T-Knife Therapeutics, Inc.

SAN FRANCISCO and BERLIN, Oct. 20, 2022 (GLOBE NEWSWIRE) -- T-knife Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to developing T cell receptor-based immunotherapies that deliver transformational benefits to cancer patients, today announced it has dosed the first patient in the IMAG1NE Phase 1/2 clinical trial. The IMAG1NE trial is designed to evaluate the safety and preliminary efficacy of TK-8001, a T cell receptor (TCR) engineered T cell therapy (TCR-T) specific for the Melanoma-associated Antigen Gene-A1 (MAGE-A1), in patients with solid tumors. “We believe our MyT Platform is distinct in its ability to identify TCRs that have been naturally optimized for affinity, specificity and sustaining long-term T cell function, making TK-8001 a promising new therapy to target MAGE-A1 positive solid tumors,” stated Eugen Leo, M.D., Ph.D., Chief Medical Officer of T-knife. “Our IMAG1NE trial combines a TCR with best-in-class potential, manufacturing designed to select the most potent T cells, and biomarker-guided patient selection criteria that seeks to enroll those patients that we believe have the highest likelihood of safe, deep and durable responses to TK-8001.” “We are excited to bring our first MyT Platform derived product candidate into the clinic,” added Thomas M. Soloway, Chief Executive Officer of T-knife. “This is a significant milestone representing the rapid progress at T-knife, and we are thankful for the support and trust we have received from our many collaborators, investigators and the patient community as we pursue our goal to build a global company focused on bringing the power of TCR-based therapies to cancer patients.” In preclinical studies, the MAGE-A1-directed TCR incorporated in TK-8001 exhibited high binding affinity and specificity to a MAGE-A1 epitope presented on HLA-A*02:01. Importantly, T cells incorporating the MyT Platform derived TK-8001 TCR demonstrated in vitro serial killing activity and enhanced in vivo anti-tumor activity compared to T cells engineered with TCRs derived from human donors. The IMAG1NE Phase 1/2 trial is an accelerated dose-titration, open-label, multi-center Phase 1/2 trial designed to evaluate the safety and preliminary efficacy of TK-8001 in patients with MAGE-A1 positive solid tumors. The Phase 1 part of the study is focused on the selection of a dose to advance into the Phase 2 part of the study. The Phase 1 dose escalation part is designed to enroll approximately 6 to 18 patients to assess the safety and tolerability of TK-8001 at various doses. Once the recommended Phase 2 dose has been identified, TK-8001 will then be evaluated in an expansion part of the trial. About TK-8001 TCR-T Targeting MAGE-A1 Positive Solid Tumors TK-8001 is a TCR-T specific for the Melanoma-associated Antigen Gene-A1, or MAGE-A1. MAGE-A1 is associated with hallmarks of aggressive cancers and poor clinical prognosis, and there is an emerging body of evidence indicating its involvement as a potential driver of tumorigenesis. MAGE-A1 represents an attractive therapeutic target given the high unmet need in MAGE-A1 expressing cancers, no reported protein expression in healthy tissues other than testis (an immune privileged site where HLA is not expressed and antigen is not presented), and significant consistency of expression between the primary tumor and metastases. As high affinity TCRs specific for MAGE-A1 in humans are eliminated through central immunological tolerance, T-knife believes its MyT Platform is a differentiated means to discover and select MAGE-A1 specific TCRs with an optimal affinity and specificity profile. About the T-knife MyT™ Platform Genetic engineering of T cells with T-cell receptors (TCRs) recognizing antigens aberrantly or over-expressed in cancers can redirect these T cells to the tumor, potentially offering curative responses to cancer patients. However, the ability to identify potent cancer-specific TCRs has been limiting for the field of TCR-T. In the case of self-antigens, T cells bearing those TCRs are eliminated during T cell development to avoid recognition and attack of healthy tissues. For non-self tumor antigens, such as those derived from mutations or viral sequences, the very low T cell frequency in the blood has limited TCR discovery efforts. To overcome these challenges, T-knife has developed transgenic mice carrying the human TCRαβ gene loci and expressing single or multiple human HLAs. Immunizing these mice with human tumor antigens, for which mice are not tolerant, allows for the identification of both CD4+ and CD8+ T cells with TCRs that have optimized affinity / specificity profiles capable of mediating significant anti-tumor activity. The TCRs from these mice are of higher affinity for tumor self-antigens than TCRs isolated from human donors and are naturally optimized to maintain a high specificity profile, making MyT mice a powerful high-throughput platform for rapidly generating TCRs with best-in-class potential. About T-knife Therapeutics T-knife is a clinical-stage biopharmaceutical company dedicated to developing T cell receptor-based immunotherapies that deliver transformational benefits to cancer patients, initially focused on T cell receptor (TCR) engineered T cell therapies (TCR-Ts), a modality that holds the potential to generate transformational responses in patients with solid tumors. The Company’s unique approach leverages its proprietary MyT Platform, a next-generation T cell receptor and epitope discovery engine that produces fully human, tumor-specific TCRs, naturally selected in vivo for optimal affinity and specificity. T-knife is advancing a portfolio of TCR-T product candidates against targets with high unmet medical need, including cancer testis antigens and commonly shared tumor-driving neoantigens. T-knife was founded by leading T cell and immunology experts utilizing technology developed at the Max Delbrück Center for Molecular Medicine together with the Charité – Universitätsmedizin Berlin. For additional information, please visit the Company’s website at www.t-knife.com.

Show me the money! This week's who's who of IPOs and financing rounds in the biopharma world. Adagio Therapeutics Adagio hopes to set a new pace for funding by going public. With terms set for a hefty $318.6 million IPO, the company will continue to push its antibody-based therapies for infectious diseases through the clinic. Its lead product, ADG20 is in development to both treat and prevent COVID-19 as a monotherapy or in combination with other treatments. In non-clinical studies, it has been shown to neutralize SARS-CoV-2, the virus that causes COVID-19, including variants of concern, in addition to a variety of other SARS-like viruses. ADG20 is currently knee-deep in two separate Phase II/III trials. Exo Pronounced “echo”, this California company is looking to disrupt the ultrasound industry with its handheld ultrasound device and simple, intuitive workflow solution. This week’s $220 million Series C will fund the commercialization of the device, once regulatory approvals are in hand. The handheld device will decentralize ultrasound technology, making it accessible everywhere, even via telemedicine. Exo sees a future where a patient at home can be sent a probe and guided through a self-scan to be reviewed by their provider. The CEO envisions a “healthcare system unconstrained by the four walls of a hospital and engineered for a world where providers can see clearly into every patient immediately.” InterVenn Biosciences Just a month after posting validation of its liquid biopsy diagnostic test, Bay Area-based InterVenn closed on a tidy $201 million Series C round. Funds will be used to advance the development and potential commercialization of its liquid biopsy capabilities and expand its network of partners for GLORI, its AI-driven glycoproteomic platform, which it recently validated. Dawn, InterVenn’s assay for immune checkpoint inhibitor response prediction, is expected to be available for use next year. DA32 Life Science Tech Acquisition Corp Another blank check company is in the works, springing from a partnership between Deerfield Management, ARCH Venture Partners and Section 32. With a $200 million IPO, the details on investment target are sparse. The company has already appointed a team of experienced executives, board of directors and strategic advisors who will be intimately involved in the investment, scaling and commercialization of various “life sciences tools, diagnostics, and data and analytics platforms to improve human health.” Icosavax, Inc. A vaccine company focused on respiratory disease, Icosavax joined the exchange with a $182 million IPO raise. The Seattle-based biotech scored $100 million in a Series B in April. These fresh funds will advance the development of Icosavax’s bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine program. The company is also evaluating a COVID-19 vaccine candidate. Last month, Icosavax announced it dosed the first patients in a Phase I/II study of its COVID-19 vaccine candidate. Deep Genomics "For the first time in history, medicine has become information,” Deep Genomics CEO Brendan Frey told BioSpace. Investors are buying into this RNA rewriting future with a $180 Series C investment in the Toronto-based company. Deep Genomics AI Workbench is upgrading to version 3.0 while fueling a massive target of 30 programs in the pipeline by 2023. The four programs furthest along – frontotemporal dementia, Wilson's disease, Niemann-Pick disease and refractory gout – are expected to all be in the clinic in the next two years. The company is also expanding into the Boston area and more than doubling its headcount from 75 to 160 by the end of next year. Rakuten Medical Rakuten’s $166 million Series D included a conversion of $91 million in convertible promissory notes and $75 million in fresh capital. The funds will be used to accelerate research efforts for ASP-1929, its lead drug that was approved last fall in Japan to treat unresectable locally advanced or locally recurrent head and neck cancer. Rakuten hopes to build on this momentum by evaluating the efficacy of the said drug in other types of therapies on its Illuminox platform. Illuminox is an investigational platform based on photoimmunotherapy and ASP-1929 is one of the first drugs developed using this tool. Nuvalent Selling 9.75 million shares at $17 a pop, Nuvalent scooped up over $165 million in its debut on the Nasdaq exchange. Having just launched this year in January with kinase-targeting oncology therapies, the Cambridge-based company has already raised $185 million between A and B Series financing rounds. With two lead programs in IND-enabling studies, preclinical data supports the therapies remain active in tumors with resistance mutations while minimizing off-target adverse events. Ring Therapeutics Ring is answering the call to better gene therapies by delivering the life-saving therapies with commensal viruses, viruses that do not cause disease and are present in most humans already. Ring’s engineered anellovirus vectors have the potential to be harmless and capable of transferring DNA to new cells without damaging healthy tissue or activating a patient’s immune system, making re-dosing a possibility. Its single-stranded DNA molecules do not integrate with a person’s existing DNA either. With last week’s $117 million Series B round, Ring is developing programs that "may focus on oncology, cardiology, ophthalmology, CNS, rare diseases, pulmonary and beyond.” T-Knife Therapeutics Harnessing a pipeline of T-cell receptor engineered T cell therapies, T-Knife raised $110 million in its Series B round this week. Lead investigational candidate TK-8001 targets MAGE-A1 positive cancers. T-knife is planning a Phase I/II study in the fourth quarter of this year to assess TK-8001. Bota Bio This global biotech raised scooped up $100 million in Series B funds, bringing its total raise so far to $145 million. Bota said the funds will be used to expand its global reach and build its lab-to-pilot scale platform for the rapid scale-up and deployment of its consumer goods, food, nutritional and pharmaceutical product pipelines. Strata Oncology Precision cancer firm Strata completed a $90 million series C to fuel ongoing development efforts on tissue and blood tests to widen precision medicine reach for patients diagnosed with different types of cancer. A good chunk of change will go toward its minimal residual disease assay for early-stage cancers and novel RNA-based treatment tests for solid tumors. Rallybio Three years after its $37 million launch, Rallybio hit the market with an $80.6 million IPO round. Its lead candidate, RLYB211, is in development for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT). Additional candidates include an antibody for prevention of a life-threatening disease that impacts fetuses and newborns and a novel protein inhibitor for th Ae treatment of patients with rare diseases of complement dysregulation. Zentera Therapeutics China’s Zentera rounded up $75 million in its Series B to support the development of three different candidates, its WEE1 inhibitor ZN-c3, its oral SERD ZN-c5, and its BCL-2 inhibitor ZN-d5. The company is also looking to expand its pipeline through business development opportunities. “Since inception last year, Zentera has made tremendous progress on both the clinical and corporate fronts, advancing its first two candidates into the clinic… as well as growing its passionate team of scientists and researchers,” Zentera’s CEO said in a statement.

Show me the money! This week’s who’s who of IPOs and financing rounds in the biopharma world. Show me the money! This week’s who’s who of IPOs and financing rounds in the biopharma world. Adagio Therapeutics Adagio hopes to set a new pace for funding by going public. With terms set for a hefty $318.6 million IPO , the company will continue to push its antibody-based therapies for infectious diseases through the clinic. Its lead product, ADG20 is in development to both treat and prevent COVID-19 as a monotherapy or in combination with other treatments. In non-clinical studies, it has been shown to neutralize SARS-CoV-2, the virus that causes COVID-19, including variants of concern, in addition to a variety of other SARS-like viruses. ADG20 is currently knee-deep in two separate Phase II/III trials. Exo Pronounced “echo”, this California company is looking to disrupt the ultrasound industry with its handheld ultrasound device and simple, intuitive workflow solution. This week’s $220 million Series C will fund the commercialization of the device, once regulatory approvals are in hand. The handheld device will decentralize ultrasound technology, making it accessible everywhere, even via telemedicine. Exo sees a future where a patient at home can be sent a probe and guided through a self-scan to be reviewed by their provider. The CEO envisions a “healthcare system unconstrained by the four walls of a hospital and engineered for a world where providers can see clearly into every patient immediately.” InterVenn Biosciences Just a month after posting validation of its liquid biopsy diagnostic test, Bay Area-based InterVenn closed on a tidy $201 million Series C round. Funds will be used to advance the development and potential commercialization of its liquid biopsy capabilities and expand its network of partners for GLORI, its AI-driven glycoproteomic platform, which it recently validated. Dawn, InterVenn’s assay for immune checkpoint inhibitor response prediction, is expected to be available for use next year. DA32 Life Science Tech Acquisition Corp Another blank check company is in the works, springing from a partnership between Deerfield Management, ARCH Venture Partners and Section 32. With a $200 million IPO , the details on investment target are sparse. The company has already appointed a team of experienced executives, board of directors and strategic advisors who will be intimately involved in the investment, scaling and commercialization of various “life sciences tools, diagnostics, and data and analytics platforms to improve human health.” Icosavax, Inc. A vaccine company focused on respiratory disease, Icosavax joined the exchange with a $182 million IPO raise. The Seattle-based biotech scored $100 million in a Series B in April. These fresh funds will advance the development of Icosavax’s bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine program. The company is also evaluating a COVID-19 vaccine candidate. Last month, Icosavax announced it dosed the first patients in a Phase I/II study of its COVID-19 vaccine candidate. Deep Genomics “For the first time in history, medicine has become information,” Deep Genomics CEO Brendan Frey told BioSpace. Investors are buying into this RNA rewriting future with a $180 Series C investment in the Toronto-based company. Deep Genomics AI Workbench is upgrading to version 3.0 while fueling a massive target of 30 programs in the pipeline by 2023. The four programs furthest along – frontotemporal dementia, Wilson’s disease, Niemann-Pick disease and refractory gout – are expected to all be in the clinic in the next two years. The company is also expanding into the Boston area and more than doubling its headcount from 75 to 160 by the end of next year. Rakuten Medical Rakuten’s $166 million Series D included a conversion of $91 million in convertible promissory notes and $75 million in fresh capital. The funds will be used to accelerate research efforts for ASP-1929, its lead drug that was approved last fall in Japan to treat unresectable locally advanced or locally recurrent head and neck cancer. Rakuten hopes to build on this momentum by evaluating the efficacy of the said drug in other types of therapies on its Illuminox platform. Illuminox is an investigational platform based on photoimmunotherapy and ASP-1929 is one of the first drugs developed using this tool. Nuvalent Selling 9.75 million shares at $17 a pop, Nuvalent scooped up over $165 million in its debut on the Nasdaq exchange. Having just launched this year in January with kinase-targeting oncology therapies, the Cambridge-based company has already raised $185 million between A and B Series financing rounds. With two lead programs in IND-enabling studies, preclinical data supports the therapies remain active in tumors with resistance mutations while minimizing off-target adverse events. Ring Therapeutics Ring is answering the call to better gene therapies by delivering the life-saving therapies with commensal viruses, viruses that do not cause disease and are present in most humans already. Ring’s engineered anellovirus vectors have the potential to be harmless and capable of transferring DNA to new cells without damaging healthy tissue or activating a patient’s immune system, making re-dosing a possibility. Its single-stranded DNA molecules do not integrate with a person’s existing DNA either. With last week’s $117 million Series B round, Ring is developing programs that “may focus on oncology, cardiology, ophthalmology, CNS, rare diseases, pulmonary and beyond.” T-Knife Therapeutics Harnessing a pipeline of T-cell receptor engineered T cell therapies, T-Knife raised $110 million in its Series B round this week. Lead investigational candidate TK-8001 targets MAGE-A1 positive cancers. T-knife is planning a Phase I/II study in the fourth quarter of this year to assess TK-8001. Bota Bio This global biotech raised scooped up $100 million in Series B funds, bringing its total raise so far to $145 million. Bota said the funds will be used to expand its global reach and build its lab-to-pilot scale platform for the rapid scale-up and deployment of its consumer goods, food, nutritional and pharmaceutical product pipelines. Strata Oncology Precision cancer firm Strata completed a $90 million series C to fuel ongoing development efforts on tissue and blood tests to widen precision medicine reach for patients diagnosed with different types of cancer. A good chunk of change will go toward its minimal residual disease assay for early-stage cancers and novel RNA-based treatment tests for solid tumors. Rallybio Three years after its $37 million launch , Rallybio hit the market with an $80.6 million IPO round. Its lead candidate, RLYB211, is in development for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT). Additional candidates include an antibody for prevention of a life-threatening disease that impacts fetuses and newborns and a novel protein inhibitor for th Ae treatment of patients with rare diseases of complement dysregulation. Zentera Therapeutics China’s Zentera rounded up $75 million in its Series B to support the development of three different candidates, its WEE1 inhibitor ZN-c3, its oral SERD ZN-c5, and its BCL-2 inhibitor ZN-d5. The company is also looking to expand its pipeline through business development opportunities. “Since inception last year, Zentera has made tremendous progress on both the clinical and corporate fronts, advancing its first two candidates into the clinic… as well as growing its passionate team of scientists and researchers,” Zentera’s CEO said in a statement.