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DelMar Pharmaceuticals Announces Dosing of the First Patient in Phase Two Clinical Trial of VAL-083 for MGMT-unmethylated Recurrent Glioblastoma Multiforme (GBM)

On February 13, 2017 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that patient dosing has commenced in a Phase 2 clinical study of its investigational drug VAL-083 (dianhydrogalactitol) for MGMT-unmethylated Avastin (bevacizumab)-naïve recurrent glioblastoma (Press release, DelMar Pharmaceuticals, FEB 13, 2017, View Source [SID1234517705]).

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The first patient was dosed by DelMar’s collaborators at the University of Texas MD Anderson Cancer Center in Houston Texas.

"The dosing of the first subject in this VAL-083 trial marks an important milestone in the advancement of our clinical development program targeting MGMT-unmethylated GBM," said Jeffrey Bacha, chairman & CEO of DelMar Pharmaceuticals.

"The majority of newly diagnosed GBM patients’ tumors are characterized as MGMT-unmethylated, which is directly correlated with resistance to current standard front-line chemoradiation with temozolomide," added Mr. Bacha. "Our research demonstrates that VAL-083 is active independent of MGMT expression. These data, combined with data from prior clinical trials sponsored by the US National Cancer Institutes that establish VAL-083’s activity against GBM, are the foundation of our belief that VAL-083 may provide a new therapeutic option for GBM patients whose tumors exhibit features making them resistant or unlikely to respond to currently available therapy."

The Phase 2 trial will test safety, tolerability and clinical efficacy of VAL-083 in 48 adult subjects with MGMT-unmethylated GBM whose tumors have recurred following surgery and standard chemo-radiation with temozolomide. Patients will receive 40 mg/m2 VAL-083 (IV) on days 1, 2, and 3 of a 21-day treatment-cycle, for up to twelve 21-day treatment cycles to determine if treatment with VAL-083 improves overall survival compared to historical controls. Further information regarding the clinical trial can be found on DelMar’s website and at clinicaltrials.gov (clinicaltrials.gov identifier: NCT02717962).

Approximately two-thirds of newly diagnosed GBM patients have tumors with an unmethylated MGMT promoter, which is correlated with high expression of the DNA repair enzyme, MGMT. Published studies have documented that expression of MGMT is an important factor in predicting the outcome of GBM patients treated with alkylating agents such as temozolomide (TMZ), carmustine (BCNU), and lomustine (CCNU).

Patients whose tumors exhibit a high expression of MGMT have a poor prognosis and significantly shorter progression free survival (PFS) and overall survival (OS) in comparison to patients with a methylated MGMT promoter and low MGMT expression. In a 2011 study of more than 800 newly diagnosed GBM patients, those with tumors carrying the unmethylated MGMT promoter had a median overall survival of 14 months versus 21 months for those with a methylated MGMT promoter. The difference in progression-free survival – the period after treatment during which the cancer does not worsen – was 5.7 and 8.7 months, respectively.

About VAL-083

VAL-083 is a "first-in-class," small-molecule chemotherapeutic that demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes. DelMar has demonstrated that VAL-083’s anti-tumor activity against GBM is unaffected by the expression of MGMT in vitro. Further details can be found at View Source

VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.

DelMar has also announced plans to advance VAL-083 into a pivotal randomized multi-center Phase 3 clinical trial for the treatment of bevacizumab-failed GBM and into a separate international Phase 2 trial for newly diagnosed MGMT-unmethylated GBM.

DelMar believes that data from its clinical trials, if successful, will form the basis of a new treatment paradigm for the vast majority of GBM patients whose tumors exhibit features that make them unlikely to respond to currently available therapies.

About Glioblastoma Multiforme (GBM)

GBM is the most common and the most lethal form of brain cancer. Approximately 15,000 new cases of GBM are expected to be diagnosed in the United States during 2017. GBM progresses quickly and patients deteriorate rapidly. Common symptoms include headaches, seizures, nausea, weakness, paralysis and personality or cognitive changes such as loss of speech or difficulty in thinking clearly. The majority of GBM patients do not survive for more than two years following diagnosis, and the median survival in newly diagnosed patients with best available treatments is less than 15 months.

Inovio and ApolloBio to Collaborate on Development and Commercialization of HPV Pre-cancer Immunotherapy VGX-3100 in Greater China

On February 13, 2017 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported that it has entered into a collaboration and license agreement providing ApolloBio Corporation (NEEQ:430187) with the exclusive right to develop and commercialize VGX-3100, Inovio’s DNA immunotherapy product designed to treat pre-cancers caused by human papillomavirus (HPV), within Greater China (China, Hong Kong, Macao, Taiwan) (Press release, Inovio, FEB 13, 2017, View Source [SID1234517704]). The agreement provides for potential inclusion of the Republic of Korea three years following the effective date.

Under the collaboration and license agreement, Inovio will receive $15 million in upfront and near term payments comprising an initial $3 million signing fee and a $12 million milestone upon lifting of the VGX-3100 phase 3 pre-initiation clinical hold by the FDA. Under a separate equity agreement, ApolloBio will invest in Inovio common stock subsequent to lifting of the clinical hold at a volume weighted average price encompassing a trading period prior to and following the lifting of the clinical hold. The aggregate investment, which is expected to be completed in the first half of 2017, will not exceed $35 million and may be a lower amount such that ApolloBio will not be the largest shareholder in Inovio. ApolloBio will fund all clinical development costs within the licensed territory, and will pay Inovio up to $20 million based upon the achievement of certain regulatory milestones in the US, China and Korea, and double digit royalties on net sales of VGX-3100. The agreements are subject to People’s Republic of China (PRC) corporate and regulatory approvals, and payments are subject to PRC currency approvals.

This collaboration on VGX-3100 encompasses the treatment and/or prevention of pre-cancerous HPV infections and HPV-driven dysplasias, and excludes HPV-driven cancers and all combinations of VGX-3100 with other immunostimulants.

Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, “As Inovio continues to focus on the path to regulatory approvals and commercialization strategies in the U.S. and European countries, this agreement opens up Greater China for our lead program and first phase III product. We believe that ApolloBio is a strong partner that brings significant capabilities and expertise relating to product development, the Chinese regulatory landscape, and the healthcare market in China.”

Dr. Weiping Yang, Chief Executive Officer of ApolloBio Corporation, said, “We are delighted to begin 2017 with a strategic collaboration with Inovio. VGX-3100 is the world’s first therapeutic vaccine being developed for HPV pre-cancers. This collaboration, license and equity investment marks our determination to introduce late stage innovative new drugs to meet severely unmet medical needs within the Greater China region.”

About VGX-3100

VGX-3100 is an HPV-specific immunotherapy that is being developed as a non-surgical treatment for high-grade cervical dysplasia and related underlying persistent HPV infection. VGX-3100 works in vivo to activate functional, antigen-specific, CD-8 T-cells to clear persistent HPV 16/18 infection and cause regression of pre-cancerous cervical dysplasia. In a phase II trial, VGX-3100 demonstrated clinical efficacy and was generally well tolerated, without the side effects and obstetric risks associated with surgical excision. VGX-3100 is a first-in-class HPV-specific immunotherapy that targets the underlying cause of cervical dysplasia, providing an opportunity for women to reduce their risk of cervical cancer without undergoing an invasive surgical procedure.

About HPV and Cervical Dysplasia

HPV is the most common sexually transmitted infection and is the main cause of cervical cancer, which kills more than 250,000 women every year worldwide. Among the 300 million women currently infected with HPV, 500,000 will be diagnosed with cervical cancer each year. Two types of HPV (HPV 16 and HPV 18) cause 70% of cervical cancer cases. High-grade cervical dysplasia is also caused by persistent HPV infection and is a pre-cancerous condition that can progress to cervical cancer if left untreated. Globally the number of high-grade cervical dysplasia cases is estimated to be in the range of 10 million.

Currently there are no approved medical treatments for persistent HPV infection or cervical dysplasia. The primary treatment for high-grade cervical dysplasia is surgical excision of the pre-cancerous lesion and a margin of healthy cervical tissue. Because surgical excision does not treat the underlying HPV infection that causes cervical dysplasia, there is a 10-16% risk of disease recurrence. Women with persistent HPV infection after surgical excision remain at high risk for cervical cancer. In addition, surgical treatment is associated with pain and cramping, and a risk for post-surgical bleeding, infection, and pre-term delivery and miscarriages during future pregnancies.

Immunomedics Enters into Exclusive Global Licensing Agreement with Seattle Genetics for Sacituzumab Govitecan (IMMU-132) with Potential Payments of up to Approximately $2 Billion, Plus Royalties

On February 10, 2017 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics") reported that it has entered into an exclusive global licensing agreement with Seattle Genetics, Inc. (NASDAQ: SGEN), an innovative global biotechnology company that develops and commercializes novel antibody-drug conjugates (ADCs) for the treatment of cancer (Press release, Immunomedics, FEB 10, 2017, View Source [SID1234517767]). Under the agreement, Seattle Genetics will develop, fund, manufacture and commercialize IMMU-132, Immunomedics’ proprietary solid tumor therapy candidate.

The agreement also provides that Seattle Genetics will be responsible for initiating the Phase 3 clinical trial of IMMU-132 in patients with metastatic triple-negative breast cancer (TNBC) and submitting the initial Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for accelerated approval. The agreement includes the development of additional indications for IMMU-132, including urothelial cancer (UC), small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC), which are currently in Phase 2 clinical studies, along with other solid tumor indications being studied in ongoing clinical trials.

Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics, said, "We are pleased to enter into this exclusive worldwide licensing agreement with Seattle

Genetics to further advance IMMU-132 on behalf of patients with late-stage cancers, who have limited therapeutic options, while delivering significant and compelling near- and long-term value to stockholders. Since its founding, Immunomedics has been dedicated to creating and advancing novel therapies in challenging diseases with unmet therapeutic needs. Seattle Genetics’ reputation, development portfolio and track record make them an ideal partner to advance IMMU-132. Additionally, this agreement validates the dedication and effort by our entire internal teams in research and development, manufacturing, clinical, regulatory and general administration. In just over three years, we have brought IMMU-132 through clinical developments in multiple indications, and have advanced the TNBC indication to a potential accelerated approval and launch by late 2017 or early 2018, which could make IMMU-132 available to patients dealing with a highly malignant form of breast cancer. We are proud to have achieved this critical milestone and thank our entire team for their hard work. Immunomedics looks forward to appropriately supporting Seattle Genetics as it seeks to bring IMMU-132 to commercialization."

Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics, said, "As the global leader in ADCs, we are excited to enter into this licensing agreement with Immunomedics for sacituzumab govitecan. This program would complement our rich pipeline of late- and early-stage programs, potentially allowing us to bring a new therapy for triple-negative breast cancer to patients in need. We have successfully demonstrated our expertise in the development, manufacturing and commercialization of ADCs in oncology, and we look forward to working with Immunomedics to advance this program."

Dr. David M. Goldenberg, Chairman and Chief Scientific Officer of Immunomedics, commented, "After extensive preclinical research conducted by our scientists, and about three years of clinical development by our clinicians and our collaborating external investigators studying over 400 patients, we have decided that this is the right time to out- license IMMU-132. Although we have had partnerships in the past, I am extremely enthusiastic about entering into this collaboration with Seattle Genetics, a company that has achieved a leadership role in antibody-drug conjugates. Both companies are committed to bringing important products to cancer patients. This common goal is sincere and will be the basis of making IMMU-132 fulfill its full potential."

Dr. Goldenberg further remarked, "After a long period of interactions with many interested partnering candidates, and a considerable period of discussion with Seattle Genetics, we concluded that working with this group of successful business and marketing executives, clinicians and scientists would allow us to contribute our own scientific and clinical knowledge to them as they further develop IMMU-132 and bring it to commercialization. We are particularly pleased with their enthusiasm, and that this arrangement allows us to continue our ongoing Phase 2 studies in a number of additional cancer types while we transition this product candidate to them."

Terms of the Agreement
The agreement provides for potential payments of approximately $2 billion across multiple indications, plus double-digit tiered royalties on global net sales. Under the terms of the agreement, Immunomedics will receive $250 million in upfront cash payment, plus, among other milestone payments, an additional $50 million (or negotiated economic splits) relating to rights outside the U.S., Canada and the EU. The remainder of the consideration comprises approximately $1.7 billion that is contingent upon achieving certain clinical, development, regulatory and sales milestones, including an anticipated near-term milestone for acceptance of the Biologics License Application (BLA) by the U.S. Food and Drug Administration for TNBC, additional milestones based on regulatory approval of IMMU-132 for TNBC in the U.S. and other territories, and future development and regulatory milestones for additional indications beyond TNBC. Future royalty payments are tiered double-digit royalties based on global net sales. In addition, Immunomedics will retain the right to elect to co-promote IMMU-132 in the United States by participating in 50% of the sales effort, subject to certain parameters set forth in the agreement.

Joint Steering Committee
Upon completion of the transaction, Immunomedics and Seattle Genetics will each appoint representatives to serve on a Joint Steering Committee (JSC) that will be chaired by a Seattle Genetics representative. The JSC will be responsible for, among other things, determining the overall development, commercialization, manufacturing and intellectual property strategy for IMMU-132.

Timing and Approvals
The companies expect the transaction to close in the first quarter of 2017, subject to expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, as well as other customary closing conditions.

Modified Go-Shop Period
Under the terms of the agreement, for a limited period, through February 19, 2017, Immunomedics has the right to continue negotiating with a select number of parties still in the strategic process, and accept a superior proposal. Seattle Genetics has the right to match any superior proposal and if it decides not to match, Immunomedics has the right to accept the superior proposal and terminate the proposed development and license agreement upon payment of a termination fee to Seattle Genetics.

Equity Investment
Concurrent with the transaction, Seattle Genetics is purchasing 3,000,000 shares of common stock, representing an approximately 2.8% stake in Immunomedics, at a per share price of $4.90, which represents a 10% premium to Immunomedics’ 15-day trading volume weighted average stock price of $4.45 for the period ending at the close of trading February 9, 2017, the last trading day prior to entering into the global licensing agreement. Seattle Genetics will also be issued a three-year warrant to purchase 8,655,804 shares of common stock at the same price, which shall be exercisable when the Company has sufficient authorized shares of common stock to enable the exercise of the warrant. Seattle Genetics will not be eligible to vote its stake at the upcoming 2016 Annual Meeting of Stockholders.

"We are delighted to welcome Seattle Genetics to our stockholder base and appreciate their commitment to Immunomedics. Our promising clinical results and this partnership validating the promise of our novel antibody-drug conjugation technology stimulates us to advance our other product candidates using this platform technology," added Ms. Sullivan.

Strategic Process
The agreement with Seattle Genetics follows a 13 months-long competitive strategic process led over the past several months by outside financial advisor, Greenhill & Co. ("Greenhill"), which was retained for their global capabilities and their significant experience in biopharma M&A and licensing transactions. Greenhill & Co. reports directly to the Transaction Committee of the Board, composed exclusively of the Company’s five independent directors.

Jason Aryeh, independent Vice Chairman of the Immunomedics Board, stated, "We are pleased to offer Immunomedics stockholders the compelling and significant value provided by this agreement with Seattle Genetics. This agreement is the culmination of a robust strategic process, led by Greenhill and the Transaction Committee. Greenhill’s outreach was to more than 45 parties and involved more than half of those parties entering into confidentiality agreements and participating in diligence. In addition to the highly competitive financial terms of the transaction, we believe that Seattle Genetics is the ideal partner for IMMU-132."

Future Financial Plans
Upon closing of the transaction, the Immunomedics Board and management will evaluate and prioritize the Company’s remaining clinical programs, long- and short-term funding requirements and tax-efficient ways to return capital to stockholders, including share buybacks. The Company will announce the outcome of this review once a decision has been reached.

Immunomedics expects that the transaction will fulfill its liquidity needs such that the Company can fund itself without additional equity raises for the foreseeable future.

Advisors
Greenhill & Co., LLC, is serving as financial advisor to Immunomedics and DLA Piper LLP (US) is serving as legal advisor on the transaction.

Seattle Genetics Announces Global License Agreement with Immunomedics for Sacituzumab Govitecan (IMMU-132), a Promising Late-Stage ADC for Solid Tumors

On February 10, 2017 Seattle Genetics, Inc. (Nasdaq: SGEN), a global biotechnology company, reported a development and license agreement with Immunomedics, Inc. (Nasdaq: IMMU) under which Seattle Genetics would receive exclusive worldwide rights to develop, manufacture and commercialize sacituzumab govitecan (IMMU-132) (Press release, Seattle Genetics, FEB 10, 2017, View Source [SID1234517693]). Sacituzumab govitecan is an antibody-drug conjugate (ADC) targeted to TROP-2, which is expressed in several solid tumors including cancers of the breast, lung and bladder. Sacituzumab govitecan is in a phase 1/2 trial for patients with triple negative breast cancer (TNBC), as well as multiple other solid tumors. It received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with TNBC who have failed prior therapies for metastatic disease. Data from the phase 1/2 trial are intended to serve as the basis for a planned Biologics License Application (BLA) submission under the FDA’s accelerated approval regulations.

"This agreement would add a promising late-stage ADC to our pipeline as we continue making progress towards our goal of becoming a global, multi-product oncology company. Sacituzumab govitecan would complement our existing pipeline by providing a potential near-term opportunity to commercialize a second drug in the United States, expand our international capabilities in Europe and elsewhere and extend our efforts in solid tumors," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "In addition, we believe our expertise in ADCs, including demonstrated success in clinical development, regulatory, manufacturing and commercialization, ideally positions Seattle Genetics to advance this program globally. We look forward to working with Immunomedics to advance this program for patients in need, including those with triple negative breast cancer and other solid tumors."

Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics, said, "After a long and robust process, we concluded that licensing our lead asset, sacituzumab govitecan, to Seattle Genetics, the leading ADC company, would give us the best opportunity to advance this product on behalf of advanced stage cancer patients. Sacituzumab govitecan has the potential to drive significant value for patients with multiple types of cancer who are in need of new therapy options, and we look forward to continuing its development with Seattle Genetics."

Upon closing of the transactions contemplated by the development and license agreement, Immunomedics would receive an upfront payment of $250 million. In addition, Seattle Genetics would pay development, regulatory and sales-dependent milestone payments across multiple indications and geographic regions of up to a total maximum of approximately $1.7 billion, as well as tiered double-digit royalties. The closing of the transactions contemplated by the development and license agreement is subject to customary conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. In addition, for a limited period of time, Immunomedics has the right to continue discussions with a small number of parties that previously expressed interest in licensing sacituzumab govitecan. If a third party provides Immunomedics with a financially superior licensing offer, Seattle Genetics has the right to match any such offer, and if it decides not to match, Immunomedics has the right to accept the superior offer and terminate the proposed development and license agreement upon payment of a termination fee to Seattle Genetics.

Concurrent with the transaction, Seattle Genetics is purchasing approximately $15 million of common stock, representing a 2.8 percent stake in Immunomedics. Seattle Genetics has also been granted the right to purchase an additional 8,655,804 shares of common stock at a price of $4.90 per share for a defined period. The equity purchase and rights are not subject to closing of the development and license agreement.

Seattle Genetics’ 2017 financial guidance provided on and as of February 9, 2017 does not take into account the impact of the transactions contemplated by the development and license agreement or the equity investment in Immunomedics. Seattle Genetics plans to update its 2017 financial guidance after the closing of the transactions contemplated by the development and license agreement.

About Sacituzumab Govitecan

Sacituzumab govitecan is an ADC composed of an anti-TROP-2 antibody linked to SN-38, the active metabolite of irinotecan. TROP-2 is a cell-surface receptor that is expressed on several tumors, including cancers of the breast, colon, lung and bladder.

In data reported from a phase 1/2 trial, in 85 evaluable patients with metastatic TNBC, sacituzumab govitecan showed an objective response rate of 29 percent and a median duration of response of 10.8 months. For all 89 patients in the intent-to-treat population, the estimated median overall survival was 18.8 months. Sacituzumab govitecan was generally well-tolerated. The most common adverse events were nausea, neutropenia, diarrhea, anemia, vomiting and fatigue.

In 2016, sacituzumab govitecan received Breakthrough Therapy Designation from the FDA for the treatment of patients with TNBC who have failed prior therapies for metastatic disease. The regulatory agency has also granted the ADC Fast Track designation for patients with small-cell lung cancer (SCLC) or non-small-cell lung cancer (NSCLC). In addition, sacituzumab govitecan has been designated an orphan drug by the FDA for the treatment of patients with SCLC or pancreatic cancer and by the European Medicines Agency (EMA) for the treatment of patients with pancreatic cancer.

Conference Call Details

Seattle Genetics’ management will host a conference call and webcast to discuss the transaction today at 5:30 a.m. Pacific Time (PT); 8:30 a.m. Eastern Time (ET). The live event will be available from the Seattle Genetics website at www.seattlegenetics.com, under the Investors and News section, or by calling 800-279-9534 (domestic) or 719-325-2108 (international). The conference ID is 2159368. A replay of the discussion will be available beginning at approximately 8:30 a.m. PT today from the Seattle Genetics website or by calling 888-203-1112 (domestic) or 719-457-0820 (international), using conference ID 2159368. The telephone replay will be available until 5:00 p.m. PT on Monday, February 13, 2017.

Kitov Announces Settlement Agreement with Minority Shareholder of Recently Acquired TyrNovo

On February 10, 2017 Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, reported that, following its acquisition of a controlling interest in TyrNovo Ltd., a privately held Israeli company developing a novel small molecule for various oncology indications, a settlement agreement between Kitov, TyrNovo and a minority shareholder of TyrNovo was finalized and a final ruling was issued by the Israeli court (Filing, 6-K, Kitov Pharmaceuticals , FEB 10, 2017, View Source [SID1234517692]).These actions follow a court motion filed on January 19, 2017, by the minority shareholder in connection with the acquisition of TyrNovo by Kitov.

As part of the settlement, agreements were signed among Kitov, TyrNovo and the minority shareholder under which the minority shareholder agreed to invest in TyrNovo up to an aggregate amount of US$ 1.75 million following the achievement of an agreed upon milestone, and Kitov agreed to invest in TyrNovo up to an aggregate amount of US$ 1.0 million, with all investments in the form of convertible loans to be made on the same terms and conditions, and according to a pre-determined schedule. In addition, Kitov, TyrNovo and the minority shareholder signed an agreement dismissing any and all legal proceedings or claims against Kitov and TyrNovo in connection with the acquisition of TyrNovo by Kitov.

"We are pleased to have reached this settlement with the TyrNovo minority shareholder. With the expected upcoming submission to the U.S. Food and Drug Administration (FDA) of the New Drug Application for our lead drug candidate, KIT-302, the settlement enables us to focus on the clinical and commercial development of KIT-302 and TyrNovo’s NT219, a promising new cancer therapy candidate. As a result of the settlement, we expect to be able to reduce the financial resources required to be funded by Kitov in TyrNovo, while creating further value for Kitov stakeholders by advancing NT219 towards a timely submission to the FDA of an Investigational New Drug Application," stated Mr. Isaac Israel, Kitov’s Chief Executive Officer.

About NT219

NT219 is a small molecule that presents a new concept in cancer therapy by promoting the degradation of two oncology-related checkpoints, Insulin Receptor Substrates (IRS) 1 and 2 as well as the inhibition of signal transducer and activator of transcription 3 (STAT3). While targeted anti-cancer drugs inhibit the "ON" signal, NT219 activates the "OFF" switch, extensively blocking major oncogenic pathways. In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects and increased survival in various cancers by preventing the tumors from developing multi-drug resistance and ameliorating multi-drug resistance after resistance is acquired. NT219, in combination with various approved oncology drugs, demonstrated potent anti-tumor effects and increased survival in various cancer models including sarcoma, melanoma, pancreatic, lung, ovarian, head & neck, prostate and colon cancers, through the prevention of acquired resistance and regression of resistant tumors.