LMPX = On December 5, 2019, LMP Automotive 2.3M share IPO priced at $5.00. The deal size was increased to 2.3M shares from 2.091M shares, after being reduced previously from 3.3M shares, and priced at the bottom of the $5.00-$6.00 range. acted as sole book running manager for the offering.
LMPX price at time of alert is $6.28.
FATE = Wells Fargo analyst Jim Birchenough upgraded Fate Therapeutics to Outperform from Market Perform with a price target of $24, up from $16. The shares closed Friday up 10c to $13.67. The analyst upgraded Fate following this weekend’s update for the company’s iPSC-derived NK-cell therapeutics pipeline, initial data for iPSC NKcell therapies FT500 and FT516, and updated comments on CD19 CAR-NK therapeutic FT596. Overall, data update appeared well received by both clinicians and investors, Birchenough tells investors in a research note. He believes “demonstrated feasibility of consistent repeat dosing” with FT500, initial evidence of monotherapy activity for FT516 in “difficult to treat patients” and expectations for monotherapy benefit with FT596 at a dose above that validated by competing CD19 CAR-NK from MD Anderson all support upside potential into 2020. The homogeneity of Fate’s “off-the-shelf” NKcell therapeutics and relatively low cost of goods “have established a high technical bar for competitors,” contends Birchenough.
FATE price at time of alert is $17.02.
DTIL = Precision BioSciences, Inc. (Nasdaq: DTIL) today announced updated interim clinical data from the ongoing Phase 1 trial of its lead investigational off-the-shelf (allogeneic) chimeric antigen receptor (CAR) T cell therapy candidate, PBCAR0191, which targets the well characterized cancer cell surface protein CD19. PBCAR0191 is being developed in collaboration with Servier, an international pharmaceutical company. Data will be presented by Bijal Shah, MD, Moffitt Cancer Center, at the 61st Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida, during a poster session from 6:00-8:00 p.m. ET today (Poster #4107, Hall B).
A total of nine patients are reported in these initial Phase 1 trial results, including six with NHL (three treated at Dose Level 1 and three treated at Dose Level 2), and three with B-ALL (all treated at Dose Level 2). Key baseline characteristics were as follows:
Dose Level 1 (3×105 cells/kg) – three NHL patients (two with diffuse large B cell lymphoma, one with mantle cell lymphoma) with a mean age of 54 years (min-max 34-64 years). Patients had received a median of four prior lines of therapy, with two patients being refractory to their last treatment, and one having previously relapsed following treatment with Yescarta®, an FDA-approved autologous CD19-targeted CAR T therapy.
Dose Level 2 (1×106 cells/kg) – three NHL patients (all with mantle cell lymphoma) with a mean age of 74 years (min-max 71-77 years) who had received a median of two prior lines of therapy, with one patient refractory to their last treatment and two who had relapsed. Three B-ALL patients were also treated at DL2, with a mean age of 56 years (min-max 48-72 years); these patients had received a median of four prior lines of therapy – all three patients were refractory to their last treatment, with two patients having poor prognostic indicators at trial entry.
Patients received a single infusion of PBCAR0191 on day 0, following three days of lymphodepletion using fludarabine 30mg/m2/day and cyclophosphamide 500mg/m2/day. The primary objective of this Phase 1 portion of the ongoing Phase 1/2a trial is to evaluate safety as measured by the occurrence of dose limiting toxicities (DLTs). Secondary objectives include assessment of objective tumor responses using standard criteria, and further evaluation of adverse events (AEs) and adverse events of special interest, including graft-versus-host disease (GvHD), cytokine release syndrome (CRS), and IEC-associated neurotoxicity syndrome (ICANS). Data are presented as of a November 4, 2019 cutoff date, with additional critical data collected through December 2, 2019, including occurrence of CRS, ICANS, GvHD and evaluation of objective responses.
No serious adverse events or evidence of GvHD was observed through December 2, 2019. Three of the nine patients (33%) treated with PBCAR0191 developed CRS, including two Grade 1 cases and one Grade 2 case. One of the nine patients (11%) developed Grade 2 neurotoxicity. All events of CRS and neurotoxicity resolved, and no deaths occurred on study. In addition, one patient experienced a Grade 3 AE that was deemed related to PBCAR0191 (pain at the site of their tumor mass for one day following infusion), and one patient experienced Grade 4 lymphopenia (seven days duration) deemed related to PBCAR0191.
Of the nine patients treated with PBCAR0191, seven (78%) had objective evidence of tumor shrinkage at any timepoint. Results also provide preliminary evidence of dose-dependent CAR T cell expansion and persistence.
In the NHL cohort, four of six patients (66%) achieved an objective response by Lugano 2014 criteria at day 28+, including three partial responses (two patients treated at DL1 and one patient treated at DL2) and one complete response (patient treated at DL2). As of December 2, 2019, one patient (treated at DL2) remains in complete response. One patient (treated at DL1) achieved a partial response then progressed six months after treatment with PBCAR0191. This was the most durable response observed to date and was also notable given the patient had relapsed following treatment with Yescarta®. The remaining two NHL patients, one treated at DL1 and one at DL2, achieved early responses (one CR, one PR respectively) at day 14; both patients had evidence of disease progression at day 28.
In the B-ALL cohort treated at DL2, one of three patients (33%) achieved a complete response by NCCN 2017 criteria at day 28+ (with undetectable B-ALL in the bone marrow by flow cytometry, described as minimal residual disease (MRD) negative), and continues to be followed on study. The remaining two patients did not respond at day 28 – these patients had poor prognostic indicators on entry into the trial, one with prior CNS involvement and 95% blast infiltration into the bone marrow, and one with 77% blast infiltration into the bone marrow and disease refractory to two previous lines of treatment.
CAR T cell expansion and persistence in the peripheral blood was assessed at DL1 and DL2 by flow cytometry and qPCR. Evidence of a dose-dependent increase in cell expansion was observed between subjects treated at DL1 and DL2, as was a dose-dependent increase in CAR T cell persistence. B-cell aplasia and serum cytokine analysis also anecdotally correspond to observed clinical responses and CAR T cell expansion.
“We are very encouraged by the evidence of cell-mediated anti-tumor activity and objective tumor responses that we have observed in both NHL and B-ALL patients treated with PBCAR0191, in the context of a manageable adverse event profile,” said Chris Heery, MD, Chief Medical Officer of Precision BioSciences. “These data give us incremental confidence in our unique approach to allogeneic CAR T cell therapy, and we look forward to the potential of this therapy positively impacting the lives of more patients as the trial continues. At these still low dose levels, and using only mild lymphodepletion, it is remarkable to see anti-tumor activity in the majority of patients treated with PBCAR0191, including a durable response that lasted six months in one patient, and two complete responses. We have also seen preliminary evidence of dose dependent CAR T cell expansion and persistence, supporting our belief that cell persistence and clinical response is likely to increase as we increase dose level.”
“New treatment options are desperately needed for patients with advanced NHL and B-ALL who often undergo multiple cycles of therapy with limited clinical benefit,” commented Bijal Shah, MD, Moffitt Cancer Center. “These first-in-human data for PBCAR0191 suggest a tolerable safety profile and encouraging early evidence of clinical activity. Further study is required to determine durability of response at the current dose levels, as well as to establish safety and activity at Dose Level 3.”
DTIL price at time of alert is $21.50.
FTSV = Forty Seven, Inc. (NASDAQ:FTSV), a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, today announced the presentation of updated clinical data from its ongoing trial evaluating magrolimab in combination with azacitidine for the treatment of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). The new results, which will be shared in an oral presentation at the 61st American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, show that the combination of magrolimab and azacitidine is highly active and well-tolerated in patients with MDS and AML.
Forty Seven’s Phase 1b trial, which is being funded in part by the California Institute of Regenerative Medicine (CIRM), is designed to evaluate magrolimab in combination with azacitidine in untreated patients with higher risk MDS and untreated patients with AML, who are ineligible for induction chemotherapy. All patients received a 1 mg/kg priming dose of magrolimab, coupled with intrapatient dose escalation, to mitigate on-target anemia. Patients were then treated with full doses of azacitidine and a magrolimab maintenance dose of 30 mg/kg once weekly.
As of the data cutoff of November 18, 2019, 62 patients had been treated with the combination in the Phase 1b portion of the trial, including 35 patients with MDS and 27 patients with AML.
As of the data cutoff, 46 patients were evaluable for response assessment, including 24 patients with untreated higher-risk MDS and 22 patients with untreated AML, who are ineligible for induction chemotherapy.
In higher-risk MDS, the overall response rate (ORR) was 92%, with 12 patients (50%) achieving a complete response (CR), eight patients (33%) achieving a marrow CR and two patients (8%) achieving hematologic improvement. Additionally, two patients (8%) achieved stable disease.
In untreated AML, the ORR was 64%, with nine patients (41%) achieving a CR, three patients (14%) achieving a CR with complete blood count recovery (CRi) and one patient (5%) achieving a morphologic leukemia-free state (MLFS). Additionally, seven patients (32%) achieved stable disease (SD) and one patient (5%) had progressive disease.
The median time to response among MDS and AML patients treated with the combination was 1.9 months.
No median duration of response or overall survival has been reached for either MDS or AML patients, with a median follow-up of 6.4 months (range 2.0 to 14.4 months) for MDS and 8.8 months (range 1.9 to 16.9 months) for AML.
Additionally, mutational analyses are ongoing to correlate subgroups with response. Seven of nine (78%) evaluable TP53 mutant AML patients achieved an objective response, with 44% achieving CR and 33% achieving CRi. TP53 mutations are often associated with a poor prognosis and patients with TP53 mutant disease are refractory to existing therapies.
Lastly, in AML patients who achieved an objective response, a significant increase in CD4 and CD8 T cell infiltration was observed in the bone marrow while on therapy, demonstrating that magrolimab and azacitidine can induce an adaptive T cell response.
As of the data cutoff, the combination of magrolimab and azacitidine was well-tolerated, with no evidence of increased toxicities compared to azacitidine alone. Adverse events (AEs) were consistent with prior clinical experience. No deaths were observed in the first 60 days on combination treatment and only one patient out of 62 (1.6%) discontinued treatment due to a treatment-related AE.
FTSV price at time of alert is $15.82.
TGTX = On December 8, 2019, TG Therapeutics announced triple therapy data from the Phase I/II study of ublituximab, the company’s novel glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, the company’s oral, dual inhibitor of PI3K delta and CK1 epsilon, and venetoclax, in patients with relapsed/refractory chronic lymphocytic leukemia. Data from this trial were presented this morning during an oral session at the American Society of Hematology Annual Meeting. The overall response rate was 87% after U2 induction period at cycle 3, prior to introduction of venetoclax, in relapsed/refractory CLL patients, including patients refractory to ibrutinib. The overall response rate was 100% after cycle 7 for the triple combination. Michael Weiss, CEO of TG Therapeutics, stated, “We are extremely pleased to share the first data from the triple combination of U2 (umbralisib and ublituximab) and venetoclax, which we believe has the potential to offer patients with CLL a highly active, time-limited, and generally well tolerated treatment option. It was exciting to see that for those patients followed for at least 12 months at the time of the presentation, there was a 100% ORR, and all of those patients achieved MRD negativity in the peripheral blood, with 7 of those 9 patients also achieving MRD negativity in the bone marrow. We look forward to updating these data at future conferences as more patients are followed for 12 months and longer.” Mr. Weiss continued, “We were also excited to see that 87% of patients responded to the U2 combination after just three months of treatment prior to the introduction of venetoclax. We believe this further demonstrates the activity of the U2 combination that is being studied in our UNITY-CLL Phase 3 trial, which we expect data from in the coming weeks or months.”
On December 9, 2019, B. Riley FBR analyst Mayank Mamtani raised his price target for TG Therapeutics to $17 from $12 citing the company’s “solid” Phase I/II triplet data. The data paint a “bright future,” says the analyst, who reiterates a Buy rating on TG Therapeutics.
TGTX price at time of alert is $8.35.
APTO = On December 7, 2019, Aptose Biosciences released highlights from a corporate event and clinical update held at the American Society of Hematology Annual Meeting.
Key findings from dose levels 1 and 2 of CG-806 in heavily pretreated R/R CLL patients:
CG-806’s safety profile remains clean; no unexpected toxicities have been observed to date
Notably, no myelosuppression, no drug-related adverse events or dose-limiting toxicity
Early evidence of clinical response has already been observed in a R/R CLL patient at dose level 2
Robust increase in peripheral blood lymphocytes (lymphocytosis)
Evidence of Bruton’s tyrosine kinase (BTK) target engagement
Lymphocytosis, which is known as an indicator of BTK inhibition
Inhibition of Phospho-BTK, Phospho-SYK and Phospho-ERK have been observed with a plasma inhibitory assay (PIA) using plasma from the CLL patient on dose level 2
Meaningful oral absorption and predictable pharmacokinetic (PK) profile
Exposures are likely therapeutic for acute myeloid leukemia (AML) patients
A separate trial with CG-806 in relapsed/refractory AML patients is in the planning stage
APTO-253, the only clinical stage agent that directly targets the MYC oncogene, is demonstrating safety and MYC target engagement in a Phase 1b clinical trial for the treatment of patients with relapsed or refractory AML or high-risk myelodysplastic syndrome (MDS).
Aptose has completed dosing of the first three cohorts (up to a dose of 66 mg/m2) of the Phase 1b trial with MYC inhibitor APTO-253 in patients with AML and MDS.
In the patients on the first three dose cohorts, no drug-related adverse events have been observed, including no myelosuppression, and dosing is planned to continue to ascend until a maximum tolerated dose is reached. The next expected dosing level is 100 mg/m2.
MYC biomarker data from AML and MDS patients in the first three cohorts continue to demonstrate reductions of MYC gene expression in their peripheral blood cells. The dose escalation portion of the study is designed to transition, as appropriate, to single-agent expansion cohorts in AML and MDS, followed by combination studies.
The company said, “As the first clinical data from CG-806 in patients with chronic lymphocytic leukemia have begun to emerge, Drs. Howell, Bejar, and Druker highlighted the consistency between the drug’s robust preclinical profile and the early clinical observations on safety, tolerability, pharmacokinetics, and activity. William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose also provided a corporate update on the clinical activities of CG-806, Aptose’s highly potent pan-FLT3/pan-BTK inhibitor.” Key findings from dose levels 1 and 2 of CG-806 in heavily pretreated R/R chronic lymphocytic leukemia patients: “CG-806’s safety profile remains clean; no unexpected toxicities have been observed to date…Early evidence of clinical response has already been observed in a R/R CLL patient at dose level 2…Evidence of Bruton’s tyrosine kinase target engagement…Meaningful oral absorption and predictable pharmacokinetic profile…Exposures are likely therapeutic for acute myeloid leukemia patients.” The company added APTO-253 is “demonstrating safety and MYC target engagement in a Phase 1b clinical trial for the treatment of patients with relapsed or refractory AML or high-risk myelodysplastic syndrome.” It continues to escalate dosing with both assets, as all current dose cohorts to date have exhibited favorable safety profiles and evidence of target engagement.
APTO price at time of alert is $2.94.
ADXS = On December 3, 2019, Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, announced it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical study of ADXS-504, the Company’s ADXS-HOT drug candidate for prostate cancer.
“We are pleased to announce continued clinical progress of our ADXS-HOT program,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “Results from our ADXS-NEO program provided important proof-of-concept data demonstrating the generation of CD8+ T cells against hotspot mutations. Based on these encouraging results, and the convenient and broadly accessible off-the-shelf approach of our HOT therapies, we are focused on expanding the HOT program to additional cancer-specific trials through various, capital-efficient avenues. In addition, we look forward to reporting immune data from the monotherapy arm of our ongoing Phase 1/2 HOT clinical trial in non-small cell lung cancer (NSCLC) in early 2020.”
ADXS-504 is part of the company’s ADXS-HOT off-the-shelf immunotherapy platform which targets hotspot neoantigens, allowing for the development of multiple cancer-type specific clinical candidates. Advaxis has designed over ten ‘HOT’ drug candidates that are in various stages of development, with the company’s Phase 1/2 clinical trial for ADXS-503 in NSCLC currently enrolling patients at five centers. Advaxis anticipates reporting the immune data from the first dose level of ADXS-503, Part A, in monotherapy, and expects to dose the first patient in Part B, which is studying ADXS-503 in combination with the checkpoint inhibitor pembrolizumab, in early 2020.
ADXS price at time of alert is $0.85.
SPCE = Morgan Stanley analyst Adam Jonas initiated coverage of Virgin Galactic with an Overweight rating and $22 price target, telling investors that he sees a “biotech-type risk/reward” for the shares. He believes the addressable market for space tourism is niche, but supported by a range of industries. However, Jonas believes what is really likely to drive upside for the stock is what he calls “the third phase of the VG business model,” namely hypersonic point-to-point, or P2P, air travel. His $22 price target factors in $10 per share in value for space tourism and $12 per share for the hypersonic opportunity, Jonas noted.
SPCE price at time of alert is $7.93.
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