On October 06, 2017 Molecular Templates, Inc., (Nasdaq:MTEM) a clinical stage biopharmaceutical company focused on the discovery and development of Engineered Toxin Bodies (ETBs), a new class of targeted biologic therapies that possess unique mechanisms of action in oncology, reported that Eric E. Poma, Ph.D., Chief Executive and Chief Scientific Officer, will provide a corporate overview at the 2017 BIO Investor Forum, being held October 17-18 in San Francisco, California (Press release, Molecular Templates, OCT 6, 2017, View Source [SID1234520805]).
BIO Investor Forum
Date: Tuesday, October 17
Time: 10:30am Pacific Time
Location: Westin St. Francis, San Francisco, Elizabethan C Ballroom
Webcast: http://www.veracast.com/webcasts/bio/investorforum2017/25111335172.cfm
Kitov Boosts Ownership in TyrNovo and Oncology Platform Through Exchange of Shares for Stock
On October 6, 2017 Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV), (“Kitov” or “the Company”) an innovative biopharmaceutical company, reported the acquisition of an additional 27% stake in TyrNovo Ltd., a privately- held developer of novel small molecules in the oncology therapeutic field, from unaffiliated minority shareholders (Press release, Kitov Pharmaceuticals , OCT 6, 2017, View Source [SID1234520804]). As announced on January 13, 2017, Kitov had acquired a controlling interest, which is now approximately 65% of TyrNovo. After the closing of this transaction, Kitov will hold approximately 92% of TyrNovo’s issued and outstanding ordinary shares.
Following negotiations with a group of unaffiliated minority shareholders who collectively hold approximately 27%, of TyrNovo, the Company has entered into an agreement to acquire their shares based on an agreed upon TyrNovo valuation of $7 million. In exchange for these TyrNovo shares, Kitov will issue 13,169,689 new shares (equivalent to 658,484 American Depositary Shares or ADSs) of Kitov, at an agreed upon price, in excess of prevailing market prices, of $2.50 per ADS.
“Since early 2017, NT219 demonstrated impressive efficacy results including in combination with Keytruda, where it converted non-responding tumors to responders and blocked tumor progression in an immuno-oncology preclinical model. We are pleased to have negotiated the opportunity for Kitov to increase its stake in TyrNovo. We are committed to the development of NT219, which we believe is a highly attractive asset for Kitov’s shareholders in the growing field of oncology” stated Mr. Isaac Israel, Chief Executive Officer. “We believe that expanding our ownership in TyrNovo provides a significant opportunity for further growth of Kitov and added value to our shareholders.”
“Based on the pre-clinical results generated to date, we are receiving solid preliminary interest from potential strategic partners for NT219, which presents a novel, first-in-class mechanism of action in the oncology field.”
About NT219
NT219 is a small molecule that presents a new concept in cancer therapy by promoting the degradation and the phosphorylation of two oncology-related checkpoints, Insulin Receptor Substrates (IRS) 1 and signal transducer and activator of transcription 3 (STAT3), respectively. 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 -drug resistance and reversing resistance after it has been acquired. In combination with various approved oncology drugs, NT219 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.
Incyte and Cancer Support Community Delaware Announce the Establishment of the Incyte Cancer Care Assistance Fund for Delaware
On October 6, 2017– Incyte Corporation (Nasdaq:INCY) and Cancer Support Community Delaware (CSCDE) reported the establishment of the Incyte Cancer Care Assistance Fund for Delaware which will provide emergency financial assistance for cancer patients, their caregivers and family members living in Delaware (Press release, Incyte, OCT 6, 2017, View Source;p=RssLanding&cat=news&id=2305148 [SID1234520802]).
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Through the Incyte Charitable Giving Foundation, Incyte has committed to providing a maximum of $100,000 each year to CSCDE over the next 5 years, beginning in 2018.
"We are very pleased to announce the creation of the Incyte Cancer Care Assistance Fund for Delaware with Cancer Support Community Delaware, an organization which, like Incyte, is dedicated to supporting patients with cancer and the local community," said Paula Swain, Executive Vice President of Human Resources and Chair of The Incyte Charitable Giving Foundation. "Today, as we celebrate the opening of our newly expanded headquarters in Wilmington, we reaffirm our commitment to Delaware and to the well-being of the communities we serve."
The fund will be administered by Cancer Support Community Delaware. Additional details about the Incyte Cancer Care Assistance Fund for Delaware will be made available in January 2018.
"Through the establishment of this fund, we aim to address the emergent needs that patients with cancer in Delaware face as they navigate their disease and its impact across all aspects of their lives," said Nicole Topkis Pickles, Executive Director of Cancer Support Community Delaware.
[PDF]Kyowa Hakko Kirin Announces Discontinuation for Developing ARQ 197 (Tivantinib)
On October 6, 2017 Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, “Kyowa Hakko Kirin”) reported the discontinuation for developing ARQ 197 (generic name: tivantinib) (Press release, Kyowa Hakko Kirin, OCT 6, 2017, View Source [SID1234520801]).
ARQ 197 is an oral agent whose molecular target is c-Met, which was discovered by ArQule, Inc. (NASDAQ: ARQL, “ArQule”). Kyowa Hakko Kirin signed a license agreement with ArQule for the exclusive rights to the development and sales of tivantinib in Japan and some parts of Asia (China, Korea, and Taiwan) on April 27th, 2007.
Under the license agreement, Kyowa Hakko Kirin developed ARQ 197 for indications of gastric cancer, non-small-cell lung cancer and hepatocellular carcinoma in its territory. However, positive results were not acquired in any studies. Concerning the situation, Kyowa Hakko Kirin discontinued ARQ 197 development project.
“We are disappointed in these results, as we had hoped ARQ197 might offer a new option for the thousands of cancer patients,” said Mitsuo Satoh, Ph.D., Head of Research and Development Division of Kyowa Hakko Kirin. “We would like to express our sincere thanks for the patients in our studies, as well as to the investigators, for their contributions to our development. We are continuously committed to tackling the unmet medical needs in cancer.”
The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.
About c-Met
c-Met is receptor tyrosine kinase. When abnormally activated, the c-Met receptor tyrosine kinase plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis.
NICE recommends access to AbbVie’s VENCLYXTO (venetoclax) to treat
most common form of adult leukaemia in England via Cancer Drugs Fund
On October 5, 2017 the National Institute for Health and Care Excellence(NICE) reported a final appraisal determination (FAD) recommending that AbbVie’s VENCLYXTO(venetoclax) is made available to NHS patients with difficult-to-treat types of chronic lymphocyticleukaemia (CLL) via the Cancer Drugs Fund (CDF), providing conditions of the managed accessagreement are followed (Press release, PharmaTimes, OCT 5, 2017, View Source [SID1234520814]). Venetoclax will now be available on the NHS to adult patients in Englandwith CLL in the absence of 17p deletion or TP53 mutation who have failed bothchemo-immunotherapy and a B-cell receptor (BCR) inhibitor. Venetoclax has also beenrecommended for the treatment of adult CLL patients in the presence of 17p deletion or TP53mutation who are either unsuitable for or have failed a BCR inhibitor.2 Please see the NICE websitefor the eligibility criteria: View Source appraisal-determination-document.
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Today’s recommendation marks the continuation of patient access across the UK, following therecent acceptance of venetoclax for use across NHS Scotland this August.
The immediate inclusion of venetoclax in the Cancer Drugs Fund is a positive step forward forpatients with CLL in England" commented David Innes, Chair of the CLL Support Association. "Accessto new treatment options is vital for patients with challenging forms of CLL, who have a short lifeexpectancy after exhausting current treatment options. We are pleased to see AbbVie and NICEworking together to expedite patient access and are hopeful that this will ultimately translate intolonger-term routine prescribing on the NHS, providing an essential treatment option for those livingwith CLL and their families."
Venetoclax, is a first-in-class, oral, once-daily medicine that selectively inhibits the function of theBCL-2 protein, restoring the body’s ability to trigger cancer cell self-destruction.2 For those patientsliving with CLL requiring treatment, the majority will eventually have their disease recur,3 with one intwo patients failing current treatments facing survival as short as three months.4,5 Venetoclax isbeing developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, amember of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
Dr Peter Hillmen, Professor of Experimental Haematology and Honorary Consultant Haematologistat Leeds Teaching Hospitals NHS Trust, commented, "Today’s recommendation is great news forpatients with CLL who have failed existing treatments, and provides clinicians with an important newtreatment option. The studies that NICE has assessed to reach this positive decision represent a 4UB 2 milestone in the management of relapsed/refractory CLL. The early clinical data is compelling,showing survival benefits for this challenging group of patients, including some who achievedcomplete remission. I would anticipate that collection of further data through the CDF will confirmthese extremely promising early findings."
CLL affects the blood and immune system and is the most common form of adult leukaemia withalmost 3,500 people affected in the UK each year, with over 3,000 cases in England alone.6,7 Forpeople who develop or harbour gene mutations, such as 17p deletion and/or TP53 mutation,treatment is particularly challenging and these are associated with poorer quality of life and amedian life expectancy of less than two to three years with current standard-of-care regimens.
In a Phase 2 study (M13-982) of 158 patients with relapsed and/or refractory CLL with a 17pdeletion, the overall response rate was 77.2% (122/158) according to investigator assessment.10,11Based on Kaplan-Meier estimations, 86.7% of patients were estimated to be alive following 12months of treatment.11 In a separate Phase 2 two arm study (M14-032) of venetoclax in 64 CLLpatients who relapsed or were refractory to BCR inhibitors (ibrutinib or idelalisib), the primaryendpoint, overall response rate, was 67% and 57% respectively, according to investigatorassessment.11 Venetoclax has also demonstrated early and sustained improvements in fatigue, adebilitating symptom of CLL, with reductions observed at just 4 weeks.
A recent study supports the use of Minimal Residual Disease (MRD) negativity as a prognosticmarker for long-term progression-free survival and as a potential therapeutic goal in CLL. MRDnegativity describes the presence of a small number of leukaemic cells that remain followingtreatment and is defined as <1 CLL cell detectable per 10,000 leukocytes.13,14 In a Phase 2 study inpatients with relapsing and refractory CLL with the del(17p) gene mutation, a high risk prognosticfactor, MRD was used as an exploratory endpoint. Of 158 patients who were treated withvenetoclax, 24% of patients (38/158) achieved MRD negativity in the peripheral blood, including 16patients who were also MRD negative in the bone marrow.
Venetoclax was the first blood cancer medicine to be given positive scientific opinion through theEarly Access to Medicines Scheme (EAMS), following its designation as a Promising InnovativeMedicine (PIM) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA)designation.
4UB 3As part of AbbVie’s ongoing focus on delivering breakthrough medicines, it has worked with theMHRA and NHSE to provide 50 patients in the UK with early access to venetoclax via EAMS. OnceEAMS ceased, AbbVie made a commitment to providing the treatment free of charge untilreimbursement. Through a combination of EAMS and free of charge supply, approximately 100patients with a high unmet need have benefitted from early access to venetoclax.