On May 24, 2022 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate immune response to cancers and infections, reported that its innate/adaptive immune activator, botensilimab, will be the subject of a late-breaking oral presentation at the upcoming ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer in Barcelona, Spain (Press release, Agenus, MAY 24, 2022, View Source [SID1234614993]). In addition, Agenus also announced broad efficiencies expected to reduce costs by 20% and drive botensilimab’s accelerated development.

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"MSS colorectal cancer is one of the tumor types where single agent checkpoint inhibitors targeting PD-1/PD-L1 have not shown significant activity; in contrast, we are seeing deep and durable responses using botensilimab and balstilimab in these heavily pretreated MSS colorectal patients," said Anthony El-Khoueiry, MD, Phase I Program Director at the USC Norris Comprehensive Cancer Center, Keck Medicine of USC. "The activity noted with this combination warrants advancing the program with further trials".i

"The clinical activity of the combination of botensilimab and balstilimab in heavily pretreated metastatic MSS colorectal cancer is remarkable," said Dr. Steven O’Day, CMO of Agenus. "Prior PD1 and PDL1 antibodies, with or without CTLA-4, have failed in this same setting. These data in MSS CRC are further supported by emerging clinical data in a wide range of poorly responsive solid tumors. We look forward to advancing botensilimab alone and in combination in the second half of 2022."

Botensilimab is an immunotherapy with the potential to transform the treatment landscape. A growing body of evidence supports botensilimab’s broad activity in indications inadequately addressed by currently approved treatments, and Agenus is focusing additional resources to accelerate its development. In this regard, Agenus will:

Prioritize its clinical development programs.
Automate and implement Vision and AI capabilities, as part of effort to streamline discovery and development.
These measures will reduce Agenus’ operating expenses and allow the company to prioritize its high potential programs, while continuing to pursue creative financing mechanisms and/or potential partnerships.

Agenus will also continue to advance clinical collaborations designed to increase the potential value of botensilimab and other clinical programs in new indications and combinations. These studies are sponsored and executed by our partners, with drug supply and scientific support provided by Agenus. Internally, the company will continue to focus on botensilimab combinations which inform its use as a foundational therapy; these combinations include Agenus’ balstilimab (anti-PD-1), AGEN2373 (anti-CD137), and AGEN1571 (anti-ILT2) antibodies, as well as chemotherapy.

"As we enter a period of unprecedented regulatory and financial challenges for the biotech industry, Agenus is poised to differentiate our capabilities and comprehensive portfolio. The enthusiasm GI experts have shown, as evidenced by a prominent presentation at ESMO (Free ESMO Whitepaper) GI, is very heartening, as is the accelerated patient enrollment in our clinical trials. We believe the value of botensilimab to be unmatched relative to existing therapies and known development candidates, and we are moving with speed to bring this potentially revolutionary treatment to patients in need," CEO of Agenus, Dr. Garo Armen.

Agenus’ plans include initiation of three phase 2 studies in 2022 (MSS colorectal cancer, melanoma and pancreatic cancer).

About Botensilimab
Botensilimab (also known as AGEN1181) is a next-generation, Fc-enhanced, immunoglobulin G1 (IgG1) antibody which has shown significant activity in activating both the innate and adaptive immune response. It is also designed to block CTLA-4 (cytotoxic T-lymphocyte associated antigen 4) inhibitory function from interacting with its ligands CD80 and CD86. The Fc region of the antibody was engineered to enhance immune activation and tumor killing, improve safety, and benefit a broader patient population versus first-generation anti CTLA-4 antibodies which act as a negative regulator of immune activation that is considered a foundational mechanism.

On May 24, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported acceptance of its abstract titled, "TAM Targeted Imaging Agents Binding CD206 and Selective Blocking of Off Target Liver Localization" for presentation at this year’s Society of Nuclear Medicine and Molecular Imaging ("SNMMI") Annual Meeting (Press release, Navidea Biopharmaceuticals, MAY 24, 2022, View Source [SID1234614992]). This work was performed as part of an ongoing research collaboration with the University of Alabama at Birmingham ("UAB"), in the laboratory of Dr. Suzanne Lapi, Professor and Vice Chair of Research in the UAB Department of Radiology. The poster will be presented by Dr. Jennifer Bartels of UAB.

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This year’s annual SNMMI meeting will be held June 11-14 in Vancouver, British Columbia, Canada. The presentation will take place Saturday, June 11, from 6 pm – 8 pm PDT (abstract ID 197; program ID 2862). The abstract will be accessible on the SNMMI’s Annual Meeting website prior to the meeting (View Source).

The objectives of this preclinical study were to evaluate tumor localization of two new CD206 targeted mannosylated dextran (Navidea’s Manocept platform) imaging agents as well as an approach to reduce uptake of these imaging agents by the liver. The new imaging agents were labeled with gallium-68 ("68Ga") to enable positron emission tomography ("PET") imaging. The ultimate goals are to develop next generation Manocept imaging agents that offer improved on-target localization and reduced off-target localization. CD206 is a receptor expressed primarily on activated macrophages, including tumor associated macrophages ("TAMs"), as well as the Kupffer cells of the liver. TAM-targeted Manocept imaging enables imaging of tumors. The information gained from these experiments also suggests strategies to improve targeted delivery of therapeutic payloads to TAMs and other clinically significant targets, while simultaneously reducing off-target liver toxicity.

The experiments described in the poster evaluated the biodistribution in mice with and without tumors of the new 68Ga-labeled Manocept imaging agents that differed in their molecular weights. Also evaluated were the effects on their biodistributions of prior administration of unlabeled constructs or a construct designed to specifically block off-target liver localization. Results showed that the amount of the two imaging agents that localized to tumors differed significantly. Also, pretreatment with the construct designed to selectively block liver localization did significantly reduced liver localization of the 68Ga-labeled imaging agents without reducing their localizations to tumors.

Dr. Suzanne Lapi said, "My research group and I are pleased to present this collaborative work with Navidea at SNMMI and to continue to further advance this project with possible far reaching medical imaging and commercial potentials."

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted by the opportunity to present these results at this internationally recognized meeting." Dr. Rosol continued, "This is another example in a line of research collaborations we have had with the highest level of researchers at top tier institutions that is resulting in work advancing our platform technology. These new technologies suggest exciting new applications in medical imaging and possibly also new therapeutic strategies."

On May 24, 2022 Incyte (Nasdaq:INCY) reported that it will present at the 43rd Annual Goldman Sachs Global Healthcare Conference on Tuesday, June 14, 2022 at 8:00 a.m. (PDT) /11 a.m. (EDT) in Rancho Palos Verdes (Press release, Incyte, MAY 24, 2022, View Source [SID1234614991]).

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The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.

On May 24, 2022 Knight Therapeutics Inc. (TSX: GUD), a pan-American (ex-USA) specialty pharmaceutical company, reported that it has entered into exclusive license and supply agreements with Rigel Pharmaceuticals granting Knight the rights to commercialize fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in Latin America (Press release, Knight Therapeutics, MAY 24, 2022, View Source [SID1234614990]).

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Fostamatinib is commercially available in the United States under the brand name TAVALISSE (fostamatinib disodium hexahydrate) and in Europe under the brand name TAVLESSE for the treatment of chronic immune thrombocytopenia (ITP). Fostamatinib is also currently being studied in a Phase 3 clinical trial for the treatment of warm autoimmune hemolytic anemia (wAIHA)1 and in two Phase 3 clinical trials for the treatment of hospitalized patients with COVID-19.2,3

Under the terms of the agreement, Rigel will receive an upfront cash payment, with the potential for additional regulatory and commercial milestones, and stepped-up royalties based on tiered net sales. In return, Knight receives exclusive rights to fostamatinib in all potential indications, including chronic ITP, wAIHA, and COVID-19 in Latin America.

"This partnership represents the continued execution of our strategy of leveraging our solid platform and expertise to bring innovative medicines to our markets," said Samira Sakhia, President and CEO of Knight. "We are excited to be working with Rigel to provide access to an innovative, first-in-class treatment option to patients across Latin America with chronic ITP."

"We consider Knight to be the partner of choice in Latin America and look forward to a productive collaboration that further expands TAVALISSE’s global reach to patients in need," said Raul Rodriguez, President and CEO of Rigel. "TAVALISSE is already available in several countries around the world for the treatment of chronic ITP, and we look forward to pivotal readouts from our Phase 3 clinical trials with fostamatinib in wAIHA and COVID-19."

About ITP

In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AIHA

Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that lead to the destruction of the body’s own red blood cells. Warm antibody AIHA (wAIHA), which is the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature. To date, there are no disease-targeted therapies approved for wAIHA, despite the unmet medical need that exists for these patients.

About COVID-19 & SYK Inhibition

COVID-19 is the infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock resulting in endothelial dysfunction and subsequently micro and macrovascular thrombosis.4 Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune response associated with increased risk of thrombosis.5

SYK is involved in the intracellular signaling pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key Fc gamma receptor (FcγR) and c-type lectin receptor (CLR) mediated drivers of pathology such as pro-inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.6,7,8,9 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thrombo-inflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

On May 24, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will release first quarter 2022 results and corporate update on Wednesday, June 1, 2022 (Press release, Affimed, MAY 24, 2022, View Source [SID1234614989]). The Company will host a conference call at 8:30 a.m. Eastern Daylight Time. The conference call will be available via phone and webcast. To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference conference ID 4440407 approximately 15 minutes prior to the call. To access the live audio webcast of the conference call please visit the "Investors" section of the Company’s website at View Source A replay of the call will be archived on Affimed’s website for 30 days after the call.

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