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Andrew Zacharakis - One of the best experts on this subject based on the ideXlab platform.

  • speed to initial public offering of vc backed companies
    Entrepreneurship Theory and Practice, 2001
    Co-Authors: Dean A Shepherd, Andrew Zacharakis
    Abstract:

    Venture capitalists realize returns on their investments when their portfolio companies either go public (IPO) or are acquired by a Publicly Traded Company. Finance theory implies that the sooner a particular return can be realized the higher the “real” return to the investor. We use an ecosystem perspective to investigate speed to initial Public Offering. Findings indicate that geography of the portfolio Company matters, that non high-tech portfolio companies go public faster than do those in the computer-related sector, and that speed is increased with the recent favorable IPO market but not at the same rate for all regions.

Dennis R. Reinstein - One of the best experts on this subject based on the ideXlab platform.

Dean A Shepherd - One of the best experts on this subject based on the ideXlab platform.

  • speed to initial public offering of vc backed companies
    Entrepreneurship Theory and Practice, 2001
    Co-Authors: Dean A Shepherd, Andrew Zacharakis
    Abstract:

    Venture capitalists realize returns on their investments when their portfolio companies either go public (IPO) or are acquired by a Publicly Traded Company. Finance theory implies that the sooner a particular return can be realized the higher the “real” return to the investor. We use an ecosystem perspective to investigate speed to initial Public Offering. Findings indicate that geography of the portfolio Company matters, that non high-tech portfolio companies go public faster than do those in the computer-related sector, and that speed is increased with the recent favorable IPO market but not at the same rate for all regions.

Suzanne Trudel - One of the best experts on this subject based on the ideXlab platform.

  • Dreamm-5 Platform Trial: Belantamab Mafodotin (Belamaf) in Combination with Four Different Novel Agents in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)
    Blood, 2020
    Co-Authors: Paul G. Richardson, Ajay Nooka, Hang Quach, Suzanne Trudel, David Routledge, Kevin Song, Hareth Nahi, Sofia Paul, Josephine Khan, Maria Brouch
    Abstract:

    Introduction: Single-agent belamaf (GSK2857916), a B-cell maturation antigen-targeting antibody-drug conjugate, induced deep and durable responses in patients with RRMM, with a manageable safety profile with 13 months of follow-up (DREAMM-2; NCT03525678; Lonial et al, ASCO 2020, Poster 436). A platform trial design allows efficient evaluation of belamaf in combination with other anti-myeloma agents, such as a humanized wild-type IgG1 anti-OX40 agonist, an IgG4-inducible T-cell co-stimulator (ICOS) agonist, a gamma-secretase inhibitor, and a humanized programmed cell death (PD)-1 antagonist. The unique, multimodal mechanisms of action (MoAs) of belamaf, in combination with MoAs of these agents, has the potential to achieve synergistic effects in RRMM to further enhance anti-myeloma activity without compromising safety. Methods: DREAMM-5 (NCT04126200) is a Phase I/II study that utilizes a master protocol with separate substudies comprised of sequential dose-exploration (DE) and cohort-expansion (CE) phases, to identify promising, effective belamaf combinations when compared with a shared single-agent belamaf control arm (CE phase only). The DE phase consists of multiple dosing cohorts with belamaf combinations in which patients are assigned to treatment slots by a predetermined algorithmic approach (N≤10 per cohort). A recommended Phase II dose (RP2D) for each combination treatment will be identified based on the safety and preliminary efficacy in the DE phase. At the end of the DE phase, an interim analysis of safety, pharmacokinetic, and efficacy data will also be performed for each substudy treatment combination to determine whether the combination should move forward at the RP2D to the CE phase. Patients in the CE phase (N≥35 per cohort) will be randomized to a substudy and within a substudy to either combination treatment or the belamaf monotherapy control arm; patients will also be stratified by number of prior therapies). Eligible patients will have RRMM and will have received ≥3 prior therapy lines, which includes a prior immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody; all patients will provide informed consent for participation. The primary objectives of the study are to identify the RP2D (DE phase) and the overall response rate (≥partial response, CE phase), along with safety and tolerability, for each combination treatment. Substudies 1 (combination with GSK3174998, OX40 agonist antibody), 2 (combination with GSK3359609, ICOS agonist antibody), and 3 (combination with nirogacestat [PF-03084014; SpringWorks Therapeutics], gamma-secretase inhibitor) are currently open to enrollment. Substudy 4 (combination with dostarlimab; PD-1 antagonist antibody) is under review. Additional substudies will be explored based on scientific rationale and/or preclinical combination study results. Funding: GSK (Study 208887); belamaf drug linker technology licensed from Seattle Genetics; belamaf monoclonal antibody produced using POTELLIGENT Technology licensed from BioWa; nirogacestat gamma-secretase inhibitor produced by and used in collaboration with SpringWorks Therapeutics. Figure: DREAMM-5 study design Figure 1 Disclosures Richardson: Celgene/BMS, Oncopeptides, Takeda, Karyopharm: Research Funding. Nooka:GlaxoSmithKline: Consultancy, Honoraria, Other: Personal Fees: Travel/accomodations/expenses, Research Funding; Karyopharm Therapeutics, Adaptive technologies: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Spectrum Pharmaceuticals: Consultancy; Adaptive Technologies: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Oncopeptides: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Bristol-Myers Squibb: Consultancy, Honoraria, Research Funding. Quach:Amgen, sanofi, celgene, Karyopharm, GSK: Research Funding; Amgen, Celgene, karyopharm, GSK, Janssen Cilag, Sanofi.: Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline, Karyopharm, Amgen, Celgene, Janssen Cilag: Consultancy; GlaxoSmithKline, Karyopharm, Amgen, Celgene, Janssen Cilag: Honoraria. Trudel:Celgene, Janssen, Takeda, Sanofi, Karyopharm, Amgen Canada: Honoraria; Celgene, Amgen, GSK: Consultancy, Research Funding; GSK, Celgene, Janssen, Amgen, Genentech: Research Funding. Routledge:Celgene, Sandoz: Consultancy; Amgen, BMS, Celgene, Sandoz: Honoraria. Song:Otsuka: Honoraria; Janssen: Honoraria, Research Funding; Amgen, Celgene,Takeda: Consultancy, Honoraria; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene/BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees. Paul:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Khan:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Brouch:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Ferron-Brady:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Yeakey:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Shelton:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Montes de Oca:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Smith:SpringWorks: Current Employment, Current equity holder in Publicly-Traded Company. Im:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Ahlers:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Paul:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Holkova:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Gupta:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company; Novartis: Current equity holder in Publicly-Traded Company. Kremer:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Rodriguez-Otero:GlaxoSmithKline: Consultancy, Current Employment, Current equity holder in Publicly-Traded Company, Honoraria; Kite: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Oncopeptides: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Medscape: Membership on an entity's Board of Directors or advisory committees; Celgene/Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care Company); Janssen: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care Company); Sanofi: Consultancy, Honoraria.

  • DREAMM-8: A Phase III Study of the Efficacy and Safety of Belantamab Mafodotin with Pomalidomide and Dexamethasone (B-Pd) Vs Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)
    Blood, 2020
    Co-Authors: Suzanne Trudel, Randy Davis, Nicole M. Lewis, Kalpana K. Bakshi, Bikramjit Chopra, Rocio Montes De Oca, Geraldine Ferron-brady, Laurie Eliason, Brandon E. Kremer, Ira Gupta
    Abstract:

    Introduction: Belantamab mafodotin (belamaf; GSK2857916) is a B-cell maturation antigen (BCMA)-targeting antibody-drug conjugate. In the pivotal Phase II DREAMM-2 study, single-agent belamaf demonstrated deep and durable responses with a manageable safety profile in heavily pretreated patients with RRMM (Lonial et al. Lancet Oncol 2020). Responses were sustained at 13 months of follow-up; with belamaf (2.5 mg/kg administered intravenously [IV] every 3 weeks [Q3W]), overall response rate (ORR) was 32% and median duration of response (DoR) was 11.0 months (Lonial et al. ASCO 2020 Poster 436). Preclinical data suggest synergistic antimyeloma activity of belamaf in combination with pomalidomide/dexamethasone (Pd). Preliminary data from an ongoing Phase I/II study (NCT03715478) evaluating belamaf in combination with Pd (B-Pd) suggest an acceptable safety profile and early signs of clinical activity in patients with RRMM. The DREAMM-8 study (NCT04484623) will evaluate the efficacy and safety of B-Pd compared with pomalidomide, bortezomib, and dexamethasone (PVd). Methods: This Phase III, two-arm, randomized, open-label, multicenter study will include patients with measurable RRMM who have received ≥1 prior line of therapy (including lenalidomide), with documented disease progression during or after their most recent line of treatment. Patients aged ≥18 years with Eastern Cooperative Oncology Group Performance Status 0-2, adequate organ system function, and who provide informed consent will be eligible. Patients with prior exposure to BCMA-targeted therapies or pomalidomide and those intolerant/refractory to bortezomib will be excluded. Approximately 450 patients will be randomized (1:1) to Arm A (B-Pd) or Arm B (PVd), stratified by number of prior lines of treatment, prior exposure to bortezomib, and International Staging System status. No more than 50% of participants with two or more prior lines of treatment will be enrolled. In Arm A, patients will receive belamaf 2.5 mg/kg (IV) Q4W on Day 1 in Cycle 1 (28-day cycle) followed by belamaf 1.9 mg/kg (IV) Q4W on Day 1 in Cycle 2 onwards (28-day cycles); pomalidomide 4 mg (orally [PO]) will be administered on Days 1-21 and dexamethasone 40 mg (PO) on Days 1, 8, 15, and 22 in all cycles (28-day cycles). In Arm B, pomalidomide 4 mg (PO) will be administered Q3W on Days 1-14 in all cycles (21-day cycles); bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8, and 11 in Cycles 1-8, and Days 1 and 8 in Cycle 9+ (21-day cycles). Dexamethasone 20 mg (PO) will be administered on the day of and the day after bortezomib. The dose level of dexamethasone in each arm will be reduced by half in patients >75 years of age. Treatment in both arms will continue until progressive disease, unacceptable toxicity, withdrawal of consent, initiation of another anticancer therapy, or end of study or death. The primary endpoint is progression-free survival (PFS; time from randomization to the earliest date of documented disease progression or death [any cause]). Minimal residual disease negativity rate is a key secondary endpoint. Additional secondary endpoints include ORR, time to response, DoR, time to progression, overall survival, PFS2 (PFS after initiation of new anticancer therapy), safety, health-related quality of life, and pharmacokinetic and pharmacodynamic parameters. The study is planned to start in August 2020. Funding: GSK (Study 207499); drug linker technology licensed from Seattle Genetics; mAb produced using POTELLIGENT Technology licensed from BioWa. Disclosures Trudel: GSK, Celgene, Janssen, Amgen, Genentech: Research Funding; Celgene, Janssen, Takeda, Sanofi, Karyopharm, Amgen Canada: Honoraria; Celgene, Amgen, GSK: Consultancy, Research Funding. Davis:GSK: Current Employment, Current equity holder in Publicly-Traded Company. Lewis:GSK: Current Employment, Current equity holder in Publicly-Traded Company. Bakshi:GSK: Current Employment, Current equity holder in Publicly-Traded Company. Chopra:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Montes de Oca:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Ferron-Brady:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Eliason:GSK: Current Employment, Current equity holder in Publicly-Traded Company. Kremer:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company. Gupta:GlaxoSmithKline: Current Employment, Current equity holder in Publicly-Traded Company; Novartis: Current equity holder in Publicly-Traded Company. Wu:GSK: Current Employment, Current equity holder in Publicly-Traded Company.

Peter Butler - One of the best experts on this subject based on the ideXlab platform.