk the entire platform and are important for progressing Prescient’s in-house programs and external collaborations with OmniCAR.

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Immunogenicity testing evaluates the immune response against a new therapy, which can adversely affect safety and efficacy. In the case of CAR-T cell therapies, high levels of immunogenicity can adversely impact CAR-T cell expansion and persistence, which can impact the overall safety and clinical response of the treatment.1

The immunogenicity of OmniCAR’s binding system components – SpyTag and SpyCatcher were tested in silico by an independent US research provider to determine if either component has the potential to elicit unfavourable immune responses that could compromise the therapy.

The results demonstrated that both SpyTag and SpyCatcher have very low immunogenicity-lower than a panel of humanised therapeutic antibodies already approved for human use and on par with circulating human antibodies. It is worth noting that in silico immunogenicity testing is widely recognised as being over-predictive as contemporary algorithms are unable to account for cellular antigen processing. 1 Gorovits B, Koren E. Immunogenicity of Chimeric Antigen Receptor T-Cell Therapeutics. BioDrugs. 2019 Jun;33(3):275-284. Figure 1: SpyCatcher and SpyTag linked to either a heavy (H) or light (L) chain human IgG, were of either lower or comparable immunogenicity when compared against human monoclonal antibodies approved for human use, and have comparable to immunogenicity to human antibodies.

Prescient’s CEO and Managing Director, Steven Yatomi-Clarke said, "This is another incremental but important milestone that significantly de-risks the entire OmniCAR platform. The immunogenicity results could not have been better. In short, it gives us confidence that if these therapies are ultimately delivered to patients, that their immune systems will not impair the therapy itself. This is essential not only for Prescient’s three in-house OmniCAR programs, but also for potential external collaborators, who consider immunogenicity very stringently."

"Prescient’s development plan is on schedule to deliver a number of important milestones. Together with our talented research team at Peter Mac, we are excited to progress our inhouse next generation cell therapies for cancer patients." The development follows the successful completion of manufacturing and delivery of critical components of the OmniCAR platform including cell binders for several cancer targets and lentiviral vectors used to produce CAR-T cells.

Prescient is developing OmniCAR programs for acute myeloid leukemia; Her2+ solid tumours, including breast, ovarian and gastric cancers; and glioblastoma multiforme (the most common form of brain cancer). In addition, Prescient has developed OmniCAR as a platform, allowing collaborations and partnerships under licence with third parties wishing to incorporate OmniCAR to enhance their respective cell therapies.

The OmniCAR platform is based on technologies developed at the University of Pennsylvania and University of Oxford. Prescient has a worldwide licence to commercialise the technologies.

On July 5, 2021 Prescient Therapeutics Limited (ASX:PTX) reported that outstanding findings from in silico immunogenicity testing of OmniCAR’s key binding components – SpyTag and SpyCatcher (Press release, Prescient Therapeutics, JUL 5, 2021, View Source;utm_medium=rss&utm_campaign=positive-results-from-immunogenicity-testing-send-prescients-shares-higher [SID1234584687]).

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SpyTag/SpyCatcher system is a technology used to combine proteins; SpyTag is a 13-amino acid peptide which reacts with SpyCatcher to form a bond.

Following the significant update, shares of the ASX-listed clinical-stage oncology firm jumped 14.130% and were trading at AU$0.260 (at 02:48 PM AEST).

PTX highlighted that the in silico tests confirm the non-immunogenic profile of SpyTag and SpyCatcher. These findings substantially de-risk the OmniCAR platform and are crucial for progressing Prescient’s OmniCAR in-house programs and external partnership/collaborations.

Immunogenicity testing assesses the immune response against a new treatment, which can negatively affect efficacy and safety. In CAR-T cell therapies, elevated levels of immunogenicity can negatively impact the expansion and persistence of CAR-T cells, affecting the treatment’s overall safety and clinical response.

WATCH NOW: Expert Talks With Mr Steven Yatomi Clarke, CEO and Managing Director of Prescient Therapeutics

In silico test demonstrates low immunogenicity of SpyTag and SpyCatcher
Prescient highlighted that the immunogenicity of OmniCAR’s binding system components – SpyTag and SpyCatcher – were analysed in silico by an independent US research provider. The study was performed to determine if these components could generate unfavourable immune responses which could have a negative impact on the therapy.

Source: PTX Update, 5 July 2021

The findings revealed that both SpyTag and SpyCatcher had extremely low immunogenicity. Notably, their immunogenicity was found to be lower than a panel of humanised therapeutic antibodies already approved for human use.

ALSO READ: Prescient Therapeutics’ major strides in anti-cancer programs set the stage for a sturdy 2021

It is interesting to note that in silico immunogenicity testing is widely considered to be over-predictive as contemporary algorithms cannot account for cellular antigen processing.

Steven Yatomi-Clarke, the CEO and Managing Director of Prescient, commented-

The crucial development follows the completion of the manufacturing and delivery of the OmniCAR platform’s critical components, including cell binders for numerous cancer targets and lentiviral vectors utilised to manufacture CAR-T cells.

READ MORE: Prescient Therapeutics reaches a major CAR-T manufacturing milestone

Prescient’s OmniCAR programs are being developed for:

Acute myeloid leukemia (AML).
Her2+ solid tumours (breast, gastric and ovarian cancers).
Glioblastoma multiforme or GBM (the most common form of brain cancer).
PTX has developed OmniCAR as a platform, allowing collaborations and partnerships under licence with third parties wanting to integrate OmniCAR for enhancing their respective cell therapies.

The platform is based on technologies developed at the University of Pennsylvania and the University of Oxford. Interestingly, Prescient owns a global licence for the commercialisation of the technologies.

DO READ: Prescient Therapeutics inks new deal with Peter Mac to rev up its OmniCAR programs

Prescient highlights that the positive findings from the in silico immunogenicity test show that if these therapies are given to patients, their immune systems will not impair the therapy itself. Furthermore, the Company is thrilled to progress its in-house next-generation cell therapies for cancer treatments.