On May 16, 2019 ImaginAb Inc., a clinical stage immuno-oncology imaging company, reported it has enrolled its first patient for the Phase II clinical trial of its lead product, CD8 tracer 89Zr-Df-IAB22M2C, at City of Hope in Los Angeles County (Press release, ImaginAb, MAY 16, 2019, View Source [SID1234536415]). City of Hope is a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases based in Duarte, California, where ImaginAb co-founder Anna Wu, Ph.D., is currently Chair of Molecular Imaging and Therapy.

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89Zr-Df-IAB22M2C is a first in class imaging agent that visualizes the immune system using non-invasive, whole-body in vivo PET imaging of CD8 T cells. Using its ‘Minibody’ platform, ImaginAb’s technology targets and visualizes CD8+ T-cells to provide highly-specific, quantitative assessment of the immunological status of each cancer lesion within a patient, potentially enabling treatment to be tailored quickly and specifically to the needs of that patient.

City of Hope is one of ImaginAb’s active clinical sites conducting Phase II baseline/on-treatment clinical trials investigating the utility of 89Zr-Df-IAB22M2C to image CD8 T cells prior to (baseline) and after (on-treatment) cancer patients receive immunotherapy-based treatment. Kim Margolin, M.D., clinical professor in the Department of Medical Oncology & Therapeutics Research at City of Hope, is the study’s principal investigator.

Ian Wilson, CEO of ImaginAb, said: "ImaginAb’s goal is to provide target-specific imaging agents to predict, inform, monitor and enable treatment of cancer disease more effectively. We are delighted to have enrolled and imaged our first patient in this ongoing clinical study at City of Hope, a world-class cancer center."

The trial will enroll metastatic cancer patients and will study the correlation of imaging signals observed using ImaginAb’s CD8 T-cell ImmunoPET imaging agent, standard-of-care scans, and immunohistochemistry analysis of CD8 in biopsied tissues. The trial will also measure changes in CD8+ T-cell distribution before and after immuno-oncology therapies.

For further information please contact:

ImaginAb

Ian Wilson
Email: [email protected]
Phone: +1 310 645 1211

Optimum Strategic Communications

Mary Clark, Supriya Mathur, Manel Mateus
Email: [email protected]
Phone: +44 20 3950 9144

On May 16, 2019 H3 Biomedicine Inc., a U.S.-based precision medicine research & development subsidiary of Eisai Co., Ltd., reported it will present four posters during the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held May 31–June 4, 2019 in Chicago (Press release, H3 Biomedicine, MAY 16, 2019, View Source [SID1234536414]).

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The presentations will include interim data from two of H3’s ongoing clinical development programs. These include a Phase 1 study of H3B-6545, a potential first-in-class, orally available Selective ERα Covalent Antagonist (SERCA), in women with ER-positive, HER2-negative breast cancer; and a Phase 1 study of H3B-6527, an investigational selective, orally available, inhibitor of fibroblast growth factor receptor 4 (FGFR4), in patients with hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC). H3 will also present posters demonstrating the utilization of biomarker and companion diagnostic strategies for both programs.

The clinical data abstracts published online today for the H3B-6545 and H3B-6527 Phase 1 studies reflect data as of December 18, 2018 and January 6, 2019, respectively. Updated results from both studies will be presented at ASCO (Free ASCO Whitepaper).

The schedule for H3’s ASCO (Free ASCO Whitepaper) presentations is as follows:

H3B-6545 Presentations
Abstract Number: 1059
Title: Phase 1 dose escalation of H3B-6545, a first-in class highly Selective ERα Covalent Antagonist (SERCA), in women with ER-positive, HER2-negative breast cancer
Session: Breast Cancer – Metastatic
Date and Time: June 2, 2019; 8:00 – 11:00 am CDT
Presenter: Erika P. Hamilton, M.D., Director, Breast and Gynecologic Cancer Research Program, Sarah Cannon Research Institute

Abstract Number: 1052
Title: Molecular characterization and monitoring of patient circulating tumor (ctDNA) in phase I study of H3B-6545 in ER+ metastatic breast cancer
Session: Breast Cancer—Metastatic
Date and Time: June 2, 2019; 8:00 AM-11:00 AM CDT
Presenter: Victoria Rimkunas, Ph.D., Associate Director, Biomarkers and Companion Diagnostics, H3 Biomedicine

H3B-6527 Presentations
Abstract Number: 4095
Title: A phase 1 study of H3B-6527 in hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC) patients Session: Gastrointestinal (noncolorectal) cancer
Date and Time: June 3, 2019; 8:00 – 11:00 AM CDT
Presenter: Teresa Macarulla, M.D., Ph.D., Gastrointestinal Tumor Unit, Institute of Oncology Barcelona-Madrid

Abstract Number: 4121
Title: H3B-6527 clinical biomarker assay development and characterization of HCC patient samples Session: Gastrointestinal (non-colorectal) cancer
Date and Time: June 3, 2019; 8:00 – 11:00 AM CDT
Presenter: Pavan Kumar, Ph.D., Head of Biomarkers and Companion Diagnostics, H3 Biomedicine

About H3B-6545
H3B-6545 irreversibly inactivates ERα by covalently binding a cysteine residue in ERα that is not present in other nuclear hormone receptors. It is believed that binding of SERCA to ERα leads to divergent biological activity that is differentiated from classical Selective Estrogen Receptor Modulators (SERMs) and Selective Estrogen Receptor Degraders (SERDs), two classes of standard-of-care endocrine therapies.

The Phase 1 H3B-6545 study is evaluating the safety, pharmacokinetics and pharmacodynamics of H3B-6545 in women with ER-positive, HER2-negative breast cancer to identify the recommended Phase 2 dose. Patients are treated with H3B-6545 administered once daily orally over a 28-day cycle after progression on at least one hormonal therapy and at least one additional therapy/regimen. Dose escalation uses a 3+3 design with the option to backfill previously cleared doses and allows for intra-patient dose escalation.

About H3B-6527
FGF19 overexpression is hypothesized to hyperactivate FGFR4 and its downstream signaling pathway leading to enhanced tumor growth in patients with HCC or ICC. Targeting FGFR4 may have therapeutic benefit in HCC/ICC with altered FGF19 signaling. A phase 1 study was initiated to assess H3B-6527, an investigational covalent FGFR4 inhibitor.

The Phase 1 H3B-6527 study is assessing the safety, pharmacokinectics and pharmacodynamics of H3B-6527 in adult patients with advanced HCC or ICC, well compensated liver function, and who progressed after at least one prior therapy. Patients are administered H3B-6527 once daily orally on a 21-day cycle following a 3+3 design. Patients in the dose escalation phase are treated regardless of FGF19 status.

On May 16, 2019 Geron Corporation (Nasdaq: GERN) reported that two abstracts containing clinical data and analyses related to imetelstat, the Company’s first-in-class telomerase inhibitor, have been accepted for presentation at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress to be held in Amsterdam, the Netherlands, from June 13-16, 2019 (Press release, Geron, MAY 16, 2019, View Source [SID1234536413]). The abstracts are available on the EHA (Free EHA Whitepaper) website at www.ehaweb.org/congress.

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"We appreciate the opportunity to present additional data and analyses at EHA (Free EHA Whitepaper) from the ongoing imetelstat clinical trials," said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer. "In the Phase 2 portion of IMerge, the 8-week transfusion independence rate increased compared to the data presented last December, supporting the initiation of the Phase 3 portion of IMerge that we plan to open for screening and enrollment by mid-year 2019. For IMbark, the analyses reported in the abstract suggest that treatment with imetelstat is associated with a lower risk of death compared to best available therapy from closely matched real-world data from patients with Intermediate-2 or High-risk myelofibrosis after JAK inhibitor failure."

Updated Efficacy and Safety Data from the Phase 2 Portion of IMerge

Abstract Title: Treatment with Imetelstat Provides Durable Transfusion Independence (TI) in Heavily Transfused Non-del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs)

The abstract, accepted for an oral presentation, reports updated efficacy and safety data from 38 patients treated with imetelstat in Part 1 of IMerge, a Phase 2 clinical trial in transfusion dependent, non-del(5q) lower risk myelodysplastic syndromes (MDS) patients who are relapsed or refractory to ESAs and naïve to hypomethylating agent (HMA) and lenalidomide treatment. The primary efficacy endpoint is 8-week RBC-TI rate, which is defined as the proportion of patients achieving red blood cell transfusion independence during any consecutive eight weeks since entry into the trial.

In the preliminary data set used to prepare the abstract, the 8-week RBC-TI rate was 45% (17/38). Based on the most recent clinical cut-off date, used to prepare the IMerge clinical data for the transition of the imetelstat program, the 8-week RBC-TI rate is 42% (16/38), which is an increase of two new responders compared to the 8-week RBC-TI rate of 37% (14/38) reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018. The most frequently reported adverse events were manageable and reversible grade ≥3 cytopenias.

The abstract states these data support initiation of Part 2 of IMerge, the Phase 3 placebo-controlled trial, which is planned to be open for screening and enrollment by mid-year 2019.

Oral Presentation Details:
Session Title: Improvements in MDS Treatment
Session Date: Saturday, June 15
Session Time: 11:30 – 11:45 a.m. CET
Abstract Code: S837

The oral presentation is expected to provide more mature efficacy and safety data for the Phase 2 portion of IMerge.

Analysis of Overall Survival Data from IMbark

Abstract Title: Favorable Overall Survival of Imetelstat-Treated Relapsed/Refractory Myelofibrosis Patients Compared with Closely Matched Real World Data

This abstract, accepted for a poster presentation, provides a new analysis of the overall survival (OS) benefit in patients treated with imetelstat 9.4 mg/kg during the IMbark Phase 2 clinical trial, compared to real-world data (RWD) from patients who had discontinued from a JAK inhibitor (JAKi). For this analysis, historical RWD were collected from a single-center study of patients who had discontinued ruxolitinib. A closely matched cohort of these patients was identified using guidelines for inclusion and exclusion criteria as defined in the IMbark clinical protocol, and consisted of patients who had discontinued JAKi due to lack or loss of response and were subsequently treated with best available therapy (BAT) at the Moffitt Cancer Center. For comparability between the IMbark data and the RWD, several baseline clinical patient characteristics, such as, platelet count, spleen size, time from diagnosis to JAKi therapy discontinuation, MF type and others, were selected to assess the average treatment effect of imetelstat or BAT. Using propensity score approaches, median overall survival in the imetelstat-treated patients from IMbark was calculated to be 30.69 months compared to a median overall survival that was calculated to be 12.04 months in patients treated with BAT at the Moffitt Cancer Center (hazard ratio 0.35, p<.0019). These analyses suggest that treatment with imetelstat is associated with a lower risk of death compared to BAT from closely matched RWD from patients with Intermediate-2 or High-risk MF after JAKi failure.

Poster Presentation Details:
Session Title: Myeloproliferative neoplasms—Clinical
Session Date: Saturday, June 15
Session Time: 5:30 – 7:00 p.m. CET
Abstract Code: PS1456

In accordance with EHA (Free EHA Whitepaper) policies, abstracts submitted to the EHA (Free EHA Whitepaper) Annual Congress are embargoed from the time of submission. To be eligible for presentation at the EHA (Free EHA Whitepaper) Annual Congress, any additional data or information to be presented at the Annual Congress may not be made public before the presentation. The slide presentation and poster will be available at www.geron.com/r-d/publications following the EHA (Free EHA Whitepaper) Annual Congress presentations.

Post-EHA Event with Key Opinion Leaders

On June 25, 2019, Geron plans to host a webcasted event after the EHA (Free EHA Whitepaper) Annual Congress. At the event, authors from each of the imetelstat abstracts will reprise the respective presentations from the EHA (Free EHA Whitepaper) Annual Congress. A press release with event details, including how to access a webcast link, will be available on Geron’s website at the beginning of June.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat include a Phase 2/3 trial, called IMerge, in lower risk myelodysplastic syndromes (MDS) and a Phase 2 trial, called IMbark, in Intermediate-2 to High-risk myelofibrosis. Imetelstat received Fast Track designation from the United States Food and Drug Administration for the treatment of patients with transfusion-dependent anemia due to lower risk MDS who are non-del(5q) and refractory or resistant to an erythroid stimulating agent.

On May 16, 2019 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing personalized cancer immunotherapies, reported the first clinical results from its ongoing Phase 1/2a trial for GEN-009, the company’s lead neoantigen vaccine candidate (Press release, Genocea Biosciences, MAY 16, 2019, View Source [SID1234536412]). Genocea employs its ATLAS platform for patient-specific neoantigen selection, using each patient’s own T cells to identify the neoantigens to which each patient mounts anti-tumor cytokine responses.

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"To date, we have analyzed full immune response data from three patients following their priming series of three vaccinations and have detected immune responses to 93% of the total administered neoantigens, a response rate that would be best-in-class if seen across the full vaccinated cohort," said Tom Davis, M.D., Genocea’s Chief Medical Officer. "We are studying a diverse group of patients and, despite this variability, we are seeing consistently broad immune responses, including ex vivo CD8+ T cell responses, which have not previously been detected after monotherapy with a neoantigen vaccine. We expect to present more detailed immunogenicity and safety data from these and additional patients at the upcoming meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)."

ASCO POSTER SESSION: Developmental Immunotherapy and Tumor Immunobiology
Poster Board: #255 • *Abstract 2611
Title:
A phase 1/2a study of GEN-009, a neoantigen vaccine based on autologous peptide immune responses
Presenter:
Roger B. Cohen, M.D., University of Pennsylvania Perelman School of Medicine
Date:
Saturday, June 1, 8:00 AM – 11:00 AM Central Time
Location:
Hall A

*Note: The abstract was submitted prior to the availability of the immunogenicity data being reported today.

Conference Call and Webcast – June 3rd at 8:30 am ET
Genocea will host a conference call and webcast to discuss the clinical results presented at ASCO (Free ASCO Whitepaper) at 8:30 am ET on June 3, 2019. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 9068006. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

On May 16, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that 15 industry sponsored abstracts regarding Genmab programs were accepted for presentation at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress 2019 in Amsterdam, the Netherlands, taking place June 13-16, 2019 (Press release, Genmab, MAY 16, 2019, View Source [SID1234536411]). A list of accepted Industry-sponsored abstracts featured at the congress includes 14 daratumumab abstracts, four of which were accepted for oral presentations, including a presentation of the Phase III CASSIOPEIA data, which the Scientific Program Committee of the EHA (Free EHA Whitepaper) selected for presentation during the Presidential Symposium, which showcases abstracts that represent innovative research in hematology. In addition, one abstract features Genmab’s proprietary DuoBody-CD3xCD20 product. The abstracts have been published on the EHA (Free EHA Whitepaper) website and may be accessed via www.ehaweb.org.

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"The presentation of impressive pre-clinical data on our DuoBody-CD3xCD20 program exemplifies how Genmab is advancing its proprietary product pipeline using our strong expertise in antibody drug development to create truly differentiated products to help patients with hematologic malignancies. We are also very pleased that the EHA (Free EHA Whitepaper) has selected the CASSIOPEIA data for presentation during the prestigious Presidential Symposium as it reinforces Genmab’s impactful contribution to multiple myeloma treatment," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Industry-Sponsored Abstracts are as follows:

DuoBody-CD3xCD20:
Potent Anti-tumor Activity of DuoBody-CD3xCD20 in Pre-clinical Models In Vitro and In Vivo – Poster presentation, Saturday, June 15, 5:30 PM – 7:00 PM CEST

Daratumumab (Submitted by Janssen Biotech, Inc.):
Phase 3 Randomized Study of Daratumumab, Bortezomib, Thalidomide, and Dexamethasone (VTd) Versus VTd in Transplant-eligible Newly Diagnosed Multiple Myeloma: Part 1 CASSIOPEIA Results – Oral presentation, Friday, June 14, 3:45 PM – 4:00 PM CEST

Efficacy of Daratumumab, Bortezomib, Thalidomide, and Dexamethasone in Transplant-eligible Newly Diagnosed Multiple Myeloma Based Minimal Residual Disease Status: Analysis of CASSIOPEIA – Oral presentation, Saturday, June 15, 4:45 PM – 5:00 PM CEST

Randomized, Open-label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA – Oral presentation, Saturday, June 15, 11:30 AM – 11:45 AM CEST

Subcutaneous Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone in Patients with Newly Diagnosed Amyloid Light Chain Amyloidosis: Updated Safety Run-in Results of ANDROMEDA – Oral presentation, Saturday, June 15, 5:00 PM – 5:15 PM CEST

Stem Cell Yield and Transplantation in Transplant-eligible Newly Diagnosed Multiple Myeloma Patients Receiving Daratumumab, Bortezomib, Thalidomide, and Dexamethasone: Phase 3 CASSIOPEIA Study – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Impact of Age on Efficacy and Safety of Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma: MAIA – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Faster and Sustained Improvement in Health-related Quality of Life in Transplant-ineligible Newly Diagnosed Multiple Myeloma Patients Treated with Daratumumab, Lenalidomide, and Dexamethasone (D-Rd) Versus Rd: MAIA – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Efficacy and Safety of Daratumumab, Lenalidomide, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Subgroup Analysis of POLLUX Based on Cytogenetic Risk – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Subgroup Analysis of CASTOR Based on Cytogenetic Risk – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Characterization of Treatments and Real-life Outcomes in Patients with Newly Diagnosed Multiple Myeloma Who Received Frontline Autologous Stem Cell Transplantation in Sweden – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Characterization of Frontline Treatment Patterns and the Proportion of Patients Reaching Subsequent Lines of Therapy in Transplant-eligible Patients with Newly Diagnosed Multiple Myeloma – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Improvement in Health-related Quality of Life for Newly Diagnosed Multiple Myeloma Transplant-eligible Patients Treated with Daratumumab, Bortezomib, Thalidomide, and Dexamethasone: CASSIOPEIA – Poster presentation, Saturday, June 15, 5:30 PM – 7:00 PM CEST

Results of the Daratumumab Monotherapy Early Access Treatment Protocol in Patients from Europe and Russia with Relapsed or Refractory Multiple Myeloma – Poster presentation, Saturday, June 15, 5:30 PM – 7:00 PM CEST

Comparative Effectiveness of Frontline Treatments for Patients with Newly Diagnosed Multiple Myeloma Who are Transplant-ineligible – Poster presentation, Saturday, June 15, 5:30 PM – 7:00 PM CEST