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ASH: CLLS Readying For CALM, IMDZ Awaits Data, Can JUNO Magic Continue?


The 59th American Society of Hematology (ASH) Annual Meeting is just around the corner. More than 250 pharmaceutical companies will be participating in the meeting which will be held between December 9 and December 12, 2017, at Atlanta, Georgia.

Here's the second list of companies that will be presenting new data or updated analyses from their hematology clinical trials.

Cellectis SA (CLLS) is down 30% from its 52-week high but has a year-to-date return of nearly 45%.

Cellectis is a gene editing company focused on developing next generation immunotherapies based on gene-edited CAR T-cells.

On December 9, 2017, preliminary results from two phase I trials with UCART19, dubbed CALM and PALL, will be presented at the ASH meeting.

The CALM study is designed to evaluate safety, tolerability and antileukemic activity of UCART19 in patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).

The PALL study is testing the safety and the ability of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory B-ALL.

In 2015, Servier acquired exclusive rights from Cellectis for UCART19, which is being co-developed by Servier and Pfizer.

CLLS closed Friday's (Dec.1) trading at $24.57, down 1.44%.

Shares of Immune Design Corp. (IMDZ) are nearly 68% lower than their 52-week high and are down about 24% year-to-date.

Immune Design is a clinical-stage immunotherapy company focused on oncology.

At the American Society of Hematology meeting, the Company will be presenting updated data from a randomized phase II study evaluating G100 and low-dose radiation (XRT), versus G100 and XRT with the systemic administration of Merck's Keytruda in follicular NHL.

According to earlier data related to the phase II study, a 31% * overall response rate (ORR) was observed for patients receiving G100 and low-dose radiation plus Keytruda compared to a 15% ORR for patients receiving G100 and low-dose radiation. Moreover, the **abscopal effect was reported in 62% of patients receiving G100 and low-dose radiation plus Keytruda compared to only 46% of patients receiving G100 and low-dose radiation.

**The abscopal effect is the effect of radiation therapy at a site distant to the area of irradiation resulting in a tumor in a non-irradiated area being spontaneously reduced. (Source: Journal of Medical Case Reports).

*ORR is defined as the proportion of patients who have a partial or complete response to therapy. (Source: Clinical Cancer Research)

IMDZ closed Friday's trading at $4.20, up 2.44%.

Shares of Juno Therapeutics Inc. (JUNO) have climbed an impressive 200% so far this year.

The Company's lead CAR-T therapy candidate is JCAR017, under phase I/II testing in Diffuse large B-cell lymphoma, Chronic lymphocytic leukemia and acute lymphocytic leukemia.

At the ASH meeting, the Company will be presenting updated data from the ongoing phase I TRANSCEND study of JCAR017.

The TRANSCEND study is a dose-finding study of JCAR017, which is administered following fludarabine/cyclophosphamide lymphodepletion in patients with aggressive B-cell NHL. Participants are treated with either of the two doses of JCAR017 - i.e., 50 million cells or 100 million cells.

As of a data cutoff date of July 7, 2017, across both the doses, the best overall response was 84% and the best overall complete response rate was 61% for patients with relapsed or refractory diffuse large B-cell lymphoma.

JUNO closed Friday's trading at $56.70, up 3.81%.

Shares of Kadmon Holdings Inc. (KDMN) which touched a 52-week low in August have since rallied strongly, and are up 69%.

Kadmon's product pipeline is focused on autoimmune and fibrotic diseases.

The Company's lead drug candidate is KD025 under phase II testing in the indications of psoriasis vulgaris, idiopathic pulmonary fibrosis, and chronic graft-versus-host disease, a serious complication following allogeneic bone marrow or stem cell transplantation.

On December 10, 2017, at the ASH meeting, the Company will be presenting new data from its ongoing phase II study of KD025 in patients with chronic graft-versus-host disease (cGVHD).

The study is testing three different dose levels of KD025 namely, 200 mg QD, 200 mg BID and 400 mg QD.

The Company reported preliminary analysis of data from the first cohort, which is testing KD025 200 mg QD, in July of this year. According to the initial data, 71% of patients treated with KD025 200 mg QD had an overall response.

KDMN closed Friday's trading at $3.60, up 0.84%.

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