Update on Clinical Trials and Foundation Funded Grants

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1 Update on Clinical Trials and Foundation Funded Grants Mary Hesdorffer, MS, APRN-BC Medical Liaison Meso Foundation

2 Delivering the Diagnosis Delivering the Diagnosis Day 1

3 Taking control of the situation After the initial shock wears off it is time to get to work Educate yourself on the disease and find out about your treatment options. This is a rare disease and a specialist is required There are many treatment options despite the rarity of your diagnosis

4 Hot New Drugs There are a number of new trials at some of our mesothelioma focused centers getting ready to or have recently opened. The next few slides will discuss these new drugs so you can become familiar with them

5 IGF-1 Insulin-Like Growth Factor 1 Secreted by the liver and thought to promote cell proliferation and apoptosis. A small number of publications have reported that targeting IGF-1 1 has demonstrated activity in mesothelioma cell lines

6 Vaccines WT-1 1 analog peptide vaccine WT-1 1 is a protein that is strongly expressed in 80% of mesothelioma tumors Clinical Trial will soon be available as an adjunct to surgery in pleural mesothelioma

7 HGF/SF and c-metc Interactions between c-met c receptor kinase and it ligand hepatocyte growth factor/scatter factor trigger signals responsible for cellular proliferation, survival, and migration There are a number of drugs in development and early phase clinical studies.

8 TGF Beta Transforming Growth Factor beta is a protein that plays a role in cell proliferation, and cell differentiation. Malignant cells lose the properties of normal cells and this process is referred to as cell differentiation.

9 TGR beta Cancerous cells increase production of TGF beta which impact on other cells Drugs have been developed that bind to TGF beta GC 1008 a drug in this class is now available in a clinical trial to mesothelioma patients that have failed prior therapies.

10 Cooperative Group Trials Sponsored by the National Cancer Institute Involves more than 3,100 institutions 14,000 individual investigators are registered and able to participate in this program 25,000+ participate in these cancer clinical trials per year

11 Cooperative Groups Cooperative groups include researchers, cancer centers, and community physicians throughout the United States, Canada, and Europe Researchers help to identify areas that need to be investigated and design trials that will generate data to answer specific questions

12 Cooperative Groups Thought leaders in the field of oncology participate in these groups. Working committee within these groups focus on specific disease In mesothelioma we are represented by many of the researchers that you have come to know and respect through the foundation

13 Eastern Cooperative Group ECOG Phase II Study of Anti-HGF Monoclonal Antibody AMG 102 in Combination With Pemetrexed Disodium and Cisplatin in Patients With Malignant Pleural Mesothelioma

14 AMG 102 in combination with Pemetrexed and Cisplatin AMG 102 is a fully human monoclonal antibody that blocks the action of hepatocyte growth factor/scatter factor The met receptor and it s ligand heptocyte growth factor regulate cell growth, survival and migration, and dysregulation of the HGF-MET pathway leads to oncogenic changes including tumor proliferation, angiogenesis and metastasis.

15 AMG 102 cont d Front line therapy for chemotherapy naïve patients, all histologies can participate in this trial

16 CALGB Study Phase II Randomized Study of Pemetrexed Disodium Maintenance Therapy Versus Observation in Patients With Malignant Pleural Mesothelioma Without Progression After First- Line Chemotherapy

17 CALGB cont d This is a trial for systemic chemotherapy naïve patients to determine if maintenance alimta will help to prevent recurrence of disease Randomized Phase II study Alimta cisplatin observation vs alimta cisplatin and maintenance with alimta following 6 cycles of tx

18 MORAb- OO9 A monoclonal antibody that targets mesothelin found on the outside of epithelial mesothelioma cells It is given in combination with pemetrexed (alimta( alimta) ) and cisplatin First line therapy for chemo naïve patients.

19 MORAb-009 cont d Preclinical data suggests that MORAB 009 works by blocking mesothelin's ability to interact with its target and second, by stimulating the patient's immune system to attack the tumor by specifically destroying those cells bound by MORAb-009.

20 MORAb-009 cont d Dr Raffit Hassan designed a Phase I trial and based upon his reported results this new trial was developed in conjunction with Morphotech Taking place in multiple site including Canada and Europe

21 CBP 501 Given in combination with pemetrexed and cisplatin G2 checkpoint inhibiting leads to sensitizing cancer cells to DNA- damaging anticancer agent without increasing adverse effects on normal cells

22 CBP 501 cont d Checkpoints occur during the G phase which when functioning stop the cell from producing daughter cell CBP 501 is thought to enhance this checkpoint and halt cancerous cells from replicating. It may also be synergistic with chemotherapy

23 CBP-501 This is a multi center trial taking place in the United States. It is a first line therapy for chemo naïve patients

24 Front line Treatment Some additional options that are offered at single centers include intracavitary administration of chemotherapy in conjunction with surgery Lung sparing therapy where intraplural chemotherapy and radiation therapy are administered without removal of lung or pleura

25 Front line therapy cont d IMRT delivered following 4 cycles of chemotherapy for patients in whom surgery is not an option. Chemotherapy or Targeted agents given prior to surgery or post surgery Gene therapy given in conjunction with chemotherapy either as first line or after treatment failure Immunotoxin in combination with chemotherapy

26 2nd Line Therapy SAHA Trial continues Multi center multi nation trial to determine if zolinza is better than placebo in the second line setting Currently there is no second line drug approved in mesothelioma

27 AZD 2171 Oral VEGF inhibitor 1 prior cytotoxic chemotherapy permitted Eligibility includes peritoneal, tunica vaginalis or pleural mesothelioma Multi Center Trial in the US and Canada

28 Salvage Therapy Strict definition is chemotherapy given after other treatments are found to be ineffective There are a number of centers that have Phase I or Phase II trials that permit multiple prior therapies. The Foundation remains your best source for learning about clinical trial options

29 Completed Trials A Phase I trial of SS1P was conducted in solid tumors which express mesothelin.. 14 patients with malignant both pleural and peritoneal mesothelioma participated in this study Due to the results of this phase 1 study a Phase I/II trial using SS1p plus pemetrexed and cisplatin is now accepting patients

30 Completed Trials cont d Dr Anna Nowak AU reported on a trial to evaluate the contribution of FDG/PET analysis to other prognostic variables. Results 89 eligible patients (28 underwent prior pleurodesis). Sarcomatoid histology found to be the strongest prognostic factor

31 Completed Trials cont d In this study FDG/PET parameters were more predictive of survival than TNM staging Possible that clinical decisions might be made on glycolytic activity, and tumor volume rather than traditional stage of disease emphasis.

32 Completed Trials cont d EPP F/by Intraoperative Hyperthermic Cisplain Purpose: study feasibility and safety of hyperthermic intraoperative intracavitary cisplatin perfusion following an EPP 121 enrolled patients with a median survival of 12.8 months

33 Completed Trials cont d Effect of induction chemotherapy on lung function and exercise capacity in patients affected by malignant pleural mesothelioma First retrospective study to demonstrate that cisplatin and pemetrexed improved lung function and exercise capactiy

34 Completed Trials cont d Multicenter trial of neo adjuvant pemetrexed and cisplatin prior to EPP Patients completing all therapy had a median survival of 29.1 months and a 2-2 year survival rate of 61.2%. Radiologic response of complete or partial response was associated with a median survival of 26.0 months compared with 13.9 months for patients with stable disease or progressive disease (P =.05).

35 Completed Trials cont d Report from an expanded access program for pemetrexed single agent or in combination with a platinum Response rates (95% CI) for PEM, PEM/CIS, and PEM/CARBO were 12.5% (3.5, 29.0), 20.0% (7.7, 38.6), and 24.1% (10.3, 43.5), respectively. Median survival for PEM was 10.3 months. One-year survival rates for PEM/CIS and PEM were 57.4% (95% CI: 10.3, 100) and 41.5% (95% CI: 4.6, 78.4), respectively, and were not available for PEM/CARBO.

36 Gene Therapy Gene therapy for thoracic malignancies represents a novel therapeutic approach and has been evaluated in a number of clinical trials over the last two decades. The next slide demonstrates a response in a pleural mesothelioma patient on a gene therapy trial

37 Gene Therapy Trials There are a number of new trial in development that will include chemotherapy combined with gene therapy. Trials will be for chemo naïve patients as well as those that have failed prior therapies.

38 PET/CT Response Pleural Meso 5/13/ months post Pre-therapy Post-therapy (2 months) Post-therapy (6 months)

39 Clinical Trial Participant There is hope We are making progress!

40 Inhibition of Il-1 1 as a Novel Target in Peritoneal Mesothelioma H. Richard Alexander, Jr., M.D. Associate Chair for Clinical Research Department of Surgery University of Maryland Medical Center

41 Inhibition of Il-1 1 as a Novel Target in Peritoneal Mesothelioma A study to characterize the molecular personality of MPM; the preliminary data show that a specific family of proteins are present in high levels with MPM tumors cells. MPM appears to require these proteins for continued growth and spread

42 Il-1 1 cont d Coincidently, there are inhibitors to these proteins that are being developed by pharmaceutical companies for other reasons The research proposal that MARF is supporting hypothesizes that inhibition of these proteins will be a possible effective and new strategy to treat patients with MPM

43 Il-1 1 cont d Preliminary data in the laboratory has supported the hypothesis; cells in which the protein is inhibited do not grow and die at a faster rate than untreted cells; the next step is to test the compound in laboratory mice with MPM tumors.

44 Enhanced Diagnostic Imaging and High Precision Gene Therapy of Mesothelioma Using Nontoxic Nanocarriers Gang Logan Liu, PhD Assistant Professor Mircro and Nanotechnology Lab University of Illinois

45 Enhanced Diagnostic Imaging and High Precision Gene Therapy of Mesothelioma Using Nontoxic Nanocarriers Developed better and non-toxic delivery nanocarriers for gene/chemo therapeutic drug to potentially improve the Mesothelioma therapy efficiency and mitigate systemic side effects

46 Nanocarriers cont d The gene/chemo therapeutic drug delivery by this nanocarrier is highly specific and localized to targeted cancer cells

47 Nanocarriers cont d The nanocarriers can serve as contrast agents in Mesothelioma diagnostic imaging besides of therapeutic benefits The gene/chemo therapeutic drug delivery by this nanocarrier is highly specific and localized to targeted cancer cells

48 Nanocarriers cont d The nanocarriers are made of FDA-approved materials and are either biodegradable or quickly metabolized With preliminary results stemming from this foundation funded grant, we have successfully received federal research grants to support our future work in testing the nanocarriers and targeted drug delivery in animal models

49 Combinatorial Targeting of Tyrosine Kinases that are Aberrantly Activated in Malignant Mesothelioma Haning Yang PhD Assistant Professor (Researcher), Cancer Research Center of Hawai i; i; Assistant Clinical Professor, Department of Pathology

50 Studies of Tumor Necrosis Factor alpha as a New Target for Human Malignant Mesothelioma Prevention We found that TNF-α and NF-kB pathway play critical roles in asbestos- induced oncogenesis and mesothelioma development We have established the in vitro (cell culture) and in vivo (animal-mouse) mouse) models for mesothelioma

51 Necrosis Factor cont d By using these models, we are testing whether by targeting TNF-α and/or NF-kB, we will be able to prevent mesothelioma development or whether we can inhibit tumor growth and invasion

52 The Hedgehog Signaling Pathway As A Target For Inhibiting Malignant Mesothelioma Growth Dr Steven Mutsaers Lung Institute of Western Australia (Inc) The University of Western Australia

53 Hedgehog Pathway cont d Increasing evidence supports an association between inappropriate activation of key proteins within a cell signalling pathway important for human development called the Hedgehog (HH) pathway

54 Hedgehog Pathway cont d Data from this labratory supports a role for the HH pathway in MM. Further studies using human cells and animal models are required to identify the best way to inhibit this pathway and prevent tumour growth

55 Combinatorial Targeting of Tyrosine Kinases that are Aberrantly Activated in Malignant Mesothelioma Joseph Testa PhD Carol & Kenneth E. Weg Chair in Human Genetics Co-Director, Cancer Biology Program Fox Chase Cancer Center

56 Combinatorial Targeting of Tyrosine Kinases that are Aberrantly Activated in Malignant Mesothelioma tested the idea of combinatorial targeted drug therapies in preclinical models of mesothelioma in hopes of demonstrating efficacy toward the clinical treatment of mesothelioma.

57 Conclusion The Foundation s s Grant Program is a leader in stimulating research into early detection, defining mechanisms contributing to malignancy and driving force behind new treatments being offered to mesothelioma patients.

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