On December 3, 2018 Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of people with cancer, reported the appointment of Dennis Kim, M.D., MPH, as chief medical officer (Press release, Sesen Bio, DEC 3, 2018, View Source [SID1234531828]). In this role, Dr. Kim will oversee the continued Phase 3 development of Vicinium, Sesen Bio’s lead targeted fusion protein, for patients with high-grade non-muscle invasive bladder cancer (NMIBC), as well as preparations for a marketing authorization submission and pre-commercial activities.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are thrilled to welcome Dennis to the Sesen Bio team and look forward to leveraging his deep drug development experience, particularly as we approach both six and 12-month data readouts from our VISTA Trial of Vicinium," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Dennis has an extensive track record of leading product candidates through development to approval and commercial launch. As the Vicinium program advances, his leadership will be instrumental in helping us bring this novel treatment to patients in need and achieving our mission of saving and renewing the lives of people with cancer."

Dr. Kim brings significant drug development and commercialization experience to Sesen Bio’s leadership team. He has played key roles in both the approval and commercial launch of more than 10 products in oncology and immunology. Prior to joining Sesen Bio, Dr. Kim held senior and leadership roles at Ipsen, Spectrum, Novartis, Biogen Idec, and Amgen. Previously, Dr. Kim was an Epidemic Intelligence Service Officer at the Centers for Disease Control and Prevention where he played active roles in environmental and infectious disease studies. Dr. Kim earned his bachelor’s degree in chemistry and biology from Harvard, his M.D. from Stanford University and his MPH from the University of California, Los Angeles.

"I am highly encouraged by the data generated to date with Vicinium in high-grade non-muscle invasive bladder cancer, and believe this therapy has the potential to change the way we treat bladder cancer," said Dr. Kim. "I am excited to work with the Sesen Bio team and board of directors to help propel Vicinium towards a potential approval so that we can help the many patients, and their families and physicians, who need a new and effective treatment option for this devastating cancer."

In connection with the appointment of Dr. Kim, Sesen Bio entered into an employment agreement with Dr. Kim that, among other things, provides for the grant of a non-statutory stock option outside of Sesen Bio’s 2014 Stock Incentive Plan as an inducement material to Dr. Kim’s entering into employment with Sesen Bio in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The stock option to purchase 425,000 shares of the company’s common stock is being granted effective as of December 3, 2018. The stock option grant was approved by the independent compensation committee of the board of directors in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). This stock option will have an exercise price per share equal to the closing price per share of Sesen Bio’s common stock on The Nasdaq Global Market on December 3, 2018. The stock option will have a ten-year term and will vest over a four-year period, with 25 percent of the shares underlying the stock option award vesting on the first anniversary of the date of grant and an additional 6.25 percent of the shares underlying the stock option vesting at the end of each successive three-month period following the one-year anniversary of the date of grant of the stock options, subject to Dr. Kim’s continued service with the company through the applicable vesting dates.

On December 3, 2018 Geron Corporation (Nasdaq: GERN) reported that updated results from Part 1 of IMerge, the Phase 2 portion of a Phase 2/3 clinical trial of imetelstat in lower risk myelodysplastic syndromes (MDS), were presented at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, California on December 2, 2018 (Press release, Geron, DEC 3, 2018, View Source [SID1234531827]). The oral presentation was made by David Steensma, M.D., Institute Physician at the Dana-Farber Cancer Institute and Associate Professor at Harvard Medical School, and an IMerge clinical investigator. Geron believes these results support initiating the Phase 3 portion of IMerge to address an unmet medical need for patients for whom erythropoiesis stimulating agents (ESAs) are not effective and for whom currently available therapies show only modest efficacy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The results from the Phase 2 portion of IMerge presented at ASH (Free ASH Whitepaper) highlight imetelstat’s broad clinical activity, especially in difficult-to-treat patients, as indicated by the high baseline transfusion burden of the patients enrolled in IMerge. As such, we believe imetelstat could offer a much-needed alternative treatment in lower risk MDS," said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer. "We remain committed to developing imetelstat and continue to plan the initiation of the Phase 3 portion of IMerge by mid-year 2019."

IMerge Phase 2/3 Clinical Trial Design

IMerge is a two-part clinical trial evaluating imetelstat in transfusion dependent patients with Low or Intermediate-1 risk MDS who have relapsed after or are refractory to prior treatment with an ESA. The first part of the trial was originally designed as a Phase 2, open-label, single-arm trial to assess the efficacy and safety of imetelstat. The second part of the trial is planned as a Phase 3 double-blind, randomized, placebo-controlled trial in approximately 170 patients. To be considered for enrollment into IMerge, patients had to be transfusion dependent, requiring ≥4 units of red blood cells (RBC) over 8 weeks prior to entry into the trial. The primary efficacy endpoint of the trial is the rate of RBC transfusion-independence (RBC TI) lasting at least 8 weeks, defined as the proportion of patients without any RBC transfusion during any consecutive 8 weeks since entry into the trial. Key secondary endpoints are the rate of ≥24-week RBC TI and the rate of hematologic improvement-erythroid (HI-E), defined as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least 8 weeks or a reduction of at least 4 units of RBC transfusions over 8 weeks compared with the prior RBC transfusion burden.

Among the first 32 patients enrolled in the Phase 2 portion of IMerge, an initial cohort of 13 patients, who were non-del(5q) and naïve to HMA and lenalidomide treatment, showed an increased RBC TI rate and durability compared to the overall trial population. Thus, earlier this year, an additional expansion cohort of 25 patients were enrolled who were non-del(5q) and naïve to HMA and lenalidomide treatment in order to increase the experience and confirm the benefit-risk profile of this target patient population.

Clinical Data Presentation

Title: Imetelstat Treatment Leads to Durable Transfusion Independence (TI) in RBC Transfusion-Dependent (TD), Non-Del(5q) Lower Risk MDS Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Who Are Lenalidomide and HMA Naïve (Abstract #463)

The oral presentation described combined data with a data cut-off date of October 26, 2018 for the target patient population (n=38) in the Phase 2 portion of IMerge, which includes 13 patients from the initial cohort and 25 patients from the expansion cohort. The initial cohort had a median follow up time of 29 months, and the expansion cohort had a median follow up of almost nine months. As of the data cut-off date, median duration of RBC TI had not been reached for the target patient population. Geron expects further data from the Phase 2 portion of IMerge for the target patient population reflecting longer follow up to be available in 2019 and anticipates submitting such data for presentation at a future medical conference.

Efficacy Highlights for Target Patient Population (n=38):

37% (14/38) of patients achieved ≥8-week RBC TI
26% (10/38) of patients achieved ≥24-week RBC TI
Rate of transfusion reduction (HI-E) was 71% (27/38)
Mean relative reduction of RBC transfusion burden from baseline was 68%
Broad clinical activity observed
• Similar 8-week RBC TI was observed in patients with baseline serum erythropoietin (sEPO) levels less than or greater than 500mU/mL
• 8-week RBC TI consistent across ring-sideroblast (RS) patient subtypes, RS+ and RS-
Reductions in mutation burden and presence of RS noted among responding patients, suggesting potential disease modifying activity
Safety Summary for Target Patient Population (n=38):

Cytopenias, particularly neutropenia and thrombocytopenia, were the most frequently reported adverse events which were predictable, manageable and reversible
The slides from the oral presentation at ASH (Free ASH Whitepaper) are available on Geron’s website at www.geron.com/r-d/publications.

Phase 3 Development Plan for Lower Risk MDS

Based on the combined data from the initial and expansion cohorts for the target patient population in the Phase 2 portion of IMerge, Geron plans to initiate the Phase 3 portion of IMerge after the sponsorship of the ongoing imetelstat clinical trials has been transferred back to Geron. Geron anticipates patient screening and enrollment for the Phase 3 portion of IMerge to begin by mid-year of 2019.

Analyst and Investor Event

On December 10, 2018, Geron will host a webcasted event for analysts and investors. At the event, Dr. Azra Raza, a clinical investigator for IMerge, will reprise the oral presentation made at the ASH (Free ASH Whitepaper) Annual Meeting, as well as describe the unmet medical need in lower risk MDS. A live audio webcast of the event will be available on Geron’s website, www.geron.com/investors/events. If you are unable to listen to the live presentation, an archived webcast of the event will be available on the Company’s website for 30 days.

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 December 3, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that it will hold a R&D Update and 2018 ASH (Free ASH Whitepaper) Data Review Meeting today, December 3, 2016 at 8:00 PM Pacific Time (5:00 AM CET / 4:00 AM GMT on 4 December) (Press release, Genmab, DEC 3, 2018, View Source [SID1234531826]). The event will take place in San Diego, California, and will also be webcast live and archived on the company’s website. The meeting will include presentations by independent experts on data from daratumumab studies presented at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), including some key aspects of the Phase III MAIA study. Genmab speakers will also discuss pre-clinical data from Genmab’s DuoBody-CD3xCD20 and DuoHexaBody-CD37 programs presented at ASH (Free ASH Whitepaper), as well as the company’s progress and key goals for 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The following cancer experts and senior Genmab staff will be at the event:

Independent experts:

Dr. Meletios A. Dimopoulos, National and Kapodistrian University of Athens, School of Medicine
Dr. Nizar Bahlis, Arnie Charbonneau Cancer Institute, University of Calgary
Dr. Saad Usmani, University of North Carolina at Chapel Hill, Levine Cancer Institute

Genmab:

Dr. Jan van de Winkel, President and CEO, Genmab
Dr. Judith Klimovsky, Executive Vice President and CDO, Genmab
Dr. Kate Sasser, Corporate Vice President, Translational Research, Genmab
Key daratumumab abstracts to be discussed during the event include:

LB-2: Phase 3 Randomized Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant (MAIA)

Abstract 156: One-year Update of a Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) in Patients (Pts) With Transplant-ineligible Newly Diagnosed Multiple Myeloma (NDMM): ALCYONE

Abstract 151: Efficacy and Updated Safety Analysis of a Safety Run-in Cohort from GRIFFIN, a Phase 2 Randomized Study of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide, and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma Eligible for High-Dose Therapy and Autologous Stem Cell Transplantation

Abstract 1996: Three-Year Follow Up of the Phase 3 POLLUX Study of Daratumumab Plus Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone Alone in Relapsed or Refractory Multiple Myeloma

Abstract 3270: Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib, and Dexamethasone in First Relapse Patients: Two-Year Update of CASTOR

Abstract 1995: Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Part 2 Safety and Efficacy Update of the Open-label, Multicenter, Phase 1b Study (PAVO)

The event will take place at the Manchester Grand Hyatt in San Diego, California, Harbor G&H. Those wishing to attend in person may register on site.

The event can also be attended via webcast. To view this webcast visit: View Source Webcast viewers may submit questions during the Q&A portion of the live webcast via the webcast player. An archive of the webcast will be available on Genmab’s website. The webcast will be conducted in English.

This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.

On December 3, 2018 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Robert M. Davis, chief financial offer and executive vice president, Merck Global Services, is scheduled to present at Citi’s 2018 Global Healthcare Conference in New York on Dec. 5, 2018 at 8:45 a.m. EST (Press release, Merck & Co, DEC 3, 2018, View Source [SID1234531824]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source

On December 3, 2018 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that new clinical data from the ongoing intratumoral trial of its CD47-blocking agent, TTI-621 (SIRPa-IgG1 Fc), were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 60th Annual Meeting, December 1-4, in San Diego, California (Press release, Trillium Therapeutics, DEC 3, 2018, View Source [SID1234531823]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"These results build upon the clinical data reported at the EORTC Cutaneous Lymphoma Task Force meeting in September and provide further evidence that intratumoral TTI-621 is well tolerated and biologically active in patients with cutaneous T-cell lymphoma," said Dr. Niclas Stiernholm, president and CEO of Trillium Therapeutics. "The signs of anti-tumor activity in non-injected lesions are particularly encouraging, as are the translational data demonstrating recruitment of cells of both the innate and adaptive immune systems. We believe that this is the most compelling evidence of single-agent activity of any CD47-targeting agent in the clinic, and we are continuing to execute a focused development plan in T-cell lymphoma."

Poster Presentation 1653:

Intralesional Administration of the CD47 Antagonist TTI-621 (SIRPaFc) Induces Responses in Both Injected and Non-injected Lesions in Patients with Relapsed/Refractory Mycosis Fungoides and Sézary Syndrome: Interim Results of a Multicenter Phase I Trial
Presenter: Christiane Querfeld, M.D., Ph.D., City of Hope National Medical Center

This poster presentation provided a further update on the safety and anti-tumor activity observed in the ongoing open label Phase 1 study of local TTI-621 administration in highly pretreated patients with relapsed or refractory mycosis fungoides or Sézary syndrome. Intratumoral TTI-621 was well tolerated in 27 treated patients, with no grade 3 or higher toxicity observed. A rapid reduction in Composite Assessment of Index Lesion Severity (CAILS) scores, which measure local lesion responses, was observed in 91% (20/22) of patients with available scores across all disease stages, with 41% (9/22) exhibiting a 50% or greater decrease in CAILS scores. Similar CAILS-based changes were seen in adjacent non-injected lesions, suggesting local regional effects that were not confined to the site of injection. Continuation monotherapy beyond the initial two week induction period led to further reductions in CAILS scores in 3/4 evaluable patients and evidence of systemic effects were observed in one patient. In addition, emerging translational data demonstrate that local TTI-621 administration leads to a rapid influx of macrophages and CD8+ T cells.