Curis, Inc.
CURIS INC (Form: 8-K, Received: 09/13/2017 16:11:38)

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): September 11, 2017

 

 

Curis, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware   000-30347   04-3505116

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification Number)

4 Maguire Road, Lexington, MA 02421

(Address of Principal Executive Offices) (Zip Code)

(617) 503-6500

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


This Current Report on Form 8-K and the exhibits attached hereto contain forward-looking statements of Curis, Inc. (“Curis,” “we” or the “Company”) that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Current Report on Form 8-K and the attached exhibits are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the initiation, timing, progress and results of our preclinical studies and clinical trials; plans to develop and commercialize our drug candidates; the timing or likelihood of regulatory filings and approvals; our commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of our products; developments and projections relating to our competitors and our industry; and the potential of CUDC-907, CA-170, CA-327, CA-4948, and any additional drug candidates that we may acquire in the future. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make due to a number of important factors. For example, we may experience adverse results, delays and/or failures in our drug development programs and may not be able to successfully advance the development of our drug candidates in the time frames we project, if at all. Our drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Favorable results seen in preclinical studies and early clinical trials of our drug candidates may not be replicated in later trials. There can be no guarantee that the collaboration agreement with Aurigene will continue for its full term, that we or Aurigene will each maintain the financial and other resources necessary to continue financing our respective portion of the research, development and commercialization costs, or that we and Aurigene will successfully discover, develop or commercialize drug candidates under the collaboration. Regulatory authorities may determine to delay or restrict Genentech’s and/or Roche’s ability to continue to develop or commercialize Erivedge in BCC. Erivedge may not demonstrate sufficient or any activity to merit its further development in disease indications other than BCC. Competing drugs may be developed that are superior to Erivedge. We face risks relating to our wholly-owned subsidiary’s royalty-collateralized loan transaction, including the risk that it may not receive sufficient levels of royalty revenue from sales of Erivedge to satisfy the debt obligation or may otherwise lose its rights to royalties and royalty-related payments as a result of a foreclosure of the loan. We will require substantial additional capital to fund our business and such capital may not be available on reasonable terms, or at all. We face substantial competition and risks relating to potential adverse decisions made by the FDA and other regulatory authorities, investigational review boards, and publication review bodies. We may not obtain or maintain necessary patent protection and could become involved in expensive and time-consuming patent litigation and interference proceedings. Unstable market and economic conditions and unplanned expenses may adversely affect our financial condition and our ability to access the substantial additional capital needed to fund the growth of our business.

Important factors that may cause or contribute to such differences are discussed in the “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2016, our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2017 and June 30, 2017, and other periodic filings we make with the SEC.

The forward-looking statements included in this Current Report on Form 8-K and the exhibits attached hereto represent our views as of the date of this Current Report on Form 8-K. We anticipate that subsequent events and developments will cause our views to change. While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this Current Report on Form 8-K.

 

Item 7.01. Regulation FD Disclosure.

From time to time, we conduct meetings with third parties in which we utilize a corporate slide presentation. A copy of our current corporate slide presentation, dated September 2017, is attached as Exhibit 99.1 to this Current Report on Form 8-K and, among other things, provides for an update on our recently announced data related to CA-170. The attached presentation is incorporated herein by reference.


The information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 8.01. Other Events.

On September 11, 2017, the Company issued a press release announcing its presentation of preliminary data from the dose escalation stage of the Phase 1 trial of CA-170 at the European Society for Medical Oncology 2017 Congress. As a result of the initial safety data and preliminary evidence of clinical benefit observed in the trial, the Company’s collaborator and discoverer of CA-170, Aurigene Discovery Technologies Limited, announced plans to initiate a Phase 2 trial of CA-170 to be conducted at sites in India.

The full text of the press release issued in connection with this announcement is attached as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference. There is one update to the information in the press release, such that in addition to the four immunotherapy treatment-naive patients treated with CA-170 who experienced tumor shrinkage, one patient who had experienced prior treatment also experienced tumor shrinkage.

 

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit
Number

  

Description

99.1    Slide Presentation dated September 2017
99.2    Press Release dated September 11, 2017


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  Curis, Inc.
Date: September 13, 2017   By:  

/S/ J AMES E. D ENTZER

    James E. Dentzer
    Chief Financial Officer and Chief Administrative Officer

SLIDE 1

Corporate Presentation September 2017 Exhibit 99.1 © Curis, Inc. 2017 - All Rights Reserved


SLIDE 2

This presentation contains certain forward-looking statements about Curis, Inc. (“we,” “us,” or the “Company”) within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “expect(s),” “feel(s),” “believe(s),” “will,” “may,” “anticipate(s)” and similar expressions are intended to identify forward-looking statements. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this presentation, and involve risks and uncertainties.  Forward-looking statements herein include, but are not limited to, statements with respect to the timing and results of future clinical and pre-clinical milestones; the timing of future preclinical studies and clinical trials and results of these studies and trials; the clinical and therapeutic potential of our drug candidates; and management’s ability to successfully achieve its goals.  These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of important factors including, without limitation, risks relating to: whether any of our drug candidates will advance further in the clinical development process and whether and when, if at all, they will receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; whether historical preclinical results will be predictive of future clinical trial results; whether historical clinical trial results will be predictive of future trial results; whether any of our drug candidate discovery and development efforts will be successful; whether any of our drug candidates will be successfully marketed if approved; our ability to achieve the benefits contemplated by our collaboration agreements; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; general economic conditions; competition; and the other risk factors contained in our periodic and interim reports filed with the Securities and Exchange Commission which are available on the SEC website at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events, except as required by law.   Forward Looking Statements


SLIDE 3

Mission: Innovative Medicines to Treat Cancer Effectively Precision Oncology Oncology-Focused Biotech Pipeline of differentiated small molecule cancer drug candidates Developing and intend to commercialize oncology drugs Partnerships: Aurigene, Genentech/Roche Immuno-oncology


SLIDE 4

Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CUDC-907 HDAC / PI3K MYC-Altered DLBCL CA-170 * PD-L1 / VISTA Solid Tumors & Lymphomas CA-4948 * IRAK4 Non-Hodgkin’s Lymphoma CA-327 * PDL1 / TIM3 Cancers Erivedge® ** Smoothened Advanced Basal Cell Carcinoma Immuno-oncology and Precision Oncology Orally available small molecules * Licensed from Aurigene **Developed and marketed by Genentech (Curis receives royalty income)


SLIDE 5

CUDC-907 has the potential to become a treatment for MYC-altered DLBCL CUDC-907 Phase 2 drug candidate to treat MYC-driven DLBCL Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CUDC-907 HDAC / PI3K MYC-Altered DLBCL


SLIDE 6

HDACi PI3Ki CUDC-907 Oral, small molecule inhibitor of HDAC & PI3K enzymes1 Down-regulates MYC mRNA and protein levels2 Phase 1 heme study completed (88 patients) – relapsed/ refractory (R/R) lymphoma or multiple myeloma3 Favorable safety and tolerability observed Objective responses (CRs and PRs) in patients with R/R DLBCL, including in MYC-altered tumors4 Phase 2 trial in MYC-altered R/R DLBCL Orphan designation in DLBCL CUDC-907 Control 1000 100 10 1 0.1 Ac-H3 pAKT MYC BCL2 (nM) 1. Qian et.al. Clin Cancer Res. 2012. 18: 4104 2. Sun et.al. Mol Cancer Ther. 2017. 6: 285 3. Younes et.al. Lancet Oncol. 2016. 17: 622 4. Oki et.al. Haematologica. 2017 (epub) Significant Downregulation of MYC protein Protein levels in treated DLBCL cells


SLIDE 7

DLBCL and MYC 35% of newly diagnosed DLBCL patients have MYC alterations1 Double-Hit Lymphoma:rearrangements of MYC and BCL2 and/or BCL6 genes, assessed by FISH Double-Expressor Lymphoma:overexpression of MYC and BCL2 proteins, assessed by IHC Newly-Diagnosed DLBCL Patient Population MYC IHC+ 30% Double-Expressor 25% MYC FISH+ 12% Double-Hit 8% 1. Curr Hematol Malig Rep. 2016 Jun;11(3):208-17 


SLIDE 8

CUDC-907 Phase 1 and Phase 2 Trials in DLBCL Study population Relapsed or refractory DLBCL after ≥2 prior regimens Total of 105 patients enrolled in Phase 1 (37) and Phase 2 (68) Treatment: oral, once daily dosing – RP2D 5/2 (5 days on, 2 days off): 60mg continuous dosing Safety and tolerability No DLT at RP2D Phase 1 DLT of diarrhea (1 pt) and hyperglycemia (1 pt) Interim results for Phase 2 show that most common (> 10% of patients) Grade ≥ 3 TEAE observed to date: diarrhea (14%), neutropenia (14%), thrombocytopenia (19%)


SLIDE 9

CUDC-907 Phase 1 and Phase 2 Interim Trial Results Monotherapy in relapsed/refractory DLBCL Durable responses, including a number of CRs observed Combined 7 durable CRs observed between Phase 1 and Phase 2 trials Responses predominantly observed in patients with MYC-altered disease status Combined response rate of 22.2% in patients with MYC-positive, and 11.8% in MYC-negative disease status   Phase 1 Trial (Interim) Phase 2 Trial (ITT) # Patients 25 44 (Evaluable) # Patients 19 36 CR 3 4 PR 6 3 SD 4 4 PD 6 25 Not Evaluable 6 8 (ITT) ORR 36.0% 15.9% (Evaluable) ORR 47.4% 19.4% Median DoRx 15.5 mo. NR*   # of Patients # of Responses Phase 1 Trial MYC+ 10 5 MYC- 5 2 Unknown 10 2 Phase 2 Trial MYC+ 44 7 MYC- 12 0 Unknown 12 0


SLIDE 10

CUDC-907 Development Status Safety and tolerability observed to date at recommended dose and schedule No new safety findings in Phase 2 trial Durable CRs and PRs observed preferentially in patients with MYC-altered DLBCL Interim results show clinical benefit predominantly observed in patients with MYC+ relapsed/refractory DLBCL disease Difficult to treat population with no approved treatment options and poor prognosis Combined 22% response rate in patients with MYC+ disease status (Phase 1 and Phase 2) Includes 7 durable CRs Orphan drug designation for treatment of patients with DLBCL Evaluating potential registrational trial to better capture and demonstrate CUDC-907 benefit in target DLBCL population


SLIDE 11

CA-170 is a first-in-class oral small molecule immune checkpoint inhibitor In Phase 1 clinical development CA-170 Oral, small molecule checkpoint inhibitor – PDL1 and VISTA Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CA-170 PD-L1 / VISTA Solid Tumors & Lymphomas


SLIDE 12

Small Molecule Checkpoint Inhibitors Oral, small molecules designed to bind inhibitory checkpoints Common folding structure in the extracellular domain PD-L1Expressed on immune and tumor cells VISTAExpressed on myeloid cells, including MDSCs TIM3Co-expressed with PD-1 on highly exhausted CD8+ T cells Multi-year, exclusive collaboration with Aurigene Curis option to royalty-bearing license for multiple programs PD-1 PD-L1 Extracellular Domain Interaction


SLIDE 13

CA-170 Concentration (log nM) Activation (%) CA-170 is a Checkpoint inhibitor Ex-vivo and in vivo T cell activation and anti-tumor activity Increase in Activated CD8+ T cells In vivo Activation of PDL1 or VISTA-inhibited T cells Activation (%) CA-170 Concentration (log nM) Anti-Tumor Activity In vivo (B16/F1 melanoma) IFN-g production


SLIDE 14

CA-170 Phase 1 Trial Dose escalation stage Patient Population Patients with advanced solid tumors or lymphoma Study sites in US, EU, and Asia Objectives Safety/Tolerability, PK, PD, Recommended Phase 2 Dose (RP2D), anti-cancer activity Treatment Oral, once daily, dosing in continuous 21-day cycles Dose escalation as needed until RP2D is identified “back-filling” of additional patients at Dose Level 4 & higher is allowed Dose Level 1 50mg QD n=1 Dose Level 2 100mg QD n=1 Dose Level 3 200mg QD n=1 Dose Level 4 400mg QD n=1 Dose Level 5 600mg QD n=3 Dose Level 6 800mg QD n=3


SLIDE 15

CA-170 Oral Exposure in Patients 50mg – 800mg dose – continuous once daily dosing PK profile in patients was similar to PK observed in non-clinical models Cmax and AUC at 50mg starting dose in patients was similar to 10mg/kg dose in mouse (active dose) Dose proportional increase in exposure with increasing doses in patients Near-linear doubling in Cmax and AUC with dose doubling: 50mg – 800mg daily dose Human PK Profile 50 100 200 400 600 800 50 100 200 400 600 800 Cycle 1, Day 1 Cycle 1, Day 15 Cmax (ng/ml) Cycle 1, Day 1 Cycle 1, Day 15 AUC (ng*hr/ml)


SLIDE 16

CA-170 is a Checkpoint Inhibitor in Patients Observed increase in T cells in Tumor Observed increase in CD8+ T cells in patient tumor biopsies after CA-170 treatment Assessed after first cycle of CA-170 treatment at 600mg dose (21 days) Patient with colorectal cancer, 5 prior treatments; immunotherapy treatment-naïve Flow Cytometry of blood sample (Day 1) IHC staining of tumor biopsies (After Cycle 1) Pre-dose Post Cycle 1 Automated Quantitation NanoString Profile


SLIDE 17

CA-170 is a Checkpoint Inhibitor in Patients Preliminary data demonstrate compelling biomarker signals and evidence of tumor shrinkage Tumor Change by Cycle Presented at the European Society for Medical Oncology (ESMO) 2017 Congress Initial Clinical Data consistent with Pre-Clinical Data Appears safe and tolerable, with no DLTs at examined doses Evidence of tumor shrinkage in 4 immunotherapy treatment-naïve patients and 1 patient who had experienced prior treatment Multiple patients remain on drug for several cycles of treatment Next Steps Continue Phase 1 dose escalation Work with our partner, Aurigene, to conduct a Phase 2 trial in selected populations of patients of interest at major cancer centers in India Analyze pre- and post-treatment tumor biopsy samples to identify potential markers for patient selection


SLIDE 18

CA-170 Phase 1b Trial Dose expansion design and plans Melanoma NSCLC RCC HL TNBC HNSCC CRC Bladder Gastric + Etc CA-170 Treatment Clinical Parameters Tumor and Immune Profile Parameters Tumor shrinkage Duration on treatment AE / irAE profile Tumor infiltrate profile Gene expression profile Expression of targets Real-time analysis & correlation PD1/L1-approved indications PD1/L1-non-approved indications Curis Confidential Biomarker or signature-defined patient selection NSCLC TNBC HNSCC CRC Gastric Ovarian Prostate Esophageal


SLIDE 19

CA-327 is an oral, small molecule immune checkpoint inhibitor IND filing expected in Q1 2018 CA-327 Oral, small molecule checkpoint inhibitor – PDL1 and TIM3 Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CA-327 PD-L1 / TIM3 Cancers


SLIDE 20

CA-327 Is a Checkpoint Inhibitor Selectively targets PDL1 and TIM3 CA-327 Vehicle Blood CD8+/CD69+ T cells Vehicle Control Anti-PD1 Antibody 1mg/kg CA-327 Tumor CD8+/CD69+ T cells Vehicle Control Anti-PD1 Antibody 1mg/kg CA-327 Tumor Model Treatment % TGI at Dose (mg/kg) 1 3 10 B16F10 melanoma CA-327 45 41 52 Anti-PD1   5   Anti-TIM3     18 MC38 colon carcinoma CA-327 24 33 40 Anti-PD1   34   CA-170 35 CA-327+ CA-170 65 Increase in Activated CD8+ T cells In vivo Anti-Tumor Activity In vivo (B16/F1 melanoma) Summary in vivo dose dependent Tumor Growth Inhibition


SLIDE 21

CA-4948 is an oral, small molecule inhibitor of IRAK4 IND filing expected in 3Q 2017 (Phase 1 trial in Non-Hodgkin’s Lymphoma) CA-4948 Oral, small molecule inhibitor of IRAK4 Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CA-4948 IRAK4 Non-Hodgkin’s Lymphoma


SLIDE 22

IRAK4 kinase is a critical component of toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways – implicated in certain cancers IRAK4 kinase, through IRAK1 is critical for NF-kB activation for cytokine secretion & cell survival Recruitment of IRAK4 to TLR/ IL-1R mediated by myD88 adaptor protein Activating MYD88 mutations are found in certain lymphomas; making IRAK4 an attractive target CA-4948 and IRAK4 Validated target in MYD88-mutated non-Hodgkin’s lymphomas Activation


SLIDE 23

Prevalence of Oncogenic MYD88 Mutations Non-Hodgkin lymphomas Indication MYD88-L265P Diffuse Large B-cell Lymphoma (ABC-DLBCL) 15-29% Immune-privileged DLBCL (IP-DLBCL) 50-80% Waldenstrom’s Macroglobulinemia (WM) 95-97% Lymphoplasmacytic Lymphoma (LPL) 79% Splenic Marginal Zone Lymphoma (SMZL) 6-10% Mucosa-Associated Lymphoid Tissue (MALT) 9% Chronic Lymphocytic Leukemia (CLL) 2.9%


SLIDE 24

CA-4948 Exhibited Significant In vivo Activity MYD88-mutant DLBCL tumor models CA-4948 is a potent and selective IRAK4 inhibitor In vivo anti-tumor activity in multiple MYD88-mutant (L265P) vs. MYD88-wt DLBCL tumor models


SLIDE 25

Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CUDC-907 HDAC / PI3K MYC-Altered DLBCL CA-170 * PD-L1 / VISTA Solid Tumors & Lymphomas CA-4948 * IRAK4 Non-Hodgkin’s Lymphoma CA-327 * PDL1 / TIM3 Cancers Erivedge® ** Smoothened Advanced Basal Cell Carcinoma Immuno-oncology and Precision Oncology Orally available small molecules * Licensed from Aurigene **Developed and marketed by Genentech (Curis receives royalty income)


SLIDE 26

CA-170 Phase 1 initial data, Clinical profilen Q4 2017 SITC CA-4948 IND filing n Q3 2017 CA-327 IND filing n Q1 2018 2017 Projected Milestones


SLIDE 27

$51.0MCash & Marketable Securities 143.9MShares Outstanding - Basic 162.5MShares Outstanding - Fully Diluted* *Diluted Shares = 143.9M basic shares + 18.6M options Summary of Financials As of June 30, 2017


SLIDE 28

END

Exhibit 99.2

 

LOGO

For More Information:

James E. Dentzer

Chief Financial Officer & Chief Administrative Officer

Curis, Inc.

617-503-6500

jdentzer@curis.com

Media Contact

David Schull

Russo Partners

(212) 845-4271

david.schull@russopartnersllc.com

Curis and Aurigene Announce CA-170 Program Update Following Data Presented at ESMO 2017

— Results from 34 Patients Demonstrate Positive Safety Profile and Support Decision to Expand Development —

— Aurigene and Curis Plan Clinical Trial of CA-170 in India —

 

 

LEXINGTON, Mass., Sept. 11, 2017 (GLOBE NEWSWIRE) – Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, today presented preliminary data from the initial 34 patients with cancer treated in the dose escalation stage of the Phase 1 trial of CA-170 conducted in the U.S., South Korea and Spain, at the European Society for Medical Oncology (ESMO) 2017 Congress. As a result of the initial safety data and preliminary evidence of clinical benefit observed in the trial, Curis’s collaborator and discoverer of CA-170, Aurigene Discovery Technologies Limited, a specialized biotechnology company engaged in discovery and early clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases, today announced plans to initiate a Phase 2 trial of CA-170 to be conducted at sites in India.

“We are pleased with these early results. Based on evidence of tumor shrinkage, multiple patients remaining on drug treatment for extended periods, and compelling signals for biomarkers of immune modulation in patient blood and tumor samples, we remain highly confident that the CA-170 program is moving in the right direction. We plan to continue with the dose escalation and continued analysis of patient biopsy samples in the Phase 1 trial,” said Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. “We expect to provide additional updates at upcoming conferences including the Society for Immunotherapy of Cancer (SITC) annual meeting in November.”


“The ability for cancer patients to administer a potential checkpoint inhibitor on their own as a once daily oral drug is a significant and unique opportunity in our field,” added Adil Daud, M.D., investigator in the CA-170 Phase 1 trial and director of Melanoma Clinical Research at the UCSF Helen Diller Family Comprehensive Cancer Center. “These initial clinical results are encouraging and merit continued development.”

“These results are consistent with the observations made in the preclinical setting and further affirm CA-170’s mechanism of action as an oral small molecule checkpoint inhibitor,” commented Mr. CSN Murthy, Chief Executive Officer of Aurigene. “Based on these initial clinical results, we are excited for the opportunity to expand testing of CA-170, possibly in earlier lines of treatment and in a greater number of immunotherapy treatment-naïve cancer patients.” Added Mr. Murthy, “Together with Curis, we have designed a Phase 2 trial in selected populations of patients of interest to be treated at major cancer centers in India. Aurigene’s decision to sponsor and fund this trial is further affirmation of our commitment to CA-170 and a reflection of the successful collaboration we have with Curis in multiple development programs.”

CA-170 is an oral small molecule targeting the immune checkpoints PDL1 and VISTA. Data presented at the ESMO 2017 conference represent the initial 34 patients treated to date in the dose escalation Phase 1 trial. 30 patients were naïve to prior immunotherapy treatment, while four patients had experienced prior treatment with approved anti-checkpoint antibodies. No dose limiting toxicities were observed at doses ranging from 50 mg to 800 mg once daily dosing examined thus far. CA-170 demonstrated good oral bioavailability and plasma drug levels were shown to increase in a near-linear manner with increasing doses. Evidence of immune modulation, including an increase in activated CD8+ T cells, was observed in patient blood and tumor biopsy samples examined following treatment. Of the 21 patients evaluable for disease assessment, 13 patients experienced disease stabilization. Four immunotherapy treatment-naïve patients treated with CA-170 experienced shrinkage of their tumors. Six patients remained on drug treatment beyond three months, including all four patients with tumor shrinkages. In addition, seven of the 34 patients remain on study and are continuing with treatment.

About Curis

Curis is a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers, including its lead development candidate, CUDC-907, which is being investigated in clinical studies in patients with lymphomas and solid tumors. Curis is also engaged in a broad collaboration with Aurigene in the areas of immuno-oncology and precision oncology. As part of this collaboration, Curis has exclusive licenses to oral small molecule antagonists of the PD1 and VISTA pathways, including PDL1/VISTA antagonist CA-170, and oral small molecule antagonists of the PD1 and TIM3 pathways, including PDL1/TIM3 antagonist CA-327, as well as to molecules designed to inhibit the IRAK4 kinase, including CA-4948. CA-170 is currently undergoing testing in a Phase 1 trial in patients with advanced solid tumors and lymphomas. Curis is also party to a collaboration


with Genentech, a member of the Roche Group, under which Genentech and Roche are commercializing Erivedge ® for the treatment of advanced basal cell carcinoma, and are further developing Erivedge in myelofibrosis. For more information, visit Curis’s website at www.curis.com .

Cautionary Note Regarding Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements with respect to the plans, strategies and objectives of management for future operations, the potential advantages and benefits of CA-170, further plans with respect to the development of CA-170, the Company’s plans and expectations for the collaboration with Aurigene, including its plans to discover and develop multiple first-in-class oral, small molecule checkpoint antagonists for the treatment of patients with cancer, and the Company’s plans to advance its development programs, including CA-170. Forward-looking statements may contain the words “believes,” “expects,” “anticipates,” “plans,” “seeks,” “estimates,” “assumes,” “will,” “may,” “could” or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. For example, Curis may experience adverse results, delays and/or failures in its drug development programs and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. Curis’s drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Favorable results seen in preclinical studies and early clinical trials of Curis’s drug candidates may not be replicated in later trials. There can be no guarantee that the collaboration agreement with Aurigene will continue for its full term, that Curis or Aurigene will each maintain the financial and other resources necessary to continue financing its portion of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Regulatory authorities may determine to delay or restrict Genentech’s and/or Roche’s ability to continue to develop or commercialize Erivedge in BCC. Erivedge may not demonstrate sufficient or any activity to merit its further development in disease indications other than BCC. Competing drugs may be developed that are superior to Erivedge. Curis faces risks relating to its wholly-owned subsidiary’s royalty-collateralized loan transaction, including the risk that it may not receive sufficient levels of royalty revenue from sales of Erivedge to satisfy the debt obligation or may otherwise lose its rights to royalties and royalty-related payments as a result of a foreclosure of the loan. Curis will require substantial additional capital to fund its business and such capital may not be available on reasonable terms, or at all. Curis faces substantial competition. Curis also faces risks relating to potential adverse decisions made by the FDA and other regulatory authorities, investigational review boards, and publication review bodies. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time consuming patent litigation and interference proceedings. Unstable market and economic conditions and unplanned expenses may adversely affect Curis’s financial conditions and its ability to access the substantial additional capital needed to fund the growth of its business. Important factors that may cause or


contribute to such differences include the factors set forth under the caption “Risk Factors” in our most recent Form 10-K and Form 10-Q and the factors that are discussed in other filings that we periodically make with the Securities and Exchange Commission (“SEC”). In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis’s views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law.