On May 25, 2022 Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and Antibody Drug Conjugate (ADC)-based therapies, reported that it has entered into a collaboration and supply agreement with Agenus Inc., an immuno-oncology company with an extensive pipeline of therapeutics designed to activate immune response to cancers and infections, to support a clinical trial evaluating the combination of OBT076 with the anti-PD1 checkpoint inhibitor (CPI) balstilimab (Press release, Oxford BioTherapeutics, MAY 25, 2022, View Source [SID1234615056]).

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OBT has observed near complete responses in two chemotherapy-refractory advanced cancer patients with low to no PD-L1 expression after 2-5 cycles of OBT076 and 1-2 cycles of a CPI, indicating preliminary signs of clinical activity. Immuno-blood profiling during translational work on these patients revealed a potential novel immuno-oncology mechanism for immune system reactivation and tumor shrinkage.

OBT plans to evaluate the clinical efficacy of OBT076 in combination with Agenus´ proprietary CPI, balstilimab. Balstilimab is an PD-1 blocking antibody currently in clinical development in several solid tumor indications.

"I am very excited about our new partnership with Agenus, which will allow us to progress the clinical development of OBT076 in combination with balstilimab," said Christian Rohlff, PhD, Chief Executive Officer (CEO) of Oxford BioTherapeutics. "Our preliminary data suggest that depletion of CD205+ immuno-suppressive cells and subsequent T-cell activation after OBT076 treatment followed by a single cycle of a CPI coincides with the rapid resolution of the primary tumor, as well as metastases, and we believe that balstilimab is the ideal combination agent for these studies."

Under the terms of the agreement, OBT will be the sponsor of the combination trial and responsible for operational execution, and Agenus will provide drug supply and scientific support.

"We look forward to collaborating with Oxford BioTherapeutics to bring this novel combination to patients," said Steven O’Day, MD, Chief Medical Officer of Agenus. "The clinical data generated with OBT076 in advanced solid tumors is promising, and we believe will broaden the therapeutic benefit of balstilimab observed across treatment-resistant tumors."

The study will be conducted in the US as well as in several European countries including France, Germany, Belgium and Greece, and will focus on patients with solid tumors including lung, gastric and ovarian cancer.

"Our initial Phase 1 findings suggest that OBT076 may activate the immune response against the tumor through a potentially novel mechanism in some patients; based on these encouraging results, we are advancing OBT076 into the next stage of clinical development in combination with a CPI," said Rahim Fandi, MD, PhD, Chief Medical Officer (CMO) of Oxford BioTherapeutics. "With their deep experience in the field of immune-oncology, Agenus is the ideal partner for us in this next stage of OBT076’s development."

About OBT076

OBT’s lead clinical program, OBT076, an ADC utilizing an ImmunoGen toxin, initiated expansion in a U.S. Clinical Trial in 2021 in patients with advanced or refractory solid tumors, including gastric, bladder, ovarian and lung cancer, where CD205 is overexpressed. Infiltration of tumors by immunosuppressive cells correlates with adverse outcomes (lower progression free and overall survival), suggesting that this process contributes to the progression of several cancers. OBT076 is advancing into Phase 1b trials assessing the efficacy of OBT076 as a monotherapy as well as in combination with a CPI in both checkpoint-naïve and resistant patients with solid tumors. Subsequent disease-specific Phase 2a trials are planned in non-small cell lung, ovarian and gastric cancer patients. OBT is also planning for later-stage trials of OBT076, including in combination with a CPI.

On May 25, 2022 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, reported that Dr. Garo Armen, Chairman and CEO of Agenus and Dr. Steven O’Day, Chief Medical Officer, will participate in a fireside chat at the Jefferies Healthcare Conference on Thursday, June 9, 2022, at 11:30 AM EST (Press release, Agenus, MAY 25, 2022, View Source [SID1234615041]). The Conference will be held at the New York Marriott Marquis from June 8th – 10th, during which Agenus will host one-on-one meetings with investors.

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A webcast/replay will be available for 90 days after completion of the fireside chat and may be accessed via View Source or on the Events & Presentations page of the Agenus website at View Source

On May 25, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the following presentations by Company management at upcoming investor conferences will be webcast (Press release, ImmunoGen, MAY 25, 2022, View Source [SID1234615058]):

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William Blair 42nd Annual Growth Stock Conference
June 8 at 11:20am CT / 12:20pm ET
Jefferies Healthcare Conference
June 9 at 9:30am ET
A webcast of each presentation will be accessible through the "Investors and Media" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay will be available at the same location.

On May 25, 2022 Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported that it will host a key opinion leader (KOL) webinar on HM43239 and luxeptinib and their roles in the treatment of acute myeloid leukemia (AML) on Thursday, June 2, 2022 at 4:30 pm Eastern Time (Press release, Aptose Biosciences, MAY 25, 2022, View Source [SID1234615026]).

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The call will feature KOLs Brian Druker, M.D., of the Oregon Health & Science University, Naval G. Daver, M.D., of The University of Texas MD Anderson Cancer Center, and Brian Andrew Jonas, M.D., Ph.D., of the University of California, Davis, who will discuss the current treatment landscape and unmet medical need in treating patients with acute myeloid leukemia AML, as well as their experiences with Aptose’s investigational therapies.

The Aptose leadership team also will provide a data update on their two potential treatments for patients with AML and B cell malignancies: HM43239, an oral genotype-agnostic small molecule inhibitor of a constellation of kinases operative in myeloid malignancies, and luxeptinib, an oral inhibitor of kinases operative in lymphoid and myeloid malignancies.

A question and answer session will follow the formal presentations. To register for the event, please click here.

Brian Druker, M.D., has devoted his career to improving the lives of cancer patients. For his contributions to medical research, Dr. Druker was nominated for the Lasker-DeBakey Clinical Medical Research Award in 2009. Dr. Druker is most well-known for his role in developing Gleevec for patients with chronic myeloid leukemia (CML). Dr. Druker’s other career milestones include being named a Howard Hughes Medical Investigator in 2002, becoming a member of the National Academy of Sciences in 2007, winning the Japan Award in 2011, and being elected to the American Academy of Arts and Sciences in 2012. Dr. Druker received his Doctor of Medicine from the School of Medicine at the University of California, San Diego, completed his residency in internal medicine at Washington University in St. Louis, Missouri, and did an oncology fellowship at Dana-Farber Cancer Institute at Harvard Medical School.

From his earliest days, Dr. Druker was a dedicated researcher, winning the President’s Undergraduate Research Award at the University of California, San Diego. He is the recipient of a Lifetime Achievement Award from the Leukemia & Lymphoma Society, the Medal of Honor from the American Cancer Society and many other awards.

Naval G. Daver, M.D. is an Associate Professor in the Department of Leukemia at MD Anderson. He completed his medical school from Grant Medical College and Sir J group of Hospitals Mumbai, followed by a residency and fellowship in hematology-oncology from Baylor College of Medicine. He is a clinical investigator with a focus on molecular and immune therapies in AML and Myelofibrosis and is principal investigator on >25 ongoing institutional, national and international clinical trials in these diseases. These trials focus on developing a personalized therapy approach by targeting specific mutations or immune pathways expressed by patients with AML, evaluating novel combinations of targeted, immune and cytotoxic agents, and identifying and overcoming mechanism of resistance. He is especially interested in developing monoclonal and bispecific antibodies, immune checkpoint and vaccine based approaches in AML, MDS, and myelofibrosis and is leading a number of these trials at MD Anderson. Dr. Daver has published >150 peer-reviewed manuscripts and is on the editorial board of numerous hematology specific journals. He has also authored numerous abstracts at national and international conferences.

Brian A. Jonas, MD, PhD, FACP is an Associate Professor and clinician scientist in the Division of Hematology and Oncology at UC Davis Comprehensive Cancer Center (UCDCCC), where he specializes in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (ALL), and other hematologic malignancies. He received his medical degree and PhD in biochemistry and molecular biology from UC Davis School of Medicine and completed his internship, residency, and a fellowship in hematology and oncology at Stanford University School of Medicine. Dr. Jonas leads the UCDCCC clinical and translational research program in AML, MDS, and ALL, with an emphasis on early drug development. He is PI on several clinical trials, including multiple investigator-initiated trials and ETCTN trials. He chairs the UCDCCC Hematological Malignancies Working Group and is Chair of the UCDCCC Data and Safety Monitoring Committee. He serves on the National Comprehensive Cancer Network panels for AML, MDS and ALL.

On May 25, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and the Vall d’Hebron Institute of Oncology (VHIO), one of Europe’s leading cancer research organizations, reported that the first blood-based cancer testing services in Europe based on Guardant Health’s industry-leading digital sequencing platform are now available at the VHIO liquid biopsy testing facility in Barcelona (Press release, Guardant Health, MAY 25, 2022, View Source [SID1234615042]).

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Guardant Health and VHIO established the partnership in January 2021 to give more patients access to Guardant Health’s industry leading liquid biopsy technology. This testing service will provide essential genomic information through comprehensive genomic profiling (CGP) for patients with any solid cancerous tumor. From a simple blood draw, the test identifies patients with actionable biomarkers more quickly than starting with tissue biopsy. The VHIO testing services will be available for clinical research and clinical care.

"The opening of this service will give more patients with advanced cancer access to blood-based biomarker testing and help their healthcare professionals make more informed treatment decisions," said Helmy Eltoukhy, Guardant Health co-CEO. "We look forward to continuing to build our partnership with VHIO, working together to ensure cancer patients across Spain and beyond have access to the latest innovations in precision oncology and striving to achieve better patient outcomes."

"The incorporation of this technology in VHIO will enable us to continue advancing towards precision medicine, improving the use of liquid biopsy to detect genomic alterations in tumors and come out with more effective treatments for patients," said Dr Josep Tabernero, Director of VHIO and Head of the Medical Oncology Department of Vall d’Hebron University Hospital. "Our goal is to ensure that the use of liquid biopsy becomes a common diagnostic option, so that oncologists can use it to determine the best treatment for their patients. Thanks to this agreement, we can move towards this scenario."

"Implementing this technology in our lab is a leap forward in the liquid field for us. We have performed an in-house extensive analytical validation of the assay and we attain very high levels of sensitivity and specificity with the test," said Dr Ana Vivancos, Group Leader of the VHIO Cancer Genomics Group, where this testing will take place. "Guardant Health’s next generation broad panel sequencing technology gives us the capabilities to screen for a large number of gene mutations and provides complete genomic results without the need for a tissue sample."

In 2020, there were over 282,000 new cancer cases in Spain and approximately 113,000 cancer deaths, with lung cancer and colon cancer being the leading causes of cancer-related death.1 Guardant Health’s tests are used by oncologists around the world to guide treatment decisions across solid tumor cancers, and by pharmaceutical companies and academic researchers in clinical trials to accelerate precision medicine drug development.