On November 2, 2018 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results for the third quarter ended September 30, 2018 and highlighted recent company achievements (Press release, GlycoMimetics, NOV 2, 2018, View Source [SID1234530626]). Quarter-end cash and cash equivalents at September 30, 2018 were $219.8 million.

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"During the third quarter, we focused our activity on planning and initiating GlycoMimetics’ comprehensive clinical program to evaluate uproleselan across the spectrum of AML. We expect to announce enrollment of the first patient in our own Phase 3 pivotal study of "upro" in relapsed/refractory patients within a very short period of time, as initiation activity is well underway at many sites, and enrollment is now open. Support among investigators for this trial as well as for our two consortia-led trials is strong. We believe that the data contained in the abstracts selected for oral and poster presentations at the ASH (Free ASH Whitepaper) meeting reinforce the benefits already shared at prior medical meetings and bolster our confidence in upro’s potential to change the treatment paradigm in AML, whether patients have AML that is relapsed, refractory, or newly diagnosed," said Rachel King, GlycoMimetics Chief Executive Officer.

Key Operational Highlights for the Third Quarter of 2018:

The company’s strategic partner Pfizer continued to enroll individuals with sickle cell disease (SCD) in its Phase 3 clinical study of rivipansel for the treatment of vaso-occlusive crisis (VOC). Pfizer advised GlycoMimetics in August that enrollment was approximately 75% complete and is estimated to be completed in early 2019, with top-line data expected to be available in the second quarter of 2019.
The GMI-sponsored pivotal Phase 3 trial of uproleselan in relapsed/refractory AML is being initiated across multiple investigative sites in the US, and work continues to expand to clinical sites across Europe, Canada and Australia.
Planning advanced for the National Cancer Institute (NCI) collaborative study of uproleselan in newly diagnosed patients fit for chemotherapy; a protocol including an interim analysis of event-free survival was finalized and posted on clinicaltrials.gov.
Planning continued for the collaborative Haemato Oncology Foundation for Adults in the Netherlands (HOVON) European study of uproleselan in newly diagnosed patients unfit for chemo with a goal of trial initiation in 2019.
Third Quarter 2018 Financial Results:

Cash position: As of September 30, 2018, GlycoMimetics had cash and cash equivalents of $219.8 million as compared to $123.9 million as of December 31, 2017. In March 2018, GlycoMimetics completed a public offering of 8,050,000 shares of common stock, yielding net proceeds of $128.4 million.
R&D Expenses: The Company’s research and development expenses increased to $9.7 million for the quarter ended September 30, 2018 as compared to $5.8 million for the prior year quarter. The increase was primarily due to an increase in clinical trial expenses related to the start-up of the Phase 3 clinical trial of uproleselan and higher manufacturing expenditures for uproleselan clinical supplies for our planned Phase 3 clinical trial and to meet our supply obligations for clinical trials of uproleselan conducted by or in collaboration with third parties.
G&A Expenses: The Company’s general and administrative expenses increased to $2.8 million for the quarter ended September 30, 2018 as compared to $2.4 million for the prior year quarter. The increase was primarily due to higher patent and other legal expenses.
Shares Outstanding: Shares outstanding as of September 30, 2018 were 43,137,227.
The company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) with passcode 9176334. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

About Uproleselan (GMI-1271)

Uproleselan (yoo’ pro le’sel an) is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed/refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, which have been derived from results from third party clinical trials evaluating standard chemotherapy, as well as lower than expected induction-related mortality rates. Treatment in these patient populations was generally well tolerated, with fewer than expected adverse effects. The U.S. Food and Drug Administration (FDA) has granted uproleselan Breakthrough Therapy Designation for the treatment of adult AML patients with relapsed/refractory (R/R) disease. GlycoMimetics is currently implementing a comprehensive development program across the clinical spectrum of AML. This includes a company sponsored Phase 3 trial in R/R AML and two consortia-sponsored trials in newly diagnosed patients. One consortium trial is being sponsored by the NCI and will enroll newly diagnosed patients fit for intensive chemotherapy. The other trial is sponsored by the HOVON group in Europe and will enroll newly diagnosed patients unfit for intensive chemotherapy.

About Rivipansel

Rivipansel, the most advanced drug candidate in the GlycoMimetics pipeline, is a glycomimetic drug candidate that acts as a pan-selectin antagonist, meaning it binds to all three members of the selectin family – E-, P- and L-selectin. The first potential indication for rivipansel is VOC of SCD, one of the most severe complications of SCD which can result in acute ischemic organ injury at one or more sites. By reducing cell adhesion, activation and inflammation that are believed to contribute to reduced blood flow through the microvasculature during VOC, GlycoMimetics believes that rivipansel could be the first drug to interrupt the underlying cause of VOC, thereby potentially enabling patients to leave the hospital more quickly. Pfizer is conducting a Phase 3 clinical trial for rivipansel in SCD.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules that keep cancer cells in the bone marrow. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma (MM) or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer. GlycoMimetics has completed a Phase 1 clinical trial of GMI-1359 in healthy volunteers.

On November 2, 2018 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported operating results for the quarter ended September 30, 2018 (Press release, ImmunoGen, NOV 2, 2018, View Source [SID1234530623]).

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"With the completion of enrollment in FORWARD I, we have initiated the activities required to support a BLA filing and launch mirvetuximab soravtansine in ovarian cancer. Over the last three months, we have completed the product validation runs for drug substance, put in place operational metrics and resources to ensure timely assessment of the primary endpoint for the study, and moved ahead with pre-launch commercial planning," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "In parallel, we continued to execute across the remainder of the business, including presentation of initial data from the FORWARD II KEYTRUDA combination at ESMO (Free ESMO Whitepaper), accelerating accrual in the FORWARD II triplet cohort, and advancing our next ADC into preclinical development in collaboration with MacroGenics. Looking ahead to the fourth quarter and the coming year, with a strong cash runway, we are well-positioned to deliver on our strategic priorities and look forward to oral presentations for our novel IGN assets, IMGN779 and IMGN632, at ASH (Free ASH Whitepaper) in December and to announcing top-line results from FORWARD I during the first half of 2019."

PIPELINE PROGRESS AND PARTNER-RELATED UPDATES

Favorable tolerability and encouraging anti-tumor activity data from the FORWARD II expansion cohort of mirvetuximab soravtansine in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with platinum-resistant ovarian cancer were presented at the 2018 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October. The goal of the combination is to prolong clinical benefit of the ADC in later-line patients through concomitant activation of the immune system.
The Food and Drug Administration (FDA) has granted orphan-drug designation to IMGN632 for the treatment of acute myeloid leukemia (AML).
ImmunoGen and MacroGenics advanced the IMGC936 (ADAM9-targeting ADC) program into IND-enabling activities. ADAM9-positive tumor types include non-small cell lung, triple-negative breast, gastric, and pancreatic cancers.
ImmunoGen presented preclinical data related to an epithelial cell adhesion molecule (EpCAM)-targeting Probody drug conjugate (PDC) at the European Antibody Congress in October. The EpCAM-targeting PDC integrates the PROBODY technology developed by CytomX, which enables the selection of targets previously thought to be incompatible with ADC development due to high normal tissue expression.
Roche announced in October that the Phase 3 KATHERINE study met its primary endpoint showing that KADCYLA (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival, iDFS) compared to HERCEPTIN (trastuzumab) as an adjuvant treatment in people with HER2-positive early breast cancer who have residual disease present following neoadjuvant treatment.
ANTICIPATED UPCOMING EVENTS

Oral presentation of data from IMGN779 Phase 1 dose finding study at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting;
Oral presentation of initial data from IMGN632 Phase 1 dose finding study at the 2018 ASH (Free ASH Whitepaper) Annual Meeting and preclinical poster sessions related to IMGN632;
Complete enrollment in the FORWARD II cohort assessing a triplet combination of mirvetuximab plus carboplatin and AVASTIN (bevacizumab) in patients with recurrent platinum-sensitive ovarian before the end of 2018, and report initial data in mid-2019;
Initiate a new expansion cohort in the FORWARD II study to evaluate mirvetuximab plus AVASTIN in patients with recurrent ovarian cancer in 1Q 2019; and
Report top-line results from Phase 3 FORWARD I trial of mirvetuximab soravtansine in 1H 2019.
FINANCIAL RESULTS
Revenues for the quarter ended September 30, 2018 were $10.9 million, compared with $8.5 million for the quarter ended September 30, 2017. License and milestone fees of $0.7 million for the third quarter of 2018 included recognition of a $0.5 million milestone pursuant to a license agreement with Fusion Pharmaceuticals. Revenues in the third quarter of 2018 included $8.4 million in non-cash royalty revenues, compared with $6.5 million for the same quarter in 2017. Revenues for the third quarter of 2018 also included $0.4 million of research and development (R&D) support fees and $1.4 million of clinical materials revenue, compared with $0.7 million and $1.2 million, respectively, for the same quarter in 2017.

Operating expenses for the third quarter of 2018 were $56.5 million, compared with $39.6 million for the same quarter in 2017. The increase was driven by R&D expenses, which were $47.2 million in the third quarter of 2018, compared with $31.7 million for the third quarter of 2017. This increase was primarily due to higher antibody and cytotoxic manufacturing costs in support of commercial validation runs for mirvetuximab soravtansine, along with higher clinical trial costs related to the FORWARD II combination assessments and, to a lesser extent, expenses resulting from stock-based compensation. General and administrative expenses in the third quarter of 2018 were $8.3 million, compared to $7.9 million in the same quarter of 2017. Operating expenses for the third quarter of 2018 also included a $0.9 million restructuring charge due to the workforce reduction related to the previously announced decommissioning of the Company’s Norwood facility.

ImmunoGen reported a net loss of $46.8 million, or $0.32 per basic and diluted share, for the third quarter of 2018, compared with a net loss of $56.7 million, or $0.61 per basic and diluted share, for the same quarter last year. Weighted average shares outstanding increased to 147.2 million from 93 million in those quarters.

ImmunoGen had $303.2 million in cash and cash equivalents as of September 30, 2018, compared with $267.1 million as of December 31, 2017, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $125.1 million for the first nine months of 2018, compared with cash provided from operations of $37.1 million for the same period in 2017. The prior period benefited from a $30 million paid-up license fee received from Sanofi, a $75 million upfront payment received from Jazz Pharmaceuticals, and a $25 million upfront payment received from Debiopharm. Capital expenditures were $4.2 million and $0.8 million for the nine months ended September 30, 2018 and 2017, respectively.

FINANCIAL GUIDANCE
ImmunoGen has updated its cash and revenue guidance for 2018. ImmunoGen now expects:

cash and cash equivalents at December 31, 2018 to be between $250 million and $255 million; and
revenues between $50 million and $55 million.
Guidance for operating expenses remains unchanged:

operating expenses between $215 and $220 million.
ImmunoGen expects that its current cash combined with the expected cash revenues from partners and collaborators will enable the Company to fund its operations at least a year beyond the top-line results from the Phase 3 FORWARD I trial, which are expected in the first half of 2019.

CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at 8:00 am ET to discuss these results. To access the live call by phone, dial 323-794-2423; the conference ID is 8582527. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through November 16, 2018.

On November 2, 2018 Kyowa Hakko Kirin Co., Ltd. (President and COO: Masashi Miyamoto, "Kyowa Hakko Kirin") announces that the company has entered into a collaboration agreement with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., to initiate a Phase 1 clinical study of Kyowa Hakko Kirin’s novel IDO inhibitor, KHK2455, in combination with avelumab*, a human anti-PD-L1 antibody for solid tumors (Press release, Kyowa Hakko Kirin, NOV 2, 2018, View Source [SID1234530621]).

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Under the terms of the agreement, Kyowa Hakko Kirin will initiate a Phase 1 clinical study in the US, to evaluate the proof-of-concept of KHK2455 by combining with avelumab in patients with solid tumors.

"I am pleased to collaborate with Merck KGaA, Darmstadt, Germany, and Pfizer Inc. on this combination study," said Mitsuo Satoh, Ph.D., Executive Officer, Vice President Head of R&D Division of Kyowa Hakko Kirin. "I hope we will find a new potential of KHK2455 through the clinical study."

"We believe that the pathway to progress treatment outcomes lies in combination approaches, and we look forward to collaborating with Kyowa Hakko Kirin to investigate how combining avelumab with KHK2455 may improve patient care and outcomes," Kevin Chin, Vice President, Global Clinical Development, Immuno-Oncology at the biopharma business of Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono. "This is another key example of how we continue to focus on opportunities to advance combination trials with avelumab."

"Evaluating and advancing the potential of immunotherapy combination approaches to support patients with challenging cancers is a key focus of our clinical development program for avelumab," said Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-Oncology, Early Development, and Translational Oncology, Pfizer Global Product Development. "We look forward to working with Kyowa Hakko Kirin to explore this novel combination for patients with solid tumors."

Avelumab has received accelerated approval by the US Food and Drug Administration (FDA) for the treatment of patients with metastatic Merkel cell carcinoma (MCC) and previously treated patients with locally advanced or metastatic urothelial carcinoma (mUC), and is under further clinical evaluation across a range of tumor types under a global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

*Avelumab is under clinical investigation for treatment of solid malignancies and has not been demonstrated to be safe and effective for these uses. There is no guarantee that avelumab will be approved for additional solid malignancies by any health authority worldwide.

About KHK2455
KHK2455 is a selective inhibitor of indoleamine 2,3-dioxygenase 1 (IDO1), which converts tryptophan to kynurenine and contributes to tumor escape from immunosurveillance. KHK2455 inhibits IDO1 apo-enzyme with long-lasting and potent activity. KHK2455 inhibits kynurenine production in preclinical models and demonstrates synergistic inhibition of tumor growth in mouse tumor models with immune checkpoint inhibitors. KHK2455 is well tolerated and suppresses kynurenine production in a dose-dependent and sustained manner in patients with advanced solid tumors.1

About Avelumab
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.2-4 Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.4-6 In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Avelumab is currently being evaluated in the JAVELIN clinical development program, which involves at least 30 clinical programs, including eight Phase III trials, and more than 9,000 patients across more than 15 different tumor types. For a comprehensive list of all avelumab trials, please visit New window opensclinicaltrials.gov.

Alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, U.S.
Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany, and Pfizer Inc. The global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US, enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer’s PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab as a monotherapy, as well as in combination regimens, and is striving to find new ways to treat cancer.

References
Yap TA, Sahebjam S, Hong DS et al. First-in-human study of KHK2455, a long-acting, potent and selective indoleamine 2,3-dioxygenase 1 (IDO-1) inhibitor, in combination with mogamulizumab (Moga), an anti-CCR4 monoclonal antibody, in patients (pts) with advanced solid tumors. ASCO (Free ASCO Whitepaper) Annual Meeting 2018;3040.
Dolan DE, Gupta S. PD-1 pathway inhibitors: changing the landscape of cancer immunotherapy. Cancer Control 2014;21(3):231-7.
Dahan R, Sega E, Engelhardt J et al. FcγRs modulate the anti-tumor activity of antibodies targeting the PD-1/PD-L1 axis. Cancer Cell 2015;28(3):285-95.
Boyerinas B, Jochems C, Fantini M et al. Antibody-dependent cellular cytotoxicity activity of a novel anti-PD-L1 antibody avelumab (MSB0010718C) on human tumor cells. Cancer Immunol Res 2015;3(10):1148-57.
Kohrt HE, Houot R, Marabelle A et al. Combination strategies to enhance antitumor ADCC. Immunotherapy 2012;4(5):511-27.
Hamilton G, Rath B. Avelumab: combining immune checkpoint inhibition and antibody-dependent cytotoxicity. Expert Opin Biol Ther 2017;17(4):515-23.

On November 2, 2018 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that the Company will present at two investor conferences in November (Press release, Constellation Pharmaceuticals, NOV 2, 2018, View Source [SID1234530619]):

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November 15 – Jefferies London Healthcare Conference at the Waldorf Hilton in London at 4:00 p.m. GMT/11:00 a.m. EST
November 28 – Evercore ISI 2018 Healthcare Conference at the Boston Harbor Hotel in Boston, at 10:15 a.m. EST
A live audio webcast of the presentation and an archive for replay will be available for both conferences on the Investor Relations section of Constellation’s website at View Source The audio webcast replays will be available for 90 days following the live presentations.

On November 2, 2018 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary immune cell-activating cancer treatments, reported the completion of a $6.5 million Series B financing (Press release, Intensity Therapeutics, NOV 2, 2018, View Source [SID1234530618]).
Intensity plans to use the proceeds of the financing to advance the clinical development of lead product candidate INT230-6, a direct intratumoral injection that is currently being evaluated in a Phase 1/2 clinical study in patients with various advanced solid tumors. The Company intends to expand the study by adding clinical sites outside the U.S. and Canada, as well as adding combination arms with an anti-PD-1 antibody.

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"The support from our investors in this round, who purchased stock at a 150 percent premium to our Series A financing, underscores the potential of INT230-6 and our proprietary DfuseRxSM technology discovery platform," said Lewis Bender, Founder and Chief Executive Officer of Intensity. "With this funding, we are well positioned to complete the ongoing Phase 1/2 study of INT230-6, including planned combination arms with an anti-PD-1 antibody, and initiate Phase 2a studies in specific tumor types next year. We look forward to further evaluating the safety and efficacy of INT230-6 to ultimately bring a novel, intratumoral, immune response-activating treatment to patients with refractory solid tumor cancers."

As the Company recently reported at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, preliminary data from the ongoing Phase 1/2 study demonstrated intratumoral injections of INT230-6 were well tolerated with no drug-related serious adverse events or dose-limiting toxicity in patients with advanced solid tumors. In addition, increases in circulating CD8 and CD4 T-cells and evidence of abscopal responses in non-injected tumors were observed. Preliminary data from this study will also be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, which is being held November 7-11 in Washington, DC.

About INT230-6

INT230-6, Intensity’s lead product candidate designed for direct intratumoral injection, is comprised of two proven, potent anti-cancer agents and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. 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-inoculations of the initial cancer and resistance to other cancers. In mouse models, INT230-6 has shown strong synergy with checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was discovered from Intensity’s DfuseRxSM platform.