|Over a week ago|
Fate Therapeutics price target raised to $40 from $34 at Oppenheimer » 07:4406/1006/10/20
Oppenheimer analyst Matthew Biegler raised the firm's price target on Fate Therapeutics to $40 from $34 and keeps an Outperform rating on the shares. The analyst notes that Fate has provided updates on its iPSC-derived cell therapy programs in conjunction with an equity financing. The update included preliminary data from the first two lymphoma patients treated with FT596, the company's COVID-19-targeting CARNK, he adds. Biegler believes the results represent an important early proof-of-concept for FT596 and support the disruptive potential of Fate's iPSC-derived cell therapy platform.
Fate Therapeutics price target lowered to $59 from $63 at Piper Sandler » 15:4606/0906/09/20
Piper Sandler analyst…
Piper Sandler analyst Edward Tenthoff lowered the firm's price target on Fate Therapeutics to $59 from $63 to account for dilution after the company issued 6.18M shares at $28.31 for gross proceeds of $175M. Tenthoff, who estimates Fate now has pro forma cash of about $494M, reiterates an Overweight rating on the shares after Fate also announced early FT596 data and updated FT516 and FT500 progress.
Fate Therapeutics 6.2M share Spot Secondary priced at $28.31 » 07:3106/0906/09/20
Jefferies, SVB Leerink,…
Jefferies, SVB Leerink, Barclays and Guggenheim acted as joint book running managers for the offering.
Fate Therapeutics announces common stock offering, no amount given » 16:0706/0806/08/20
Fate Therapeutics announced that it has commenced an underwritten public offering of its common stock. Fate Therapeutics intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies, the manufacture of its clinical product candidates, the expansion of its cGMP compliant manufacturing operations, including the construction, commissioning and qualification of its new facility, the conduct of preclinical research and development, and for general corporate purposes. Jefferies, SVB Leerink and Barclays are acting as joint book-running managers for the offering.
|Over a month ago|
Fate Therapeutics announces FDA clearance of IND application for FT538 » 08:1505/2005/20/20
Fate Therapeutics announced that the U.S. Food and Drug Administration has cleared the Company's Investigational New Drug application for FT538, the first CRISPR-edited, iPSC-derived cell therapy. FT538 is an off-the-shelf natural killer cell cancer immunotherapy that is derived from a clonal master induced pluripotent stem cell line engineered with three functional components to enhance innate immunity: a novel high-affinity, non-cleavable CD16 Fc receptor; an IL-15/IL-15 receptor fusion; and the elimination of CD38 expression. The Company plans to initiate clinical investigation of three once-weekly doses of FT538 as a monotherapy in acute myeloid leukemia and in combination with daratumumab, a CD38-directed monoclonal antibody therapy, for the treatment of multiple myeloma. The three functional components of FT538 are designed to boost the innate immune response in cancer patients, where endogenous NK cells are typically diminished in both number and function due to prior treatment regimens and tumor suppressive mechanisms. In preclinical studies, FT538 has shown superior NK cell effector function, as compared to endogenous NK cells, with the potential to confer significant anti-tumor activity to patients through multiple mechanisms of action including: Expression of the hnCD16 Fc receptor, which improves antibody-dependent cellular cytotoxicity, a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells; Expression of the IL-15RF cytokine complex, which promotes NK cell survival and persistence and induces trans-activation of endogenous NK cells and CD8 T cells; and Elimination of CD38 expression, which enhances innate effector function, including granzyme and perforin levels and resistance to oxidative stress, and prevents anti-CD38 antibody-mediated NK cell death. The first-in-human, multi-center, dose-escalation Phase 1 clinical trial of FT538 is designed to determine the maximum tolerated dose of three once-weekly doses of FT538 in up to 105 adult patients across four dose cohorts. The study will assess two treatment regimens: Regimen A as a monotherapy in patients with relapsed / refractory AML; and Regimen B in combination with daratumumab, an FDA-approved anti-CD38 monoclonal antibody, in patients with relapsed / refractory multiple myeloma who have failed at least two lines of therapy. In addition, the Company may initiate a third treatment regimen in combination with elotuzumab, an FDA-approved anti-SLAMF7 monoclonal antibody, in patients with relapsed / refractory multiple myeloma who have failed at least two lines of therapy starting at one dose level below the MTD of Regimen B. For all regimens, multiple indication- or dose-specific dose-expansion cohorts of up to 15 patients per cohort may be enrolled to further evaluate the clinical activity of FT538. FT538 is the fourth off-the-shelf, iPSC-derived NK cell product candidate from the Company's proprietary iPSC product platform cleared for clinical investigation by the FDA. The Company has initiated clinical manufacture of FT538 at its GMP facility in San Diego, CA.
Fly Intel: Top five analyst initiations » 10:0505/1305/13/20
WW, CGEN, CLSD, FATE, VTSI
Catch up on today's…
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. WW (WW) initiated with a Buy at Jefferies. 2. Compugen (CGEN) initiated with a Buy at Stifel. 3. Clearside Biomedical (CLSD) initiated with a Buy at Roth Capital. 4. Fate Therapeutics (FATE) initiated with a Buy at H.C. Wainwright. 5. VirTra (VTSI) resumed with a Buy at Roth Capital. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
Fate Therapeutics initiated with a Buy at H.C. Wainwright » 07:2405/1305/13/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Debjit Chattopadhyay initiated coverage of Fate Therapeutics with a Buy rating and $42 price target. The analyst believes FT596 is "poised to build upon the early and promising experience of cord blood NK CARs." Given the surge of interest in the space, and the "plethora" of Fate's clinical milestones, "there is headroom for the stock," Chattopadhyay tells investors in a research note.
Fly Intel: After-Hours Movers » 19:0805/1105/11/20
CBAY, IIVI, VRRM, SGRY, GDOT, GO, CZR, NVAX, AMC, EB, DIOD, ICAD, TLRY, TME, AIMT, SGMO, HALO, FATE, PLYA, JCOM, SGMS, MAXR, FSCT, OMER, SCPL, HTZ, AKBA, QTWO
Check out this evening's…
Fate Therapeutics reports Q1 EPS (44c), consensus (39c) » 16:0505/1105/11/20
Reports Q1 revenue…
Reports Q1 revenue $2.52M, consensus $1.8M. "We are encouraged by the resilience of our employees, our clinical trial investigators and participating patients, and our collaboration partners in the face of the challenge posed by the global pandemic. Like others, we have been affected by COVID-19, which has impacted clinical site initiation, slowed the cadence of new patient enrollment, and changed how we conduct our day-to-day business," said Scott Wolchko, President and CEO of Fate Therapeutics. "Nevertheless, we have continued to enroll patients across our three Phase 1 clinical programs, expanded the clinical footprint of our FT596 program into relapse prevention following autologous HSCT, and submitted our IND application to the FDA for FT538, the first-ever CRISPR-edited, iPSC-derived cell therapy, in multiple myeloma. Additionally, we entered into a transformative collaboration with Janssen that leverages our iPSC product platform and Janssen's proprietary tumor-targeting antigen binders to develop novel CAR NK and CAR T-Cell product candidates for hematologic malignancies and solid tumors, supporting our fundamental goal of bringing off-the-shelf, iPSC-derived cell-based cancer immunotherapies to patients."
Fate Therapeutics to present cell-based cancer immunotherapy program data » 16:4604/2804/28/20
Fate Therapeutics announced the presentation of a new off-the-shelf, iPSC-derived, chimeric antigen receptor, or CAR-targeted, cell-based cancer immunotherapy program at the American Society of Gene & Cell Therapy. The new preclinical program targets MHC class I related proteins A, or MICA, and , or MICB, and is supported by an exclusive license from the Dana-Farber Cancer Institute to intellectual property covering novel antibody fragments binding MICA/B for iPSC-derived cellular therapeutics. MICA and MICB are stress proteins that are selectively expressed at high levels on many solid tumors. While it is well known that tumor resistance to cytotoxic T cells is mediated by loss of MHC Class I expression, proteolytic shedding of the a1 and a2 domains of MICA/B expressed on tumor cells is a common mechanism of NK cell evasion. A recent publication in Science, demonstrated that antibody targeting of the MICA/B a3 domains specifically prevents MICA/B shedding and restores NK cell-mediated immunity. Additionally, in a more recent publication in Cancer Immunology Research, it was demonstrated that cancers with B2M and JAK1 inactivating mutations resulting in loss of MHC Class I expression can be effectively targeted with MICA/B a3 domain-specific antibodies to restore NK cell-mediated immunity against solid tumors resistant to cytotoxic T cells. Using a clonal master induced pluripotent stem cell, or iPSC, line previously engineered with an expression cassette introduced into the CD38 locus that encodes for a high-affinity, non-cleavable CD16 Fc receptor and an IL-15 receptor fusion, scientists from Fate Therapeutics introduced a second expression cassette encoding for the novel CAR MICA/B construct. In vitro differentiation of the clonal iPSC lines produced homogeneous NK cell populations with uniform expression of CAR MICA/B, hnCD16, and IL15RF, and without any expression of CD38. The iPSC-derived CAR NK cells displayed enhanced cytokine production and cytotoxicity against MICA/B positive tumor cells compared to non-engineered, iPSC-derived NK cells.