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On November 1, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that on October 29, 2021, the Company participated in a productive Type A Meeting with the US Food and Drug Administration (FDA) (Press release, Sesen Bio, NOV 1, 2021, View Source [SID1234594029]). The purpose of the meeting was to discuss questions related to Chemistry, Manufacturing and Controls (CMC) raised in the FDA’s Complete Response Letter (CRL) regarding the Company’s Biologics License Application (BLA) for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (CMC Type A Meeting).

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During the CMC Type A Meeting, the Company and the FDA reviewed issues related to CMC to be further discussed during the review of the BLA for Vicineum upon potential resubmission. The Company believes it has a clear understanding of what additional information regarding CMC is required for resubmission of the BLA.

Additionally, although not an issue raised in the CRL, the FDA confirmed that Vicineum manufactured using the proposed commercial process is comparable to Vicineum used in prior clinical trials. The FDA also confirmed that Sesen Bio can utilize Vicineum manufactured during process validation for any potential future clinical trials needed to address issues raised in the CRL, and that these potential trials can proceed while addressing CMC issues.

"We are pleased by the collaborative dialogue with the FDA during our CMC Type A Meeting," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Our team looks forward to continued progress as we prepare for the Clinical Type A Meeting, and we remain committed to working diligently to fulfill our mission of saving and improving the lives of patients by bringing new treatment options to market."

As previously disclosed, Sesen Bio is preparing for a separate Type A Meeting to discuss the recommendations specific to additional clinical/statistical data and analyses that the FDA raised in the CRL (Clinical Type A Meeting), which the Company expects to occur later this year. The Company intends to use the information from the CMC Type A Meeting and the Clinical Type A Meeting to synchronize the regulatory reviews of Vicineum for the treatment of BCG-unresponsive NMIBC in the US and the European Union.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immunooncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On November 1, 2021 Compass Therapeutics, Inc. (OTC:CMPX) reported an update on the clinical development of CTX-009 (also known as ABL001), a dual anti-angiogenic bispecific antibody targeting DLL4 and VEGF-A (Press release, Compass Therapeutics, NOV 1, 2021, View Source [SID1234594046]).

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A Phase 2a study for CTX-009 in combination with paclitaxel was initiated by Handok Pharmaceuticals, Inc. (KOSDAQ: 002390) in Q1 2021 in patients with BTC and the enrollment in the first part of the study has been completed. The study has been enrolling patients who have unresectable advanced, metastatic, or relapsed BTC’s who have received one or two prior systemic therapies. The Phase 2a design was informed by the CTX-009 Phase 1b study, where CTX-009 in combination with either paclitaxel or irinotecan led to an overall response rate of 23.5% and a clinical benefit rate of 76.5%, including two confirmed and durable partial responses among four patients with advanced cholangiocarcinoma (clinicaltrials.gov Identifier: NCT04492033).

The Phase 2a study utilizes a Simon Two-Stage adaptive design where the criteria to advance to the second stage of the study is three or more partial responses observed in 21 patients. So far, there have been five partial responses observed among the first 17 patients evaluated, which is an overall response rate of 29%, and accordingly, the criteria to advance to the second part of the study has been met. In the second part of the Phase 2a study, 45 additional patients will be enrolled. The preliminary adverse event profile of CTX-009 in this Phase 2a study is consistent with prior studies of CTX-009 with hypertension and neutropenia being the most common events related to CTX-009 and paclitaxel, respectively. Handok initiated the study in Q1 2021 at four leading medical centers in South Korea. Compass plans on submitting an IND for CTX-009 in the United States later this quarter and subject to the IND going into effect with the FDA, plans on initiating a Phase 2 study in the United States in Q2 2022.

"Patients with cholangiocarcinoma have limited treatment options following front line combination chemotherapy. In the Phase 1b and Phase 2a studies, we have seen a total of seven partial responses in 21 total patients evaluated. Impressively, there have been measurable tumor declines in 19 of the 21 advanced patients treated across both studies. We are looking forward to filing our IND in the United States this quarter and pursuing the global development of CTX-009," said Thomas Schuetz, M.D., Ph.D., CEO and scientific founder of Compass. Compass holds the global rights to CTX-009 with the exception of South Korea rights, which are held by Handok, and China rights, which were out-licensed to Elpiscience Biopharma.

About CTX-009

CTX-009 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Preclinical and early clinical data of CTX-009 suggest that blockade of both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic and non-small cell lung cancer. Partial responses to CTX-009 as a monotherapy have been observed in heavily pre-treated cancer patients, who were resistant to currently approved anti-VEGF therapies. CTX-009 has completed a Phase 1 monotherapy dose escalation and dose expansion study. Phase 1b and Phase 2a combination studies are ongoing.

On November 1, 2021 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), reported that it will report financial results for the third quarter ended September 30, 2021 on Monday, November 8, 2021, after the close of U.S. markets (Press release, Ziopharm, NOV 1, 2021, View Source [SID1234594013]). Following the announcement, the Company will host a conference call and webcast at 4:30 p.m. ET to provide a corporate update and review the financial results.

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The conference call can be accessed by dialing 877-451-6152 (United States) or 201-389-0879 (International) with the conference code 13724384. A live webcast may be accessed using the link here, or by visiting the "Investors" section of the Ziopharm website at www.ziopharm.com. After the live webcast, the event will be archived on Ziopharm’s website for approximately 90 days after the call.

On November 1, 2021 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer, reported that final clinical data from the Phase 1b study, CMP-001-001, of vidutolimod, an advanced generation Toll-like receptor 9 (TLR9) agonist, in combination with pembrolizumab or as a monotherapy will be presented at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting to be held in person and virtually November 10-14, 2021 (Press release, Checkmate Pharmaceuticals, NOV 1, 2021, View Source [SID1234594030]).

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Presentation Details:

Title: Final analysis: phase 1b study investigating intratumoral injection of Toll-like receptor 9 agonist vidutolimod ± pembrolizumab in patients with PD-1 blockade–refractory melanoma
Presenting Author: John M. Kirkwood
Abstract #: 16269
ePoster #: 950
Location: Virtual Poster Hall Exhibit, November 12, 7:00am – 8:30pm ET