On June 29, 2017 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported that the company has advanced CX-2029, a Probody drug conjugate (PDC) targeting CD71 and being developed in collaboration with AbbVie, into GLP toxicology studies, a key step on the path to filing an Investigational New Drug (IND) application in 2018 (Press release, CytomX Therapeutics, JUN 29, 2017, View Source [SID1234519720]). Upon commencement of the GLP toxicology study, CytomX will receive a $15 million milestone payment from AbbVie as part of the 2016 strategic oncology collaboration between the companies. Schedule your 30 min Free 1stOncology Demo! "CD71 is highly attractive for delivery of cytotoxic payloads to cancer cells, but its presence on normal cells has precluded the development of antibody drug conjugates using this high-potential target. We have used our Probody platform to design and optimize CX-2029, a CD71-targeting Probody drug conjugate with the potential to safely and effectively treat a wide range of cancers," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "Rapid progression of the CX-2029 program to this important milestone has been enabled by our close collaboration with AbbVie, and we look forward to advancing this first-in-class molecule into the clinic."
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About CD71 and the CytomX/AbbVie 2016 Strategic Oncology Collaboration
CytomX and AbbVie are co-developing a PDC against CD71, with CytomX leading pre-clinical and early clinical development. CD71 is also known as the transferrin receptor 1 (TfR1), the biological function of which is to internalize iron-complexed transferrin into dividing cells. CD71 is highly and homogeneously expressed on many solid and hematologic tumor types. These properties render CD71 an ideal target for antibody drug conjugate strategies except for the fact that the target is present on most normal cells. CX-2029 has been designed to target CD71 on tumor cells and spare normal cells by localizing the drug candidate’s activity primarily to cancer tissue. AbbVie will lead later development and commercialization with global late-stage development costs shared between the two companies. CytomX received an upfront payment of $30 million and is eligible to receive up to $470 million in development, regulatory and commercial milestones, pending the achievement of pre-determined outcomes. AbbVie will lead global commercial activities with CytomX eligible to receive a profit share in the U.S. and tiered double-digit royalties on net product sales outside of the U.S. CytomX retains an option to co-promote in the U.S.
AbbVie also receives exclusive worldwide rights to develop and commercialize Probody drug conjugates against up to two additional, undisclosed targets. Should AbbVie ultimately pursue these targets, CytomX is eligible to receive additional milestone and royalty payments per target on any resulting products.
Author: [email protected]
141st Ordinary General Meeting of Shareholders
June 28, 2017 141 st Ordinary General Meeting of Shareholders Christophe Weber President & CEO 1 Important Notice Forward ‐ Looking Statements This presentation contains forward ‐ looking statements regarding Takeda’s future business, financial position and results of operations, including estimates, forecasts, targets and plans. These forward ‐ looking statements may be identified by the use of forward ‐ looking words such as "aim," "anticipate," "assume," "believe," "continue," "endeavor," "estimate," "expect," "forecast," "initiative," "intend," "may," "outlook," "plan," "potential," "probability," "pro ‐ forma," "project," "risk," "seek," "should," "strive," "target," "will" or similar words, or expressions of the negative thereof, or by discussions of strategy, plans or intentions. Any forward ‐ looking statements in this document are based on the current assumptions and beliefs of Takeda in light of the information currently available to it. Such forward ‐ looking statements do not represent any guarantee by Takeda or its management of future performance and involve known and unknown risks, uncertainties and other factors, including but not limited to: the economic circumstances surrounding Takeda’s business, including general economic conditions in Japan, the United States and worldwide; competitive pressures and developments; applicable laws and regulations; the success or failure of product development programs; decisions of regulatory authorities and the timing thereof; changes in exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; and post ‐ merger integration with acquired companies, any of which may cause Takeda’s actual results, performance, achievements or financial position to be materially different from any future results, performance, achievements or financial position expressed or implied by such forward ‐ looking statements. Neither Takeda nor its management gives any assurances that the expectations expressed in these forward ‐ looking statements will turn out to be correct, and actual results, performance or achievements could materially differ from expectations. Any forward looking statements herein speak only as of the date of this document, and Takeda and its management undertake no obligation to update or revise any forward ‐ looking statements or other information contained in this presentation, whether as a result of new information, future events or otherwise. Medical Information This presentation contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drug including the ones under development. 2 Our mission is to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine Vision 2025 • We serve the needs of our patients, wherever they are. • We earn the trust of society and customers through Takeda ‐ ism. • We are recognized as best in class because of agility and innovation, qualities that help us build a steady pipeline and deliver growth, year on year. Mission Major trends shaping our business environment 3 Society Pharma industry Science & technologies advancing Unmet medical needs Demand for access to medicine Aging population Healthcare system under significant financial pressure Digital More scientific innovation Growth driven by innovation in the U.S. and by innovation and demand in EM More access to medicine in EM Pressure on drug prices and reimbursements Pharma industry’s reputation EM=Emerging markets 4 Value Driven: Takeda ‐ ism • Pa Ɵ ent → Trust → Reputa Ɵ on → Business Global, Agile, and Committed to Innovation • Created global organization and capabilities • Driving patient ‐ centricity and local empowerment • Therapeutic area focus: Oncology, GI, CNS, plus Vaccines World ‐ class Governance & Diverse Leadership • BOD with majority of external directors, and with Audit & Supervisory committee • Diverse & seasoned Takeda Executive Team • Comprehensive talent development programs Grow Portfolio Rebuild Pipeline Boost Profitability Transformation momentum is backed by Takeda’s values and culture GI=Gastrointestinal, CNS=Central Nervous System, BOD=Board of Directors Takeda’s Corporate Philosophy 5 Takeda ‐ ism will guide us to reach our Vision We take action and make decisions by focusing on our four priorities, in order of: Putting the patient at the center 1234 Building trust with society Reinforcing our reputation Developing the business Values Continue to commit to CSR, Access to Medicine and R&D initiatives for patients & people CSR programs Access to Medicines R&D initiatives Recent progress Global CSR programs 2017: Voted by employees Access to Medicine Our focus e.g.-Employee volunteer opportunities-Disaster Relief-x-z CSR=Corporate Social Responsibility 6 Environment, Health and Safety e.g.-Patient Assistance Programs-Access Accelerated e.g. Proposed Board of Directors for a best ‐ in ‐ class governance 7 Christophe Weber Representative Director President & CEO Masato Iwasaki Director, JPBU President Andrew Plump Director, Chief Medical & Scientific Officer Yasuhiko Yamanaka Director, A&SC member Shiro Kuniya External Director, Chair A&SC Koji Hatsukawa External Director, A&SC member Jean ‐ Luc Butel External Director, A&SC member Masahiro Sakane External Director Chair of the Board meeting Yoshiaki Fujimori External Director Toshiyuki Shiga External Director Emiko Higashi External Director Michel Orsinger External Director James Kehoe Director, Chief Financial Officer Internal directors External directors Audit & Supervisory Committee (A&SC) directors Compensation committee Chair Compensation committee Nomination committee Chair Nomination committee C C C C Developing our global workforce with around 30,000 employees in 74 countries 8 Takeda’s employee distribution Emerging markets 35% Japan 27% EUCAN 21% US 17% Note: March 2017 data excluding Wako Pure Chemical Industries (Europe + Canada) Global, Diverse and Experienced Takeda Executive Team (TET) 9 Giles Platford President EUCAN BU Thomas Wozniewski Global Manufacturing and Supply Officer Ramona Sequeira President US BU Gerard Greco Global Quality Officer Andrew Plump Chief Medical and Scientific Officer Christophe Bianchi President Global Oncology BU Rajeev Venkayya President Global Vaccine BU Christophe Weber President & CEO Masato Iwasaki President Japan Pharma BU James Kehoe Chief Financial Officer Haruhiko Hirate Corporate Communications and Public Affairs Officer Yoshihiro Nakagawa Global General Counsel David Osborne Global Human Resources Officer Ricardo Marek President EM BU U.S. JAPAN SINGAPORE SWITZERLAND BU=Business Unit 10 Transforming R&D: Therapeutic Area focus and footprint concentrated in Japan & U.S. Oncology GI Vaccine CNS Regenerative Medicine Vaccine U.S. Bushu Pharmaceuticals SCOHIA Partnership Research Engine Functional partnership Asset externalization Research site location Health Innovation Park at Shonan Japan CNS=Central Nervous System, GI=Gastroenterology All trademarks and registered trademarks are the property of their respective owners 11 Pipeline as of May 10, 2017 Investing heavily in our early pipeline, while maximizing the value of our marketed portfolio Phase 1 Phase 2 Phase 3 /Filed Life cycle management Oncology GI CNS Other Vaccines TAK ‐ 659 Hematologic malignancies TAK ‐ 931 Solid Tumors TAK ‐ 058 CIAS TAK ‐ 831 Schizophrenia, Ataxia TAK ‐ 020 RA TAK ‐ 906 Gastroparesis TAK ‐ 202 Solid Tumors TAK ‐ 243 Solid Tumors TAK ‐ 580 Solid Tumors TAK ‐ 954 Enteral Feeding Intolerance TAK ‐ 041 CIAS, Neg. symptoms TAK ‐ 653 TRD TAK ‐ 021 EV71 Vaccine TAK ‐ 079 RA CX601 Perianal Fistulas in CD AD ‐ 4833/ TOMM40 Delay of MCI TAK ‐ 003 Dengue Vaccine Relugolix Uterine Fibroids (JP), Endometriosis, Prostate Cancer NINLARO FL MM, Amyloidosis, Maint MM post ‐ SCT, Maint MM w/o SCT ALUNBRIG ALK+ NSCLC (EU), FL ALK+ NSCLC ICLUSIG CML, SL CML, Ph+ ALL ENTYVIO UC/CD, SubQ, GvHD, IO Colitis, H2H, PSC TRINTELLIX TM Cognition in MDD, MDD (JP), ADHD ADCETRIS FL HL, MTCL, CTCL Cabozantinib Solid Tumors (JP) TAKECAB ARD (Asia), NERD (JP) Rasagiline Parkinson’s disease (JP) AMITIZA Ped Constipation, New Formulation TAK ‐ 788 (AP32788) NSCLC TAK ‐ 071 LBD ‐ AD TAK ‐ 935 Epilepsy XMT ‐ 1522 HER2 positive Solid Tumors pevonedistat HR MDS sapanisertib RCC, Breast, Endometrial TAK ‐ 214 Norovirus Vaccine namilumab RA Late ‐ stage / Life cycle management 12 Enhance pipeline through collaborations and external innovation mainly focused on early stage Oncology GI CNS Value Creation Discovery / Preclinical Phase 1 Vaccines XMT ‐ 1522 TAK ‐ 788 (AP32788) TAK ‐ 906 TAK ‐ 954 TAK ‐ 094 TAK ‐ 792 TAK ‐ 233 TAK ‐ 935 Undisclosed TAK ‐ 272 Relugolix Cx ‐ 601 ALUNBRIG, ICLUSIG Cabozantinib Not all ‐ inclusive. All trademarks and registered trademarks are the property of their respective owners BARDA 13 Grow Portfolio • Underlying Revenue +6.9%, every region growing • Growth Drivers +14.7%, Entyvio 146.5 Bn yen Rebuild Pipeline • Significant progress in R&D transformation • Over 50 collaborations in 18 months Boost Profitability • Underlying CE growth: +24.2% • Underlying CE margin: +180 bps • ROE is recovering: 6.0% in FY16 (+2.1pp from FY15) FY2016 results reflect transformation success Note: • "Underlying growth" compares two periods of financial results on a common basis, showing the ongoing performance of the business excluding the impact of foreign exchange and divestitures from both periods • CE="Core Earnings" is calculated by taking reported Gross Profit and deducting SG&A expenses and R&D expenses. In addition, certain other items that are non ‐ core in nature and significant in value may also be adjusted • bps=basis point: one hundredth of a percent • ROE=Return on equity 14 ROE performance is recovering (%) Takeda’s historical ROE evolution 15.1 10.9 14.4 11.8 6.1 6.3 4.5-6.3 3.9 6.0 0% Actos settlement FY07 08 09 10 11 12 13 14 15 16 15 FY2017 and future outlook 16 Projecting strong underlying performance in FY2017 Underlying Revenue Underlying Core EPS Underlying Core Earnings FY2017 guidance (growth %) Low single digit Mid ‐ to ‐ high teen Low ‐ to ‐ mid teen Annual dividend per share 180 yen 17 +100 ‐ 200bps Underlying Core Earnings margin improvement every year driven by: Gross profit for ~50% Global Opex Initiative • Pay less • Buy less • Work better OPEX for ~50% R&D transformation + + + + ‐ Inflation and Investments ‐ Price pressure COGS improvement Product mix 18 Capital allocation priorities Internal investment in R&D and product launches Dividend as key component of shareholder returns Maintain investment grade credit rating Disciplined and focused M&A 1 2 3 4 19 Thank you
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U.S. Patent Office to Confirm Kite’s Seminal Eshhar CAR-T Patent
On June 28, 2017 Kite Pharma, Inc., (Nasdaq:KITE), a leading cell therapy company, reported that the United States Patent and Trademark Office (USPTO) has provided a Notice of Intent to issue an Ex Parte Reexamination Certificate that confirms the patentability of amended claims presented in U.S. Patent No. 7,741,465, known as the Eshhar ‘465 patent (Press release, Kite Pharma, JUN 28, 2017, View Source [SID1234519709]). The Eshhar ‘465 patent, exclusively licensed by Kite in 2013, protects the axicabtagene ciloleucel franchise and may impact competitive CAR-T therapies. Schedule your 30 min Free 1stOncology Demo! "This notice by the USPTO outlining its intent to confirm the Eshhar patent further asserts the pioneering role of Dr. Zelig Eshhar in developing CAR-T technology," said Arie Belldegrun, MD, FACS, Chairman, President and Chief Executive Officer of Kite. "Our significant patent portfolio, combined with our positive data and industry-leading manufacturing process, reinforces our position as one of the foremost companies in cell therapy."
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The Eshhar ‘465 patent term continues to June 2027, not including certain potential extensions. Kite’s growing intellectual property portfolio now encompasses more than 200 patent assets relating to its broad cell therapy pipeline and manufacturing excellence.
Axicabtagene ciloleucel is the first engineered cell therapy to be reviewed by the U.S. Food and Drug Administration (FDA) in aggressive non-Hodgkin’s lymphoma (NHL). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2017.
About axicabtagene ciloleucel
Kite’s lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.
ZIOPHARM Oncology Announces Initiation of Stereotactic Treatment Cohort in Phase 1 Study of Ad-RTS-hIL-12 + Veledimex in Recurrent Glioblastoma
On June 28, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, reported the initiation of enrollment in the stereotactic arm of its Phase 1 multicenter study of Ad-RTS-hIL-12 + veledimex, a gene therapy for controlled expression of IL-12, in patients with recurrent glioblastoma multiforme (rGBM) (Press release, Ziopharm, JUN 28, 2017, View Source [SID1234519708]). The stereotactic cohort will include rGBM patients that are not scheduled to undergo surgical resection to assess the safety and tolerability of a single dose of Ad-RTS-hIL-12 administered via injection and activated with orally-administered veledimex (20 mg QD, days 1-14). Schedule your 30 min Free 1stOncology Demo! "Supported by strong clinical data highlighting the potential for controlled immune activation to affect survival outcomes in recurrent GBM, we are expanding our innovative Ad-RTS-hIL-12 + veledimex gene therapy into new treatment settings and combinations," said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM. "By introducing stereotactic administration, we broaden the population of patients who may be eligible for treatment, including pediatric patients with diffuse intrinsic pontine glioma, a rapidly fatal and inoperable form of brain cancer. Additionally, preclinical studies of this tunable IL-12 gene therapy in combination with an immune checkpoint inhibitor have yielded promising results, notably a 100 percent survival rate of treated mice, and we look forward to bringing this approach into the clinic."
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Following an observation period, the Company expects to immediately:
Initiate enrollment in a study of adult patients with rGBM who will receive a single dose of Ad-RTS-hIL-12 + veledimex in combination with a checkpoint inhibitor targeting programmed cell death protein 1 (PD-1);
Initiate enrollment in a study of pediatric patients with recurrent/progressive glioma who will receive a single dose of Ad-RTS-hIL-12 + veledimex. The Company anticipates children with diffuse intrinsic pontine glioma (DIPG) will be eligible for enrollment.
At the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held in June, the Company reported encouraging results from patients receiving intratumoral Ad-RTS-hIL-12 with 20 mg of orally-administered veledimex (n = 15) following craniotomy, with a median overall survival (mOS) of 12.5 months comparing favorably to historical controls. Based on the observed ratio of CD8+/FOXP3+ (effector/suppressor) T cells, overall survival appears directly correlated with IL-12-mediated cellular immune activation. Furthermore, patients who received low dose steroids have a much better survival rate than those who received elevated systemic steroids, as the latter presumably interferes with immune activation. The Company continues to progress towards a registration study for Ad-RTS-hIL-12 + veledimex for rGBM to start in 2017 and is also evaluating partnership opportunities for this promising treatment candidate.
"Stereotactic treatment serves as a runway into our next phase of development for Ad-RTS-hIL-12 + veledimex including combination therapy and pediatric studies," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM Oncology. "We anticipate translating the combination approach to patients imminently and further leveraging initial observations on the survival benefit of IL-12-driven immune activation. As a pediatric oncologist, I know full well the devastating impact of DIPG and am also looking forward to seeing the effect of controlling IL-12 in this difficult-to-treat disease."
Brain tumors
Recurrent GBM represents approximately 15% of all primary adult brain tumors and remains a high unmet clinical need that affects roughly 74,000 people worldwide annually.i,ii GBM is an aggressive form of brain cancer with recurrence rates near 90%, and prognosis for patients is poor with treatment often combining multiple approaches including surgery, radiation, and chemotherapy. Patients with recurrent GBM typically have a mOS of 6-7 months, and overall survival in patients who have failed temozolomide, bevacizumab or equivalent salvage chemotherapy, is approximately 3-5 months.iii,iv DIPG is a rapidly progressive brain tumor of children with tragically near universal fatal outcomes and a median survival less than 12 months.v
Mateon Therapeutics Announces New Interim Preclinical Data on CA4P in Combination with Checkpoint Inhibitors
On June 28, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported that CA4P in combination with a checkpoint inhibitor significantly reduced tumor size in a CT-26 colon cancer animal model (Press release, Mateon Therapeutics, JUN 28, 2017, View Source [SID1234519707]). Schedule your 30 min Free 1stOncology Demo! Mateon evaluated its lead investigational drug CA4P, which is also currently being studied in a phase 2/3 clinical trial in platinum-resistant ovarian cancer, in a syngeneic mouse model in combination with a checkpoint inhibitor. In order to assess the effects of CA4P on more advanced and difficult-to-treat tumors, tumors in this study were allowed to grow for 13 days prior to treatment. Consequently, beginning tumor sizes were approximately three times larger than those generally evaluated in preclinical studies. Results following two weeks of treatment are as follows:
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Treatment Baseline
Tumor Size Day 14
Tumor Size Day 14 Survival Survival
p-values
Vehicle 159 mm3 2005 mm3 0 / 8 Not applicable
CA4P 159 mm3 1265 mm3 2 / 8 Not significant
Anti-CTLA-4 156 mm3 1016 mm3 4 / 8 0.048
CA4P + Anti-CTLA-4 157 mm3 229 mm3 8 / 8 0.001 *
* p=0.032, Anti-CTLA-4 vs. CA4P and anti-CTLA-4
"CA4P increases the effects of checkpoint inhibitors because it rapidly causes tumor cell death, which likely increases tumor antigen presentation and T-cell activation and the overall immunologic response," said William D. Schwieterman, M.D., President and Chief Executive Officer. "These new results reinforce similar results observed in other studies and, importantly, the animals in the combination CA4P and anti-CTLA-4 antibody treatment group are continuing to show declines in tumor volume beyond Day 14. We look forward to additional data from this study and other on-going preclinical work over the next several months."
Mean Tumor Volume in CT-26 Colorectal Mouse Model
Mean Tumor Volume in CT-26 Colorectal Mouse Model
An infographic accompanying this announcement is available at View Source
This is the second study and tumor type to demonstrate robust complementary effects when Mateon’s CA4P is provided in combination with a checkpoint inhibitor; results obtained approximately four months ago in a smaller tumor EMT-6 mammary model also showed strong synergy when anti-CTLA-4 antibodies were combined with CA4P.