On June 16, 2025 Shasqi, Inc. ("Shasqi"), a biotech company whose mission is to make cancer drugs more effective with pre-targeting enabled by click chemistry, reported the publication of a manuscript detailing the preclinical development and translation of SQ3370 to a first-in-human dose-escalation clinical trial in patients with advanced solid tumors (Press release, Shasqi, JUN 16, 2025, View Source [SID1234653928]).

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The manuscript titled, Development of a first-in-class click chemistry-based cancer therapeutic, from preclinical evaluation to a first-in-human dose escalation clinical trial, was published today in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

"This groundbreaking clinical validation marks a paradigm shift in oncology—we’ve demonstrated for the first time that in vivo click chemistry can be used in humans to pre-target and concentrate therapeutics at tumor sites," said Dr. Sangeetha Srinivasan, Director of In-Vivo Biology at Shasqi. "By decoupling tumor targeting from the payload, our CAPAC platform enables delivery of 12-fold higher doses of doxorubicin per cycle compared to conventional approaches, while reducing systemic toxicity."

Shasqi’s Click Activated Protodrugs Against Cancer (CAPAC) platform is a pre-targeting technology composed of a tumor binding agent and a protodrug. Administered sequentially, these components are designed to only click with each other via a click chemistry reaction occurring directly at the tumor site. This releases high concentrations of cancer drugs at the tumor while sparing healthy tissues.

The manuscript describes the development and first-in-human study of SQ3370, an intratumorally injected biopolymer paired with a doxorubicin payload, and the first in vivo click chemistry based therapeutic to be tested in humans. In the study, 12x the standard dose of doxorubicin was administered per cycle with mild and manageable toxicities, including less than anticipated myelosuppression. The lack of immunosuppression and high drug doses enabled T-cell-dependent immune responses, including cytotoxic CD8 + T-cell expansion and activation in tumors and systemically.

"The significance of this work expands far beyond the current study, as it demonstrates that click chemistry can be harnessed inside the human body to redefine how therapeutics are activated in the body," said Carolyn Bertozzi, PhD, Professor of Chemistry at Stanford University, and winner of the Nobel Prize for Chemistry in 2022 for the development of click and biorthogonal chemistry. "This study shows that biorthogonal chemical groups and their reaction products are tolerated in humans, unlocking a new frontier for oncology innovation and beyond."

"This breakthrough study shows, for the first time, that click chemistry can be used inside the human body to activate cancer drugs at the tumor," said Jason S. Lewis, PhD, whose work as the Emily Tow Chair in Oncology and Deputy Director of Sloan Kettering Institute (OSET) at Memorial Sloan Kettering Cancer Center in New York is focused on pre-targeting radiopharmaceutical therapies using click chemistry. "This opens up new opportunities for targeted delivery of other cancer therapeutics such as radiopharmaceutical therapy."

On June 16, 2025 Immumem Therapeutics, an emerging biotechnology company focused on developing novel oncology therapeutics, reported it has been awarded a $75,000 non-dilutive grant from ScaleReady’s G-Rex Grant Program (Press release, Immumem Therapeutics, JUN 16, 2025, View Source [SID1234656571]). This funding will support the advancement of Immumem’s innovative manufacturing processes for next-generation cell therapies.

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The competitive grant provides Immumem with critical resources to expand its research platform and accelerate development timelines in the cell and gene therapy space. The award package includes access to advanced bioreactor technology, specialized reagents, and expert consulting services designed to enhance the company’s pre-clinical development capabilities.

"This non-dilutive funding represents a significant opportunity to accelerate our cell therapy manufacturing capabilities while preserving shareholder value," stated a spokesperson for Immumem Therapeutics. "The support from ScaleReady’s G-Rex Grant Program will enable us to optimize our production processes and advance our therapeutic pipeline toward key developmental milestones."

The G-Rex Grant Program is specifically designed to foster innovation within the cell and gene therapy sector by providing promising biotechnology companies with the resources needed to overcome manufacturing challenges and accelerate therapeutic development.

Immumem Therapeutics will utilize the grant to further refine its proprietary cell therapy manufacturing platform, with the goal of improving production efficiency and therapeutic potency. This advancement aligns with the company’s mission to develop more effective and accessible treatments for patients with cancer and other serious diseases.

For more information about Immumem Therapeutics and its development programs, please visit www.immumemtx.com or the company’s knowledge center.

On June 16, 2025 Circio Holding ASA (OSE: CRNA), a biotechnology company developing circular RNA technology for gene and cell therapy and mutant RAS-targeting cancer vaccines, reported that interim data from the TG01 phase 1/2 clinical trial in multiple myeloma at Oslo University Hospital (OUS) has been presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 annual meeting in Milan, Italy (Press release, Circio, JUN 16, 2025, View Source [SID1234653913]).

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The results show preliminary signals of clinical efficacy for TG01 vaccination and confirm an excellent safety profile, thus providing justification for continued clinical development for a major unmet medical need. The trial is a collaboration between OUS and Circio to test TG01/QS-21 vaccination as a monotherapy in 20 KRAS or NRAS mutated multiple myeloma patients with remaining measurable disease after completion of standard of care treatment. The aim is to assess whether T-cell responses to mutant RAS induced by TG01 can enhance and prolong the clinical benefit. OUS is the study sponsor, with Dr. Hanne Norseth as the primary investigator.

"RAS-mutant multiple myeloma has poor prognosis and there are currently no available targeted treatment options for this patient population," said Dr. Fredrik Schjesvold, Founder and Leader Oslo Myeloma Center, at Oslo University Hospital, and President of the Nordic Myeloma Study Group "Interim data from the first twelve patients demonstrate the capability of TG01 to induce RAS-specific T-cell responses in a subset of patients, and suggest that these responses are associated with disease stabilization. This is an important early indication of clinical benefit. We look forward to completing the study, including a broad set of genetic and immunological analyses, which will help us build the understanding of how TG01 vaccination can fit as a future treatment option to deepen and prolong responses in this underserved patient population."

Oncogenic RAS mutations drive up to 30% of all cancers and an estimated 15-20% of multiple myelomas, and remain a major unmet medical need with few effective treatment alternatives. Circio has previously been awarded two prestigious research grants from Innovation Norway and the Norwegian Research Council to advance the TG mutant RAS cancer vaccine program. These grants have provided funding towards two active clinical studies, including the present multiple myeloma study at OUS, Norway, and a phase 2 trial at Georgetown University, Washington D.C. USA, where TG01 is tested in pancreatic and lung cancer.

"Consistent with our prior observations in pancreatic cancer, it is very reassuring that this early-stage multiple myeloma trial has generated results showing immunological activity of the TG01 vaccine associated with clinical benefit," said Dr. Victor Levitsky, Chief Scientific Officer of Circio Holding ASA. "The biomarker findings are consistent with the current understanding of tumor immune control requiring a proper match between the characteristics of the tumor and the of patient´s genetic buildup. This important connection provides a mechanistic validation of clinical benefit and suggests specific biomarkers to select patients who can benefit most from TG01 treatment in follow-up clinical studies. We will continue to pursue our strategy to develop TG01 through external partnerships in parallel with our core in house circular RNA program."

Poster title:
The phase I/II TG01-study: Vaccinating against RAS-mutated Multiple Myeloma

Presentation date and location:
14 June 2025, EHA (Free EHA Whitepaper) 2025 Annual Meeting, Milan – Italy

The main conclusions from the poster presentation were as follows:

Available data demonstrate excellent tolerability and safety of TG01/QS-21 vaccination
50% (6/12) of vaccinated patients show vaccine-induced specific T-cell responses against mutant K/N-RAS-peptides
50% (6/12) of patients remain on study with stable disease (SD), no objective responses have so far been observed
67% (4/6) of patients with SD had a K/N-RAS-peptide specific immune response by ELISPOT (1/2 negative patients fell very narrowly below positivity threshold)
Enrollment and analysis of the TG01 vaccine-specific responses are ongoing

On June 16, 2025 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma", SSE: 600196, HKEX: 02196) reported that the companies, through their respective subsidiaries, have entered a strategic partnership for the development of investigational TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy (Press release, Teva, JUN 16, 2025, View Source [SID1234653929]). Teva’s internally developed ATTENUKINE technology provides a new mechanism of action, potentially offering high efficacy and low toxicity in a broad array of oncology indications.

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Under the terms of the agreement, which aims to accelerate clinical data generation, Fosun Pharma is granted an exclusive license to develop, manufacture and commercialize TEV-56278 in Chinese mainland, Hong Kong Special Administrative Region (SAR), Macau SAR and Taiwan region and select Southeast Asian countries. Teva retains all development, manufacturing and commercialization rights to the licensed molecule in the rest of the world. The strategic partnership presents a significant step forward in the global development of TEV-56278, giving Teva the opportunity to leverage Fosun Pharma-generated data in other geographies.

"This partnership with Fosun Pharma in the development of our internally developed TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy with the potential to treat devastating cancers, is the latest advance to ensuring acceleration of our pipeline," said Eric Hughes, MD, PhD, Executive Vice President, Teva Global R&D and Chief Medical Officer. "TEV-56278 demonstrates the strength of Teva’s innovative drug development capabilities and how strategic partnerships with companies such as Fosun Pharma play a pivotal role in advancing therapies on behalf of patients."

Anti-PD1-IL2 fusion proteins like TEV-56278 represent a novel approach to cancer immunotherapy. TEV-56278 is designed to deliver IL-2 selectively to PD-1+ T cells, thus amplifying anti-tumor T-cell activity while minimizing off-target systemic toxicities. The targeted approach holds promise for improving outcomes for patients with a variety of oncology diseases.

"We are pleased to partner with Teva on the development of TEV-56278," said Xingli WANG, MD, PhD, Executive President of Fosun Pharma and CEO of the Global R&D Center, "This collaboration brings together Teva’s expertise in innovative drug development with Fosun Pharma’s strong oncology development experience and commercial capabilities in the China market, creating a powerful synergy to accelerate the delivery of this important therapy to patients globally."

About TEV-56278

TEV-56278 is an anti-PD-1 antibody-cytokine fusion protein designed to selectively deliver an interleukin-2 (IL-2), i.e., ATTENUKINE, to PD-1-expressing T cells within the tumor microenvironment. This targeted approach aims to amplify anti-tumor T-cell activity while minimizing systemic toxicities. TEV-56278 is being evaluated as a monotherapy and in combination with pembrolizumab. Preclinical data has demonstrated tumor regression, enhanced T-cell infiltration, and durable immune memory.

On June 16, 2025 Circle Pharma, a clinical-stage biopharmaceutical company advancing macrocycle therapeutics for difficult-to-treat cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CID-078 for the treatment of small cell lung cancer (SCLC) (Press release, Circle Pharma, JUN 16, 2025, View Source;utm_medium=rss&utm_campaign=circle-pharma-receives-fda-orphan-drug-designation-for-cid-078-for-the-treatment-of-small-cell-lung-cancer [SID1234653914]).

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Small-cell lung cancer is a highly aggressive form of lung cancer that accounts for approximately 13–15% of all lung cancer cases1 and is strongly linked to tobacco exposure. Despite existing treatments, SCLC has a high recurrence rate and is associated with poor overall prognosis. While improvements in overall survival are occurring with newer therapies, most patients experience rapid disease progression2.

"The Orphan Drug Designation from the FDA underscores both the seriousness of small cell lung cancer and the lack of effective treatment options," said Michael C. Cox, PharmD, MHSc, BCOP, SVP, and head of early development Circle Pharma. "We are committed to accelerating the clinical development of CID-078 to offer new hope for patients who face limited therapeutic choices."

The FDA’s Orphan Drug Designation program is intended to promote the development of drugs for rare diseases or conditions affecting fewer than 200,000 people in the United States3. This designation provides several development incentives, including seven years of market exclusivity upon regulatory approval, tax credits for qualified clinical trial costs, and eligibility to apply for FDA-administered research grants4.

Circle Pharma has initiated a Phase 1 clinical trial (NCT06577987) of CID-078 to evaluate its safety, tolerability, pharmacokinetics, and early signs of anti-tumor activity in patients with advanced solid tumors, including SCLC.

About CID-078, Circle Pharma’s Cyclin A/B RxL Inhibitor Program
CID-078 is an orally bioavailable macrocycle with dual cyclin A and B RxL inhibitory activity that selectively targets tumor cells with oncogenic alterations that cause cell cycle dysregulation. In biochemical and cellular studies, Circle Pharma’s cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and Myt1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple in vivo models. A multi-center phase 1 clinical trial (NCT06577987) is currently enrolling patients.