On June 15, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, Zytiga-resistant prostate cancer and leukemia, reported presentation of final results of its Phase 1b study, and preliminary positive data from its Phase 2 study, in relapsed or refractory acute myeloid leukemia (AML) (Press release, Cardiff Oncology, JUN 15, 2020, View Source [SID1234561098]). The data was presented as a virtual poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) annual conference.

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The presentation highlighted the efficacy, durability of response, favorable safety and tolerability profile, as well as correlative biomarker data. Anti-leukemic activity was observed at a wide range of onvansertib doses (27 to 90 mg/m2), indicating a large therapeutic window.
The EHA (Free EHA Whitepaper) poster presentation is available for download from the Scientific Presentations page on the Cardiff Oncology website at View Source

"While the trial is still ongoing, we are encouraged by the efficacy we are seeing thus far in patients with relapsed/refractory AML, particularly the durability of response observed in some patients," said Dr. Amer Zeidan, lead investigator and associate professor of Medicine at the Yale School of Medicine, and the medical director of Hematology Early Therapeutics Research at Yale Cancer Center. "As we continue with enrollment and assessment of efficacy in the Phase 2 portion of the trial, I look forward to seeing additional clinical benefit with the combination of onvansertib and decitabine in our patients in an indication that is in dire need of new safe and effective treatment options."

Presentation Highlights
Safety and Tolerability:
•In Phase 1b, the maximum tolerated dose (MTD) was established at 60 mg/m2 with no dose-limiting toxicities through this dose level
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•Treatment-related toxicities continue to be primarily on-target hematological; with rash and mucositis being reported at higher onvansertib doses
Efficacy
Completed Phase 1b:
•Anti-leukemic activity was observed at a wide range of onvansertib doses (27 to 90 mg/m2), indicating a large therapeutic window
•Of the 21 patients evaluable for efficacy in the completed Phase 1b dose escalation study, 7 (33%) achieved an objective response; 5 (31%) of 16 patients who achieved a complete response (CR/CRi) were treated at the four highest onvansertib dose levels (27 – 90 mg/m2)
•3 patients remain on treatment; time since clinical response is 6, 12 and 15 months, respectively
Ongoing Phase 2:
•Of the 7 patients completing 1 cycle of treatment as of the data cutoff, 28% achieved an objective response:
◦1 patient achieved a CRi at cycle 1 and a CR at cycle 2; time since response is 3 months and the patient continues on treatment
◦1 patient achieved a partial response at cycle 1 and remains on treatment
Biomarker Analysis:
•Decreases in mutant ctDNA after 1 cycle of treatment were highly predictive of clinical response
•Target engagement in circulating blasts was associated with greater decrease in bone marrow blasts

About the Phase 2 Clinical Trial of Onvansertib in AML
The Phase 2 AML trial (NCT03303339) of onvansertib in combination with decitabine will enroll 32 patients who are either treatment naïve and not candidates for induction therapy or who have relapsed disease after treatment with one prior regimen. Patients will receive onvansertib, administered orally, on days 1 through 5 of each 21-28-day cycle in combination with decitabine. The primary efficacy endpoint of objective response (CR + CRi) will be assessed in patients who complete at least 1 cycle of treatment.
About Onvansertib
Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported.
Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Cardiff Oncology
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believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), KRAS-mutated colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer.
Cardiff Oncology has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga (NCT03414034); a Phase 1b/2 Study of onvansertib in combination with FOLFIRI and Avastin for second-line treatment in patients with mCRC with a KRAS mutation (NCT03829410); and a Phase 2 clinical trial of onvansertib in combination with decitabine in patients with relapsed or refractory AML (NCT03303339).
Cardiff Oncology licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array/Pfizer, Ignyta/Roche and Genentech.

On June 15, 2020 Genoscience Pharma, a clinical-stage biotechnology company dedicated to discovering and developing anticancer treatment drugs, reported that its poster demonstrating promising results from a combination study with a PD-1 inhibitor in a transgenic mouse model of hepatocarcinoma (HCC) was selected for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held June 22-24, 2020 in a virtual format only due to COVID-19 worldwide crisis (Press release, GenoScience, JUN 15, 2020, View Source [SID1234561097]).

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This in vivo study was performed the ASV-B transgenic immunocompetent mouse model of HCC. Animals were treated by the vehicle, GNS561 or PD-1 inhibitor as monotherapy or GNS561 in combination with PD-1 inhibitor. Results showed an outstanding anticancer response, with a 59% and 77% decrease of the macronodules count using GNS561 alone and in the combination group compared to controls respectively.

"We are delighted to be presenting this positive in vivo study at the AACR (Free AACR Whitepaper) Meeting 2020. These results may open a new horizon in the area of immuno-oncology by enlarging indication of the use of immune checkpoint inhibitors in tumor types that are marginally sensitive to immunotherapy or for patients developing resistance to checkpoint inhibitors. We believe our results provide a strong rationale for combining our drug to a PD-1 inhibitor antibody in clinical trials with HCC patients." said Pr Eric Raymond, Chief Medical Officer at Genoscience Pharma.

"We are looking forward to assess this combination in HCC patients, for which immunotherapy hasn’t answered the current medical need.", commented Pr Philippe Halfon, President and Founder of Genoscience Pharma.

The details for the Company’s poster presentation are as follows:

Presenting Author: Dr Madani RACHID, PharmD, MSc.

Poster title: GNS561, A NEW ORAL CLINICAL-STAGE SMALL MOLECULE COMBINED WITH ANTI-PD1 SHOWED REMARKABLE ANTI-TUMOR EFFECTS IN A TRANSGENIC IMMUNOCOMPETENT HEPATOCELLULAR CARCINOMA MOUSE MODEL (ASV-B), Poster 899.

Presentation date and time: June 22, 2020 (from 9 am to 6 pm)

On June 15, 2020 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing precision immuno-oncology therapies, reported the appointment of Marie-Louise Fjällskog, M.D., Ph.D., as Chief Medical Officer, responsible for leading clinical and development strategy and operations (Press release, Sensei Biotherapeutics, JUN 15, 2020, View Source [SID1234561096]). Dr. Fjällskog joins Sensei from Merus, where she served as Vice President Clinical Development and led the development of several clinical and preclinical bispecific antibody therapeutics.

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"We are thrilled to welcome Marie-Louise to our team. Her deep knowledge of oncology research and medicine from both an industry and academic perspective are a strong addition to Sensei as we prepare for key Phase 2 readouts and additional INDs in the coming months," said John Celebi, CEO of Sensei Biotherapeutics. "I’m excited to welcome her to Sensei as she shares our commitment to patients, our values, and culture. Her experience developing early stage programs into commercial products will be instrumental as our pipeline continues to mature and we evolve into a late-stage oncology development company over the next several years."

"Sensei’s unique approach represents an exciting new wave of oncology research and development that I am extremely excited to be a part of," said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Sensei Biotherapeutics. "I look forward to continuing the development of SNS-301 and working to expand the company’s pipeline. Immunophage therapies are a new approach for cancer and infectious diseases that have the potential to drive precise antigen specific immunity and stimulate key immunomodulatory signals."

Before assuming her most recent role at Merus, Dr. Fjällskog served as Vice President of Clinical Development at Infinity Pharmaceuticals, where she played an integral role in the expanded clinical development of IPI-549. Earlier, she worked at the Novartis Institute for Biomedical Research, where she served as a Clinical Program Leader, Translational Clinical Oncology and as the global lead for several oncology programs, including those targeting CDK4/6, BCL-2, CSF-1,PD-1 and CD73. Dr. Fjällskog is an Associate Professor of Oncology at Uppsala University, Sweden and has over twenty-five years of experience in clinical oncology, translational research, and drug development. She holds an M.D. and Ph.D. from Uppsala University School of Medicine

On June 15, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that Vernalis Research, a Ligand company, has expanded its oncology research collaboration with Servier, an international pharmaceutical company based in France, to jointly identify and enable new therapeutic targets (Press release, Ligand, JUN 15, 2020, View Source [SID1234561094]).

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The new three-year research collaboration combines Vernalis’ strengths in structure and biophysics-based methods as part of the Vernalis Design Platform (VDP) with the oncology expertise at Servier to enable drug discovery related to several undisclosed proteins identified as potential therapeutic targets. The agreement builds on the successful collaboration between the two companies that has led to the discovery of a number of compounds currently in clinical trials.

Vernalis will receive research and success fees, along with potential for milestone payments, and royalties on sales of any target advanced by Servier. Financial terms of the agreement were not disclosed.

"This new collaboration further validates our fragment and structure-based drug discovery platform, as well as the strength and success of our relationship with Servier. We look forward to working together to develop exciting new cancer treatment opportunities that may add to the successes we’ve had in targeting Bcl-2 and Mcl-1," commented Mike Wood, Managing Director of Vernalis.

"We are extremely pleased with the progress we have made in partnership with Vernalis. This new research collaboration provides the framework to establish drug discovery against a number of therapeutic targets and further contribute to addressing important unmet needs of cancer patients," added Olivier Geneste, Director of Oncology Research at Servier.

About Vernalis Research

Based in Cambridge, UK, Vernalis Research is a world leader in fragment and structure-guided drug discovery. The Vernalis Design Platform (VDP) integrates protein structure determination and engineering, fragment screening and molecular modeling with medicinal chemistry to enable success in novel drug discovery programs against highly-challenging targets. A key element to the success of VDP is establishing a robust drug discovery platform for each target to validate hit identification using multiple proprietary assay and biophysical systems. Vernalis Research has collaborations across multiple therapeutic areas including oncology, CNS, anti-infectives and inflammation, with global partners and a heritage of successful internal drug discovery in oncology and anti-infectives.

On June 15, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported that it will present novel genomic data from patients with adrenocortical carcinoma at the 2020 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Corcept Therapeutics, JUN 15, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-present-data-american-association-cancer [SID1234561093]). This year’s annual meeting will be held in a virtual format starting June 22. Following its presentation, a copy of our poster will be available at the Research & Pipeline / Publications tab of our website.

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"Excessive cortisol in patients with adrenal cancer causes Cushing’s syndrome and may also blunt the efficacy of immunotherapeutic agents such as checkpoint inhibitors," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "The data we are presenting informed our Phase 1b trial of our proprietary, selective cortisol modulator relacorilant in combination with the PD-1 checkpoint inhibitor pembrolizumab (Merck’s drug, Keytruda) in patients with metastatic or unresectable adrenocortical cancer.1 Our trial will examine whether relacorilant can, in addition to treating Cushing’s syndrome in these patients, also help immunotherapy achieve its maximum effect, by reducing the immunosuppressive effects of excess cortisol activity."

Suppression of Tumor Immune Activity in Adrenocortical Carcinoma with Excess Glucocorticoid

Session Title: Late-Breaking Research: Clinical Research 1 / Endocrinology
Session Type: Poster session
Poster No: LB-130
Location: Virtual meeting
Presentation Available Online: Beginning June 22 (meeting registration required)
About Relacorilant

Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor, the receptor for cortisol which is activated when cortisol levels are high. Relacorilant does not bind to the body’s other hormone receptors, including the progesterone receptor. Corcept is studying relacorilant as a potential treatment for a variety of serious disorders, including Cushing’s syndrome and advanced adrenal, ovarian and pancreatic cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. Relacorilant has received orphan drug designation in the United States for the treatment of Cushing’s syndrome and pancreatic cancer.