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Cardiff Oncology to Host Key Opinion Leader Call Discussing KRAS-Mutated Colorectal Cancer and Highlighting Data from Onvansertib Phase 1b/2 Trial

On September 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, reported that it will host a key opinion leader (KOL) call focused on KRAS-mutated colorectal cancer and highlighting data from its onvansertib Phase 1b/2 clinical trial, on Wednesday, Sept. 23, 2020 from 11 a.m. – 12:30 p.m. EDT (Press release, Cardiff Oncology, SEP 15, 2020, View Source [SID1234565201]).

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On the call, Dr. Mark Erlander, Cardiff Oncology’s chief executive officer, and Key Opinion Leaders Afsaneh Barzi, M.D., Ph.D. (City of Hope Comprehensive Cancer Center) and Heinz-Josef Lenz, M.D., FACP (USC Norris Comprehensive Cancer Center) will participate in a discussion featuring the latest data from Cardiff’s Phase 1b/2 clinical trial evaluating onvansertib in combination with FOLFIRI and bevacizumab for the second line treatment of patients with KRAS-mutated metastatic colorectal cancer. Dr. Barzi will begin the discussion by providing an overview of the history of KRAS in clinical practice, the challenges of drug development and targeting of KRAS, and the value of KRAS as a biomarker for patient selection and predicting response to treatment. Dr. Lenz will follow with a presentation of the onvansertib clinical trial data featured at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Conference 2020. A question and answer session will follow the formal presentations.

You may register for the call by clicking here.

About the KOLs

Afsaneh Barzi, M.D., Ph.D. is a practicing medical oncologist, associate clinical professor for gastrointestinal oncology, and clinical director of AccessHope at City of Hope Comprehensive Cancer Center. Prior to joining City of Hope, Dr. Barzi was an associate professor of clinical medicine at the Keck School of Medicine of the University of Southern California. She earned her M.D. from Tehran University of Medical Sciences, then went on to earn a Master’s in Health Informatics and a Doctorate in Public Health Management and Policy Sciences from the University of Texas Health Science Center in Houston. Dr. Barzi completed a fellowship in hematology and oncology at the Cleveland Clinic’s Taussig Cancer Center. Her research and practice are focused on gastrointestinal malignancies with an emphasis on colorectal cancers. Her unique perspective on patterns of care in patients with colorectal cancer arises from the combination of her expertise in real-world data and her experience with biomarker discovery and the use of biomarkers for personalized care.

Heinz-Josef Lenz, M.D., FACP is the associate director for clinical research and co-leader of the gastrointestinal (GI) cancers program at the University of Southern California Norris Comprehensive Cancer Center. Dr. Lenz is professor of medicine and preventive medicine, section head of gastrointestinal oncology in the division of medical oncology and co-director of the Colorectal Center at the Keck School of Medicine of the University of Southern California. Dr. Lenz received his medical degree from Johannes-Gutenberg Universität in Mainz, Germany, in 1985. He completed a residency in hematology and oncology at the University Hospital Tübingen in Germany, a clerkship in oncology at George Washington University in Washington, DC, and a clerkship in hematology at Beth Israel Hospital of Harvard Medical School in Boston, Massachusetts. He served subsequent fellowships in biochemistry and molecular biology at the University of Southern California Norris Comprehensive Cancer Center. An active researcher, Dr. Lenz focuses on topics including the regulation of gene expression involved in drug resistance, patients at high risk of developing colorectal cancer, and determination of carcinogenesis, methods of early detection, and better surveillance of these cancers. He is a member of several professional societies, including the American Association for Cancer Research (AACR) (Free AACR Whitepaper), the American Gastroenterology Association, and the National Society of Genetic Counselors. He also serves on the National Advisory Board of a number of professional organizations. Dr. Lenz is the author of numerous peer-reviewed publications and invited papers, reviews, and editorials. He also serves as co-chair of the GI Committee and Correlative Science Committee for SWOG. He is a member of the National Cancer Institute (NCI) Task Force for Gastroesophageal Cancer, the NCI Steering Committee, and the NCI Translational Science Committee.

BioMarin to Participate in Four Upcoming Virtual Investor Conferences

On September 15, 2020 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that management will participate in four upcoming virtual conferences (Press release, BioMarin, SEP 15, 2020, View Source [SID1234565200]). An audio webcast of the presentations will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

Transcenta Successfully Scaled up the Continuous Perfusion Process and Completed GMP Manufacturing of a Novel Bispecific Antibody for Cancer Immunotherapy

On September 15, 2020 Transcenta, a global biotherapeutics company, reported success in scaling up the continuous perfusion process to 200L and completion of GMP production of a bispecific antibody for a Phase 1 clinical study (Press release, Transcenta, SEP 15, 2020, View Source [SID1234565195]).

"This is an important milestone for Transcenta as we continue to develop and implement a highly productive perfusion platform using in-house developed chemically defined media to our pipeline programs," said Dr. Chris Hwang, CTO of Transcenta. "Given the high volumetric productivity of our perfusion processes, typical pre-pivotal clinical demand can be met with < 200L scale single-use bioreactor (SUB) while commercial supply can be met with 500L scale SUB."

This is another breakthrough for Transcenta’s perfusion platform after achieving productivity to greater than 4 g/L per day for multiple cell lines earlier this year. Transcenta will work on developing innovative technology like Integrated Continuous Bioprocessing and improving development and manufacturing capability to help accelerate new biologics’ clinical progress, moving forward to our mission of employing cutting edge technology to deliver speed and affordable high-quality innovative biologics to patients around the world.

Ryvu Therapeutics Reports 2020 Half-Year Financial Results

On September 15, 2020 Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, reported today its 2020 H1 financial results and provided a corporate update (Press release, Ryvu Therapeutics, SEP 15, 2020, View Source [SID1234565194]).

"At Ryvu, we always excelled in moving forward at a rapid pace; however, the first half of 2020 was an exceptionally eventful and intensive period for us. We have managed to achieve a couple of significant clinical milestones such as successful completion of Phase I for SEL24/MEN1703 in acute myeloid leukemia, as well as the receipt of an Orphan Drug Designation for SEL120 for the treatment of AML patients.

"We announced a collaboration with Galapagos focused on the discovery and development of novel small molecule drugs in inflammation. In June, we completed the construction of the R&D Center for Innovative Drugs and subsequently moved into our new laboratories and offices. Soon afterward, we have announced our updated development strategy for 2020-2022, which was followed by the issue of series I shares and raise of over USD 36 million of new capital" – commented Pawel Przewiezlikowski, Chief Executive Officer of Ryvu.

"We have also secured additional non-dilutive grant financing to support the development of our targeted immuno-oncology program. Despite the global pandemic, we participated in numerous scientific and business conferences presenting very good data from our early pipeline projects. What is exceptional is that we managed to do all of this and much more during the ongoing COVID-19 pandemic, including the continuation of SEL120 Phase I study in AML/MDS in the U.S.

"The epidemiological situation required us to adopt numerous preventive measures across our entire organization to keep our scientists safe and, at the same time, assure business continuity. I believe we passed that test with flying colors, and I am proud of the work we have done at Ryvu in these six months" – adds Przewiezlikowski.

Recent Achievements

On February 21, Ryvu signed a grant agreement for the development of targeted oncology therapies based on the synthetic lethality concept. This grant provides Ryvu with almost USD 8.3 million of non-dilutive financing to discover, develop, and select a clinical candidate targeting cancers which had been considered in the past as largely undruggable using rational approaches. The total net value of the project amounts to USD 14 million, and the anticipated project duration is until December 2023.
On March 5, Menarini Group announced the successful completion of Phase I clinical study of SEL24/MEN1703 in Acute Myeloid Leukemia, which entitled Ryvu to receive a USD 1.96 million milestone payment. The full data from the study was be presented as a poster "Results of the dose escalation part of DIAMOND trial (CLI24-001): First-in-human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia" during the Virtual 25th EHA (Free EHA Whitepaper) Congress taking place June 11-21. Throughout the dose escalation part, SEL24/MEN1703 showed an acceptable safety profile up to the recommended dose established at 125 mg/day (14 days ON – 7 days OFF in 21-days cycles). Initial evidence of single agent efficacy was observed with 1 CR and 1 CRi in elderly patients who had exhausted standard therapeutic options. A cohort Expansion study planned in relapsed/refractory AML patients in the United States and Europe, including Poland, will further investigate the single agent activity and the safety profile of SEL24/MEN1703.
On March 27, the U.S. Food and Drug Administration (FDA) granted an orphan drug designation (ODD) to Ryvu’s SEL120 for the treatment of patients with acute myeloid leukemia (AML).
On April 15, Galapagos NV (Euronext &NASDAQ: GLPG) and Ryvu Therapeutics announced a collaboration focused on the discovery and development of novel small molecule drugs in inflammation. Ryvu will contribute its biology and chemistry platform as well as related intellectual property to the program. During the joint research collaboration, Ryvu is responsible for early drug discovery, and Galapagos will be responsible for all further development of the program.
On June 2, Ryvu obtained the occupancy permits for its newly built R&D Center for Innovative Drugs, meaning it has completed the construction of the facility. Subsequently, Ryvu has initiated its move to the new headquarters.
On June 3, NodThera, Ryvu spin-off company, secured GBP 44.5 million (USD 54.5 million) Series B financing. NodThera was founded by Epidarex Capital and Ryvu in 2016 based on world class research on NLRP3 inflammasome conducted at Ryvu (at that time Selvita) in 2012-2016. The Company focused on the development of inflammasome inhibitors has already raised over GBP 80.8 million (over USD 100 million) in three funding series. After the full completion of Series B capital increase, Ryvu owns 4.8% in NodThera.
On June 4, Ryvu signed a grant agreement for the development of targeted immuno-oncology therapy, which provides Ryvu with almost USD 5.6 million of non-dilutive financing to discover, develop and select a clinical candidate targeting cancers which had been considered in the past as largely undruggable using rational approaches. The total net value of the project amounts to over USD 8.9 million, and the anticipated project duration is until December 2023.
On June 15, Ryvu announced its updated development strategy for 2020-2022, which assumes, i.a.: completing Phase I clinical development of SEL120 in AML/MDS by the end of 2022, expanding therapeutic potential for SEL120 in solid tumors and launching a new Phase I study in selected indications in parallel to the ongoing hemato-oncology studies, advancing at least one program into the Phase I of clinical trials from preclinical pipeline.
Important milestones in 2020, before the report date

On July 22, the Extraordinary General Meeting of Ryvu Therapeutics’ Shareholders has decided to issue up to 2,384,245 Series I ordinary bearer shares, with the exclusion of pre-emptive rights. The share issue constituted up to 15 percent of the current Company’s share capital. As a result, Ryvu Therapeutics raised over USD 36 million. Proceeds from the share issue will be allocated primarily to the Company’s R&D programs.
In H1 2020, Ryvu Therapeutics participated and presented at several scientific and investor conferences, including AACR (Free AACR Whitepaper) 2020 Virtual Annual Meeting, Virtual 25th Annual European Hematology Association (EHA) (Free EHA Whitepaper) Congress, Jefferies 2020 Virtual Healthcare Conference, BIO Digital 2020, Solebury Trout Investor Access during JP Morgan 2020, Solebury Trout Virtual Investor Conference, BIO-Europe Spring 2020 and 32nd Annual ROTH Conference.

Ryvu 2020 Half-Year Financial Results

In the first half of 2020, Ryvu Therapeutics noted a 38%* increase in its revenues, up to PLN 24.5 million (USD 6.1 million). Revenues from partnering contracts have increased from PLN 1.9 million (USD 0.5 million ) in H1 2019, up to PLN 14.7 million (USD 3.7 million ) in H1 2020.

Operational costs related in majority to the research and development expenditures amounted in H1 2020 to PLN 36.3 million (USD 9.1 million), as compared to PLN 38.7 million (USD 10.2 million) in the same period last year. Operational loss has decreased and amounted to PLN 11.8 million (USD 3.0 million), compared to PLN 21 million (USD 5.5 million) in H1 2019.

On June 30, 2020, Ryvu Therapeutics held PLN 38.5 million (USD 9.7 million) in cash, cash equivalents, and short-term investments. On September 10, the balance, following the share issue, amounted to PLN 176.9 million (USD 44.4 million).

*Percentage changes in the press release are calculated based on the functional currency [PLN].

Cullinan Oncology, German Cancer Research Center (DKFZ) and the University of Tübingen Announce the Formation of Cullinan Florentine to Develop CLN-049, a Novel Bispecific Antibody for AML

On September 15, 2020 Cullinan Oncology, LLC, the German Cancer Research Center and the Eberhard Karls University of Tübingen, Faculty of Medicine (University of Tübingen), Germany, reported the formation of Cullinan Florentine, a company focused on developing a novel FLT3 x CD3 bispecific antibody for the treatment of patients with acute myeloid leukemia (AML) (Press release, Cullinan Oncology, SEP 15, 2020, View Source [SID1234565193]). This antibody has been developed in Tübingen within the German Cancer Consortium (DKTK), whose core center is the German Cancer Research Center (DKFZ) in Heidelberg. Cullinan Florentine has acquired an exclusive license to develop CLN-049 from the University of Tübingen and the DKFZ.

"We believe the receptor tyrosine kinase FLT3 is among the most attractive targets in AML but is largely untapped as a target for T cell engaging antibodies," stated Jennifer Michaelson, Ph.D., Chief Development Officer, Biologics at Cullinan Oncology. "Given CLN-049’s robust preclinical package and ease of manufacturability, we believe this bispecific antibody has the potential to be a superior treatment option for AML patients. We are looking forward to filing an IND for CLN-049 by year end."

AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood cells in the bloodstream and bone marrow. AML remains one of the most challenging blood cancers, with high unmet medical need due to low median survival rates in patients. FLT3 is expressed on leukemic cells from the majority of AML patients, including prominent expression on leukemic progenitor cells.

FLT3 is a commercially validated target in AML, yet unlike small molecule inhibitors targeting FLT3, a T cell engaging antibody like CLN-049, which binds to the extracellular domain of FLT3, is agnostic to mutations in the intracellular signaling domain, opening up a broader patient population and avoiding resistance mechanisms. FLT3 has potential advantages over the more commonly selected target antigens for T cell engagers, such as CD33 and CD123, given the low-level expression of FLT3 on normal myeloid cells and hematopoietic stem cells. CLN-049 is therefore predicted to have an improved safety profile.

"We’ve long held the belief that FLT3 is among the most attractive targets in AML," stated Helmut Salih, DKFZ/DKTK Professor and physician at Tübingen University Hospital, and Gundram Jung, Professor at Tübingen University, the originators of the molecule. "And we look forward to advancing CLN-049 into clinical testing with the help of the Cullinan team given their deep domain expertise in the bispecific field."