On May 23, 2024 2seventy bio, Inc. (Nasdaq: TSVT) reported that members of the management team will present at the following upcoming investor conferences (Press release, 2seventy bio, MAY 23, 2024, View Source [SID1234643567]):

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TD Cowen 5th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper) in a virtual fireside chat on Tuesday, May 28, 2024 at 8:30 a.m. ET
Goldman Sachs 45th Annual Global Healthcare Conference in Miami Beach, FL, on Monday, June 10, 2024 at 8:40 a.m. ET

Live webcasts of the fireside chats will be available via the Investors and Media section of the company’s website at View Source Replays will be archived on the 2seventy bio website for 30 days following the events.

On May 22, 2024 Alphamab Oncology (stock code: 9966.HK) reported that the first patient has been successfully dosed in the phase I clinical study (JSKN016-101) of JSKN016, a novel bispecific antibody-drug conjugate (ADC) targeting HER3 and TROP2, in the treatment of Chinese patients with advanced malignant solid tumors.

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Trophoblast cell surface antigen 2 (TROP2) is widely expressed in solid tumors, and its up-regulation can stimulate tumor growth, proliferation and invasion. Studies have showed that high TROP2 expression was observed in 64% of lung adenocarcinomas, 75% of lung squamous cell carcinoma, and up to 78% of breast cancer. Overexpression of Human epidermal growth factor receptor 3 (HER3) may be associated with poor prognosis of a variety of solid tumors such as lung cancer, breast cancer, gastric cancer, ovarian cancer, and melanoma. Therefore, molecules targeting TROP2 or HER3 may play anti-tumor activity in solid tumors.

JSKN016 is a bispecific antibody-drug conjugate (ADC) simultaneously targeting HER3 and TROP2, which is independently developed by Alphamab. After binding with TROP2 and/or HER3 on the surface of tumor cells, JSKN016 enters the lysosome through target-mediated endocytosis, releasing cytotoxic topoisomerase I inhibitor (TOPIi), and then inducing apoptosis of TROP2 and/or HER3 positive tumor cells. In addition, the inhibitor can penetrate the cell membrane and enter the antigen-negative tumor cells to exert bystander effect. These effects can effectively inhibit the growth of tumor cells.

JSKN016-101 is an open-label, multi-center, first-in-human (FIH) phase I clinical trial of JSKN016, including dose-escalating and dose-expansion phases. The primary endpoint is to evaluate the safety, tolerability, pharmacokinetics (PK)/pharmacodynamics, and antitumor activity of JSKN016 in Chinese patients with advanced malignant solid tumors, as well as to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D).

About JSKN016

JSKN016 is a bispecific antibody-drug conjugate (ADC) targeting HER3 and TROP2, which is developed inhouse with proprietary Glycan-specific conjugation platform. JSKN016 can induce apoptosis of TROP2 or HER3 positive tumor cells, and penetrate the cell membrane into antigen-negative tumor cells to exert bystander effect, thus effectively inhibiting the growth of tumor cells. The phase I clinical study of JSKN016 for the treatment of advanced malignant solid tumors is currently being conducted in China.

(Press release, Alphamab, MAY 22, 2024, View Source [SID1234657013])

On May 22, 2024 Captain T Cell GmbH, a biotechnology company developing next-generation T cells against solid tumors, reported the successful closing of a seed financing round totaling € 8.5 million (Press release, Captain T Cell, MAY 22, 2024, View Source [SID1234644416]). A syndicate of experienced life science investors including i&i Biotech Fund I SCSp, Brandenburg Kapital GmbH, and HIL-INVENT Ges.m.b.H participated in the round. In addition, the German Federal Ministry of Education and Research (BMBF) is supporting the Company through its prestigious GO-Bio program. The financing also marks the appointment of biotech veteran Jörn Aldag as Chairman of the Board of Directors.

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The funds will be used to further progress Captain T Cell’s first-in-class lead program towards the clinic along with a novel allogeneic platform for off-the-shelf treatments of solid tumors.

Captain T Cell develops first-in-class efficacy-enhanced TCR-T cells for solid tumors that are not addressed by existing therapies. Using a toolbox of next-generation technologies, Captain T Cell generates TCR-T cells with enhanced persistence and the capacity to cope with the hostile tumor microenvironment of difficult-to-treat solid tumors. In preclinical in vivo models, the Company has been able to completely eradicate aggressive tumors using these efficacy-enhanced T cells. A key technology established by the Captain T Cell team is its proprietary TCR-ALLO platform for off-the-shelf treatment of solid tumors. The TCR-ALLO platform is a versatile tool that can be expanded to a variety of cancer indications.

The Company is a spin-off from the renowned Max Delbrück Center, Berlin, Germany, a leading European biomedical research institution. The institute provided valuable financial and infrastructural support throughout the pre-seed phase and together with its technology transfer partner Ascenion remains a close partner for future endeavors.

Dr. Felix Lorenz, CEO of Captain T Cell, said: "This successful financing round allows us to accelerate our high-potential therapies and brings us closer to providing life-saving options for patients underserved by current treatments. We are steadfast in our mission to progress our lead candidate towards the clinic and to establish our TCR-ALLO platform as a leader in off-the-shelf solid tumor therapeutics."

"We have been following the Captain T Cell team for some time and have been impressed by their scientific depth and management capabilities. The team has generated highly convincing preclinical data. Also, we see tremendous potential in their off-the-shelf approach. It holds the promise of bringing life-saving therapies to patients at much lower cost. If successful, it could be applied to any TCR-T cell therapy currently in development, enabling widespread use of these therapies. Captain T Cell has the potential to become a global leader in the development of novel oncology drugs," said Dr. Jaromir Zahrádka, Managing Partner of i&i Bio.

"T cell-based immunotherapies represent a powerful tool in the challenging fight against solid tumors. We believe Captain T Cell is positioned at the forefront of cancer therapy with its unique toolbox technology approach," said Hao Nam Nguyen, Investment Manager at Brandenburg Kapital. "Brandenburg Kapital looks forward to supporting the highly ambitious team at Captain T Cell and to bringing this very promising project to fruition together with our co-investors and the BMBF funding from the GO-Bio program."

"Captain T Cell combines a powerful proprietary drug development platform with an advanced preclinical product pipeline," commented Dr. Friedrich Hillebrand, Managing Director of HIL-INVENT. "The Company’s programs address a high unmet medical need in the treatment of aggressive solid tumors. We are therefore pleased to participate in the Company’s seed financing round and support its future growth."

On May 23, 2024 Orna Therapeutics, a biotechnology company dedicated to designing and delivering a new class of fully engineered circular RNA therapeutics (oRNA), reported its acquisition of ReNAgade Therapeutics, a pioneer in unlocking the potential of RNA therapeutics that demonstrated industry-leading delivery to multiple extra-hepatic cells in non-human primate (NHP) models over the past 18 months (Press release, Orna Therapeutics, MAY 22, 2024, View Source [SID1234643612]).

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Amit D. Munshi, Chief Executive Officer of ReNAgade, will succeed Tom Barnes, Ph.D., to lead Orna as Chief Executive Officer.

"RNA-centric approaches are poised to eclipse traditional cell therapy-based methods and reshape the future of medicine," said Mr. Munshi. "This strategic acquisition unifies Orna’s and ReNAgade’s strengths and capabilities under one roof, expanding technological synergies and multiplying the companies’ depth and breadth of expertise to drive a unique RNA therapeutic-focused R&D engine. Orna will now advance an industry-leading approach combining the Company’s circular RNA expression technology with ReNAgade’s broad portfolio of LNP-based RNA delivery systems and comprehensive editing programs to solve the most pressing challenges in drug development."

An industry veteran of more than 30 years, Mr. Munshi is former President and CEO of Arena Pharmaceuticals Inc., which he built from a $300 million market cap into a late clinical stage company before its acquisition for $6.7 billion by Pfizer. Dr. Barnes will retain his position on Orna’s Board of Directors and serve as chair of its Scientific Advisory Board.

"Orna remains singularly focused on developing the right tools and technologies and building the right company to power an entirely new class of RNA-based medicines," said Dr. Barnes, founding Chief Executive Officer of Orna Therapeutics. "The combination of technologies positions Orna to advance best-in-classpanCAR in vivo CAR RNA therapies and expand existing gene editing delivery solutions with circular RNA to address the massive unmet need in multiple diseases."

"Both Orna and ReNAgade were founded on our bold vision to push the boundaries of RNA medicine," said Ansbert Gadicke, M.D., Managing Partner of MPM BioImpact. "The fusion of these industry leaders in circular RNA and delivery will transform the landscape of RNA therapeutics and accelerate clinical milestones leading to greater impact for patients living with cancer and autoimmune diseases. The combined company is supported by a substantial financial position enabling these milestones."

Built by MPM BioImpact, both Orna and ReNAgade bring significant financing. Orna launched with $100 million in Series A financing in February 2021, subsequently announcing in August 2022 a $221 million Series B in addition to a strategic partnership. ReNAgade launched in May 2023 with $300 million Series A financing. The combined company will have a robust pipeline with panCAR programs in oncology and autoimmune disease, vaccine programs partnered with Merck, and genetic disease programs.

On May 22, 2024 Valerio Therapeutics S.A. (Euronext Growth Paris: ALVIO), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) and driver oncogenes, reported the completion of dosing for the first cohort of subjects in its Phase 1/2 trial of lead candidate, VIO-01, a pan-DDR decoy for the treatment of solid tumors (Press release, Valerio Therapeutics, MAY 22, 2024, View Source [SID1234643563]).

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VIO-01 is the next-generation DNA decoy generated from Valerio Therapeutics’ proprietary PlatON platform. An optimized product with modifications for increased half-life, plasma stability and tumor targeting, VIO-01 is a potent pan-DDR trapper capable of abrogating multiple DNA damage pathways including homologous recombination and non-homologous end joining. The pan trapping nature of VIO-01 allows for treatment of a wide range of potential solid tumor indications rather than restrictions to BRCA1/2 mutations or HRD positivity as with other DNA damage inhibitors.

The Clinical Review Committee (CRC) is composed of Valerio Therapeutics Medical and Safety teams as well as Principal Investigators convened to review all available and relevant safety information from the first cohort of 3 patients. No clinically significant adverse events or serious adverse events were reported and no MTD was declared, allowing the Clinical Review Committee to unanimously agree to escalate to the second dose cohort.

The VIO-01-101 Phase 1b portion of the trial aims to determine to recommended phase 2 dose and/or pharmacologically active dose in patients with selected solid tumors including, HRD+ Ovarian cancer, BRCA1/2 mutant Breast Cancer, HRR mutated prostate cancer, and solid tumors with HRR mutations. The dose escalation to clinically relevant exposures and safety expansion is expected to continue through 2024.

Dr. Shefali Agarwal, Chairwoman of the Board of Directors and CEO, stated:

"The result of this meeting represents one of the key milestones in the development of VIO-01 and the PlatON platform. This is an import step on our way to becoming a leader in the development of innovative drugs with unique mechanisms of action. We are pleased with the encouraging tolerability seen in this first cohort of patients and look forward to bringing this drug-candidate another step closer to patients. Most importantly, we’d like to thank our dedicated investigators and patients for their willingness to participate in this trial and are excited for our continued future work together."