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Curis Shares Soar 300% on Positive Data from Two Ongoing Phase 1 Cancer Studies

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Curis Inc. shares reached a new 52-week high after the cancer therapeutics developer reported positive preliminary data from two Phase 1 studies, one treating relapsed or refractory acute myeloid leukemia and myelodysplastic syndromes and another treating relapsed or refractory non-Hodgkin's lymphoma.

Cancer therapeutics focused biotechnology company Curis Inc. (CRIS:NASDAQ) today announced "positive preliminary data from its ongoing open-label, single arm Phase 1 dose escalation study of CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS)."

The firm stated that "IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, and these pathways are frequently dysregulated in patients with AML and MDS."

Curis Inc.'s President and CEO James Dentzer commented, "We are highly encouraged by the breadth of clinical activity with CA-4948 seen with this early data, especially as this study is both monotherapy and in a late line, relapsed/refractory population. Historically, monotherapy studies in AML and MDS have proven underwhelming; monotherapy studies in a relapsed/refractory setting have been especially challenging...We look forward to continuing to advance CA-4948 and reporting additional Phase 1 data in the second half of 2021."

Dr. Guillermo Garcia-Manero, chief of the Section of Myelodysplastic Syndromes within the Department of Leukemia at The University of Texas MD Anderson Cancer Center, stated, "As a clinician intimately familiar with the treatment challenges faced by patients with AML or high-risk MDS, I am very encouraged by the early data coming out of this study...While there have been important advancements in the development of new therapeutics for patients with previously untreated AML or MDS in recent years, relapsed and refractory patients are still in need of better treatment options. These preliminary data suggest, for the first time in a clinical setting, that successfully targeting the long isoform of IRAK4, which we know to be preferentially expressed in over half of AML and MDS patients, could be the first major breakthrough in over a decade for patients with these diseases."

The company reported that the preliminary data was drawn from its Phase 1 dose escalation study of CA-4948 monotherapy in AML or high-risk MDS adult patients. Curis stated that the main purpose of the study is to determine the maximum tolerated dosage for a future Phase 2 study.

The company highlighted some of the key findings in the study and advised that marrow blast reductions were observed in all six of the evaluable patients in trial and that "two patients experienced a marrow complete response, one with blast count going from 23% pretreatment to 1% on treatment and the other going from 11% pretreatment to 2% on treatment." The firm noted that there were no dose-limiting toxicities (DLT) in the seven patient treated with either 200 mg BID or 300 mg BID. The company said that it has commenced enrollment in a new 400 mg BID cohort.

In addition, Curis Inc. yesterday announced "updated data from its ongoing Phase 1, open-label, dose escalation study of CA-4948, an IRAK4 kinase inhibitor, for the treatment of patients with relapsed or refractory (R/R) non-Hodgkin's lymphoma (NHL), including patients with diffuse large B-cell lymphoma (DLBCL), Waldenström's macroglobulinemia (WM) and oncogenic MYD88 mutations, and also declared the recommended Phase 2 dose of the investigational drug."

President and CEO Dentzer stated, "We are tremendously pleased to report that IRAK4 inhibition with CA-4948 monotherapy could potentially offer a novel treatment approach for patients with NHL...We believe these preliminary data, demonstrating the tolerability and durable anti-cancer activity of single-agent CA-4948 therapy for these extremely sick patients, validate our development approach for this program and reaffirm our enthusiasm for the therapeutic potential of a combination therapy with proven synergistic treatments like ibrutinib."

The firm's Head of Research & Development Robert Martell added, "CA-4948 consistently reduced tumor burden at the recommended Phase 2 dose of 300 mg twice daily. Data like these, even at this early stage, are compelling for the patients and physicians contending with this degree of relapsed or refractory disease...the unique synergistic potential of a CA-4948/BTK inhibitor combination, could potentially offer a groundbreaking development in a disease area with considerable need."

The company explained that the data presented is from its ongoing Phase 1 study that was established in order to evaluate the pharmacokinetics, pharmacodynamics, anti-cancer activity and biomarker correlations as well as tolerability and safety of CA-4948 in patients with R/R NHL.

The firm stated that it set up seven separate dosing cohorts of trial participants who were given various levels of medication over 21 days. The company advised that CA-4948 demonstrated to be well-tolerated in the study which supports potential long-term treatment and combination with other active drugs against NHL. The firm pointed out that "anti-cancer activity, as measured by reduction of tumor burden, was observed in 6 of 7 evaluable patients receiving RP2D of 300 mg BID, with a mean reduction of 27% (ranging from 6% to 67%)."

Curis Inc. is a biotechnology company based in Lexington, Mass., that concentrates its efforts on developing new therapeutics for cancer treatment. The firm stated that it entered into a collaboration with Aurigene in 2015 in the areas of immuno-oncology and precision oncology which it gained exclusive licenses to several oral small molecule antagonists of immune checkpoints. These include VISTA/PDL1 antagonist CA-170, TIM3/PDL1 antagonist CA-327 and the IRAK4 kinase inhibitor CA-4948.

The company noted that it is also collaborating with other firms in the areas of solid tumors and advanced basal cell carcinoma.

Curis started off the day with a market capitalization of around $84.7 million with approximately 58.8 million shares outstanding and a short interest of about 1.1%. CRIS shares opened 280%% higher today at $5.47 (+$4.03, +279.86%) over yesterday's $1.44 closing price and reached a new 52-week high price this morning of $7.90. The stock has traded today between $5.20 and $7.90 per share and is currently trading at $6.44 (+$5.00, +347.23%).

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