On April 12, 2023 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that enrollment has been completed in Part A of the Phase 2 DeFianCe study evaluating DKN-01, Leap’s anti-Dickkopf-1 (DKK1) antibody, in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with advanced colorectal cancer (CRC) (Press release, Leap Therapeutics, APR 12, 2023, View Source [SID1234629998]).

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"The completion of enrollment of Part A of the DeFianCe study is an important milestone for the DKN-01 colorectal cancer development program," said Cynthia Sirard, M.D., Chief Medical Officer of Leap. "We were very pleased with the enthusiasm of our investigators and patients for participating in Part A, which reflects the unmet medical need of second-line CRC patients and their conviction in the DKN-01 preclinical data and mechanism of action. We look forward to initial data from the study in mid-2023."

The DeFianCe study (NCT05480306) is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy for advanced disease. The study began with an initial Part A cohort that has enrolled 33 patients and is designed to expand into a 130-patient Part B randomized controlled trial. The primary objective is progression free survival. Secondary objectives include overall response rate, duration of response, and overall survival.

About DKN-01

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein. DKK1 has an important role in mediating an immune suppressive tumor microenvironment and in promoting tumor proliferation, metastasis, and angiogenesis. By removing free DKK1 from the tumor microenvironment, DKN-01 activates NK cells, reduces immune suppressor cells, and stimulates an immune-mediated anti-tumor response. In addition to the DeFianCe study, DKN-01 is being evaluated in the randomized controlled DisTinGuish study in first-line gastric cancer patients in combination with tislelizumab and chemotherapy and in an investigator-sponsored trial in advanced endometrial cancer patients in combination with pembrolizumab.

About Colorectal Cancer

Colorectal cancer (CRC) includes colon cancer, rectal cancer, and anal cancer. When the symptoms of CRC appear, such as rectal bleeding, anemia, or abdominal pain, most patients are already in the advanced stage where cancers are aggressive, malignant, and metastatic. CRC is the third most frequent cancer globally and the second leading cause of cancer-related death. According to the WHO, there were nearly 2,000,000 new cases of CRC in 2020, with nearly 1,000,000 deaths. It is estimated that there will be approximately 150,000 cases of CRC in the US in 2023, resulting in more than 50,000 deaths.

On April 12, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that the first patient has been dosed in a Phase 1/2 clinical study evaluating KVA12123 alone and in combination with the immune checkpoint inhibitor pembrolizumab in patients with advanced solid tumors (Press release, Kineta, APR 12, 2023, View Source;utm_medium=rss&utm_campaign=kineta-announces-first-patient-dosed-in-phase-1-2-clinical-study-of-kva12123-for-advanced-solid-tumors [SID1234629994]). KVA12123 is a novel VISTA blocking immunotherapy designed to address immunosuppression in the tumor microenvironment (TME). Patients are currently being enrolled for this study across multiple clinical sites in the United States. Initial readout of Phase 1 data is expected by the end of 2023.

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There is a strong clinical rationale for targeting VISTA with an antibody immunotherapy. VISTA is up-regulated after checkpoint inhibitor therapy and the protein is highly expressed in colorectal, renal cell carcinoma, head and neck, ovarian, and non-small cell lung cancers. These factors correlate with poor outcomes in cancer patients. KVA12123 is a fully human engineered IgG1 monoclonal antibody that was designed to bind to VISTA through a unique epitope at both physiologic and acidic pH levels. KVA12123 has demonstrated compelling activity in a range of preclinical cancer models as monotherapy and in combination with checkpoint inhibitor therapy. It was also observed to be well-tolerated in preclinical toxicology studies.

"New cancer immunotherapies continue to transform the standard of care and have significantly improved overall survival for patients with cancer. Despite the introduction of these novel therapies, most patients still progress following treatment leaving an urgent medical need for new treatments," said Evan Yu, M.D., Section Head for Cancer Medicine, Clinical Research Division at the Fred Hutchinson Cancer Center and Principal Investigator of the study. "We are excited to kick off this Phase 1 trial to evaluate Kineta’s VISTA blocking immunotherapy as a potential approach to alleviate immunosuppression and promote antitumor immune responses in the tumor microenvironment."

The Phase 1/2 clinical study (NCT05708950) is designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and tumor response of KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors. The study will be conducted in 4 parts. The Phase 1 study (Parts A and B) will focus on dose escalation of KVA12123 as a single-agent and in combination with pembrolizumab and will transition into a Phase 2 study (Parts C and D) that will focus on dose expansion. Additionally, Parts A and B will be used to determine a recommended Phase 2 dose (RP2D) for Parts C and D.

"KVA12123 represents a potentially promising new treatment option for a number of difficult-to-treat cancers," said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. "Initiation of this first-in-human trial of KVA12123 marks an important milestone for Kineta and brings us one step closer to delivering a next-generation immunotherapy that addresses cancer immune resistance."

On April 12, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer, is scheduled to participate in fireside chats at following investor conferences (Press release, Geron, APR 12, 2023, View Source [SID1234629993]):

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22nd Annual Needham Virtual Healthcare Conference
Thursday, April 20 at 10:15 a.m. ET

Stifel 2023 Virtual Targeted Oncology Days
Tuesday, April 25 at 2:00 p.m. ET

A webcast of each fireside chat and corporate presentation will be available through the Investor Relations section of Geron’s website under Events. Following each scheduled conference event, the related webcast will be archived and available for replay for a period of 30 days.

On April 12, 2023 Gennao Bio, a genetic medicines company developing first-in-class, targeted nucleic acid therapeutics, reported the appointment of Christopher Duke, MBA, M.P.H., as chief executive officer, effective immediately (Press release, Gennao, APR 12, 2023, View Source [SID1234629992]). Mr. Duke succeeds executive chairman and founding chief executive officer, Stephen Squinto, M.D., who will transition to a scientific advisor.

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"Chris has made significant contributions to the growth of Gennao since its inception in 2020, demonstrating strong leadership and strategic agility. As a seasoned biotechnology executive, Chris spearheaded the advancement of Gennao’s gene monoclonal antibody (GMAB) platform for cancer and skeletal muscle diseases, while managing the buildout of a talented team and core operations. His appointment as CEO is a testament to the strong pipeline progress and execution to date that enables Gennao to be well positioned for its next chapter of innovation," said Julie Hambleton, M.D., independent member of Gennao’s Board of Directors. "The Board also wishes to recognize Dr. Squinto for his early leadership of Gennao and is delighted for his continued collaboration as an advisor."

Mr. Duke brings more than 25 years of global research and development, operational and commercial experience at several leading rare disease and immuno-oncology companies. He has served as Gennao’s interim chief executive officer since 2022 and previously held the role of chief operating officer, where he established and led key corporate functions, including business development, program management, manufacturing, legal, business operations, human resources, and information technology.

"I am honored to lead Gennao and accelerate the development of our next-generation, non-viral delivery system for nucleic acids," said Mr. Duke. "The GMAB platform represents a potentially disruptive approach to delivering genetic therapies and treating devastating diseases such as cancer and rare, skeletal muscle disorders. I look forward to continuing to advance this differentiated and highly targeted technology closer to the clinic and ultimately to patients and families in need."

Before Gennao, Mr. Duke led operations and the commercial team in Japan for Amicus Therapeutics, after previously serving as the company’s vice president of global commercial operations. He previously served as chief operating officer for Advaxis, Inc., and executive director of international commercial operations for NPS Pharma. Earlier in his career, Mr. Duke held clinical and scientific positions at Merck & Co. and The Schering-Plough Corporation. He received an MBA from the Wharton School at the University of Pennsylvania, as well as an M.P.H. and a B.S. in chemical engineering from Rutgers University.

On April 12, 2023 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported that it will present new data highlighting the company’s novel technology and approaches to early cancer detection at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, April 14-19, in Orlando, Florida (Press release, Exact Sciences, APR 12, 2023, View Source [SID1234629991]).

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Exact Sciences’ data presentations support its blood-based, multi-cancer early detection (MCED) test, initial data for the company’s molecular residual disease (MRD) technologies, strategies to improve colorectal cancer screening outcomes, and a study involving the OncoExTra test, which uses next-generation sequencing (NGS) to assess a tumor’s RNA and DNA to help inform treatment decisions.

"Our data at AACR (Free AACR Whitepaper) show notable progress across our pipeline of cancer tests, from screening to late-stage therapy selection," said Jorge Garces, Ph.D., chief science officer, Exact Sciences. "The potential of MCED tests to detect many cancers from one blood draw is an incredible advancement for healthcare providers and their patients, and our data inform the optimal approach to identify where the cancer is located."

Data presentations across Exact Sciences’ Screening and Precision Oncology portfolios at AACR (Free AACR Whitepaper) 2023:

Poster #769: Evaluating the diagnostic burden of tumor localization strategies for multi-cancer early detection tests

Data embargoed until 1:30 p.m. ET on Sunday, April 16
Authors: Tyson, C, et al.
Date/Time: Sunday, April 16, 1:30 p.m. – 5:00 p.m. ET
Location: Section 28

Summary: In this analysis, advanced imaging identified the tissue of cancer origin following a positive MCED test resulting in fewer procedures to achieve cancer diagnosis when compared to molecular testing.

Poster #6694: Evaluation of a multi-omics approach to molecular residual disease detection

Data embargoed until 9:00 a.m. ET on Wednesday, April 19
Authors: Culver B, et al.
Date/Time: Wednesday, April 19, 9:00 a.m. – 12:30 p.m. ET
Location: Section 40

Summary: MRD methodologies developed using variants specifically derived from the patient tumor (tumor-informed) and a pre-defined set of markers (tumor-agnostic) showed high concordance in cancer detection and complemented each other in differentiating cancer samples from non-cancer samples.

Poster #770: Provider communication contributes to colorectal cancer screening intention through improving screening outcome expectancies and perceived behavioral control

Data embargoed until 1:30 p.m. ET on Sunday, April 16
Authors: Zhu X, et al.
Date/Time: Sunday, April 16, 1:30 p.m. – 5:00 p.m. ET
Location: Section 28

Summary: Improving health care provider communication with patients regarding beliefs about the effectiveness and ease of use of multi-target stool DNA screening may contribute to colorectal screening completion.

Poster #2150: CLDN18/ARHGAP26 in gastric cancers

Data embargoed until 9:00 a.m. ET on Monday, April 17
Authors: Josefson D, et al.
Date/Time: Monday, April 17, 9:00 a.m. – 12:30 p.m. ET
Location: Section 39

Summary: OncoExTra, an ultra-comprehensive DNA and RNA-based genomic test, was used to examine the prevalence of gastric cancer fusion CLDN18/ARHGAP26, that has been known to appear more often in young females and is associated with a poor prognosis and higher likelihood of metastasis.