On May 20, 2021 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company developing proprietary, intratumoral products to kill tumors and increase immune system recognition of cancers, reported two poster presentations to be made at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held virtually from June 4 to 8 (Press release, Intensity Therapeutics, MAY 20, 2021, View Source [SID1234580395]).

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Title: A Phase 1/2 Study of Intratumoral INT230-6 Alone (IT-01) or in Combination with Pembrolizumab [KEYNOTE-A10] in Adult Subjects with Locally Advanced, Unresectable and Metastatic Solid Tumors Refractory to Therapy
Authors: El-Khoueiry, A.B., et al.
Session: Developmental Therapeutics – Immunotherapy
Session type: Poster Session
Abstract: 2592

Title: Early Results of Intratumoral INT230-6 Alone or in Combination with Ipilimumab in Subjects with Advanced Sarcomas
Authors: Ingham, M., et al.
Session: Sarcoma
Session type: Poster Session
Abstract: 11557

"INT230-6 is a novel, proprietary, locally-delivered anti-cancer product candidate that has shown very promising clinical results as monotherapy in a basket study of patients with advanced and refractory disease," said Lewis H. Bender, President and CEO of Intensity Therapeutics. "We are excited that ASCO (Free ASCO Whitepaper) has offered us the opportunity to share our encouraging results in two presentations. The data to be reported in our first poster will update our safety and efficacy results for patients receiving INT230-6 alone or in combination with pembrolizumab. The second presentation details preliminary results of INT230-6 with or without ipilimumab to treat sarcomas, a complex cancer type with high unmet medical need."

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed 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.

About Intensity Therapeutics’ Clinical Studies

INT230-6 is currently being evaluated in several Phase 2 cohorts (NCT03058289) in patients with various advanced solid tumors as part of Study IT-01. In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6, Intensity’s lead product candidate, and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced pancreatic, colon, squamous cell and bile duct malignancies. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb Company to evaluate the combination INT230-6, with Bristol Myers Squibb’s anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with advanced liver, breast and sarcoma cancers. In 2021, the Company executed agreements with the Ottawa Hospital Research Institute and the Ontario Institute of Cancer Research to study INT230-6 in a randomized, controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT04781725).

On May 20, 2021 Nordic Nanovector ASA (OSE: NANOV) reported that it will report its results for the first quarter 2021 on Wednesday, 26 May 2021 (Press release, Nordic Nanovector, MAY 20, 2021, View Source [SID1234580411]).

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A presentation by Nordic Nanovector’s senior management team will be webcast live the same day at 8:30am CET.

The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event.

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2021 from 7:00am CEST the same day.

On May 20, 2021 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with pediatric cancers, solid tumors, and other cancers, reported the publication by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) of three abstracts accepted for poster presentations during the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting (Press release, Salarius Pharmaceuticals, MAY 20, 2021, View Source [SID1234580429]). ASCO (Free ASCO Whitepaper) 2021 will take place June 4-8, 2021 via a virtual platform.

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Salarius submitted three abstracts disclosing clinical research involving its lead drug candidate, seclidemstat. Details on the presentations can be found below. Key findings include data showing that seclidemstat has a manageable safety profile with no significant hematological toxicities, which can be a limitation for other LSD1 inhibitors. In addition, seclidemstat showed proof-of-concept preliminary drug activity in relapsed/refractory Ewing sarcoma and other advanced cancer patients, including FET-rearranged sarcomas, at or below the recommended phase 2 dose (RP2D), which was established to be 900 mg BID.

"We are excited to have the opportunity to present clinical data regarding safety, dosing, and initial efficacy signals for seclidemstat during ASCO (Free ASCO Whitepaper) 2021," said David Arthur, President and Chief Executive of Salarius Pharmaceuticals. "For the first time, we will report full data and the recommended Phase 2 dose from the recently completed dose-escalation stage of our Phase 1/2 clinical trial in Ewing sarcoma. We will also discuss in more detail the preliminary drug activity data observed in FET-rearranged sarcoma patients from our Advanced Solid Tumor (AST) trial that supports our continued development of seclidemstat as single-agent therapy in select sarcomas."

The full abstracts are available on ASCO (Free ASCO Whitepaper)’s 2021 Meeting Library. Details from the Salarius abstracts are as follows:

Abstract #11514: Phase 1 trial of seclidemstat (SP-2577) in patients with relapsed/refractory Ewing sarcoma
Session Type & Title: Poster Discussion Session, Sarcoma
Presenting Author: Damon R. Reed, M.D., H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida.
Date & Time: June 4, 2021, 9 a.m. ET
Key Information & Findings: Seclidemstat has a manageable safety profile with proof-of-concept preliminary activity in heavily pretreated patients with relapsed or refractory Ewing sarcoma.

900 mg BID established as the RP2D
A patient dosed at 600 mg BID achieved a reduction in target lesions after 58 days (cycle 2) with further tumor shrinkage after 112 days (cycle 4) and 168 days (cycle 6) for a maximum 76% tumor shrinkage; Coincident new non-target lesion appearance at end of cycle 2
Two additional patients dosed at 600 mg BID and 900 mg BID had overall stable disease
No treatment-related deaths; The most common (>5%) Grade 3 treatment-related adverse events (TRAEs) were vomiting (15%), abdominal pain (11%), and hypokalemia (11%); One patient with Grade 3 pancreatitis reported elevated lipase, a Grade 4 adverse event (AE); No significant hematological TRAES (Grade 3 occurred in <5% of patients)
Abstract #3073: Preliminary efficacy from an ongoing phase 1 dose escalation study of seclidemstat (SP-2577) in patients (pts) with advanced solid tumors (AST)
Session Type & Title: Poster Session, Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Presenting Author: Sant P. Chawla, M.D., Sarcoma Oncology Research Center, Santa Monica, California
Date & Time: Friday, June 4, 2021, 9 a.m. ET
Key Information & Findings: Seclidemstat has shown activity among advanced sarcoma patients with a manageable safety profile. Dose escalation is ongoing and preliminary clinical data supports further exploration in FET-translocated sarcomas as single agent and in combination therapy. Safety data will be presented after completion of Phase 1 dose-escalation.

As of December 30, 2020, 19 patients were enrolled in AST trial, including patients with prostate ovarian, pancreatic, renal, cervical and breast cancer, as well as sarcomas; Patients received a median of four prior systemic treatments
13 patients were evaluable for response after 58 days of treatment (cycle 2); 7 patients had best response of stable disease (SD) with median time to progression (TTP) of 4.3 months, including 3 patients with advanced FET-rearranged sarcomas
All 7 patients were dosed at 300 mg BID or 600 mg BID
The most common Grade 3 TRAEs were gastrointestinal-related and included diarrhea (5.3%) and abdominal pain (5.3%)
No treatment-related deaths and no Grade 4 TRAEs have been reported
Abstract #TPS11577: Phase 1 expansion trial of the LSD1 inhibitor seclidemstat (SP-2577) with and without topotecan and cyclophosphamide (TC) in patients (pts) with relapsed or refractory Ewing sarcoma (ES) and select sarcomas
Session Type & Title: Poster Session, Sarcoma
Presenting Author: Damon Reed, M.D., H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida.
Date & Time: June 4, 2021, 9 a.m. ET
Key Information: This is an ongoing dose-expansion study assessing seclidemstat at the RP2D (900 mg BID) in two cohorts: a single-agent expansion in select sarcoma patients and a safety lead-in dose escalation and expansion of seclidemstat in combination with topotecan and cyclophosphamide (TC) in Ewing sarcoma patients.

The sarcoma cohort will enroll patients with myxoid liposarcoma or other select sarcomas with FET family translocations, including desmoplastic small round cell tumor (DSRCT); The trial will allow patients treated with one to three prior lines of therapy
The Ewing sarcoma cohort will allow patients treated with up to two prior lines of therapy
Primary objective is safety and tolerability, and secondary objective is efficacy
Recruiting patients across eight U.S. locations
This year, ASCO (Free ASCO Whitepaper) received and reviewed more than 5,400 abstracts for the 2021 Annual Meeting, the world’s largest gathering of physicians, biopharmaceutical companies, researchers, and investors to discuss cancer research and therapeutics. Information about the Annual Meeting may be accessed at View Source

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.