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British Company Behind Groundbreaking Breast Cancer Treatment

On June 7, 2019 Astex Pharmaceuticals reported A new set of statistically significant overall survival (OS) data unveiled at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract# LBA1008), and published in The New England Journal of Medicine, are being heralded as a major breakthrough forpre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancerpremenopausal women with advanced breast cancer (Press release, Astex Pharmaceuticals, JUN 7, 2019, View Source [SID1234536950]).

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Kisqali was discovered and developed by the Novartis Institutes for Biomedical Research (NIBR) under a research collaboration entered into with Astex in 2005. Kisqali is a CDK4/6 inhibitor that slows the progression of cancer by inhibiting two proteins (CDK4 & CDK6) which, when over-activated, can enable cancer cells to grow and divide quickly.

Successful results from the phase III MONALEESA-7 clinical trial resulted in Kisqali receiving marketing approval in the US and EU in 2018 in combination with an endocrine-based therapy for pre- and perimenopausal women with (HR+/HER2-) locally advanced or metastatic breast cancer in combination with an aromatase inhibitor.

The UK’s National Institute for Health and Care Excellence (NICE) recommended Kisqali as a cost-effective treatment option for postmenopausal women within England and Wales with advanced breast cancer in November 2017. Advanced breast cancer in premenopausal women is the leading cause of cancer death in women 20-59 years old [1],[2].

Kisqali is the only CDK4/6 inhibitor to show superior overall survival in a clinical trial (alt. "v. placebo") in advanced breast cancer (HR=0.712; p=0.00973)[3]. In its announcement at ASCO (Free ASCO Whitepaper), Novartis noted that the new data from its MONALEESA-7 trial showed that after a median of 42 months follow-up, survival rate for women was 70.2% for women who received Kisqali combination therapy compared to 46.0% for women who received endocrine therapy alone. The breakthrough data has been widely reported in the world’s press.

Harren Jhoti Ph.D., President and CEO of Astex, UK, said, "It’s fantastic to see such a significant advance in cancer treatment. Ultimately as life science entrepreneurs, our goal is to improve lives through the discovery of new therapies. Kisqali was the first new cancer drug discovered and developed from our collaboration with Novartis to reach marketing approval and was a milestone for the company in 2017. These new data are a real milestone for patients."
The paper,Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer, was a published in The New England Journal of Medicinetoday and is available online.

See the discovery journey for Kisqali, here: View Source

AbbVie to Present at the Goldman Sachs Global Healthcare Conference

On June 7, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the Goldman Sachs 40th Annual Global Healthcare Conference on Wednesday, June 12, 2019 (Press release, AbbVie, JUN 7, 2019, View Source [SID1234536949]). Michael Severino, vice chairman and president, will present at 10:00 a.m. Central time.

A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

Otsuka and Taiho Announce that Taiho Will Commercialize Two of Astex Pharmaceuticals’ Drug Candidates in North America

On June 7, 2019 Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Taiho Pharmaceutical Co., Ltd. reported that commercialization rights in the U.S. and Canada for anti-cancer drug candidates guadecitabine and ASTX727 will be transferred to Taiho Oncology, Inc. and Taiho Pharma Canada, Inc., respectively, from Astex Pharmaceuticals, an Otsuka subsidiary (Press release, Taiho, JUN 7, 2019, View Source [SID1234536942]). Otsuka and Taiho are both part of the Otsuka group of companies.

Taiho Pharmaceutical presently markets its antineoplatic agent LONSURF (trifluridine and tipiracil) in the U.S. and Canada, respectively, through subsidiaries Taiho Oncology and Taiho Pharma Canada. Astex will remain responsible for development of its two promising, late-stage-development candidates, guadecitabine and ASTX727.

Otsuka Pharmaceutical and Taiho Pharmaceutical aim to maximize their business impact and value by bringing together assets from across the Otsuka group of companies, including their respective strengths and experiences in the oncologic, psychiatric, neurologic, cardiovascular and renal fields.

Astex’s development-stage drug candidates for which North American commercialization rights will be transferred include: Guadecitabine Acute myeloid leukemia（AML） Phase 3 Myelodysplastic syndrome（MDS） Phase 3 Ovarian cancer Phase 2 A next-generation, low-molecular-weight DNA methylation inhibitor that is designed to allow the active metabolite decitabine to work longer in the body and thereby efficiently reach tissues such as the bone marrow. Therapeutic effects on patients with MDS and AML are hypothesized to occur through restoration of the function of inactivated tumor suppressor genes in cancer cells, thereby suppressing cancer formation and growth.

ASTX727 Myelodysplastic syndrome（MDS） Phase 3 The first-ever, fixed-dose-combination, oral DNA methylation inhibitor that combines the metabolic enzyme inhibitor cedazuridine with decitabine, the active ingredient of the DNA methylation inhibitor Dacogen. Preliminary results of phase 3 trials in patients with MDS indicated that the plasma drug concentration-time curve (AUC) and pharmacodynamics, safety, and tolerability were equivalent to those of Dacogen injections.

Nordic Nanovector to present preclinical studies with 212Pb-NNV003, a novel CD37-specific Targeted Alpha Therapy for CLL and NHL, at TRP 2019

On June 6, 2019 Nordic Nanovector ASA (OSE: NANO) reported that its Chief Scientific Officer, Jostein Dahle, will present results from preclinical studies with 212PB-NNV003, a novel Targeted Alpha Therapy comprising its proprietary CD37-specific antibody (NNV003) coupled with the alpha-particle generating radioisotope lead-212 (212Pb) in models of chronic lymphocytic leukaemia (CLL) and non-Hodgkin lymphoma (NHL) at the Targeted Radiopharmaceuticals Summit taking place in Munich, Germany on 12-13 June (Press release, Nordic Nanovector, JUN 6, 2019, View Source [SID1234553448]).

The presentation will take place at 13th June 09:30-10:00 CEST and is entitled:

Targeted alpha therapy with 212Pb-NNV003 for the treatment of CD37 positive B-cell chronic lymphocytic leukaemia (CLL) and non-Hodgkin lymphoma (NHL)

CD37 is highly and selectively expressed on the surface of mature B lymphocytes and B-cell malignancies and may become a useful alternative to the CD20 target, due to the emergence of resistance to anti-CD20 therapies.

Alpha-emitting radionuclides have demonstrated good potential for cancer targeted therapies because of short-range alpha energy deposition (50–100 µm) that causes irreparable DNA double-strand breaks and localized cytotoxicity while sparing surrounding healthy tissues.

The targeted alpha therapy 212Pb-NNV003 has been developed under a collaboration between Nordic Nanovector and Orano Med.

Kiadis Pharma completes acquisition of CytoSen Therapeutics, Inc.

On June 6, 2019 Kiadis Pharma N.V. ("Kiadis" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company, reported that it has closed the previously announced acquisition of CytoSen Therapeutics, Inc. ("CytoSen") (Press release, Kiadis, JUN 6, 2019, View Source [SID1234551152]).

The transaction creates a leader in cell-based cancer immunotherapy with proprietary and synergistic NK-cell and T-cell therapy platforms that have the potential to revolutionize HSCT and create a pipeline with novel cancer treatments. Kiadis now has a complementary development pipeline focused on improving outcomes for patients undergoing hematopoietic stem cell transplants (HSCT) with a T-cell therapy (ATIR101; in EU registration and a global Phase 3 clinical trial) and a NK-cell therapy (CSTD002; expected to enter the clinic in the US in 2020).

Arthur Lahr, CEO of Kiadis commented: "Our vision is to leverage the strengths of the human immune system to help patients with life-threatening diseases and through this acquisition we can now create novel cell therapies that combine the innate and adaptive arms of the immune system. This transaction is transformative for Kiadis as we now have two synergistic proprietary cell-based immunotherapy platforms and the ability to create a pipeline of innovative treatments for cancer patients."

Total upfront consideration paid to the holders of CytoSen shares and options on closing consists of 1,513,052 newly issued Kiadis shares and 159,778 options to acquire Kiadis shares. Upon acceptance by aforementioned parties of the shares issued to them, the newly issued Kiadis shares shall be admitted to trading on Euronext Amsterdam and Euronext Brussels on the basis of the listing prospectus within the meaning of Directive 2003/71/EC, as amended and Directive 2010/73/EU consisting of the registration document approved by the Netherlands Authority for the Financial Markets (Autoriteit Financiële Markten, "AFM") dated May 31, 2019 and the summary and securities note approved by the AFM dated May 31, 2019 that have been made generally available. Of the 1,513,052 newly issued Kiadis shares, 874,129 shares (57.8%) are subject to lock-up restrictions during a two-year period, and the other 638,923 shares (42.2%) are subject to lock-up restrictions during a 180-day period.

Further to the abovementioned 1,513,052 newly issued Kiadis shares, the holders of CytoSen shares have a conditional entitlement to receive 267,012 newly issued Kiadis shares – the Holdback Shares as defined in the listing prospectus. The Holdback Shares serve as a source for the satisfaction of indemnification and other claims that Kiadis may have on the CytoSen shareholders pursuant to the acquisition agreement. Subject to reduction in respect of these indemnification and other claims, the Holdback Shares will be issued 18 months from the completion date. Also, as per the acquisition agreement, the holders of CytoSen shares and options are eligible to potential future consideration of up to 5,819,460 additional Shares upon the achievement of six clinical development and regulatory milestones.

About ATIR101 and CSTD002
Administered as adjunctive immunotherapeutics on top of HSCT, ATIR101 and CSTD002 provide a lymphocyte infusions with functional, mature and potent immune cells from a haploidentical family member. The T-cells in ATIR101 and NK-cells in CSTD002 will help fight infections and remaining tumor cells, until the immune system has fully re-grown from stem cells in the transplanted graft. In addition, CSTD002 has shown promise in the treatment of relapse/refractory AML.

In ATIR101, T-cells that would cause GVHD are depleted from the donor lymphocytes, using our photodepletion technology. At the same time, ATIR101 contains potential cancer-killing T-cells from the donor that could eliminate residual cancer cells and help prevent relapse of the disease.

In CSTD002, nanoparticle processing technology enables improved ex vivo expansion and activation of NK-cells supporting multiple high-dose infusions with potent anti-cancer cytotoxicity.