On May 24, 2022 CASI Pharmaceuticals, Inc. (NASDAQ: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported the signing of a Sublicense Agreement with Beijing Tianshi Tongda Pharmaceuticals Technology Co., Ltd., ("TIANSHI") a clinical stage pharmaceutical company organized and existing under the laws of the People’s Republic of China ("PRC") (Press release, CASI Pharmaceuticals, MAY 24, 2022, View Source [SID1234615009]). The Sublicense Agreement grants TIANSHI an exclusive, perpetual, worldwide license for the investigational anti-CD38 monoclonal antibody (Mab), CID-103, in the treatment, prevention, and diagnosis of autoimmune diseases, conditions, and disorders in humans.

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Under the terms of the agreement, CASI shall maintain the exclusive commercialization and co-marketing rights of CID-103 in autoimmune indications and book all revenue in the United States. CASI has the co-commercial rights in autoimmune-derived hematology and oncology indications of CID-103 in China, but not obligated to co-commercialize those programs.

As part of the agreement, TIANSHI agreed to pay CASI a $10 million upfront payment in two instalments, as well as certain future milestone and royalty payments. Following the execution of this agreement, TIANSHI will complete its first equity financing. Upon completion of such equity financing, CASI, through its wholly-owned PRC subsidiary, will hold 15% equity of TIANSHI, which is expected to receive 120 million RMB from two venture capital investors and 20 million RMB from CASI Pharmaceuticals (China) Co., Ltd.

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "Recent research reveals that anti-CD38 antibodies can play a role in the treatment of diseases beyond hematological malignancies, which include pathologic antibody-mediated autoimmune diseases. We are excited by this development and potential opportunity to maximize the clinical usefulness of CID-103. We are pleased to have entered this agreement with TIANSHI, which may benefit more patients and allow CASI to maintain its focus on the hematology-oncology space."

Dr. He continued, "CASI is a company with a high entrepreneurial spirit. We have a unique business model and equity investment philosophy. This transaction demonstrates our commitment to our business partners and patients. In addition to sublicense agreement, CASI entered into an investment agreement with TIANSHI. CASI will subscribe to 15% of TIANSHI’s equity at the price of 20 million RMB (approx. $3 million) because we firmly believe that with the implementation of precision diagnostics, treatment of autoimmune disorders with innovative medicines has a bright prospect. The sublicense agreement and equity investment in TIANSHI are mutually beneficial for both parties, and we anticipate the positive clinical results of CID-103 in both multiple myeloma and autoimmune disease fields."

About CID-103 (Anti-CD38 Mab)

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that recognizes a unique epitope on CD38. It was engineered to have strong activity against CD38 malignant cells and to reduce certain safety issues observed with existing treatments. Preclinical data of CID-103 demonstrates enhanced activity against a broad array of malignancies which express CD38 and demonstrates a better preclinical safety profile when compared to other CD38 mAbs. These attributes offer the potential for accelerated development and regulatory review, including rapid advancement into earlier lines of therapy.

On May 24, 2022 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold placed on its NEON-2 trial evaluating davoceticept (ALPN-202), a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor, in combination with pembrolizumab in adults with advanced malignancies (Press release, Alpine Immune Sciences, MAY 24, 2022, View Source [SID1234614973]).

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The FDA removed the hold after review of the Company’s Complete Response, which included a comprehensive review of the davoceticept safety database, as well as a revised investigator brochure and study protocol. As previously disclosed, under the terms of the hold, previously enrolled participants continued to receive study drug, but no new participants could be enrolled until the partial clinical hold was removed. The ongoing NEON-1 study was not subject to the hold.

About Davoceticept (ALPN-202)

Davoceticept (ALPN-202) is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor intended for the treatment of cancer. Preclinical studies of davoceticept have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a Phase 1 monotherapy dose escalation and expansion trial in patients with advanced malignancies, has completed dose escalation and is currently enrolling its expansion cohorts. NEON-2 (NCT04920383), a combination study of davoceticept (ALPN-202) and pembrolizumab, was initiated in June 2021.

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 ImaginAb, Inc., a market leading global biotechnology company focused on developing next generation immuno-oncology imaging agents and therapeutic radiopharmaceuticals (RPT), reported the signing of an exclusive license with [Yantai] DongCheng Pharmaceutical Group to commercialize ImaginAb’s CD8 ImmunoPET agent (zirconium Zr 89 crefmirlimab berdoxam) in the Greater China market (Press release, ImaginAb, MAY 24, 2022, View Source [SID1234615010]). Zirconium Zr 89 crefmirlimab berdoxam will be initially used in third party sponsored clinical trials with the intention of achieving market authorization.

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Ian Wilson, CEO of ImaginAb, said: "ImaginAb’s objective is to be a leading global imaging and radiotherapy company and, as such, China is an important market for our products. We are pleased to sign this exclusive license agreement and are looking forward to working with DongCheng to deliver our diagnostic imaging agent to cancer patients in China. DongCheng’s extensive experience in molecular imaging, combined with its technical experience and execution infrastructure make it an ideal development and commercial partner for ImaginAb in China. The addition of DongCheng to our customer portfolio provides additional support as we progress our business strategy and third-party validation of crefmirlimab berdoxam."

Grant Luo, CEO of [Yantai] DongCheng Pharmaceutical Group, commented: "By partnering with ImaginAb, we will be introducing to Greater China an ImmunoPET tracer to visualize cytotoxic CD8+ T cells in the tumor microenvironment, which has the potential to accurately select and monitor the appropriate population receiving immune checkpoint inhibitor treatment and further promote the effectiveness of immunotherapy treatments. In addition, we hope to collaborate with clinical experts and pharmaceutical companies through our nationwide Good Manufacturing Practice (GMP) nuclear pharmacies network, to help accelerate the clinical development and commercial launch of novel therapeutics with high clinical benefits and to address patients’ needs."

ImaginAb will receive license and milestone payments and up to double digit royalties for the CD8 ImmunoPET license and commercial partnership in the Greater China market. No other terms have been disclosed.

On May 23, 2022 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported the publication of findings from a preclinical study showing enhanced anti-tumor function and eradication of solid tumors by combining its Amphiphile (AMP) platform vaccine, carrying cognate peptide and adjuvant cargos, with T cell receptor T cell therapies (TCR-Ts) (Press release, Elicio Therapeutics, MAY 23, 2022, View Source [SID1234614933]). These results, co-authored by Drs. Dylan Drakes and Peter DeMuth, with Elicio colleagues, were published in the preprint server, bioRxiv, and can be found here.

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"The AMP platform continues to show boosting capabilities in our preclinical studies of cancer immunotherapies by successfully targeting the lymph nodes," said Peter DeMuth, Ph.D., Chief Scientific Officer. "T cell receptor (TCR)-modified T cell therapies have historically shown promise but challenges to clinical efficacy against solid tumors persist. Often, suboptimal clinical performance can be attributed to insufficient in vivo persistence of current treatments and tumor antigen escape. With this study, we’ve shown that combining TCR-T cell therapies with our lymph node targeted AMP-vaccines can overcome these challenges to significantly improve preclinical efficacy in animal models of solid tumors."

Robert Connelly, Chief Executive Officer at Elicio, added, "Our AMP platform has huge potential to address some of the major challenges that continue to plague the field of immuno-oncology. We are delighted to share the results of this study because it provides rationale and evidence to support combining our AMP-peptide vaccine with TCR-T cell therapies to augment clinical responses."

About the Amphiphile Platform
Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The Amphiphile platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability.