On October 17, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products, and services, reported the expanded commercial availability of CNSide for patients with metastatic melanoma (Press release, Biocept, OCT 17, 2022, View Source [SID1234622076]). Previously validated for lung, breast, and all other carcinomas, Biocept’s CNSide is a proprietary CSF assay designed to better detect and inform treatment decisions for patients with metastatic cancers involving the central nervous system (CNS).

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The new CNSide for melanoma assay uses a novel antibody cocktail optimized for the capture of melanoma cells based on unique cellular characteristics. This assay represents a significant development in the field of neuro-oncology related diagnostics. It is believed to be the first CLIA-validated assay designed for the quantitative identification of melanoma cells in CSF.

Melanoma is the third most common tumor type involved in CNS metastasis, with more than 60% of Stage IV melanoma patients developing CNS metastasis from their disease. Overall survival expectancy is low and patient management can be challenging due in part to diagnostic limitations. CNSide addresses a high unmet clinical need, as current standard of care approaches—CSF cytology and MRI imaging—have limited sensitivity for detecting CNS metastasis and are not adequate to assess the response to therapy. CNSide can also help identify molecular biomarkers considered targets for novel therapy approaches. Combined, these features help clinicians answer three key questions for patients with CNS metastasis: Is there tumor? Is there a target for treatment? Is there a trend or favorable response to treatment?

"Our early development experience evaluating patients with melanoma with CNSide is similar to what we have seen in carcinomas, supporting the expanded clinical use of this CLIA laboratory developed test," said Michael Dugan, M.D., Biocept’s Chief Medical Officer and Medical Director. "Physicians are finding CNSide valuable for managing patients with CNS metastasis, particularly to assess treatment response. Declining CSF tumor cell counts have correlated well with successful response to therapy and symptom resolution, while better illustrating residual, recurrent or resistant disease. CSF can also be more frequently and easily evaluated while the patient is in the clinic, compared to follow-up radiologic imaging that might occur weeks later."

"We are pleased to expand the commercial use of CNSide for physicians treating patients with metastatic melanoma," said Samuel D. Riccitelli, Biocept’s Chairman, and interim President and CEO. "This is another step toward our goal of establishing CNSide as a new standard-of-care diagnostic test for patients with metastatic cancer that has spread to the CNS; patients who have no time to waste."

About CNSide

CNSide is based on Biocept’s proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. Given the genetic changes that can occur as metastatic cancer spreads to the CNS, the evaluation of cerebrospinal fluid with CNSide provides a unique opportunity to identify biomarkers such as HER2 and EGFR in patients with metastatic carcinoma or melanoma to help guide physicians in therapy selection. In addition, the quantitative tumor cell count assay can be used in a serial fashion to monitor the response to therapy more effectively than other current methods.

On October 17, 2022 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, reported the dosing of the first patient in the expansion cohorts of its ongoing Phase 1 study for IO-108 (Press release, Immune-Onc Therapeutics, OCT 17, 2022, View Source [SID1234622075]). The Company also entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) ("Regeneron") to evaluate IO-108 in combination with Regeneron’s anti-PD-1 therapy, Libtayo (cemiplimab), as part of its ongoing clinical development program.

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IO-108 is a novel myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) in adult patients with advanced or refractory solid tumors.

"We are incredibly excited to have enrolled the first patient in an expansion cohort of the IO-108 study. To date, IO-108 has been well tolerated and has demonstrated promising clinical activity in various tumor types, both as a monotherapy and in combination with an anti-PD-1 antibody," said Paul Woodard, M.D., chief medical officer of Immune-Onc. "Additionally, on the heels of initiating this important phase of our study, we are excited to enter into a supply agreement with Regeneron, which enables us to accelerate the global development of IO-108 in multiple expansion cohorts of select solid tumors. We hope to establish our pipeline products as the preferred combination agents with T cell checkpoint inhibitors and other standard of care therapies."

The Phase 1 expansion phase includes IO-108 monotherapy cohorts and IO-108 combination cohorts with anti-PD-1 antibodies (pembrolizumab or cemiplimab, depending on tumor types). Under the terms of the agreement, Immune-Onc will sponsor and fund the planned clinical trials and Regeneron will provide cemiplimab (Libtayo). Immune-Onc retains global development and commercial rights to IO-108.

"I have been very encouraged by both the pre-clinical and early clinical data observed for IO-108 in the ongoing Phase 1 study, and look forward to better understanding how combination therapy with various anti-PD1 therapies can further activate the body’s immune system to attack some of the hardest-to-treat cancers," said IO-108 Phase 1 investigator, Matthew H. Taylor, M.D., assistant member, Developmental Cancer Therapeutics Laboratory and co-medical director, Providence Melanoma Program, Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon. "Currently, 70-80 percent of cancer patients with solid tumors do not achieve durable responses to T-cell checkpoint therapies alone, and people with many types of cancer have yet to benefit from the promise of this class of immunotherapy. This underscores the need for investigating novel combination regimens."

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A and CD1d. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s annual meeting and the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor and promotes innate and adaptive anti-cancer immunity.

The ongoing Phase 1 study of IO-108 in adult cancer patients in the U.S. (NCT05054348) has completed dose escalation and is actively enrolling several expansion cohorts, as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab or cemiplimab). To date, IO-108 has been well tolerated with demonstrated clinical activity in multiple tumor types, both as a monotherapy and in combination with pembrolizumab. The company is also actively enrolling a Phase 1 clinical trial in China to evaluate IO-108 in solid tumors.

On October 17, 2022 Ankyra Therapeutics, a company developing targeted immune potentiating agents for the treatment of cancer, reported the appointment of Joseph J. Elassal, M.D., as chief medical officer (Press release, Ankyra Therapeutics, OCT 17, 2022, View Source [SID1234622074]). Dr. Elassal will fill the role formerly served by Howard Kaufman, M.D., who was recently promoted to president and chief executive officer of Ankyra Therapeutics.

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"Joe is a well-respected leader in our field who brings a breadth of experience to Ankyra, having held roles within the biotech and financial industries, while also serving as a practicing physician for 20 years," said Dr. Kaufman. "Joe has spent a large portion of his career focused on leading efforts to advance intra-tumoral applications of immunotherapy – expertise that will be critical to enabling Ankyra to rapidly progress our lead compound, ANK-101, into the clinic. We are delighted to welcome Joe to the team at this important stage of our development, and I, along with the rest of the management team and the board, look forward partnering with him."

Dr. Elassal has served as an attending physician at Stamford Hospital for nearly 20 years, while also holding industry roles across the pharmaceutical and financial industries. Most recently, he served as enior medical director, global medical affairs – oncology at Regeneron, where he led efforts on cemiplimab and other immunotherapy approaches for patients with cervical and non-melanoma skin cancer. He also held roles within the inflammation and immunology, and cardiovascular and metabolic divisions at Regeneron. His other industry roles included senior medical director at Replimune, biosimilars medical affairs at Pfizer, deputy vice president at Pharmaceutical Research and Manufacturers of America (PhRMA), and vice president, senior medical director at Cline Davis & Mann. Prior to industry, Dr. Elassal was a research associate at JP Morgan Securities. Dr. Elassal earned his M.D. from Eastern Virginia Medical School and MBA from Columbia Business School. He completed his internship and residency at Columbia University/New York Presbyterian Hospital and is certified by the American Board of Internal Medicine.

"I am excited to join Ankyra, a company which is at the forefront of intratumoral oncology drug development. Ankyra’s anchored immunotherapy platform has the potential to transform the therapeutic application of cytokine drugs by delivering enhanced efficacy and limiting systemic exposure, a challenge experienced with many cytokine-based therapies today," said Dr. Elassal. "I look forward to joining a strong and dedicated team at Ankyra working to advance our lead compound ANK-101 into the clinic as well as additional pipeline opportunities in the future."

On October 17, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported the publication of promising new pre-clinical data from the Company’s next-generation radioligand therapy (RLT) program for prostate cancer, PNT2001 (Press release, Point Biopharma, OCT 17, 2022, View Source [SID1234622073]).

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"We are entering an exciting stage in POINT’s prostate cancer franchise," said Joe McCann, Ph.D., Chief Executive Officer of POINT Biopharma. "Our PNT2001 actinium-225 program exemplifies our team’s deep expertise in the rapid development of new and innovative radioligands. And while we are advancing the next generation of PSMA-targeted radioligand therapy, we are simultaneously continuing our pre-commercial planning for our lead asset, PNT2002, by evaluating the most capital efficient approaches to commercialization including resourcing of internal commercial capabilities and exploring strategic commercial partnership options."

PNT2001 builds on POINT’s first-generation, lutetium-based program with a next-generation ligand optimized for use with the alpha-emitting radioisotope actinium-225.

The new PNT2001 data were shared in E-poster #039, "Development and characterization of a next-generation 225Ac-PMSA radioligand", at the 35th Annual Congress of the European Association of Nuclear Medicine, currently taking place in Barcelona, Spain.

In pre-clinical models, 225Ac-PNT2001 demonstrated:

Increased internalization by tumor cells in vitro, compared to that of a first-generation ligand
More precise tumor targeting in vivo (due to decreased kidney uptake, high tumor retention, and rapid renal clearance), leading to a promising safety profile in murine models
Compelling therapeutic activity, including suppression of tumor growth and metastases, along with improved survival, following the administration of a single dose in mice
These pre-clinical findings support the advancement of 225Ac-PNT2001 to clinical evaluation.

Having secured access to actinium-225 from the US Department of Energy, as well as agreements with Ionetix, TerraPower, and Northstar, POINT aims to accelerate radiochemistry and formulation optimization, as well as cGMP process and method development and validation, to facilitate progression to an IND/CTA submission in H1 2023.

About the SPLASH Trial
The phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in participants with PSMA-expressing mCRPC who have progressed on androgen receptor pathway inhibitor (ARPI) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study is expected to enroll approximately 400 participants across North America, Europe, and the United Kingdom. Participants will be randomized 2:1 with participants in arm A receiving PNT2002 and participants in arm B receiving either abiraterone or enzalutamide. Participants in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from their first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall response rate, overall survival, and pharmacokinetics.

On October 17, 2022 Leap Therapeutics, Inc. (NASDAQ: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that the first patient has been enrolled in the Phase 2 DeFianCe study evaluating DKN-01, Leap’s anti-Dickkopf-1 antibody (DKK1), 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, OCT 17, 2022, View Source [SID1234622072]).

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"We believe that DKN-01 has broad clinical potential. Based on the role of DKK1 in suppressing the immune system in the tumor microenvironment and enabling resistance to chemotherapy in CRC, we are excited to explore this new indication, one of the most frequent and dangerous types of GI cancers where patients continue to look for new treatment options," said Cynthia Sirard, M.D., Chief Medical Officer of Leap Therapeutics. "Enrolling the first CRC patient is an important milestone for the DKN-01 clinical program, and we look forward to reporting initial data from this 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. The study is designed with an initial 20 patient cohort and to then expand into a 130-patient randomized controlled trial against bevacizumab and standard of care chemotherapy. 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 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways and has an important role in promoting tumor proliferation, metastasis, angiogenesis, and in mediating an immune suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells.

About Colorectal Cancer
Colorectal cancer is the third most frequent cancer globally and the second leading cause of death. According to the WHO, there were nearly 2 million new cases of colorectal cancer in 2020, with nearly 1 million deaths. Colorectal cancer includes colon cancer (57.5%), rectal cancers (35%), and anal cancer (2.5%). 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.