DOCSLIB.ORG

Actinium Pharmaceuticals, Inc

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Actinium Pharmaceuticals, Inc Actinium Pharmaceuticals, Inc. ATNM: NYSE AMERICAN November 2019 Disclaimer and Safe Harbor The information presented herein contains express and implied forward-looking statements regarding the current intentions, expectations, estimates, opinions and beliefs of Actinium Pharmaceuticals, Inc. (“Actinium”) that are not historical facts. These forward- looking statements include statements regarding Actinium’s expectations for its product candidates (including their therapeutic and commercial potential, anticipated future development activities, anticipated timing of development activities, including initiation of clinical trials and presentations of clinical data and the indications Actinium and its collaborators plan to pursue), future results of operations and financial position, business strategy, strategic collaborations, any royalty or milestone payments and Actinium’s ability to obtain and maintain intellectual property protection for its product candidates. Such forward-looking statements may be identified by words such as “believes”, “may”, “will”, “expects”, “endeavors”, “anticipates”, “intends”, “plans”, “estimates”, “projects”, “should”, “objective” and variations of such words and similar words. These statements are based on management’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium’s products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the “SEC”), including without limitation its most recent annual report on Form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time. Any forward-looking statements that Actinium makes in this presentation speak only as of the date of this presentation. Except as required by law, Actinium assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date hereof. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by Actinium or any director, employee, agent, or adviser of Actinium. This presentation does not purport to be all-inclusive or to contain all of the information you may desire. The content of this presentation is subject to copyright, which will be asserted by Actinium, and no part of this presentation may be reproduced, stored in a retrieval system, or transmitted in any form or by any means without prior permission in writing from Actinium. Actinium Pharmaceuticals 2 Company Highlights Late-stage and diverse Antibody Radiation-Conjugate (ARC) pipeline maturing and generating data amidst growing interest for targeted radiotherapies Iomab-B is a highly differentiated and potentially transformative targeted conditioning agent for bone marrow transplant (BMT) Pivotal Phase 3 SIERRA trial for Iomab-B over 50% enrolled with promising interim results showing clear value proposition in AML despite 8 recently approved therapies Leading late-stage pipeline focused on targeted conditioning for BMT and CAR-T leveraging our ARC capabilities and expertise Potential best-in-class CD33 program under development in multiple indications including targeted conditioning, ARC combinations and therapies AWE technology platform drives innovation and future opportunities including partnerships, next-generation ARC’s and solid tumor initiatives Actinium Pharmaceuticals 3 Executive Management Team Highly seasoned and experienced management team executing on clinical, R&D, IP & BD milestones Sandesh Seth Mark Berger, MD Dale Ludwig, PhD Chief Executive Officer and Chief Medical Officer Chief Scientific Officer Chairman of the Board Anil Kapur Steve O’Loughlin Chief Commercial Officer Principal Financial Officer Actinium Pharmaceuticals 4 AWE Platform Enables Pipeline, Future Opportunities Our AWE technology platform allows us to create Antibody Radiation-Conjugates (ARC’s) for multiple areas of clinical development AWE Technology Platform Areas of Focus Scientific Founders Linker Isotope Targeted Conditioning ▪ Bone Marrow Transplant (BMT) Antibody ▪ CAR-T and Adoptive Cell Therapy ▪ Two Pivotal Programs Collaborators ARC Therapeutics and Combinations ▪ Internalized targeted radiation ▪ Synergistic with chemotherapy, Strong, Growing IP Portfolio of 100+ Patents targeted agents and immunotherapy Multiple Targets Other Near-Term Opportunities CD45 CD33 CD38 Leukemia, Lymphoma AML, MDS MM and Solid Tumors Next-Generation ARC’s and immune cells and MM leukemia cells Multiple Isotopes(1) Iodine-131 Actinium-225 Lutetium-177 Range: 2.3 mm Range: .048 mm Range: 1.5 mm Energy: 0.6 MeV Energy: 5.8 MeV Energy: 0.47 MeV Actinium Pharmaceuticals 1) Pouget J.-P. et al. Nat. Rev. Clin. Oncol. 8, 720–734 (2011); published online 8 November 2011. 5 AWE Platform Powers Our Pipeline of ARC’s Deep pipeline, including a Phase 3 asset with near-term data Potential Development Stage Focus Program Indication Preclinical Phase 1 Phase 2 Phase 3 Iomab-B Targeted Conditioning r/r AML 55+ Pivotal Phase 3 SIERRA BMT – CD45 Iomab-B AML, MM, ALL, Phase 1/2 BMT – CD45 NHL/HL Iomab-ACT CAR-T Programs Planned Phase 1 CAR-T – CD45 SBU Opportunity Actimab-MDS MDS Phase 1 Planned Pivotal Program BMT – CD33 Actimab-A + ARC Therapeutics and r/r AML Phase 1 Combinations Venetoclax Actimab-A r/r AML Phase 1 CLAG-M Actimab-M Multiple Myeloma Phase 1 Ac-225- AWE Platform Multiple Myeloma Preclinical Daratumumab (CD38) Ac-225 ARC’s Solid Tumor Preclinical Ac-225 + Undisclosed Undisclosed Collaboration Targeting Agents Actinium AML – Acute Myeloid Leukemia, MDS – Myelodysplastic Syndrome, MM – Multiple Myeloma, ALL – Acute Lymphoblastic Leukemia, NHL / HL – Non-Hodgkin’s / Hodgkin’s Pharmaceuticals Lymphoma 6 Why BMT and Targeted Conditioning BMT is a potential cure for multiple diseases with significant opportunity for innovation and growth • The bone marrow may start to produce cancerous cells, leading to diseases like leukemia, lymphoma, and other disorders • In many instances, a BMT is the only curative treatment option for patients with these diseases Actinium is focused on the conditioning necessary prior to Bone Marrow Transplant 01 Conditioning 02 Transplant 03 Engraftment 04 Outcomes BMT Process Eliminate cancer cells Infuse healthy cells Infused cells take hold and Potential for extended and the diseased bone from patient or donor rebuild patient’s blood and survival or curative marrow immune systems outcomes Actinium Pharmaceuticals 7 The Current BMT Conditioning Dilemma Patients have restricted access and suboptimal outcomes to potentially curative BMT Why is patient access restricted and outcomes ARC’s like Iomab-B can solve the BMT How big is the BMT access gap? suboptimal conditioning dilemma and access gap Today’s standard of care conditioningOnly regimens are either “too hot” or “too21,000 cold” patients Limitation:received Tooa toxic BMT, many in patients Chemotherapy - cannot2017 tolerate(2) Myeloablative Conditioning Result: Restricted access and high Treatment Related Morality Limitation: Low-dose ARC Advantages: Can’t eliminate all disease chemo/radiation >150,000 - Delivers greater amounts of radiation to target cells - Faster time to BMT - Reduced Result: - Fewer toxicities Intensity High Relapse Rates Patients - Simultaneous tumor and marrow ablation Conditioning that could potentially benefit from a BMT - Better tolerated, stronger patient for BMT that do not receive one today Actinium 1) Cancer Facts & figures, 2018. American Cancer Society, 2018. Leukemia, Lymphoma and Myeloma. 2) CIBMTR 2017 US Data. Transplants for AML, NHL, Hodgkin Disease and Multiple Myeloma Pharmaceuticals 8 Iomab-B Value Proposition: Enhanced Access, Improved Outcomes Transplant becomes a viable option for older patients with active, relapsed or refractory disease Prior Clinical Experience 300+ patients 12 clinical trials 6 diseases Improved (AML, MDS, MM, survival and ALL, NHL/HL) curative outcomes AML – Current Situation vs. POC Results Current BMT Conditioning Approaches Iomab-B BMT Conditioning(3) Salvage Chemo(1) Chemo + BMT(2) 30% 19% Observed ~10% ~10% Overall Survival ~0% ~0% 1-year 2-year 1-year 2-year 1-year 2-year Observed Patients with active disease Time to 42 days 12 days generally do not receive BMT BMT 1) Roboz et al. J Clin Oncol 32:1919-1926 (2014) Intl Randomized Phase III Study of Elacytarabine Versus Investigator Choice in Patients with Relapsed/Refractory Acute Myeloid Leukemia (N=381) Actinium 2) Armistead et al. Biol Blood Marrow Transplant 15 :1431-1438 (2009) MD Anderson outcomes analysis. (Chemo + BMT N=19) Pharmaceuticals 3) Pagel et. al. Blood 114:5444-5453 (2009) and additional data on file (N=36) 9 Ongoing Pivotal Phase 3 SIERRA Trial for Iomab-B The only randomized Phase 3 trial investigating a BMT option for patients older than 55 years with active, relapsed or refractory AML • 150 patients total, 75 patients per arm • Primary Endpoint: Durable Complete Response (dCR) at 6 months • Secondary Endpoint: 1-year overall survival
Load more

Recommended publications
  • For Acute Myeloid Leukemia
    Published OnlineFirst September 21, 2010; DOI: 10.1158/1078-0432.CCR-10-0382 Published OnlineFirst on September 21, 2010 as 10.1158/1078-0432.CCR-10-0382 Clinical Therapy Clinical Cancer Research Sequential Cytarabine and α-Particle Immunotherapy with Bismuth-213–Lintuzumab (HuM195) for Acute Myeloid Leukemia Todd L. Rosenblat1, Michael R. McDevitt1, Deborah A. Mulford1, Neeta Pandit-Taskar1, Chaitanya R. Divgi1, Katherine S. Panageas1, Mark L. Heaney1, Suzanne Chanel1, Alfred Morgenstern2, George Sgouros1, Steven M. Larson1, David A. Scheinberg1, and Joseph G. Jurcic1 Abstract Purpose: Lintuzumab (HuM195), a humanized anti-CD33 antibody, targets myeloid leukemia cells and has modest single-agent activity against acute myeloid leukemia (AML). To increase the potency of the antibody without the nonspecific cytotoxicity associated with β-emitters, the α-particle–emitting ra- dionuclide bismuth-213 (213Bi) was conjugated to lintuzumab. This phase I/II trial was conducted to determine the maximum tolerated dose (MTD) and antileukemic effects of 213Bi-lintuzumab, the first targeted α-emitter, after partially cytoreductive chemotherapy. Experimental Design: Thirty-one patients with newly diagnosed (n = 13) or relapsed/refractory (n = 18) AML (median age, 67 years; range, 37-80) were treated with cytarabine (200 mg/m2/d) for 5 days followed by 213Bi-lintuzumab (18.5-46.25 MBq/kg). Results: The MTD of 213Bi-lintuzumab was 37 MB/kg; myelosuppression lasting >35 days was dose limiting. Extramedullary toxicities were primarily limited to grade ≤2 events, including infusion-related reactions. Transient grade 3/4 liver function abnormalities were seen in five patients (16%). Treatment- related deaths occurred in 2 of 21 (10%) patients who received the MTD.
    [Show full text]
  • Guide to Treatment Role of Antibodies in Acute Leukemia: Focus on Transplant-Eligible Populations
    PRACTICE AID Guide to Treatment Role of Antibodies in Acute Leukemia: Focus on Transplant-Eligible Populations Acute Myeloid Leukemia DRUG STATUS TARGET DOSE EU EMA approved: In combination with daunorubicin and Induction: 3 mg/m2 (up to 5 mg/m2 in EU and 4.5 mg/m2 in US) cytarabine for pts aged ≥15 y with previously untreated, on d 1, 4, and 7 in combination with daunorubicin and cytarabine de novo CD33+ AML, except APL CD33 Consolidation: 3 mg/m2 (up to 5 mg/m2 in EU and 4.5 mg/m2 in US) Gemtuzumab US FDA approved: Newly diagnosed CD33+ AML in adults and 1,2 on d 1 in combination with daunorubicin and cytarabine ozogamicin pediatric pts aged ≥1 month; R/R CD33+ AML in adults and Please consult label for single-agent dosing and dosing in R/R AML. pediatric pts aged 2 y Phase 3 SIERRA study CD45 Adults aged ≥55 y with active R/R AML, adequate organ Dosimetry directed (SIERRA study) Iomab-B3 function, and related/unrelated matched donor (BC8 mAb linked to radioisotope iodine-131) Acute Lymphoblastic Leukemia EU EMA approved: Adults with R/R CD22+ B-cell ALL; adults Cycle 1 dose: 0.8 mg/m2 on d 1; 0.5 mg/m2 on days 8 and 15 for 21 d 2 Inotuzumab with Ph+ R/R B-cell ALL who failed treatment with at least one TKI CD22 Patients in CR/CRi: 0.5 mg/m on days 1, 8, and 15 for 28 d ozogamicin4,5 US FDA approved: Adults with R/R CD22+ B-cell ALL Patients not in CR/CRi: Use cycle 1 dose for 28 d EU Dose: By patient’s weight (≥45 kg = 9 mcg/d on d 1-7 and 28 mcg/d on EU EMA approved: Adults with B-cell ALL who are in d 8-28; <45 kg = 5 mcg/m2/d on
    [Show full text]
  • Whither Radioimmunotherapy: to Be Or Not to Be? Damian J
    Published OnlineFirst April 20, 2017; DOI: 10.1158/0008-5472.CAN-16-2523 Cancer Perspective Research Whither Radioimmunotherapy: To Be or Not To Be? Damian J. Green1,2 and Oliver W. Press1,2,3 Abstract Therapy of cancer with radiolabeled monoclonal antibodies employing multistep "pretargeting" methods, particularly those has produced impressive results in preclinical experiments and in utilizing bispecific antibodies, have greatly enhanced the thera- clinical trials conducted in radiosensitive malignancies, particu- peutic efficacy of radioimmunotherapy and diminished its toxi- larly B-cell lymphomas. Two "first-generation," directly radiola- cities. The dramatically improved therapeutic index of bispecific beled anti-CD20 antibodies, 131iodine-tositumomab and 90yttri- antibody pretargeting appears to be sufficiently compelling to um-ibritumomab tiuxetan, were FDA-approved more than a justify human clinical trials and reinvigorate enthusiasm for decade ago but have been little utilized because of a variety of radioimmunotherapy in the treatment of malignancies, particu- medical, financial, and logistic obstacles. Newer technologies larly lymphomas. Cancer Res; 77(9); 1–6. Ó2017 AACR. "To be, or not to be, that is the question: Whether 'tis nobler in the pembrolizumab (anti-PD-1), which are not directly cytotoxic mind to suffer the slings and arrows of outrageous fortune, or to take for cancer cells but "release the brakes" on the immune system, arms against a sea of troubles, And by opposing end them." Hamlet. allowing cytotoxic T cells to be more effective at recognizing –William Shakespeare. and killing cancer cells. Outstanding results have already been demonstrated with checkpoint inhibiting antibodies even in far Introduction advanced refractory solid tumors including melanoma, lung cancer, Hodgkin lymphoma and are under study for a multi- Impact of monoclonal antibodies on the field of clinical tude of other malignancies (4–6).
    [Show full text]
  • TRUNCATED EPIDERIMAL GROWTH FACTOR RECEPTOR (Egfrt)
    (19) TZZ _T (11) EP 2 496 698 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: C07K 14/71 (2006.01) C12N 9/12 (2006.01) 09.01.2019 Bulletin 2019/02 (86) International application number: (21) Application number: 10829041.2 PCT/US2010/055329 (22) Date of filing: 03.11.2010 (87) International publication number: WO 2011/056894 (12.05.2011 Gazette 2011/19) (54) TRUNCATED EPIDERIMAL GROWTH FACTOR RECEPTOR (EGFRt) FOR TRANSDUCED T CELL SELECTION VERKÜRZTER REZEPTOR FÜR DEN EPIDERMALEN WACHSTUMSFAKTOR-REZEPTOR ZUR AUSWAHL UMGEWANDELTER T-ZELLEN RÉCEPTEUR DU FACTEUR DE CROISSANCE DE L’ÉPIDERME TRONQUÉ (EGFRT) POUR LA SÉLECTION DE LYMPHOCYTES T TRANSDUITS (84) Designated Contracting States: • LI ET AL.: ’Structural basis for inhibition of the AL AT BE BG CH CY CZ DE DK EE ES FI FR GB epidermal growth factor receptor by cetuximab.’ GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO CANCER CELL vol. 7, 2005, pages 301 - 311, PL PT RO RS SE SI SK SM TR XP002508255 • CHAKRAVERTY ET AL.: ’An inflammatory (30) Priority: 03.11.2009 US 257567 P checkpoint regulates recruitment of graft-versus-host reactive T cells to peripheral (43) Date of publication of application: tissues.’ JEM vol. 203, no. 8, 2006, pages 2021 - 12.09.2012 Bulletin 2012/37 2031, XP008158914 • POWELL ET AL.: ’Large-Scale Depletion of (73) Proprietor: City of Hope CD25+ Regulatory T Cells from Patient Duarte, CA 91010 (US) Leukapheresis Samples.’ J IMMUNOTHER vol. 28, no.
    [Show full text]
  • Multiple Myeloma and Engineered Cell Therapy
    Multiple Myeloma and Engineered Cell Therapy Sarah M. Larson, MD Assistant Professor of Medicine September 2018 Spectrum of Disease Morgan GJ Nat Cancer Rev 2012 SMM: Janssen SMM3001 • Patients randomized to dara sc vs active monitoring •Study duration 8 years • Primary endpoint PFS • Prior SMM treatment is an exclusion • NCT03301220 Van de Donk NWCJ Immunol Rev 2016 Multiple Myeloma • Second most common heme malignancy • 33,000 new cases 2017 • >100,000 people with multiple myeloma • Increasing number of patients • Incidence • Improved survival SEER database Treatment Treatment of Initial Consolidation/ ASCT relapsed Therapy Maintenance disease Supportive Care Minimal Residual Disease (MRD) Undetectable MRD: The Goal of Frontline Therapy? PFS OS Landgren O BMT 2016 IFM2009 • Newly diagnosed patients eligible for transplant • Patients <65 years of age PFS 50 mos (p<0.001) CR 59% Transplant MRD neg 79% (p<0.001) R 2 cycles A Len Main RVD N 3 D Cycles O RVD M PFS 36 mos I CR 48% Z MRD neg 65% E 5 Cycles D RVD Len Main Attal M NEJM 2017 Response at Each Treatment Phase Treatment Arm Induction Consolidation Maintenance (%) (%) (%) RVD 45 69 76 Transplant 47 78 85 Attal M NEJM 2017 Conclusions • Transplant remains a standard therapy • Delayed transplant is reasonable • Collection and storage of stem cell frequently not covered • Following second line of treatment • Trials to improve the transplant course Stem Cell Mobilization Trial • BL-8040 Phase III, randomized, double-blinded, placebo controlled trial of BL-8040 and G-CSF vs G- CSF and
    [Show full text]
  • 20 13 Rep Or T
    2013 REPORT More Than 240 Medicines in Development for Leukemia, Lymphoma and Other Blood Cancers Every 4 minutes a person is diagnosed with leukemia, Medicines in Development lymphoma or For Leading Blood Cancers myeloma; Accounting for Application Submitted 9% of all cancers Phase III diagnosed each year Phase II Biopharmaceutical research companies • 15 each for myeloproliferative neo- Phase I are developing 241 medicines for blood plasms, such as myelofibrosis, poly- cancers—leukemia, lymphoma and cythemia vera and essential throm- 97 98 myeloma. This report lists medicines in bocythemia; and for myelodysplastic human clinical trials or under review by syndromes, which are diseases affect- the U.S. Food and Drug Administration ing the blood and bone marrow. (FDA). These medicines in development offer The medicines in development include: hope for greater survival for the thou- sands of Americans who are affected by • 98 for lymphoma, including Hodgkin these cancers of the blood. and non-Hodgkin lymphoma, which 52 affect nearly 80,000 Americans each Definitions for the cancers listed in this year. report and other terms can be found on page 27. Links to sponsor company web • 97 for leukemia, including the four sites provide more information on the major types, which affect nearly potential products. 50,000 people in the United States 24 each year. For information on the value of medi- cines, an in-depth look at current in- • 52 for myeloma, a cancer of the novation and key medical breakthroughs plasma cells, which impacts more benefiting blood cancer patients, please than 22,000 people each year in the see Medicines in Development for Leu- United States.
    [Show full text]
  • Pharmaceutical Appendix to the Tariff Schedule 2
    Harmonized Tariff Schedule of the United States (2007) (Rev. 2) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2007) (Rev. 2) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. ABACAVIR 136470-78-5 ACIDUM LIDADRONICUM 63132-38-7 ABAFUNGIN 129639-79-8 ACIDUM SALCAPROZICUM 183990-46-7 ABAMECTIN 65195-55-3 ACIDUM SALCLOBUZICUM 387825-03-8 ABANOQUIL 90402-40-7 ACIFRAN 72420-38-3 ABAPERIDONUM 183849-43-6 ACIPIMOX 51037-30-0 ABARELIX 183552-38-7 ACITAZANOLAST 114607-46-4 ABATACEPTUM 332348-12-6 ACITEMATE 101197-99-3 ABCIXIMAB 143653-53-6 ACITRETIN 55079-83-9 ABECARNIL 111841-85-1 ACIVICIN 42228-92-2 ABETIMUSUM 167362-48-3 ACLANTATE 39633-62-0 ABIRATERONE 154229-19-3 ACLARUBICIN 57576-44-0 ABITESARTAN 137882-98-5 ACLATONIUM NAPADISILATE 55077-30-0 ABLUKAST 96566-25-5 ACODAZOLE 79152-85-5 ABRINEURINUM 178535-93-8 ACOLBIFENUM 182167-02-8 ABUNIDAZOLE 91017-58-2 ACONIAZIDE 13410-86-1 ACADESINE 2627-69-2 ACOTIAMIDUM 185106-16-5 ACAMPROSATE 77337-76-9
    [Show full text]
  • Natural Killer Cell-Based Immunotherapy for Acute Myeloid Leukemia
    Xu and Niu J Hematol Oncol (2020) 13:167 https://doi.org/10.1186/s13045-020-00996-x REVIEW Open Access Natural killer cell-based immunotherapy for acute myeloid leukemia Jing Xu and Ting Niu* Abstract Despite considerable progress has been achieved in the treatment of acute myeloid leukemia over the past decades, relapse remains a major problem. Novel therapeutic options aimed at attaining minimal residual disease-negative complete remission are expected to reduce the incidence of relapse and prolong survival. Natural killer cell-based immunotherapy is put forward as an option to tackle the unmet clinical needs. There have been an increasing num- ber of therapeutic dimensions ranging from adoptive NK cell transfer, chimeric antigen receptor-modifed NK cells, antibodies, cytokines to immunomodulatory drugs. In this review, we will summarize diferent forms of NK cell-based immunotherapy for AML based on preclinical investigations and clinical trials. Keywords: Acute myeloid leukemia, Natural killer cells, Immunotherapy, Adoptive NK cell transfer, Chimeric antigen receptor-modifed NK cells, Antibodies, Cytokines Background cells and substances in the immune system play pivotal Acute myeloid leukemia (AML) is a clinically and geneti- roles in detecting and destroying pathogen-infected or cally heterogeneous disease with unsatisfactory out- neoplastically transformed cells. But they become less comes. Over the last few years, considerable progress has potent in cancer elimination when malignant cells dis- been achieved in the treatment of AML with the devel- play the loss of antigenicity and/or immunogenicity and opment and implementation of new drugs [1, 2]. How- are surrounded by an immunosuppressive microenvi- ever, allogeneic hematopoietic cell transplantation (HCT) ronment [6].
    [Show full text]
  • Radiolabeled Cetuximab Conjugates for EGFR Targeted Cancer Diagnostics and Therapy †
    Pharmaceuticals 2014, 7, 311-338; doi:10.3390/ph7030311 OPEN ACCESS pharmaceuticals ISSN 1424-8247 www.mdpi.com/journal/pharmaceuticals Review Radiolabeled Cetuximab Conjugates for EGFR Targeted Cancer Diagnostics and Therapy † Wiebke Sihver 1,*, Jens Pietzsch 1,2, Mechthild Krause 3,4,5,6, Michael Baumann 3,4,5,6, Jörg Steinbach 1,2 and Hans-Jürgen Pietzsch 1 1 Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Institute of Radiopharmaceutical Cancer Research, Bautzner Landstraße 400, Dresden 01328, Germany; E-Mails: [email protected] (J.P.); [email protected] (J.S.); [email protected] (H.-J.P) 2 Department of Chemistry and Food Chemistry, Technische Universität Dresden, Dresden 01062, Germany 3 Department of Radiation Oncology and OncoRay, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden 01307, Germany; E-Mails: [email protected] (M.K.); [email protected] (M.B.) 4 OncoRay—National Center for Radiation Research in Oncology, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden 01307, Germany 5 German Cancer Consortium (DKTK) Dresden and German Cancer Research Center (DKFZ), Heidelberg 69120, Germany 6 HZDR, Institute of Radiation Oncology, Bautzner Landstraße 400, Dresden 01328, Germany † Dedicated to Prof. Bernd Johannsen (Dresden-Rossendorf) on the occasion of his 75th birthday * Author to whom correspondence should be addressed; E-Mail: [email protected]; Tel.: +49-351-260-2424; Fax: +49-351-260-3232. Received: 20 December 2013; in revised form: 11 February 2014 / Accepted: 21 February 2014 / Published: 5 March 2014 Abstract: The epidermal growth factor receptor (EGFR) has evolved over years into a main molecular target for the treatment of different cancer entities.
    [Show full text]
  • Seattle Genetics and Agensys, an Affiliate of Astellas, Expand Antibody-Drug Conjugate Collaboration
    For release: Monday, November 23, 2009 6:00 a.m. Pacific Time Seattle Genetics and Agensys, an Affiliate of Astellas, Expand Antibody-Drug Conjugate Collaboration Bothell, WA and Santa Monica, CA – November 23, 2009 – Seattle Genetics, Inc. (Nasdaq: SGEN) and Agensys, Inc., an affiliate of Astellas, announced today an expansion of the companies’ antibody- drug conjugate (ADC) collaboration. Under the amended agreement, Agensys will pay a $12 million fee for exclusive rights to ADC licenses against additional antigen targets. Seattle Genetics also receives an option to co-develop another ADC at the time of investigational new drug (IND) submission. “Combining Agensys’ proprietary antibodies, directed to novel cancer targets, with Seattle Genetics’ industry-leading ADC technology has already led to product candidates for different cancer indications, including ASG-5ME, an ADC for cancers including prostate, pancreatic and gastric that is being co-developed by both companies,” said Aya Jakobovits, Ph.D., Executive Vice President and Head of Research and Development of Agensys. “Expansion of the collaboration will allow Astellas to further enhance its growing pipeline in oncology.” “Through this broadened collaboration, we continue to leverage the increasing value of our ADC technology to generate revenue as well as to obtain product rights that expand our pipeline of ADCs for the treatment of cancer,” said Eric L. Dobmeier, Chief Business Officer of Seattle Genetics. “We look forward to continuing our work with Agensys to bring ADC programs into clinical trials, including ASG-5ME planned for phase I trials in 2010.” Seattle Genetics and Agensys originally entered into the ADC collaboration in January 2007, under which the companies agreed to co-develop and co-fund an initial ADC program, ASG-5ME, and share equally in any profits upon commercialization.
    [Show full text]
  • WO 2015/067570 A2 14 May 2015 (14.05.2015) P O P C T
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2015/067570 A2 14 May 2015 (14.05.2015) P O P C T (51) International Patent Classification: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, C07K 16/28 (2006.01) BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (21) International Application Number: HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, PCT/EP2014/073612 KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, (22) International Filing Date: MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, 3 November 20 14 (03 .11.20 14) PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, (25) Filing Language: English TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (26) Publication Language: English (84) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of regional protection available): ARIPO (BW, GH, 13 19 1839.3 6 November 2013 (06. 11.2013) EP GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, (71) Applicant: BOEHRINGER INGELHEIM INTERNA¬ TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, TIONAL GMBH [DE/DE]; Binger Strasse 173, 55216 In DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, gelheim am Rhein (DE).
    [Show full text]
  • Hematology Drugs in the Pipeline
    102 HemOnc today | NOVEMBER 25, 2015 | Healio.com/HemOnc Hematology Drugs in the Pipeline HEMONC TODAY presents the most recent information about hematology drugs in the pipeline. Drugs listed here are in phase 2 or phase 3 development for a variety of indications. Clinicians can use this chart as a quick reference to learn about the status of those drugs that may be clinically significant to their practice. To view the entire chart online, go to www.Healio.com/HematologyPipeline. Generic name (Brand name, Manufacturer) Indication(s) Development status A6 peptide (Angstrom Pharmaceuticals) chronic lymphocytic leukemia, small lymphocytic lymphoma phase 2 AAV5-hFIX (UniQure Biopharma) hemophilia phase 2 ABC294640 (RedHill Biopharma) diffuse large B-cell lymphoma phase 2 abemaciclib (Eli Lilly) mantle cell lymphoma phase 2 abexinostat (Pharmacyclics) follicular lymphoma, mantle cell lymphoma phase 2 ABP 798 (Allergan/Amgen) non-Hodgkin’s lymphoma phase 3 ACP-196 (Acerta Pharma) B-cell malignancies (combination therapy), mantle cell lymphoma phase 2 READ PERSPECTIVE on this drug from Richard R. chronic lymphocytic leukemia phase 3 Furman, MD, on page 108. ACP-319 (Acerta Pharma) B-cell lymphoma (combination therapy), chronic lymphocytic leukemia phase 2 (combination therapy) adeno-associated virus serotype 8 Factor IX gene therapy hemophilia B phase 2 (AskBio009, Baxalta) AEB071 (Novartis) diffuse large B-cell lymphoma (combination therapy for CD79-mutant or phase 2 ABC-subtype disease) AFM 13 (Affimed Therapeutics) Hodgkin’s lymphoma phase
    [Show full text]