On May 20, 2021 Checkmate Pharmaceuticals Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported that Barry Labinger, CEO, will present at the Jefferies Virtual Healthcare Conference from 2:00-2:25pm ET on Tuesday, June 1, 2021 (Press release, Checkmate Pharmaceuticals, MAY 20, 2021, View Source [SID1234580446]). Checkmate will also host 1×1 investor meetings during the conference.

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the Checkmate website. An archived copy of the webcast will be available on the Checkmate website for approximately 30 days after the event.

On May 20, 2021 CARsgen Therapeutics Corporation, an innovative biotechnology company pursuing medicines to treat cancer reported that it will create approximately 200 jobs and invest $157 million in Durham, Governor Roy Cooper (Press release, Carsgen Therapeutics, MAY 20, 2021, View Source [SID1234580460]). The company’s selection of the Research Triangle area will establish its first biomanufacturing site in North America. CARsgen Therapeutics currently has its U.S. clinical development operations in Houston, Texas.

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"Global companies know that North Carolina is a world class leader in biotechnology," said Governor Cooper. "Our state’s skilled workers, educational institutions and business environment provide life science companies with the tools they need to succeed."

CARsgen Therapeutics Corporation, a wholly-owned subsidiary of CARsgen Therapeutics Holdings Limited, is a clinical stage biotechnology company specializing in what’s known as chimeric antigen receptor (CAR) T cell therapies, a type of therapy that engages people’s immune systems in a new way. The therapeutic approach can yield medicines for various human cancers, including leukemia, lymphoma, and solid tumors. The company’s project in North Carolina will establish a 37,000 square foot clinical/early-stage commercial manufacturing facility and then a 100,000 square foot cGMP commercial manufacturing facility in Durham that will eventually produce FDA approved cell therapies.

"We are very excited to receive the JDIG grant approval from the State of North Carolina," said Dr. Zonghai Li, CEO, CSO and Chairman of CARsgen Therapeutics. "CARsgen will continuously develop and embed innovations to advance the revolutionary CAR-T cell therapy for unmet clinical needs. The company has launched clinical studies of our leading CT053 and CT041 CAR-T cell therapies in the United States. The new facilities will expand our global cGMP manufacturing capacity to produce the innovative CAR-T cell products for the U.S. patients."

"It’s exciting to see a company at the cutting-edge of science join our growing biotech industry cluster," said North Carolina Commerce Secretary Machelle Baker Sanders. "From companies exploring gene therapies to the innovative work CARsgen is conducting with immune-oncology, there’s no question that North Carolina will continue to play an important role in the future of this industry and the many lives of those impacted by the life sciences sector."

Although wages will vary by job position, the aggregate average salary of the new positions will reach $76,061, bringing a payroll impact of $15.2 million to the region each and every year. The current average wage in Durham County is $75,892.

CARsgen Therapeutics’ project in North Carolina will be facilitated, in part, by a Job Development Investment Grant (JDIG) approved by the state’s Economic Investment Committee earlier today. Over the course of the 12-year term of this grant, the project is estimated to grow the state’s economy by $1.04 billion. Using a formula that takes into account the new tax revenues generated by the 200 new jobs, the JDIG agreement authorizes the potential reimbursement to the company of up to $1,616,250, spread over 12 years. Over the 12 years, those state tax revenues will exceed $31.1 million.

State payments only occur following performance verification by the departments of Commerce and Revenue that the company has met its incremental job creation and investment targets. JDIG projects result in positive net tax revenue to the state treasury, even after taking into consideration the grant’s reimbursement payments to a given company.

CARsgen’s JDIG agreement also could move as much as $538,750 into the state’s Industrial Development Fund – Utility Account for use by rural communities elsewhere in the state. The Utility Account helps finance necessary infrastructure upgrades in more economically challenged areas of the state to attract future business.

"Durham attracts the most innovative companies in the world and today’s decision continues that positive trend," said N.C. Representative Zack Hawkins. "We welcome these new jobs and the talent they will bring to our area and look forward to the life-saving medicines these employees will bring to people in need."

"Research Triangle Park broke records as one of the nation’s first research parks, but I’m proud we didn’t rest on our laurels," said N.C. Senator Natalie Murdock. "It’s great to see this treasured resource continue to grow and renew itself by attracting new ideas and companies to our area."

Partnering with the North Carolina Department of Commerce and the Economic Development Partnership of N.C. on this project were the North Carolina General Assembly, the North Carolina Community College System, the North Carolina Biotechnology Center, Duke Energy, the City of Durham, Durham County and the Greater Durham Chamber of Commerce.

On May 20, 2021 Nippon Kayaku reported that Financial Results for the Fiscal Year Ending March 31, 2021 (FY 2021) (Press release, Nippon Kayaku, MAY 20, 2021, View Source_fiscal_ym14/100505/00.pdf" target="_blank" title="View Source_fiscal_ym14/100505/00.pdf" rel="nofollow">View Source [SID1234580346])

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FY 2021 : Topics
(1) 4 Consolidated Results
• Net sales and profit was decreased from the previous fiscal year. But net sales and profit was increased from the forecast in January, 2021
• Sales of Functional Chemicals and Safety systems in 1st half declined due to COVID-19 pandemic, but sales in 2nd half was rapidly recovered with automobile market demand
• Catalyst of Functional Chemicals achieved 10.9 billion yen sales, record high
• Biosimilars was 10.4 billion yen sales, record high, while the drug price revisions

FY 2021 : Topics (2) Functional Chemicals Business
• Sales of epoxy resins were strong for semiconductor and circuit board due to the growth in 5G base stations and IT devices, and recovered for automobile applications from 3rd quarter
• Sales of epoxy resins for use in automobile applications were strong
• The cleaner for LCD and semiconductor industry business acquired from Henkel AG &Co. KGaA was performed well for semiconductor usage
• Teikoku Taping Systems Co., Ltd were acquired, to spread the semiconductor applications
• Sales of colorants for inkjet printers for consumer use were strong, owing to the positive impact of working from home during the COVID-19 pandemic
• Sales of colorants for inkjet printers used in industrial applications declined abruptly due to the decrease in demand for printed advertising, sales for textile dyes declined due to the clothing sales decrease, and thermal developer declined due to the decrease in demand for movie and theater ticket, but all applications slightly recovered from 3rd quarter • Sales of Catalyst achieved 10.9 billion yen sales, record high
• Polatechno Co., Ltd was made a wholly owned subsidiary, was integrated from October and proceeded the strength of the governance and integrated operations. The sales slightly recovered for automobile application from 3rd quarter

5 FY 2021 : Topics (3) Pharmaceuticals Business
• Biosimilars: Sales growth for INFLIXIMAB BS and TRASTUZUMAB BS was strong
New products: The cancer-related generic drug APREPITANT recorded strong growth The biomedicine PORTRAZZA achieved market penetration, increased its adaption Approach for the domestic manufacturing with Calitivecs Inc. Continue to focus on co-promotion of NUBEQA Tab., a therapeutic drug for prostate cancer
• Products under development: NK105 (Polymeric micelle paclitaxel) was canceled to develop for breast cancer due to Phase II clinical trial results Launch for development related bio and polymeric technology with Biomedical companies 6 FY 2021 : Topics (4) Safety Systems Business
Rapidly decline due to the stagnation of global automobile market
• Demands rapidly recovered in China from 1st quarter, in Japan and North America from 2nd quarter
Sales rapidly recovered in all regions from 3rd quarter, although there were regional differences
• Total shipment of automobile safety devices glowed to 80 million devices in 3rd quarter
• Safety equipment for drones, PARASAFE progress to develop on schedule towards the start of sales in December, 2021 Agrochemicals and Other Businesses
• Domestic sales was strong, but oversea sales declined due to the procurement difficulty of some of raw materials
• Acquired sales rights of "Teron" and "Ashahi D-D," then started of those sales from 4th quarter 7 ESG :

FY 2021 Topics 8
▸ Enlargement and Strengthened of Corporate Governance
・Increased the number of independent outside directors by one
・Established the Nomination and Remuneration Advisory Committee Members: five directors, the majority are independent outside directors (3 out of 5) Roles: strengthen the fairness, transparency and objectivity of the procedures related to the nomination and remuneration etc. of directors etc.
・Formulated our Basic Policy on Corporate Governance
・Enlargement on Corporate Governance (consider to enlargement towards the general meeting in June)
▸ Environment target FY 2031 NK groups’ GHG emission target in FY 2031 (Scope 1+2)setting at 32.5% decrease via FY 2019
▸ Further information-CSR information: View Source report: View Source _fiscal_ym17/88077/00.pdf

On May 20, 2021 IconOVir Bio, Inc. (IconOVir), a preclinical-stage biotechnology company pioneering the next generation of oncolytic virus (OV) therapy to improve the treatment of patients with cancer, reported new preclinical data demonstrating proof-of-concept for a proprietary combination of two selectivity mutations, made to Adenovirus (Ad) proteins E1A and E4-ORF6/7, both of which are incorporated into its rationally designed OV product candidates (Press release, IconOVir Bio, MAY 20, 2021, View Source [SID1234580363]). The data, which were generated by IconOVir’s partners at the Salk Institute for Biological Studies, were shared in an abstract (e14543) titled "Highly selective and potent p16-CDK-RB-E2F targeted oncolytic virus therapies," which was included in the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting Proceedings, an online supplement to the Journal of Clinical Oncology.

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"IconOVir was founded on the belief that OVs can be rationally engineered to deliver deeper, more durable benefit to patients," said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of IconOVir. "Our proprietary platform enables rapid, iterative and combinatorial engineering, screening and optimization of next-generation OVs, enabling us to impart desirable attributes to novel viruses while still maintaining the qualities that make Ad an attractive OV backbone. In the case of ICVB-1042, we incorporate a series of mutations to optimize potency, selectivity and tumor tropism, and potentially enable both intratumoral and intravenous administration. The abstract shared at ASCO (Free ASCO Whitepaper) describes the first pair of mutations that we introduced into ICVB-1042, which improve tumor selectivity without impacting replicative efficiency or sacrificing lytic potency. We look forward to advancing ICVB-1042 into clinical studies in 2022, as we pursue our mission of curing cancer and restoring life to every patient, everywhere."

In normal cells, the p16/RB tumor suppressor pathway regulates E2F transcription factors, which activate critical genes for DNA replication. However, in nearly all solid tumors, one or more mutations in the p16-CDK-RB-E2Fpathway genes aberrantly activate E2F and are critical in driving uncontrolled tumor proliferation. While difficult to target with traditional therapeutic modalities, these tumor suppressor loss of function mutations represent ideal targets for driving durable anti-tumor responses.

Ad has evolved viral proteins, such as E1A, that bind to RB to activate E2F transcription of viral and cellular genes required for viral replication. On this basis, multiple first-generation Ad OV candidates have been engineered to contain RB binding domain mutations in the E1A gene in an effort to prevent E2F activation and replication in healthy cells. However, IconOVir’s partners at the Salk Institute have shown that another viral protein, E4-ORF6/7, activates E2F independently of E1A and drives virus replication in normal cells, even when the E1A gene has been mutated.

In the abstract published in the ASCO (Free ASCO Whitepaper) Annual Meetings Proceedings, the Salk Institute team describes data showing that combining E1A and E4-ORF6/7 mutations in an Ad OV yields an improved selectivity/efficacy profile over first-generation OVs engineered with E1A-RB mutations alone by conferring E2F-dependent tumor-selective replication without negatively impacting lytic potency in cancer cells. Furthermore, this high degree of tumor-selectivity is maintained when combined with additional mutations to enhance the lytic potency, tropism and systemic bioavailability of Ad OVs, as in IconOVir’s lead candidate, ICVB-1042.

"While OV-based therapies have delivered meaningful benefit to select patient populations, first-generation therapies are limited in their lytic potency, tumor selectivity, and systemic bioavailability, which has prevented the full realization of the modality’s potential," said Clodagh O’Shea, Ph.D., Wicklow Chair and Professor of Molecular and Cell Biology at the Salk Institute and Scientific Founder and Chair of the Scientific Advisory Board of IconOVir. "The data announced today demonstrate proof-of-concept for our belief that rationally designed OVs can overcome these historical challenges, by introducing mutations that enable viruses to specifically replicate in tumor cells, while leaving healthy cells unharmed. I look forward to collaborating with the IconOVir team as they advance ICVB-1042, the first rationally engineered OV to incorporate the dual E1A and E4-ORF6/7 mutation, into clinical development next year."

IconOVir’s lead product candidate, ICVB-1042, is derived from Ad, a common cold virus. In preclinical studies, ICVB-1042 has been shown to infect and kill a broad range of tumor cells, including head and neck, bladder, lung and breast, suggesting that it could have potential utility in a wide range of solid tumor indications. IconOVir is advancing ICVB-1042 through preclinical development, with plans to file an Investigational New Drug application with the U.S. Food and Drug Administration in the first half of 2022.

On May 20, 2021 Replimune Group, Inc. (NASDAQ: REPL), a biotechnology company developing a series of oncolytic immuno-gene therapies derived from its Immulytic platform, reported financial results for the fiscal fourth quarter and year ended March 31, 2021 and provided a business update (Press release, Replimune, MAY 20, 2021, View Source [SID1234580379]).

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"We have made good progress advancing our programs over the quarter and look forward to providing a data update with RP1 and RP2 at our virtual investor event being held in June as we continue to enroll into our registration-directed clinical trials in CSCC and anti-PD1 failed melanoma, with expected readouts in 2022," said Philip Astley-Sparke, CEO of Replimune. "Our vision extends well beyond our initial lead skin cancer indications, with the broader aim of becoming a cornerstone for immuno-oncology treatments across a wide spectrum of tumor types. With this in mind, and as we move closer to market, we recently expanded our senior management team with two key hires with a considerable track record of success in bringing multiple high profile programs to BLA approval and in overseeing the launch of new drugs in the immuno-oncology space."

Corporate Updates

Expanded management team with key hires to prepare for the transition to a commercial company. The Company hired Sushil Patel, Ph.D. as Chief Commercial Officer, arriving from Genentech where he was the head of their global oncology franchise for lung cancer, skin cancer and rare / agnostic tumor types, and previously the lifecycle leader in lung cancer for the multi-billion-dollar checkpoint blockade drug Tecentriq. In addition to hiring Dr. Patel, the Company also appointed Tanya Lewis as Chief Development Operations Officer. Ms. Lewis’s past accomplishments include successful negotiations related to registration trial designs, approval, and/or commercialization of XPOVIO, VELCADE, VARUBI, INTEGRILIN and ZEJULA.

Announced plans to amend the CERPASS clinical trial protocol to add complete response (CR) rate as an additional independent primary endpoint. The amendment is based on the depth and durability of responses and the manageable safety profile seen in patients with non-melanoma skin cancers treated with RP1 in combination with Opdivo to date. Under the modified clinical trial protocol for CERPASS, Replimune plans to add CR rate as an additional independent primary endpoint, in addition to overall response rate (ORR), and to reduce target enrollment from 240 patients to 180 patients. Secondary endpoints will continue to include duration of response, progression-free survival (PFS), and overall survival (OS). Replimune plans to submit the amended protocol to the FDA by the end of this quarter and is maintaining its guidance to expect primary data read out in 2022.

Held Type B meeting with the FDA to discuss the regulatory pathway for RP1 in combination with Opdivo (nivolumab) in anti-PD1 failed melanoma. Replimune recently held a Type B meeting with the FDA to discuss the design of the currently enrolling 125-patient registration-directed cohort of patients with anti-PD1 failed melanoma in the IGNYTE clinical trial. The FDA expressed that while a randomized controlled clinical trial would always be preferred for registration, if the clinical data is sufficiently compelling in this patient population with no clear standard of care, then the data could be submitted to the FDA for review under the accelerated approval pathway. The FDA also indicated that a randomized confirmatory trial would be needed as is required under the accelerated approval process.

Presented new biomarker and pre-clinical data for RP1 and RP2, at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data presented continues to confirm potent anti-tumor activity and activation of robust systemic immune activation by RP1 and RP2.

Virtual Investor Event to be held on Thursday, June 3, 2021. The Company will host a virtual investor event to present updated data from its Phase 2 skin cancer cohorts combining RP1 with Opdivo and data from its Phase 1 study of RP2 alone and in combination with Opdivo. The event will include presentations by the management team and Mark Middleton, Professor of Experimental Cancer Medicine in the Department of Oncology, consultant Medical Oncologist at the Oxford Cancer and Hematology Centre and Head of the Department of Oncology at the University of Oxford.

First RP1 batches produced and filled at state-of-the-art manufacturing facility. Release testing is underway for the first GMP RP1 batches produced at its 63,000-square-foot manufacturing facility in Framingham, MA, that was built to support the commercialization of all of its products. Technology transfer for RP2 has also commenced and is expected to complete in the next quarter.
Program Highlights and Upcoming Milestones

RP1 in combination with Libtayo (cemiplimab) in CSCC: CERPASS, the Company’s Phase 2, global, randomized, controlled, registration-directed clinical trial continues to actively enroll patients and remains on track for a primary data read out in 2022.

RP1 in combination with Opdivo in anti-PD-1 failed melanoma: The Company’s 125-patient cohort in the IGNYTE Phase 2 clinical trial of RP1 in combination with Opdivo, continues to actively enroll patients and remains on track to report the primary data read out in 2022.

RP1 in combination with Opdivo in melanoma and non-melanoma skin cancers (NMSC): Following a positive Phase 2 data update in October 2020 and enrollment of the initial melanoma cohort (including anti-PD1 naïve and anti-PD1 failed patients) being complete, the Company continues to enroll its 45-patient cohort evaluating RP1 in combination with Opdivo in NMSC. The Company plans to provide an update on these programs at its June 3rd investor event.

RP1 in anti-PD1 failed NSCLC: The first patient in the cohort of 30 anti-PD1 failed NSCLC patients treated with RP1 combined with Opdivo has been dosed, and the Company expects to report initial data in the second half of 2021.

RP1 as monotherapy in solid organ transplant recipients with CSCC: The Company is currently enrolling a 30 patient Phase 1b clinical trial (ARTACUS) assessing the safety and efficacy of RP1 in liver and kidney transplant recipients with CSCC. Enrollment in this immuno-compromised population has been hampered by COVID 19, but as the effects of the pandemic reduce the Company expects recruitment to increase. Early data from this clinical trial is intended to be presented in the second half of 2021.

RP1 in combination with Opdivo in MSI-H/dMMR tumors: The Company continues to expect to be able to decide whether to pursue RP1 for MSI-H/dMMR tumors into registration-directed development by the end of 2021.

RP2 alone and in combination with Opdivo: Following positive data with RP2 given as monotherapy that were presented in October 2020, the Company is actively enrolling a 30-patient cohort evaluating RP2 in combination with Opdivo. Updated data from this clinical trial, including an update on patients treated with RP2 monotherapy and initial data with RP2 in combination with Opdivo will be presented at the upcoming June 3rd investor event.

RP3 alone and in combination with anti-PD-1 therapy: The Phase 1 clinical trial evaluating RP3 alone and in combination with anti-PD1 therapy in solid tumor patients is actively enrolling and the Company remains on track to report initial data in the second half of 2021.

Target evaluation for new indications is currently underway: The Company remains on track to disclose part of its initial development plans for RP2 and/or RP3 in less immune responsive tumor types at the upcoming June 3rd investor event.
Financial Fiscal Quarter Four and Year End Highlights:

Cash Position: As of March 31, 2021, cash, cash equivalents and short-term investments were $476.3 million, as compared to $168.6 million as of March 31, 2020. This increase was primarily related to $372.5 million in net proceeds from financing activities offset by an increase in cash utilized in operating activities in advancing our expanded clinical development plan.

Based on the current operating plan, Replimune believes that existing cash and cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements into the second half of 2024.
R&D Expenses: Research and development expenses were $16.2 million for the fourth quarter and $56.8 million for the fiscal year ended March 31, 2021, as compared to $11.2 million for the fourth quarter and $38.8 million for the fiscal year ended March 31, 2020. This increase was primarily due to clinical expenses driven by the company’s lead programs, expansion into additional studies, operating our dedicated manufacturing facility and related increased personnel costs. Research and development expenses included $2.0 million in stock-based compensation expenses for the fourth quarter and $5.7 million in stock-based compensation expenses for the fiscal year ended March 31, 2021.

G&A Expenses: General and administrative expenses were $6.0 million for the fourth quarter and $23.2 million for the fiscal year ended March 31, 2021, as compared to $5.2 million for the fourth quarter and $17.4 million for the year ended March 31, 2020. The increase was primarily driven by personnel related costs, professional fees, and facility expansion. General and administrative expenses included $1.5 million in stock-based compensation expenses for the fourth quarter and $6.0 million in stock-based compensation expenses for the fiscal year ended March 31, 2021.

Net Loss: Net loss was $21.5 million for the fourth quarter and $80.9 million for the fiscal year ended March 31, 2021, as compared to a net loss of $15.8 million for the fourth quarter and $52.6 million for the fiscal year ended March 31, 2020.
About CERPASS
CERPASS is Replimune’s registration-directed randomized, global Phase 2 clinical study to compare the effects of Libtayo alone versus a combination of Libtayo and Replimune’s investigational oncolytic immunotherapy RP1. The clinical trial will enroll 180 patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are naïve to anti-PD1 therapy. The trial will evaluate complete response (CR) rate and overall response rate (ORR) as its two primary efficacy endpoints as assessed by independent review, as well as duration of response, progression-free survival (PFS), and overall survival (OS) as its secondary endpoints. The study is being run under a clinical trial collaboration agreement with Regeneron in which the costs of the trial are shared and full commercial rights retained by Replimune. Libtayo is being jointly developed by Regeneron and Sanofi.
Libtayo is a registered trademark of Regeneron.

About IGNYTE
IGNYTE is Replimune’s multi-cohort Phase 1/2 trial of RP1 plus Opdivo. There are 4 tumor specific cohorts currently enrolling in this trial including a 125-patient extension cohort of RP1 combined with Opdivo in anti-PD-1 failed cutaneous melanoma. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same trial of approximately 30 patients with melanoma. The additional thirty patient cohorts are studying RP1 in combination with Opdivo in non-melanoma skin cancers which includes both naïve and anti-PD-1 failed CSCC, in microsatellite instability high, or MSI-H/dMMR tumor types and anti-PD-1 failed non-small cell lung cancer, or NSCLC. This trial is being done under a collaboration and supply agreement with Bristol Myer Squibb.
Opdivo is a registered trademark of Bristol-Myers Squibb Company.

About RP1
RP1 is Replimune’s lead Immulytic product candidate and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.

About RP2 & RP3
RP2 and RP3 are derivatives of RP1 that express additional proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 are intended to provide targeted and potent delivery to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.