On January 5, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body, along with LG Chem Life Sciences, reported that a key milestone in the selection of a clinical product candidate has been reached in their collaboration for CUE-102, an Immuno-STAT biologic, jointly developed to selectively target WT1-expressing cancers (Press release, Cue Biopharma, JAN 5, 2022, View Source [SID1234608263]). The milestone represents significant progress for the CUE-102 program and an important achievement in generating promising preclinical activity and data to be shared with the FDA as part of an investigational New Drug (IND) filing that is planned for the first quarter of 2022. Under the terms of the collaboration agreement, Cue Biopharma will receive a $3 million milestone payment from LG Chem Life Sciences, the life sciences division of LG Chem Ltd.

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"We are highly encouraged with the progress made in our collaboration with LG Chem, our partner and collaborator for CUE-101 and CUE-102 in certain Asia countries, and pleased to be advancing CUE-102 for a planned IND submission this year," said Daniel Passeri, chief executive officer of Cue Biopharma. "This milestone reflects ongoing progress for CUE-102, our second program from the IL-2 based CUE-100 series, and we believe provides a significant opportunity to address a high unmet need in a wide range of solid tumors and hematologic WT1-positive malignancies. The CUE-102 preclinical data continues to support and bolster the versatility and modularity of our CUE-100 series biologics and the Immuno-STAT platform, and we look forward to executing on our goal to advance this drug candidate into the clinic for patients in need."

Dr. Jeewoong Son, president of LG Chem Life Sciences added, "This significant milestone for CUE-102 underscores the spirit of the partnership and collaboration for advancing our shared vision with Cue Biopharma. We are very pleased and encouraged by the clinical data reported from the CUE-101 program and believe these data support the potential for CUE-102 to provide a significant therapeutic advancement for patients with WT1-expressing cancers."

Cue Biopharma presented preclinical data on CUE-102 and interim clinical data on CUE-101, its lead oncology asset, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting in November 2021.

About Immuno-STAT
The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) platform biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-major histocompatibility complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in selective T cell modulation. Because our drug candidates are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo) and reinfused.

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-major histocompatibility complex (pMHC) molecules along with rationally engineered interleukin 2 (IL-2) molecules. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About CUE-102
Leveraging the Immuno-STAT (Selective Targeting and Alteration of T cells) platform of targeted interleukin 2 (IL-2) therapies and the ongoing development of CUE-101, CUE-102 is being developed as a novel therapeutic fusion protein to selectively activate tumor antigen-specific T cells to treat Wilms’ Tumor 1 (WT1)-expressing cancers. CUE-102 consists of two human leukocyte antigen (HLA) molecules presenting a WT1 peptide, four affinity-attenuated IL-2 molecules, and an effector attenuated human immunoglobulin G (IgG1) Fc domain.

On January 5, 2022 Genprex reported that The FDA granted fast track designation to quaratusugene ozeplasmid (Reqorsa), an immunogene therapy, in combination with pembrolizumab (Keytruda) as a potential treatment for patients with histologically confirmed, unresectable stage III or IV non–small cell lung cancer (NSCLC) who progressed after treatment with pembrolizumab (Press release, Genprex, JAN 5, 2022, View Source [SID1234607479])

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Data that were previously presented have shown a strong synergy between quaratusugene ozeplasmid and pembrolizumab in patients with NSCLC compared with pembrolizumab alone. The data highlighted a survival benefit, as well as an increase in natural killer cells and a decrease in PD-L1 expression on tumor cells following treatment with the immunogene therapy in a population of mice with a humanized immune system and metastatic lung cancers.

On January 5, 2022 Genprex reported that The FDA has granted fast track designation (FTD) for Reqorsa Immunogene Therapy (Genprex) in combination with Keytruda (Merck) for individuals with histologically confirmed unresectable stage III or IV non–small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda (Press release, Genprex, JAN 5, 2022, View Source [SID1234607478]).

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In the first quarter of 2022, Genprex expects to initiate its Acclaim-2 clinical trial, a multi-label, open-label phase 1/2 trial evaluating Reqorsa in combination with Keytruda for this population.

Genprex received its first FTD for Reqorsa in combination with AstraZeneca PLC’s Tagrisso for individuals with histologically confirmed unresectable stage 3 or 4 NSCLC with epidermal growth factor receptor mutations that progressed after treatment with Tagrisso.

"This fast track designation is an important step in our efforts to accelerate clinical development of Reqorsa and another validation of the potential of Reqorsa to treat the unmet medical need of patients with late-stage NSCLC. With a strong balance sheet of $42 million in cash as of the end of the third quarter of 2021 and expert clinical trial management led by Chief Medical Officer and industry veteran Mark Berger, MD, who joined Genprex in September 2021, we are well positioned to advance our Acclaim-1 and Acclaim-2 clinical trials in a meaningful way in 2022," Rodney Varner, president and CEO of Genprex, said in a statement.

Preclinical data have previously shown that Reqorsa combined with Keytruda was more effective than Keytruda alone in increasing the survival of mice with a humanized immune system that had metastatic lung cancers.

The studies in mice with a humanized immune system also documented multiple effects of Reqorsa on the immune system, such as an increase in Natural Killer cells and a decrease in PD-L1 expression on tumor cells, which is believed likely to contribute to the synergy between and Keytruda and Reqorsa.

"[The] FDA may award fast track designation if it determines that non-clinical or clinical data demonstrate the potential for a drug to address unmet medical need for a serious or life-threatening disease or condition. This provision is intended to facilitate development and expedite review of such drugs, so that a product, if approved, can reach the market expeditiously," Berger said.

"Advanced NSCLC represents a large patient population that is in desperate need of new therapies," he said.

FTD recipients may also be eligible for accelerated approval or rolling review of the recipient’s biologics license application (BLA) if other criteria are met.

Additionally, FTD product candidates could be eligible for priority review if supported by clinical data at the time of the BLA submission.

The initial intended disease indication for the development of Reqorsa is NSCLC.

Genprex is a clinical-stage gene therapy company that focuses on developing therapies for individuals with cancer and diabetes and hope to provide new therapies for large patient populations that have limited treatment options.

On January 5, 2022 Sigyn Therapeutics, Inc. (OTC Markets: "SIGY"), a medical technology company focused on the treatment of pathogen-related conditions that precipitate sepsis, reported that its Chairman and CEO, Jim Joyce, will give a corporate presentation at today’s virtual Emerging Growth Conference (Press release, Sigyn Therapeutics, JAN 5, 2022, View Source [SID1234607419]).

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Mr. Joyce’s presentation is scheduled to begin at 3:30pm Eastern and will be followed by questions from online participants. Please register through the following link to attend the event:

About the Emerging Growth Conference

The Emerging Growth Conference provides an interactive platform for publicly traded companies to present their endeavors to the investment community. The Conference focus and coverage includes companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long term growth. Its audience includes potentially tens of thousands of Individual and Institutional investors, as well as Investment advisors and analysts.

On January 5, 2022 Shanghai Junshi Biociences Co., Ltd ("Junshi Biosciences", HKEX: 1877, SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, and DotBio Pte. Ltd ("DotBio"), a biotech company specialized in next generation antibody therapies, reported that they have entered into a collaboration to develop next-generation antibody therapies (Press release, Shanghai Junshi Bioscience, JAN 5, 2022, View Source [SID1234598438]). Junshi Biosciences will obtain the license to one of DotBio’s DotBody modules, to be used within the oncology field for the development of several multi-specific antibodies. DotBio will be entitled to upfront and milestone payments, as well as royalties as the molecules progress through clinical development, regulatory approvals, and commercialization.

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DotBio’s proprietary DotBody technology platform is based on the concept of modular design. By prefabricating antibody modules with specific functions, DotBio is able to combine them on demand to build multi-functional antibodies quickly and efficiently, improving antibody quality, development success rate and efficiency. This high throughput process allows DotBio to generate multi-specific antibodies, ADCs and intracellular antibodies in a matter of months as opposed to over a year. The DotBody platform has been optimized for autonomous folding, better stability, high expression levels, high concentration and low aggregation. The DotBody module licensed by Junshi Biosciences benefits from these improved properties and modularity and is an ideal building block to developing novel and high-quality treatment options.

Dr. Hui Feng, COO of Junshi Biosciences, said, "As a leading China-based, innovation-driven global biopharma company, Junshi Biosciences has established an impressive pipeline through internal R&D as well as external collaborations. Nevertheless, we constantly search for complementary novel drug targets and technology platforms that can further our goal of delivering novel therapies to patients in China and beyond and to achieve this goal by the most efficient means. DotBio’s technology platform provides a revolutionary approach to produce antibodies with high efficiency and quality. We anticipate our partnership with DotBio would provide patients with better treatment solutions in the near future."

Dr. Ignacio Asial, CEO and founder of DotBio, said, "DotBio believes that the creation of multi-functional antibody molecules through a modular design opens unprecedented possibilities for the development of more effective therapies that can reach patients faster. This licensing deal with Junshi Biosciences, a company with a strong track record in the R&D of immuno-oncology therapies, is an important milestone in our efforts to validate our vision and improve patients’ lives in a meaningful way. We are very excited about this first out-licensing deal with Junshi Biosciences and look forward to seeing the module progress into clinical development as part of several innovative multi-specific cancer therapies."

About Junshi Biosciences

Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising 45 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou).

For more information about Junshi Biosciences, please visit: View Source