MEDTECH, INDUSTRIAL IMPACT
Janux | December 29, 2022
Janux Therapeutics, Inc. is a clinical-stage biopharmaceutical company that uses its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms to develop a diverse pipeline of novel immunotherapies. On December 27, 2022, the company announced that it had submitted an investigational new drug (IND) application for JANX008 to U.S. Food and Drug Administration, an EGFR-TRACTr in (SCCHN).
The company is pleased to announce its second IND. It considers this a big step forward for its TRACTr platform, which has also helped many next-generation immunotherapies move forward.
JANX008 is made in a particular way to avoid cytokine release syndrome and the known harmful effects of EGFR in on-target healthy tissue. As a result, the company thinks it could be easier to treat EGFR-expressing cancers in many ways.
JANX008 is a double-masked TRACTr that conceals both the EGFR-binding and T-cell-specific binding domains (CD3). JANX008 exhibited minor cytokine release syndrome and healthy tissue toxicity in preclinical studies. Besides, it demonstrated superior safety and pharmacokinetic (PK) qualities compared to unmasked TCEs. These data and JANX008's strong manufacturability qualities justify its continued development as a potential therapy for solid tumors.
About theJanux
Janux Therapeutics is a clinical-stage business developing immunotherapies that target cancers without affecting healthy tissue. The company uses platform masking to generate innovative therapeutic candidates that address T-cell engager toxicity and efficacy limitations. It develops next-generation cancer therapeutics using TRACTR platform. Janux Therapeutics focuses on developing medically-validated T cell engagers (TCEs). Its pipeline includes PSMA, EGFR, and TOP2 efforts. All of its programs are IND-enabling or discovery.
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MEDTECH, INDUSTRIAL IMPACT
MaxCyte | January 04, 2023
MaxCyte, a leading commercial cell-engineering company, announced the signing of a strategic platform license (SPL) with Catamaran Bio, a biotechnology enterprise creating off-the-shelf chimeric antigen receptor (CAR)-NK cell therapeutics to cure a wide range of cancers.
While Catamaran acquires non-exclusive clinical and commercial rights to use MaxCyte's Flow Electroporation® technology and ExPERT™ platform per the terms of the agreement, in exchange, MaxCyte will receive platform licensing fees and revenue related to its programs.
Catamaran is actively developing highly potent allogeneic, cryopreserved CAR-NK cell therapeutics using synthetic biology and non-viral cell engineering capable of treating challenging cancers, including solid tumors, by integrating new functional features with the inherent cancer-fighting properties of NK cells. In addition, the company created the TAILWIND® platform, an integrated set of technologies, to engineer, expand, and process NK cells into safe and effective off-the-shelf cell therapy products for numerous cancer types.
The MaxCyte ExPERT™ instrument portfolio is the next generation of clinically verified electroporation technology for complicated and scalable cell creation. The ExPERT™ platform provides the high-end performance required to enable the next era of biological and cellular treatments by delivering high transfection efficiency, seamless scaling, and expanded functionality. MaxCyte's Catamaran agreement is the company's 19th overall SPL.
About MaxCyte
MaxCyte is a prominent commercial cell-engineering firm dedicated to advancing breakthrough cell-based research and next-generation cell therapy discovery, development, and commercialization. Over the years, it has been developing and commercializing its unique Flow Electroporation® platform, which allows for the intricate creation of a wide range of cells. In addition, its ExPERT™ platform, based on its Flow Electroporation technology, has been created to assist the rapidly increasing cell therapy market and can be used across the high-growth cell therapy sector, from discovery and development to commercialization of next-generation cell-based therapies.
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CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Exelixis | February 14, 2023
On February 13, 2023, Exelixis, Inc., a leading global oncology firm innovating next-generation medicines and regimens at the forefront of cancer care and Sairopa B.V. (Sairopa), a renowned firm developing novel therapeutics for cancer by modulating the patient's immune system, announced that FDA has approved Sairopa's Investigational New Drug (IND) Application to assess the pharmacokinetics and safety of ADU-1805 in adults with advanced solid tumors.
ADU-1805, being a monoclonal antibody active against all human SIRPα alleles, has the potential to reach a broader patient population than existing SIRPα-directed therapeutics.
ADU-1805 has the potential to boost the immune system's ability to combat tumors by suppressing SIRPα, an important immuno-suppressive component of the tumor microenvironment. When compared to other SIRP family members, ADU-1805 has been designed to bind preferentially to SIRPα, which may improve its capacity to stimulate immune cells.
In accordance with the clinical development and option agreement announced in November 2022, Exelixis has the option to obtain an exclusive, global license to commercialize and develop ADU-1805 and other anti-SIRPα antibodies after reviewing data from predetermined phase 1 clinical studies of ADU-1805 to be conducted by Sairopa during the option period. This IND approval results in a $35 million milestone payment to Sairopa to be paid in the first quarter of 2023.
About Exelixis
Founded in 1994, Exelixis is a leading global oncology firm at the vanguard of cancer care, developing next-generation drugs and regimens. Fueled by bicoastal centers of research and development expertise, its clinically distinct pipeline of small molecules, antibody-drug conjugates, and other biotherapeutics is quickly expanding its product portfolio to address a growing spectrum of tumor types and indications. In addition, the company has demonstrated an excellent track record of endurance in the face of adversity after working in the competitive biotech industry for over 25 years. Its main product's success has provided it with a robust commercial basis, allowing re-energizing research activities and team expansion in clinical development, drug discovery, and commercial areas.
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