On August 21, 2020 Tiziana Life Sciences plc (Nasdaq: TLSA; AIM: TILS) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, reported that the United States Patent and Trademark Office ("USPTO") has granted a patent on use of Milciclib in combination with tyrosine kinase inhibitors (TKIs) such as Sorafenib (Nexavar), Regorafenib (Stivarga) and Lenvatinib (Lenvima) for the treatment of hepatocellular carcinoma (HCC) and other cancers in humans (Press release, Tiziana Life Sciences, AUG 21, 2020, View Source [SID1234568595]). This patent will be published by the USPTO on 1 September 2020 as Patent No. 10,758,541 (Inventor: Kunwar Shailubhai). Like most human cancers, HCC is a complex multi-factorial cancer with multiple underlying mechanisms causing enormous heterogeneity in patient populations. Consequently, patients with HCC often develop resistance towards the monotherapies of existing therapeutics. Thus, there is an urgent need for combination drug treatment approaches targeting different mechanisms to achieve better clinical outcomes.

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Recently, the Company presented two posters on clinical evaluation of Milciclib at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO2020). The poster on Phase 2a clinical evaluation of Milciclib, a broad-spectrum inhibitor of cyclin dependent kinases, indicated that the treatment was well-tolerated, and it produced encouraging clinical activity in sorafenib-resistant patients of HCC(1). The second poster was on the evaluation of Milciclib in combination with Regorafenib, a specific TKI drug, in liver transplant patients with HCC recurrence in the MiHRCO (Milciclib and Half Regorafenib CO administration) trial. The combination treatment was safe and produced promising clinical response(2) in these delicate and difficult to treat patients. Additionally, the Company earlier reported data from an animal study suggesting that the combination of Milciclib with Sorafenib, both acting via different mechanisms, suppressed expression of protooncogene c-Myc to produce pronounced synergistic anti-HCC activity(3).

Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Lifesciences, commented, "Advanced cases of patients with HCC have limited therapeutic options because of the heterogeneity of the multiple mechanisms underlying the development of drug resistance and limited clinical responses. Thus, combination of drugs with different mechanism of actions are necessary to achieve superior clinical outcome. We are delighted that we now have this key patent on use of Milciclib in combination with other HCC drugs, including a TKI. Issuance of this patent strengthens our clinical strategy as we move forward with the combination of Milciclib and a TKI for the clinical evaluation of advanced cases of HCC as well as in patients with recurrent HCC after liver transplantation."

The person who arranged for the release of this announcement was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company

Cited References:

1. Villa, E., Piscaglia, F., Geva, R., Dalecos, G., Papatheodoridis, G., Ciomei, M., Davite, C., Crivori, P., Palejwala, V., Jacob, J., Hamzeh, F., Shailubhai, K., Santoro, A., and A., S. (2020) Phase 2a Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma Patients. ASCO (Free ASCO Whitepaper) Abstract #29856

2. Pivetti, A., Di Marco, L., Bristot, L., Milosa, F., Maria Critelli, R., De Maria, N., Di Benedetto, F., Palejwala, V., Jacob, J., Shailubhai, K., and Villa, E. (2020) Safety and Clinical Activity of Combination Treatment with Regorafenib and Milciclib in Liver Transplant Patients with Hepatocellular Carcinoma Recurrence. ASCO (Free ASCO Whitepaper) Abstract #307309

3. Jindal, A., Palejwala, V. a., and Shailubhai, K. (2018) Oral Treatment with Milciclib Either Alone or in Combination with Sorafenib Inhibited Tumor Growth in an Orthotopic Model of Hepatocellular Carcinoma. Hepatology 68, 879A

About Milciclib (TZLS-201)

Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK2, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signaling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in NSCLC, pancreatic and colon cancer, thymic carcinoma and thymoma.

On August 21, 2020 Prescient reported that it is focused on developing novel, personalised therapies against a range of cancers (Press release, Prescient Therapeutics, AUG 21, 2020, View Source;utm_medium=rss&utm_campaign=health-kick-podcast-chemos-diminishing-role-the-personalised-approach-to-cancer-treatment-and-ptxs-car-t-innovations [SID1234567639]).

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The company’s universal CAR-T and targeted therapies are both personalised medicine approaches that seek to improve patient outcomes and provide new tools for clinicians in combating cancer.

Prescient has a broad pipeline of personalised cancer treatments, comprising CAR-T and targeted therapies, and spanning a range of different cancers.

The company made headlines earlier this month with news of its partnership with global cancer heavyweight Peter MacCallum Cancer Centre to develop new treatments.

As of August 21, 2020, NantKwest, Inc. (the "Company") reported that it entered into a definitive collaboration agreement (the "Collaboration Agreement") with ImmunityBio, Inc., an affiliate of the Company, to pursue collaborative joint development, manufacturing and marketing of certain Covid-19 therapeutics and vaccines (Filing, 8-K, NantKwest, AUG 21, 2020, View Source [SID1234563975]). The terms of the Collaboration Agreement supersede and replace the terms of the binding term sheet executed on May 22, 2020 as previously disclosed. Through their efforts, the parties agreed to jointly develop ceNK, haNK, mesenchymal stem cells (MSC), adenovirus constructs (Ad5), and N-803, a novel IL-15 cytokine superagonist, for the prevention and treatment of SARS-CoV-2 viral infections and associated conditions in humans, including without limitation, COVID-19. NantKwest will contribute the ceNK, haNK, MSC and certain of its manufacturing capabilities and ImmunityBio will contribute Ad5 and N-803. Ad5 will be developed as a vaccine, and ceNK, haNK, MSC and N-803 will each be developed as a therapeutic for treating COVID-19 at various stages of infection.

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From and after the effective date of the Collaboration Agreement, the parties will share equally in all costs relating to developing and manufacturing of the product candidates globally. With the exception of N-803, NantKwest will be primarily responsible for the manufacture of the products. Each party will be responsible for the regulatory affairs and the commercialization relating to its contributed products. The global net profits from the collaboration products will be shared 60% / 40% in favor of the party contributing the product on which the sales are based except if the parties mutually agree because of certain circumstances. All net profits from sales of combined collaboration products will be shared equally. This collaboration will be supervised by the joint steering committee which will be comprised of an equal number of representatives from both parties.

The foregoing description of the Collaboration Agreement does not purport to be complete and is subject to, and qualified in its entirety, by the full text of the Collaboration Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2020, the terms of which are incorporated herein by reference.

On August 21, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that leadership will present at the 2020 Cross-Border Healthcare Webinar Series on Wednesday, August 26, 2020 (Press release, TYME, AUG 21, 2020, View Source [SID1234563956]). The Company will present its corporate overview with a focus on:

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Growth opportunities driven by advances in the science of cancer metabolism
Recently launched pivotal and late-stage trials in pancreatic cancer and a Phase II trial in high-risk sarcoma
Plans for expanding clinical programs for its lead candidate SM-88 (racemetyrosine) in prostate, breast and hematological cancers
Potential for development and commercialization of SM-88 and TYME-18 in Asia
Event: 2020 Virtual CHINABIO Partnering Forum

Topic: Evolving Science & Development of Cancer Metabolism-Based Therapies

Presentation Date: Wednesday, August 26, 2020

The presentation will be accessible on the events page under the investor relations section of Tyme Technologies’ website at www.tymeinc.com. There are no planned webcasts for this event.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. Learn more.

About TYME-18

TYME-18 is composed of a proprietary surfactant delivery agent with a specific sulfonic acid component. It is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells. TYME-18 is distinct in composition, but like SM-88, aims to leverage susceptibilities of a cancer that are related to its altered metabolism. Initial preclinical data for TYME-18 in animal tumor models demonstrate rapid and complete tumor regression, with no reported local or systemic toxicities. TYME-18 continues to be studied as a potential therapy for difficult to treat tumors that may not be eligible for surgical or other interventions. Learn more.

About TYME-88-Panc Pivotal Trial

The TYME-88-Panc pivotal trial applies the latest advances in the field of cancer metabolism by evaluating the efficacy and safety of an oral investigational compound that targets the metabolic mechanisms of the disease at its source. A prospective, open label pivotal trial in metastatic pancreatic cancer for patients who have failed two lines of any prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in advanced pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. Learn more.

On August 21, 2020 Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), a pharmaceutical company developing novel immunotherapies against cancer, reported its second quarter 2020 results (Press release, Ultimovacs, AUG 21, 2020, View Source [SID1234563955]). A presentation by the company’s management team will take place today on a webcast at 09:00 CEST.

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The presentation can be followed as a live webcast (access through the link https://channel.royalcast.com/webcast/hegnarmedia/20200821_4/) which will also be available on our website.

Highlights for the second quarter of 2020:

The first patient in the INITIUM trial was enrolled in June, and a total of three patients have been enrolled as per reporting date. The first site in the INITIUM trial opened for patient inclusion in May. The INITIUM trial is a randomized, comparative, multi-center Phase II trial for evaluating UV1 as a treatment for first-line patients with metastatic malignant melanoma.
Similarly, the first patient in the NIPU trial was enrolled in June, and four patients are enrolled as per reporting date. The NIPU trial is a randomized, comparative, multi-center Phase II trial in which UV1 is investigated as a second-line treatment in mesothelioma.
In the US based Phase I trial in malignant melanoma, patient enrollment is now completed with all 10 patients in cohort 2 (dose finding GM-CSF) included. No unexpected safety issues have been observed to date.
The Covid-19 situation has so far had limited impact regarding site openings and patient inclusion. The longer-term effect of the pandemic on the biotech industry and the general ability to conduct clinical trials is still uncertain.
In May 2020, Ultimovacs announced a collaboration with a non-specified big pharma company and a leading European oncology clinical trial group to evaluate UV1 in a third Phase II clinical trial. More information is expected to be disclosed during the third quarter of 2020.
A private placement of new shares to fund the above-mentioned clinical trial was successfully completed in May 2020, raising gross proceeds of MNOK 160.
Carlos de Sousa was appointed the new CEO of Ultimovacs ASA effective 1 June 2020.
Cash flow from operations was MNOK -33.2 in Q2-20. With the proceeds from the private placement in May 2020, total cash and cash equivalents increased by MNOK 115.2 during Q2-20 and amounted to MNOK 483.2 as per 30 June 2020.
The report and presentation are also available on the company website: www.ultimovacs.com/investors/reports-and-presentations