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Oncopeptides present updated interim data from the ongoing HORIZON trial with Ygalo® at the 23rd Congress of The European Hematology Association (EHA)

On June 15, 2018 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that they are presenting updated interim data with Ygalo (melflufen) from the ongoing HORIZON trial at the 23rd EHA (Free EHA Whitepaper) congress in Stockholm (Press release, Oncopeptides, JUN 15, 2018, View Source [SID1234527353]).

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The updated phase II-data show a clinical data set with an Overall Response Rate (ORR) of 32.1% and a Clinical Benefit Rate (CBR) of 39.3% with Ygalo in relapsed/refractory multiple myeloma patients refractory to pomalidomide and/or daratumumab after failing on immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs).

The data are presented in a poster that can be found at: www.oncopeptides.se/presentations/EHA

CEO comments

"In HORIZON, we are studying the activity of Ygalo in myeloma patients that have failed on all, or the majority of, treatments that are currently in use. In addition, half the patients in HORIZON are ISS stage III and half the patients have high-risk cytogenetics. This means that the patients are very ill, since both parameters are strong predictors of poor treatment outcome. To our knowledge this is the highest combined number in any study in myeloma to date. Despite all this, we see a tumor response in 32% of patients, disease stabilization in 84% of patients, positive initial indication of the duration of the treatment effect as well as a manageable safety profile for Ygalo. We have made the decision to expand the HORIZON trial to further understand the efficacy of Ygalo in this very difficult to treat patient population", said Jakob Lindberg, CEO of Oncopeptides.

Professor Paul G. Richardson comments

"With an increasing number of patients with highly resistant myeloma there is a real need for additional treatment options based on new mechanisms of action. Ygalo, a peptidase-enhanced compound, with its potent activity, manageable tolerability and lack of shared resistance mechanisms with other modalities, is a promising molecule that is making encouraging progress in clinical development" said Professor Paul Richardson, Harvard Medical School at the Dana-Farber Cancer Institute, Boston, USA.

About the HORIZON study

The study recruitment is ongoing. The interim data presented at the EHA (Free EHA Whitepaper) congress are based on a data cut-off dated May 10th 2018 with 62 patients treated. The patients in the study should be refractory to pomalidomide and/or daratumumab after failing on IMiDs and PIs.

Conclusions regarding HORIZON

The study continues to develop positively in this heavily pretreated patient group that is refractory to pomalidomide and/or daratumumab after failing on IMiDs and PIs with few remaining treatment options.

54% of patients in the study had high-risk cytogenetics, 46% of patients were ISS stage III, the median number of prior lines of therapy was 5.5 and the median time since initial diagnosis was 6.1 years.
100% of patients were refractory to pomalidomide or daratumumab, 98% had disease progression on or within 60 days of completion of the last therapy, 89% were double-refractory to IMiD:s and PI:s and 56% were refractory to both pomalidomide and daratumumab.
Analysis of the preliminary efficacy results showed an ORR of 32.1%, a CBR of 39.3% and that 84% of the patients achieved disease stabilization (SD or better).

Subgroup analysis suggests that response does not vary across refractory subsets but rather with the underlying disease and health status of the patient (in line with the observation made in Oncopeptides phase II study O-12-M1).
Time-to-next-treatment was maintained compared to the previous line of therapy without the deterioration normally seen in myeloma patients.
In the previous line of therapy, 75% of the patients were treated with antibody-based therapies or 2nd/3rd generation PI:s and IMiD:s, and 46% received triple combination therapies.
This study confirms earlier results from the O-12-M1 study in a more resistant patient population. The efficacy results in this interim analysis are encouraging with an ORR of 32,1% and a CBR of 39,3%.

Ygalo showed a manageable safety and tolerability profile. Treatment-related grade 3/4 AEs were reported in 48 (77%) patients with the majority being hematologic. Treatment-related non-hematologic grade 3/4 AEs were rare with infections in only 6% of patients.

About Ygalo

Ygalo is an alkylating peptide, belonging to the novel class of Peptidase Enhanced Compounds (PEnCs), targeting the multiple myeloma (MM) transformation process with a unique mechanism of action.

Aminopeptidases are heavily over-expressed in MM cells and are key to the transformational process of the disease. Ygalo selectively targets MM cells through aminopeptidase-driven accumulation, where in vitro experiments show a 50-fold enrichment of alkylating metabolites in MM cells. The enrichment results in selective cytotoxicity (increased on-target potency and decreased off-target toxicity), overcomes resistance pathways of existing myeloma treatments (including alkylators) and demonstrates strong anti-angiogenic properties.

Ygalo in clinical development

Ygalo has been used to treat late-stage RRMM patients in both phase I and phase II clinical studies (O-12-M1) with favorable results. Currently, Ygalo is being studied in three clinical trials for the treatment of multiple myeloma. The current studies are HORIZON, OCEAN and ANCHOR. A fourth study, BRIDGE in RRMM patients with impaired renal function will be initiated during Q3 this year to further investigate Ygalo in multiple myeloma.

The current clinical study program is intended to demonstrate better results from treatment with Ygalo compared to established alternative drugs for patients with late-stage multiple myeloma. Ygalo could potentially provide physicians with a new treatment option for patients suffering from this serious disease.

Ygalo has been investigated in the treatment of late-stage relapsed refractory multiple myeloma (RRMM) patients. This was done in the clinical study O-12-M1 where strong final results were reported in December 2017. Currently, three clinical studies are ongoing with Ygalo.

HORIZON is a Phase II study that studies the effect of Ygalo in late-stage RRMM patients with few or no remaining established treatment options. Updated interim data from this study are presented at EHA (Free EHA Whitepaper) in June 2018.

OCEAN is Oncopeptides´ pivotal Phase III study where Ygalo is compared directly with current standard of care, pomalidomide, in late-stage RRMM patients.

In the ANCHOR study, Ygalo will be administered in combination with either bortezomib or daratumumab in RRMM patients. The results of this study aim to create understanding and knowledge among treating physicians for how Ygalo can be used in combination with these drugs. In addition, the results could open up for the use of Ygalo in earlier lines of treatment.

Novartis study of real-world data concludes Jakavi is associated with a reduction in risk of death and dangerous blood clots for patients with rare blood cancer

On June 15, 2018 Novartis reported results from a new comparison study showing that Jakavi(ruxolitinib)-treated patients with polycythemia vera (PV), who were resistant or intolerant to hydroxyurea (HU), had a significantly reduced risk of thrombosis (blood clots) and death compared to PV patients who received best available therapy[1] (Press release, Novartis, JUN 15, 2018, View Source [SID1234527352]). The study findings are based on a comparison of patients in the Phase III RESPONSE Jakavi clinical trial and the real-world Spanish GEMFIN patient registry. PV is a rare and incurable blood cancer associated with an overproduction of blood cells that can cause serious cardiovascular complications, such as blood clots, stroke and heart attack[4].

The new findings were presented at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, Sweden.

"When you can complement clinical trial data with real-world experiences, it can provide valuable insight into how treatments affect patients in their day-to-day lives," said lead study investigator, Alberto Alvarez-Larran, MD, Hematology Department, Hospital Clinic, Barcelona, Spain. "This latest research supports the use of Jakavi to help people with polycythemia vera gain better control of their disease when hydroxyurea is not an option."

Additional Jakavi data presented at the EHA (Free EHA Whitepaper) Annual Congress includes efficacy and safety analyses of the largest expanded access trial of myelofibrosis (MF) patients treated with Jakavi to date (JUMP). An efficacy analysis showed that patients with lower-risk MF achieved spleen size reductions when treated with Jakavi, with most patients (82.1%) achieving a >=50% reduction at any time[2],[3]. A separate analysis identified factors that may lead to a greater spleen response in patients with MF treated with Jakavi, including treating earlier in the course of the disease and at a higher dose (>=10 mg BID)[5].

"With limited treatment options, patients with myeloproliferative neoplasms (MPNs) often struggle to keep their disease under control," said Samit Hirawat, MD, Head, Novartis Oncology Global Drug Development. "The research conducted by Novartis teams and our physician partners in both PV and MF is helping to clarify how Jakavi can help relieve disease burden for patients."

Additionally, 48-week data from the EXPAND study support Jakavi 10 mg BID as a starting dose in patients with MF with low platelet counts, providing important information in a patient population at an increased risk of bleeding and serious complications[5]. Nearly one-third of patients in the study treated with Jakavi achieved a >=50% reduction in spleen size at week 48 (31.8% of patients [7/22] with a platelet count of 75 to 99 x 109/L and 35.7% [5/14] of patients with a platelet count of 50 to 74 x 109/L)[5].

About the PV Real-World Comparison Study
The new data presented at EHA (Free EHA Whitepaper) compares overall survival and thrombosis (blood clots) rates using data from patients treated in the Jakavi arm of the RESPONSE trial and patients treated in a real-world setting with best available therapy (BAT) from the Grupo Español de Enfermedades Mieloproliferativas Crónicas Filadelfia Negativas (GEMFIN) registry[1].

In the previously reported Phase III RESPONSE trial, the high rate of crossover from BAT to Jakavi precluded the comparison of overall survival and thrombosis rates. RESPONSE was a global, open-label study that included patients with PV resistant to or intolerant of hydroxyurea, who were randomized 1:1 to receive either Jakavi (starting dose of 10 mg twice daily) or BAT, which was defined as investigator-selected monotherapy or observation only. The GEMFIN registry patients in the real-world BAT group had resistance or intolerance to hydroxyurea according to the modified European Leukemia Net criteria and received hydroxyurea (44%), busulfan (10%), radioactive phosphorus (2%), interferon (6%), anagrelide (12%), other therapy (11%) or no cytoreductive therapy (26%). Some patients were also treated with multiple therapies[1].

In the GEMFIN study, patients treated with Jakavi had a significantly prolonged overall survival (HR=0.28 [0.11-0.72]) and a lower risk of blood clots (HR=0.21 [0.06-0.76]) when compared to real-world patients treated with BAT[1].

About the JUMP Study
JUMP is an expanded access Phase IIIb study designed to further evaluate the safety and efficacy of Jakavi in MF. It includes the largest cohort of patients with MF treated with Jakavi, 2,233, to date. The study provided access to Jakavi for patients who had no access to the treatment outside of a clinical trial and included 60 patients who were determined to have DIPSS low-risk disease[2],[3].

About the EXPAND Study
EXPAND is an open-label, Phase Ib, dose-finding study in patients with MF with baseline platelet counts of 50 to 99 x 109/L. Results presented at EHA (Free EHA Whitepaper) are from the 48-week follow- period[5].

The study evaluated 10 mg BID as a safe starting dose of Jakavi. The key secondary endpoints are safety and efficacy, including proportion of patients achieving >=50% of reduction in spleen size. Safety findings were also consistent with previous studies of Jakavi[5].

About Myelofibrosis and Polycythemia Vera
Myelofibrosis (MF) and polycythemia vera (PV) are part of a group of related and rare blood cancers called myeloproliferative neoplasms (MPNs) in which bone marrow cells responsible for the body’s blood cells develop and function abnormally[4],[6].

In patients with MF, the bone marrow can no longer produce enough normal blood cells, causing the spleen to enlarge. MF affects approximately one in every 100,000 people[6].

PV is associated with an overproduction of blood cells that can cause serious cardiovascular complications if left inadequately controlled, such as blood clots, stroke and heart attack. PV affects up to three per 100,000 people globally each year[4].

About Jakavi
Jakavi (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. Jakavi is approved by the European Commission for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea and for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (MF) (also known as chronic idiopathic MF), post-polycythemia vera MF or post-essential thrombocythemia MF. Jakavi is approved in 101 countries for patients with MF, including EU countries, Switzerland, Canada, Japan and in more than 75 countries for patients with PV, including EU countries, Switzerland, Japan and Canada. The exact indication for Jakavi varies by country. Additional worldwide regulatory filings are underway in MF and PV.

Novartis licensed ruxolitinib from Incyte Corporation for development and commercialization outside the United States. Jakavi is marketed in the United States by Incyte Corporation as Jakafi for the treatment of patients with PV who have had an inadequate response to or are intolerant of hydroxyurea and for the treatment of patients with intermediate or high-risk MF.

The recommended starting dose of Jakavi in PV is 10 mg given orally twice daily. The recommended starting dose of Jakavi in MF is 15 mg given orally twice daily for patients with a platelet count between 100,000 cubic millimeters (mm[3]) and 200,000 mm[3], and 20 mg twice daily for patients with a platelet count of >200,000 mm[3]. Doses may be titrated based on safety and efficacy. There is limited information to recommend a starting dose for MF and PV patients with platelet counts between 50,000/mm[3] and <100,000/mm[3]. The maximum recommended starting dose in these patients is 5 mg twice daily, and patients should be titrated cautiously[7].

Jakavi is a registered trademark of Novartis AG in countries outside the United States. Jakafi is a registered trademark of Incyte Corporation. The safety and efficacy profile of Jakavi has not yet been established outside the approved indications.

Jakavi Important Safety Information for Treatment of Myelofibrosis (MF) and Polycythemia Vera (PV)
Jakavi can cause serious side effects, including a decrease in blood cell count and infections. Complete blood count monitoring is recommended. Dose reduction or interruption may be required in patients with any hepatic impairment or severe renal impairment or in patients developing hematologic adverse reactions such as thrombocytopenia, anemia and neutropenia. Dose reductions are also recommended when Jakavi is co-administered with strong CYP3A4 inhibitors or fluconazole. Use of Jakavi during pregnancy is not recommended, and women should avoid becoming pregnant during Jakavi therapy. Women taking Jakavi should not breast feed. Progressive multifocal leukoencephalopathy (PML) has been reported. Physicians should be alert for neuropsychiatric symptoms suggestive of PML. Hepatitis B viral load (HBV-DNA titer) increases have been reported in patients with chronic HBV infections. Patients with chronic HBV infection should be treated and monitored according to clinical guidelines. Non-melanoma skin cancer (NMSC) has been reported in Jakavi treated patients. Periodic skin examination is recommended. Very common adverse reactions in MF (>10%) include urinary tract infections, anemia, thrombocytopenia, neutropenia, hypercholesterolemia, dizziness, headache, alanine aminotransferase increased, aspartate aminotransferase increased, bruising and weight gain. Common adverse reactions in MF (1 to 10%) include herpes zoster and flatulence. Uncommon adverse reactions in MF include tuberculosis. Very common adverse reactions in PV (>10%) include anemia, thrombocytopenia, hypercholesterolemia, hypertriglyceridemia, dizziness, alanine aminotransferase increased and aspartate aminotransferase increased. Common adverse reactions in PV (1 to 10%) include urinary tract infections, herpes zoster, weight gain, constipation and hypertension.

Please see full Prescribing Information available at www.jakavi.com.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

MEI Pharma Presents Clinical Data on ME-401 at the European Hematology Association Congress

On June 15, 2018 MEI Pharma, Inc. (NASDAQ: MEIP) a pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer, reported that results from a Phase 1b study of ME-401 in patients with relapsed or refractory follicular lymphoma (FL), chronic lymphocytic lymphoma (CLL) and small lymphocytic lymphoma (SLL) are being presented during a poster presentation today, Friday, June 15, 2018 at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, Sweden (Press release, MEI Pharma, JUN 15, 2018, View Source [SID1234527351]). Complete data results on the Phase 1b study were previously announced at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago in June 2018.

"The data demonstrates that ME-401 achieved a 90% response rate across all patient groups treated and was generally well tolerated with no dose-limiting toxicities identified at any dose level," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "The full data from our ME-401 study is very encouraging and we expect to initiate a registration study for ME-401 this year for the treatment of adults with relapsed or refractory FL."

ME-401 is being evaluated in a Phase 1b dose escalation study in patients with relapsed or refractory FL, CLL and SLL. As of May 14, 2018, 46 patients were enrolled: 31 patients received monotherapy and 30 were evaluable for efficacy (12 patients at 60 mg, 12 patients at 120 mg and six patients at 180 mg). Based on the data, the Company determined that no further dose escalation was required. An expansion cohort of up to 30 patients with FL, CLL and SLL was added to further evaluate the safety and efficacy of ME-401 as a single agent at the 60 mg dose. An additional 15 patients are enrolled in the study arm evaluating ME-401 (60 mg) in combination with rituximab (marketed as Rituxan) in patients with various B cell malignancies.

The ME-401 EHA (Free EHA Whitepaper) 2018 poster can be accessed on the MEI Pharma website.

TG Therapeutics, Inc. Announces Clinical and Preclinical Data Presentations at the 23rd Congress of the European Hematology Association

On June 15, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the presentation of an integrated analysis of long term safety data of umbralisib (TGR-1202), the Company’s PI3K delta inhibitor, either dosed as a single agent and in combination, in patients with relapsed or refractory lymphoid malignancies, as well as the first preclinical data presentation of TG-1701, the Company’s orally available and covalently-bound BTK inhibitor (Press release, TG Therapeutics, JUN 15, 2018, View Source [SID1234527350]). Data from these trials are being presented today during the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper).

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We are extremely pleased to present updated data from our integrated safety analyses of umbralisib. There is a generally held belief that severe toxicities are more common following 6 months of exposure on a PI3K delta inhibitor. While this has held true for first generation delta inhibitors, we are pleased to present data from 177 patients on daily umbralisib for more than 6 months, ranging upwards of 5+ years, and believe the long-term follow-up data demonstrates that umbralisib has a differentiated safety profile, uniquely distinct from prior generation PI3K delta inhibitors." Mr. Weiss continued, "The differentiated safety profile of umbralisib is critical as we think about potential triple and quad combination strategies, especially in combination with our novel, proprietary BTK inhibitor, TG-1701, for which we also presented some exciting pre-clinical data. The kinase profile of TG-1701 looks quite competitive with the most specific BTK inhibitors and more selective than ibrutinib. We look forward to seeing more data on TG-1701 and expect to open a TG sponsored Phase 1/2 trial later this year."

Highlights from today’s presentations include the following:

Poster Presentation: Long term integrated safety analysis of umbralisib (TGR-1202), a PI3K delta/CK1-epsilon inhibitor with a differentiated safety profile in patients with relapsed/refractory lymphoid malignancies

This presentation builds on a prior integrated analysis of 347 patients with relapsed or refractory lymphoid malignancies presented last year. The presentation includes data that were pooled from 4 completed or ongoing Phase 1 or 2 studies containing umbralisib, focusing on 177 patients who have been on daily umbralisib for a minimum of 6 months. Patients were heavily pretreated, with 45% of patients having seen 3 or more prior lines of therapy.

Highlights from this poster include:

● Umbralisib continues to exhibit a differentiated safety profile compared to prior generation PI3K delta inhibitors

● 177 patients have been treated with daily umbralisib for 6+ months, with a median duration of exposure of 1.3 years, and 33% patients on drug 2+ years and the longest patients on daily umbralisib for over 5 years

o Serious adverse events occurring in >1% of patients were limited to pneumonia (3%), diarrhea (2%), and cellulitis (2%)

o Only 2% of patients discontinued as a result of diarrhea/colitis after being on umbralisib for more than 6 months
oDiscontinuations due to other adverse events (AEs) of interest for prior generation PI3K inhibitors were also rare

Poster Presentation: TG-1701 is a novel, orally available, and covalently-bound BTK inhibitor

● TG-1701, a novel, specific and covalent BTK inhibitor, is more selective than ibrutinib toward a set of kinases

● BTK occupancy assays in vitro and in vivo suggest that 100% occupancy can be reached using low doses of TG-1701 in human dose escalation clinical trial

● In pre-clinical experiments, TG-1701 inhibited the phosphorylation of BTK and other kinases downstream of the BCR pathway.

● In cellular and animal models of b-cell malignancies, TG-1701 demonstrated similar antitumor efficacy to ibrutinib and acalabrutinib

Kitov Announces Positive Pre-Clinical Data from NT219
Demonstrating its Dose-Dependent Anti-Tumor Efficacy

On June 15, 2018 Kitov Pharma Ltd. (NASDAQ: KTOV) (TASE: KTOV), an innovative biopharmaceutical company, reported positive results in a pre-clinical study testing NT219, a first-in-class small molecule targeting IRS1/2 and STAT3, two signal proteins that are part of an anti-cancer drug resistance mechanism (Press release, Kitov Pharmaceuticals , JUN 15, 2018, View Source [SID1234527349]). The study, conducted by Kitov’s majority-owned subsidiary, TyrNovo Ltd., evaluated NT219 in combination with gemcitabine in a patient-derived xenograft (PDX) model of pancreatic cancer and was conducted in accordance with guidance from the U.S. Food and Drug Administration (FDA). The results support the planned submission of the Investigational New Drug (IND) Application for NT219.

NT219 was tested at three dose levels in combination with gemcitabine vs. gemcitabine alone. A clear dose response effect was observed among treatment arms with statistically significant differences among groups (p-value <= 0.0166). In addition, the study confirmed previous findings that demonstrated the beneficial effect of the combination of NT219 with gemcitabine vs. gemcitabine alone (p-value <0.0001).

Kitov also announced that it has agreed to acquire all of the shares of TyrNovo held by the last remaining unaffiliated shareholder, representing approximately 3.1% of TyrNovo’s issued and outstanding shares, based on an agreed upon TyrNovo company valuation of $10 million. In exchange for the TyrNovo shares and termination of all shareholder and investment agreements with this shareholder, Kitov will issue 2,816,900 new ordinary shares (equivalent to 140,845 American Depositary Shares (ADS)) of Kitov. Following the closing of this transaction, Kitov will hold approximately 97.1% of TyrNovo’s issued and outstanding ordinary shares. The remaining 2.9% of TyrNovo’s shares are held by Dr. Hadas Reuveni, TyrNovo’s founder and chief technology officer.

"These compelling NT219 pre-clinical results represent an important milestone towards the submission of an IND and the initiation of a clinical trial, which we expect will occur in 2019," said Isaac Israel, Kitov’s CEO. "Based on the results generated to date and its profile, we believe NT219 has the potential to be a new treatment option for pancreatic cancer patients. This compelling product candidate previously demonstrated impressive efficacy results in converting non-responding tumors to responders, as well as blocking tumor progression in combination with various oncology drugs, and in a wide range of tumor types. These positive data also further our confidence in the potential of TyrNovo to create significant value for Kitov’s shareholders. As such, we are pleased to have completed the acquisition of substantially all of the remaining minority shares of TyrNovo, and look forward to the continued development of NT219 in oncology."

About TyrNovo

TyrNovo Ltd., a Kitov Pharma (NASDAQ/TASE: KTOV) company, is a developer of novel small molecules in the oncology therapeutic field. TyrNovo is developing NT219, an oncology product designed to be used in combination with other oncology drugs. NT219 is a small molecule dual inhibitor of Insulin Receptor Substrate (IRS1/2) and of Signal Transducer and Activator of Transcription (STAT3), two signal pathways that are involved in the development of cancer drug resistance. In combination with various approved oncology drugs, NT219 has demonstrated potent anti-tumor effects and increased survival in various cancer models, including sarcoma, melanoma, pancreatic, lung, ovarian, head & neck, prostate and colon cancers. Its mechanism of action is through the prevention of acquired resistance in tumors and by regression of resistant tumors. For more information on TyrNovo please visit View Source