On January 5, 2023 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported a clinical trial collaboration and supply agreement with Merck (known as MSD outside the U.S. and Canada) (Press release, Triumvira Immunologics, JAN 5, 2023, View Source [SID1234625930]). Triumvira’s ongoing TACTIC-2 trial will evaluate the use of its novel autologous cell therapy TAC01-HER2 as a monotherapy but also in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of HER2-positive solid tumors.

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"We believe the addition of an immune checkpoint inhibitor, such as KEYTRUDA, to TAC01-HER2 will effectively release inhibitory PD-L1/PD1 signaling in T cells, potentially leading to improved and durable therapeutic responses, said Paul Lammers, M.D., M.Sc., Chief Executive Officer of Triumvira. We are pleased to work collaboratively with Merck to explore the potential of this approach to treat relapsed or refractory solid tumors and bring new drug therapies to patients who do not respond to existing treatments."

At the European Society for Medical Oncology 2022 Congress, Triumvira presented interim data from the ongoing TACTIC-2 Phase 1/2 trial that demonstrated the safety and preliminary efficacy of TAC01-HER2 in patients with HER2-positive solid tumors regardless of level of expression. TACTIC-2 is actively enrolling participants at five clinical trial sites across the U.S. and Canada. The expansion phase of the trial is expected to launch in 2023. The trial will enroll a monotherapy arm with TAC01-HER2 and a combination therapy arm with TAC01-HER2 and KEYTRUDA, in patients with HER2-positive solid tumors.

"We are encouraged by the interim preliminary safety and efficacy data to date from our TACTIC-2 trial, and this has the potential to drive a real breakthrough in the treatment of solid tumors that express HER2," said Deyaa Adib, M.D., Chief Medical Officer of Triumvira. "Beyond TAC01-HER2 monotherapy, we hope to demonstrate the benefits of using TAC01-HER2 in combination with KEYTRUDA, and we look forward to collaborating with Merck on this trial."

Merck will supply Triumvira with KEYTRUDA for the trial and the two companies will form a Joint Development Committee to review the clinical trial results. More details on the Phase 1/2 TACTIC-2 trial can be found at clinicaltrials.gov using ClinicalTrials.gov Identifier NCT04727151.

On January 5, 2023 Shanghai Xianbo Biotech Co., Ltd., also known as Simnova outside of China, an affiliate of Simcere Investment Group and a clinical-stage biotechnology company developing proprietary off-the-shelf CAR-NK and BiTE-armed CAR-T cell therapies, and Orna Therapeutics, a biotechnology company pioneering a new investigational class of engineered circular RNA (oRNA) therapies, reported a collaboration agreement to discover, develop, and commercialize multiple potential therapeutics in the area of oncology (Press release, Shanghai Simnova Biotechnology, JAN 5, 2023, View Source [SID1234625929]).

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Under the terms of the agreement, Simnova will gain access in greater China to certain programs built on Orna’s breakthrough isCAR technology, including Orna’s lead anti-CD19 in situ CAR (isCAR) program, ORN-101. In addition, Orna will gain access to investigator-initiated clinical trials in China to accelerate the validation of select programs in patients. Orna will receive an upfront payment from Simnova and be eligible for development, regulatory, and sales milestones as well as royalties on any approved products derived from the collaboration.

Orna’s proprietary isCAR technology comprises two components: elegantly engineered circular RNAs (oRNAs) expressing chimeric antigen receptors, and custom-built lipid nanoparticles (LNPs) designed to deliver the oRNAs to cells of the immune system. oRNAs have greater stability in immune cells and are engineered to produce more proteins inside the body, than linear mRNAs. More broadly, Orna’s oRNA-LNP platform has potential across a range of indications including oncology, genetic and infectious disease, and more.

"This strategic collaboration broadens Orna’s capability to develop circular RNA therapeutics in China through Simnova’s development capabilities," said Dr. Zhouxiao Cao, Simnova’s Chief Executive Officer. "We look forward to closely working with the innovative scientific and technical teams at Orna."

"This collaboration again recognizes the value of our oRNA-LNP platform and will allow us together to diversify the number of programs using isCAR technology while bringing the value of isCAR to patients more efficiently," said Tom Barnes Ph.D., Orna’s Chief Executive Officer. "This marks another important step in our overall business strategy where we look to thoughtfully engage partners to deliver on the promise of circular RNA therapies."

About ORN-101:

ORN-101, Orna’s lead program, is an in situ CAR therapy designed to modify a patient’s immune cells inside their body. Comprising an oRNA molecule packaged inside a proprietary LNP, this easily redosable format could avoid patient lymphodepletion and allow for reliable dose control, overcoming barriers of existing ex vivo CAR-T therapies without sacrificing efficacy. Preclinical data presented at a scientific conference demonstrated tumor suppression and eradication in an animal model, suggesting the possibility that oRNA-LNP based cancer therapies could eventually overtake cell therapies.

On January 5, 2023 bluebird bio, Inc. (Nasdaq: BLUE) reported that Andrew Obenshain, chief executive officer, bluebird bio, will present a corporate update at the 41st Annual J.P. Morgan Healthcare Conference on Thursday, January 12, 2023, at 7:30AM PT (Press release, bluebird bio, JAN 5, 2023, View Source [SID1234625892]).

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To access the live webcast of bluebird bio’s presentation, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source A replay of the webcast will be available on the bluebird bio website for 30 days following the event.

On January 5, 2023 OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of Elite Cancer Responders, reported that Clifford Stocks, Chief Executive Officer, will present a company overview at the 41st Annual J.P. Morgan Healthcare Conference on Thursday, January 12, 2023, at 11 a.m. PST (Press release, OncoResponse, JAN 5, 2023, View Source [SID1234625928]).

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Following the live event, the accompanying slide presentation will be accessible on the Events & Presentations page of the OncoResponse website at View Source

On January 5, 2023 Jubilant Therapeutics Inc., a clinical stage biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, reported that the United States Food and Drug Administration (US FDA) has granted Orphan Drug Designation for JBI-802 for the treatment of small cell lung cancer (SCLC) and acute myeloid leukemia (AML) (Press release, Jubilant Therapeutics, JAN 5, 2023, View Source [SID1234625927]).

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JBI-802 is a dual epigenetic modulator engineered in a single pharmacophore to achieve optimal inhibition of the transcriptional regulator CoREST, which regulates the development of cellular lineages responsible for neuroendocrine tumors like SCLC and hematopoietic tumors like AML.

This unique profile has shown synergistic anti-tumor activity and it is expected to overcome tolerability limitations of first-generation, single target epigenetic modulators.

"JBI-802 is the lead product candidate from our TIBEO (Therapeutic Index and Brain Exposure Optimization) Discovery Engine. It is our unique approach of structure-based drug design to generate novel pharmacophores with improved target product profile compared to existing agents. The Orphan Drug Designations (ODD) were supported by several relevant preclinical models. In SCLC, JBI-802 showed unique activity not just in normal neuroendocrine models but also in the ‘variant’ models driven by MYC amplification. This data also supports the ongoing Ph I/II clinical trial in neuroendocrine tumor patients. In AML the activity was uniquely seen in models of erythroleukemia, a subset of leukemia, with a unique erythroid phenotype and a very high unmet need based on its aggressive nature and limited therapy. This designation and emerging clinical data from the ongoing fist-in-human JBI-802 study will now underpin expansion of our clinical activities in thrombocythemia, leukemia and other erythroid tumors like MPN," said Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc.

The US FDA’s Office of Orphan Products Development (OOPD) grants orphan designation status to a drug that is intended to treat a rare disease or condition that affects fewer than 200,000 persons in the United States.

About JBI-802

JBI-802 is an oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6. It targets stem cell modulation by inhibiting LSD1 and modulates immune suppression with isoform selective HDAC6 inhibition. Preclinical research has demonstrated its synergistic anti-tumor activity, which is superior vs. either target alone inhibitors and has a favorable safety profile with no significant safety concerns or accumulation. It is being clinically evaluated in multiple neuroendocrine tumors including SCLC, with a goal to expand in to hematological cancers such as acute myelogenous leukemia, essential thrombocythemia, and other myeloproliferative cancers. Positive clinical data was recently reported for bomedemstat, a LSD1 only inhibitor, in essential thrombocythemia, thereby establishing a pivotal role of epigenetic modulators in hematological malignancies.