On November 7, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine oncology therapeutics company developing drugs that target cell division (mitosis) for the treatment of various cancers including prostate, colorectal and leukemia, reported company highlights and financial results for the third quarter ended September 30, 2019 (Press release, Trovagene, NOV 7, 2019, View Source [SID1234550795]). The company is issuing this press release in lieu of conducting a conference call .

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"We are pleased with the positive response to treatment with onvansertib that we are seeing across all three of our clinical trials and the continued progress and rapid advancement of our development programs," said Dr. Thomas Adams, Chief Executive Officer and Chairman of Trovagene. "In the third quarter, we achieved a number of key milestones including: presentation of data from our ongoing Phase 2 trial in mCRPC demonstrating the efficacy of onvansertib in patients showing resistance to the ARS inhibitor, Zytiga, even those with the highly-aggressive and difficult-to-treat androgen receptor variant 7 (AR-V7) tumor; positive data from the initial cohort of patients treated in our Phase 1b/2 trial in CRC showing decreases in tumor KRAS mutational burden in all four patients completing their first cycle of therapy; and completion of our AML Phase 1b trial and initiation of enrollment of patients in the Phase 2 continuation trial."

The Company has advanced its business, with the following recent activities and milestone achievements:

Clinical Development:

Announced Positive Response to Treatment in Phase 1b/2 Trial of Onvansertib in Patients with KRAS-Mutated Metastatic Colorectal Cancer
On October 22, 2019, Trovagene announced data demonstrating positive response to treatment in patients enrolled in its Phase 1b/2 trial of onvansertib in combination with FOLFIRI and Avastin (bevacizumab) for second-line treatment of KRAS-mutated metastatic colorectal cancer (mCRC). Decreases in tumor KRAS mutational burden in response to treatment was observed in all four patients who completed their first cycle of therapy with the combination regimen, as measured by quantitative analysis of circulating tumor DNA (ctDNA).

Announced Data Presented at ESMO (Free ESMO Whitepaper) Provides Rationale for Clinical Trial of Onvansertib in Subset of Patients with Highly-Aggressive Triple-Negative Breast Cancer (TNBC)
On October 2, 2019, Trovagene announced the presentation of preclinical data demonstrating significant tumor regression with the combination of onvansertib and paclitaxel, versus either agent alone, in models of triple-negative breast cancer (TNBC).

Announced Presentation of Overview of Phase 1b/2 Trial of Onvansertib in Patients with KRAS-Mutated Metastatic Colorectal Cancer (mCRC) at ESMO (Free ESMO Whitepaper)
On October 1, 2019, Trovagene announced the presentation of its Phase 1b/2 trial evaluating onvansertib in combination with FOLFIRI and Avastin (bevacizumab) in patients with KRAS-mutated metastatic Colorectal Cancer (mCRC). The trial overview, featured in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress showed the supportive preclinical data underlying the scientific rationale for the trial, as well as the trial design and primary safety and efficacy endpoints. In addition, early biomarker data demonstrates proof-of-concept that patient response can be monitored by a non-invasive blood test to quantitate the KRAS mutation burden within one week following initial dosing with onvansertib.

Announced Positive Data from Trovagene Phase 1b/2 Study of Onvansertib in Acute Myeloid Leukemia (AML) was Featured in an Oral Presentation at ESMO (Free ESMO Whitepaper)
On September 30, 2019, Trovagene announced that results from the Company’s Phase 1b/2 study of onvansertib in patients with relapsed/refractory acute myeloid leukemia (AML) were presented in an oral plenary session at the 2019 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Conference in Barcelona, Spain, on Saturday, September 28th. The presentation highlighted the favorable safety profile and clinical efficacy of onvansertib, as well as correlative biomarker data from the recently completed Phase 1b trial.

Announced Successful Completion of Phase 1b Trial of Onvansertib in Acute Myeloid Leukemia (AML) and Initiation of Patient Enrollment in Phase 2
On September 19, 2019, Trovagene announced the successful completion of its Phase 1b trial of onvansertib in combination with standard-of-care chemotherapy in acute myeloid leukemia (AML) and initiation of patient enrollment in Phase 2. The Phase 1b dose-escalation trial confirmed that onvansertib in combination with standard-of-care chemotherapy is safe and well tolerated. Additionally, the primary efficacy endpoint of objective response (CR + CRi) was achieved in 5 of 21 patients treated with onvansertib + decitabine, indicating anti-leukemic activity in this difficult-to-treat relapsed/refractory AML population. Importantly, 30% of patients treated were biomarker positive, which was associated with an increase in response to treatment as measured by decreases in bone marrow blasts and the rate of complete response.

Announced Presentation of Positive Clinical Data from Ongoing Phase 2 Study of Onvansertib in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
On August 26, 2019, Trovagene announced the presentation of positive clinical data from its ongoing Phase 2 clinical trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone, an androgen-receptor signaling (ARS) inhibitor, in metastatic Castration-Resistant Prostate Cancer (mCRPC), at the 20th Asia-Pacific Prostate Cancer Conference in Melbourne, Australia. These data demonstrate the efficacy of onvansertib in patients showing resistance to the ARS inhibitor, Zytiga (Johnson & Johnson), including those with the highly-aggressive and difficult-to-treat androgen receptor variant 7 (AR-V7) tumor.

Announced Initiation of Enrollment for Phase 1b/2 Clinical Trial in KRAS-Mutated Colorectal Cancer at Leading Cancer Centers
On July 9, 2019, Trovagene announced the initiation of patient enrollment of its Phase 1b/2 study of onvansertib in combination with FOLFIRI and Avastin (bevacizumab) for second-line treatment of patients with metastatic colorectal cancer (mCRC) with a KRAS mutation (NCT03829410). The trial is being conducted at USC Norris Comprehensive Cancer Center, Hoag Cancer Center and The Mayo Clinic, under the leadership of recognized colorectal cancer key opinion leaders, Heinz-Josef Lenz, MD, FACP, Section Head of GI Oncology and Co-Director of the Colorectal Center at USC Norris, and Afsaneh Barzi, MD, PhD, oncologist at USC Norris and principal investigator of the trial.

Financial:

Announced $5.0 Million Private Placement Priced At Market
On October 25, 2019, Trovagene announced that it has entered into a private placement with certain institutional investors for gross proceeds of approximately $5.0 million. We sold an aggregate of 2,756,340 shares of common stock (including common stock equivalents) and Series G and Series H Warrants to purchase 2,756,340 shares of Common Stock for each class of Warrant.

Announced Equity Investments of $1.5 Million at Premium to Market Price from Institutional Investor, Lincoln Park Capital
On August 21, 2019, Trovagene announced that it has entered into a definitive purchase agreement with Lincoln Park Capital Fund, LLC ("Lincoln Park") an existing institutional investor, in which Lincoln Park agreed to purchase in a registered direct offering shares of common stock and pre-funded warrants. In a concurrent private placement, Lincoln Park agreed to purchase warrants to purchase shares of common stock.

Third Quarter 2019 Financial Results

Total operating expenses were approximately $4.3 million for the three months ended September 30, 2019, an increase of $0.3 million from $4.0 million for the same period in 2018. The increase in operating expenses is primarily attributed to advancing clinical programs and associated costs, offset by restructuring charges incurred in 2018.

Net cash used in operating activities in the third quarter of 2019 was approximately $3.2 million, compared to $3.5 million in the same period in 2018. The year-over-year decrease of $0.3 million can be attributed primarily to changes in assets and liabilities, and partially offset by the increase in development expenses as we advance our clinical trials.

Research and development expenses increased by approximately $1.0 million to $2.8 million for the three months ended September 30, 2019 from $1.8 million for the same period in 2018. The overall increase in expenses was primarily due to costs associated with our clinical programs and outside services for two ongoing clinical trials and the start of a third clinical trial related to the development of our drug candidate, onvansertib. We expect increases in research and development costs as we advance the onvansertib clinical development programs in AML, mCRPC and mCRC.

Selling, general and administrative expenses decreased by approximately $0.2 million to $1.5 million for the three months ended September 30, 2019 from $1.7 million for the same period in 2018. The decrease was primarily due to decreases in facilities and other costs, and reduction in salaries and staff costs.

The weighted average diluted shares of common stock outstanding used to calculate per share results for the three months ended September 30, 2019 was 5.8 million shares.

As of September 30, 2019, Trovagene had approximately $9.0 million of cash and cash equivalents.

On November 7, 2019 Sierra Oncology, Inc. (Nasdaq: SRRA), a late-stage drug development company focused on the development and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, reported that it has agreed to amend its Asset Purchase Agreement with Gilead Sciences, Inc. for momelotinib upon Sierra closing a qualified financing (Press release, Sierra Oncology, NOV 7, 2019, View Source [SID1234550605]).

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"These are significant amendments that meaningfully enhance the potential long-term value of momelotinib for Sierra and its stockholders. The amendments also affirm Gilead’s support for the continued development of momelotinib with the goal of bringing meaningful benefit to patients with myelofibrosis," said Dr. Nick Glover, President and CEO of Sierra Oncology. "Following the closing by Sierra of a qualified financing, Gilead will become a stockholder in Sierra, the annual royalty rates payable to Gilead will be reduced, which will benefit the company and all its stockholders should momelotinib prove commercially successful, and we will also eliminate a milestone payment that would be due to Gilead in the coming months with the anticipated initiation of the MOMENTUM Phase 3 trial for momelotinib, further extending our financial resources."

"We are pleased to enter into this amended agreement with Sierra in order to support the company’s continued advancement of momelotinib. Gilead continues to believe in the potential of momelotinib, and we are pleased that Sierra will continue development of the compound in hopes that it will benefit patients in the future," said Andrew Dickinson, Chief Financial Officer of Gilead.

In consideration for amending the royalty rates and milestones in the Asset Purchase Agreement, following the automatic conversion of shares of preferred stock to be issued in connection with Sierra’s recently announced financing, Sierra and Gilead Sciences would enter into a Securities Purchase Agreement, pursuant to which Sierra would issue to Gilead Sciences shares of Sierra Common Stock and a warrant to purchase Sierra Common Stock. The number of shares of Common Stock to be issued would be equal to 7.5% of Sierra’s outstanding shares of Common Stock, after giving effect to certain adjustments related to the financing. The Warrant would be exercisable to purchase up to an additional 7.5% of Sierra’s outstanding shares of Common Stock. The Warrant would include a blocker provision, that may be waived by Gilead upon specified notice, that prevents Gilead from exercising the warrant for a number of shares that would result in Gilead owning more than 9.99% of Sierra’s issued and outstanding shares of Common Stock.

On November 7, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported third quarter 2019 financial results (Press release, CytomX Therapeutics, NOV 7, 2019, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-third-quarter-2019-financial" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-third-quarter-2019-financial" rel="nofollow">View Source [SID1234550635]).

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As of September 30, 2019, CytomX had cash, cash equivalents and short-term investments of $325.7 million.

"The CytomX clinical pipeline made excellent progress in Q3 as we continued to advance multiple Probody therapeutic programs across the portfolio," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "The initiation of a Phase 2 trial of our anti-PD-L1 Probody CX-072 in combination with ipilimumab in patients with relapsed refractory melanoma marks our ongoing evolution into a product-focused company seeking to realize the full potential of our novel technology platform. Our first in class Probody Drug Conjugate programs, CX-2009 and CX-2029, also continued to move forward and our pipeline overall is positioned for significant data updates in 2020."

Business Highlights and Recent Developments

CX-072 Anti-PD-L1 Probody Therapeutic Clinical Program

In October, CytomX announced the initiation of the PROCLAIM (Probody Clinical Assessment In Man) CX-072-002 Phase 2 study evaluating the efficacy and tolerability of the anti-PD-L1 Probody CX-072, in combination with the anti-CTLA-4 antibody, ipilimumab, in patients with relapsed or refractory melanoma. The study utilizes a Simon Two-Stage design with approximately 40 patients being enrolled into Stage 1. CytomX anticipates initial data from Stage 1 in 2020. Additional information on this trial is available at ClinicalTrials.gov using the identifier NCT03993379.
The Company also announced in October updated clinical data from the Phase 1 PROCLAIM-CX-072-001 dose-finding study of CX-072 in combination with ipilimumab. With enrollment complete, 27 evaluable patients had received ipilimumab (3, 6 or 10 mg/kg) combined with CX-072 (0.3, 1, 3 or 10 mg/kg), with the study achieving a disease control rate (stable disease or better) of 37%. 5 patients achieved confirmed objective responses by RECIST v1.1, including one complete response, for an overall response rate (ORR) of 19% in this heavily pretreated patient population. The median duration of response was 14.6 months (1.9 – 21.2 months) with 4 of the 5 responders still on treatment as of the latest data snapshot. Of the 27 patients treated across all doses, Grade 3/4 treatment related adverse events (TRAEs) were reported in 9 (33%) patients. Grade 3/4 immune-related adverse events (irAEs) were reported in 3 (15%) patients.
Enrollment within the monotherapy cohorts of the PROCLAIM-CX-072-001 study is complete with evaluation of the activity and tolerability of CX-072 monotherapy continuing with ongoing treatment in select cohorts. Additional information on this trial is available at ClinicalTrials.gov using the identifier NCT03013491.
CX-2009 Anti-CD166 Probody Drug Conjugate Clinical Program

CytomX anticipates announcing next steps for the PROCLAIM-CX-2009 clinical program by the end of 2019.
BMS-986249 Anti-CTLA-4 Probody Therapeutic Clinical Program

Bristol-Myers Squibb (BMS) is conducting a Phase 1/2a dose escalation clinical study evaluating BMS-986249 alone and in combination with OPDIVO (nivolumab) in advanced solid tumors.
BMS is preparing to initiate the Phase 2 portion of this clinical trial, upon which CytomX is entitled to a $10 million milestone payment. Additional information on this trial is available at ClinicalTrials.gov using the Identifier NCT03369223.
CX-2029 Anti-CD71 Probody Drug Conjugate Clinical Program

CytomX continued enrollment of patients in the PROCLAIM-CX-2029 Phase 1/2 study, which is partnered with AbbVie, evaluating CX-2029 as monotherapy in patients with solid tumors or lymphomas. Additional information on this trial is available at ClinicalTrials.gov using the Identifier NCT003543813.
Additional Corporate Highlights

In October, the Company announced the appointment of Amy C. Peterson, M.D., as executive vice president and chief development officer. In this new role, Dr. Peterson will have oversight of a multi-disciplinary team focused on advancing all aspects of CytomX’s clinical development activities.
In July, the Company announced that its partner AbbVie selected a second target under the companies’ 2016 Discovery Collaboration and Licensing Agreement to discover and develop Probody drug conjugates. The target selection triggered a $10 million payment to CytomX from AbbVie.
Third Quarter 2019 Financial Results
Cash, cash equivalents and short-term investments totaled $325.7 million as of September 30, 2019, compared to $436.1 million as of December 31, 2018.

Revenue was $10.7 million for the three months ended September 30, 2019, compared to $12.5 million for the three months ended September 30, 2018. The decrease in revenue of $1.8 million for the three months ended September 30, 2019 compared to the corresponding period in 2018 was primarily due to a $1.7 million decrease in revenue recognition under the CD71 Agreement with AbbVie due to ongoing dose escalation.

Research and development expenses increased $0.4 million during the three months ended September 30, 2019 compared to the corresponding period in 2018. The increase was attributable to an increase of $1.3 million in personnel-related expenses primarily due to an increase in headcount; an increase of $0.7 million in consulting expenses resulting from increased clinical trial activities and an increase of $0.8 million in the allocation of information technology and facilities related expenses driven partly from an increase in headcount; which amounts were offset by a decrease of $2.4 million in laboratory contracts and services and laboratory supplies as a result of timing of manufacturing activities as well as reduced costs relating to CX-188 which is not presently being advanced.

General and administrative expenses increased by $0.3 million during the three months ended September 30, 2019 compared to the corresponding period in 2018. The increase was attributable to an increase of $0.4 million in consulting expenses primarily related to IT, software implementation and finance services; an increase of $0.5 million in dues and subscriptions primarily related to software and other IT services; an increase of $0.2 million in building maintenance charges; which amounts were partially offset by a decrease of $0.8 million of information technology and facilities-related expenses allocated to the general and administrative functions.

Teleconference Scheduled Today at 5:00 p.m. ET
Conference Call/Webcast Information

CytomX management will host a conference call today at 5:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the "Investor & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 9449326. An archive of the webcast will be available on the CytomX website from November 7, 2019, until November 14, 2019.

On November 7, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), reported that five abstracts relating to the Company’s lead product candidate, rigosertib, were accepted for presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando, FL, which takes place December 7-10, 2019 (Press release, Onconova, NOV 7, 2019, View Source [SID1234550651]).

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Oral Presentation:

1.Phase II Study of Oral Rigosertib Combined with Azacitidine (AZA) As First Line Therapy in Patients (Pts) with Higher-Risk Myelodysplastic Syndromes (HR-MDS)
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Combination Therapies
Abstract: 566
Date: Monday, December 9, 2019
Presentation Time: 7:00 AM – 8:30 AM
Location: W311 EFGH (Orange County Convention Center)
Presenter: Shyamala C. Navada, MD, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY
Poster Presentations:

2.Genomic Profiling in Patients with Higher-Risk Myelodysplastic Syndrome (HR-MDS) Following HMA Failure: Baseline Results from the INSPIRE Study (04-30)
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Poster II
Abstract: 3015
Date: Sunday, December 8, 2019
Session Time: 6:00 PM – 8:00 PM
Location: Hall B (Orange County Convention Center)
Presenter: Guillermo Garcia-Manero, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

3.The INSPIRE Study in Higher-Risk Myelodysplastic Syndrome (HR-MDS): A Novel Phase 3 Study Adaptive Design for Hematological Malignancies in Adults
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Poster III
Abstract: 4249
Date: Monday, December 9, 2019
Presentation Time: 6:00 PM – 8:00 PM
Location: Hall B (Orange County Convention Center)
Presenter: Anna Jonasova, MD, General University Hospital in Prague, 1st Internal Clinic – Clinic of Hematology, Prague, Czech Republic

4.Phase 3, Multi-Center, International, Randomized, Double-Blind, Placebo Controlled Study of Oral Rigosertib + Injectable Azacitidine (AZA) Versus Injectable Azacitidine in Treatment-Naïve Patients with Higher-Risk Myelodysplastic Syndrome (HR-MDS)
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Poster III
Abstract: 4268
Date: Monday, December 9, 2019
Session Time: 6:00 PM – 8:00 PM
Location: Hall B (Orange County Convention Center)
Presenter: Guillermo Garcia-Manero, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

5.The Sequenced Combination of Rigosertib and Azacitidine Has Modulatory Effects on CXCL8, RIG-I like Receptor (RLR) and Wnt/β-Catenin Signaling and Downstream Hematopoiesis Pathways in an in Vitro Model of the Myelodysplastic Syndrome
Session Name: 636. Myelodysplastic Syndromes – Basic and Translational Studies: Poster III
Abstract: 4231
Date: Monday, December 9, 2019
Session Time: 6:00 PM – 8:00 PM
Location: Hall B (Orange County Convention Center)
Presenter: Richa Rai, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY

On November 7, 2019 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary intratumoral immunotherapy products to kill tumors and increase immune system recognition of solid cancers, reported new preliminary data from the ongoing Phase 1/2 clinical study of INT230-6, the Company’s lead product candidate (Press release, Intensity Therapeutics, NOV 7, 2019, View Source [SID1234550667]). These data will be presented on Saturday, November 9, in an oral podium presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting, being held in National Harbor, MD.

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"The data being presented at SITC (Free SITC Whitepaper) advance our understanding of this new treatment, and identify a patient population that seems to derive the most benefit," said presenter and study investigator Jacob Thomas, MD, Assistant Professor of Clinical Medicine, Keck School of Medicine of the University of Southern California. "Our study included a highly refractory patient population, nonetheless several patients have had long term benefit. We observed a disease control rate of 39 percent in evaluable patients, with several patients showing disease control for over one year. In patients that had over 50 percent of total tumor burden injected, seven out of eight patients have shown disease control including all four patients enrolled with metastatic breast cancer. The treatment is well tolerated, and no patients had to discontinue therapy due to treatment-related toxicity. Additional benefits included tumor shrinkage and no further tumor growth or new tumors."

"We are excited that the data thus far reproduce the animal findings that intratumoral injection of INT230-6 stays in the tumor and the patients tolerate the procedure and drugs well. It also demonstrates cancer cell death in treated and in uninjected tumors with systemic immune activation," said Ian B. Walters, MD, Chief Medical Officer of Intensity Therapeutics. "Having the ability to safely reduce tumor cell burden and prime an immune response is an important advance in our ability to manage refractory cancers, we look forward to evaluating the combination with Keytruda and other immune agents."

The oral podium presentation includes data on 45 heavily pretreated patients with 17 different types of advanced or metastatic solid tumors who have failed a median of three prior therapies and are not candidates for approved, available therapies.

A pharmacokinetic (PK) analysis revealed limited exposure in the blood of INT230-6’s active anticancer agents, cisplatin (CIS) and vinblastine (VIN), supporting that the majority of INT230-6 is retained in the tumor, with few systemic toxicities. The findings are consistent with the low incidence of systemic adverse events despite intratumoral doses of INT230-6 escalating up to 160 mL, which is twice the amount of VIN that would typically be contained in a standard intravenous (IV) dose.

Furthermore, the immune activation data observed were consistent with nonclinical data, as local delivery of INT230-6 into tumors induced an immune response with increases of CD4+ and CD8+ T-cells in the blood and in the tumor microenvironment without any immune-related adverse events. An abscopal response was demonstrated in seven patients who overall showed tumor shrinkage in 10 non-injected tumors.

Oral Podium Presentation Information

Title: Intratumoral INT230-6 injection into solid tumors kills tumors and induces immune cell infiltration leading to abscopal responses and prolonged disease control in multiple refractory cancer types
Abstract Number: O31
Date/Time: Saturday, November 9, 2019, 3:45-4:00 p.m. ET
Session: Concurrent Session 309: Single Agent Phase 1 Clinical Trials
Location: Prince George’s Exhibition Hall C
Presenter: Jacob Thomas, MD, Assistant Professor of Clinical Medicine, University of Southern California

About INT230-6

INT230-6, Intensity’s lead proprietary product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor killing, releasing tumor antigens and recruitment of immune cells to the tumor. Results generated by the National Cancer Institute (NCI) showed treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-challenges of the initial cancer and resistance to other cancers. The NCI and Intensity collaborative research, published in July 2019, showed that there was also strong synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. There have been no dose limiting adverse events observed in patients to date, even when dosing into deep tumors in the lung and liver. Several patients demonstrated tumor shrinkage, symptomatic improvement, and evidence of cancer cell death and immune cell activation on tumor biopsy.