On May 12, 2025 Circle Pharma, a clinical-stage biopharmaceutical company advancing macrocycle therapeutics for difficult-to-treat cancers, reported that its Trials in Progress abstract has been selected for poster presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30 to June 3 in Chicago (Press release, Circle Pharma, MAY 12, 2025, View Source;utm_medium=rss&utm_campaign=circle-pharma-to-present-trials-in-progress-poster-on-cid-078-a-first-in-class-cyclin-a-b-inhibitor-at-the-asco-2025-annual-meeting [SID1234652872]). The poster will showcase the design and ongoing progress of its Phase 1 study of CID-078 (NCT06577987), a first-in-class, oral macrocycle cyclin A/B RxL inhibitor.

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The abstract will be featured in a Poster Session focused on Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology, under the New Targets and New Technologies (non-IO) subtrack.

Presentation Details
Title:

Abstract Title: A phase 1 study to evaluate the safety, pharmacokinetics, and efficacy of the first-in-class cyclin A/B RxL inhibitor CID-078, an orally bioavailable, cell-permeable macrocycle.

First Author: Nehal Lakhani, MD, PhD, The START Center for Cancer Research, Grand Rapids, MI,
Abstract Number: TPS3175
Poster Board Number: 481a
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date & Time: June 2, 2025, from 1:30 PM – 4:30 PM CDT

"CID-078 exemplifies Circle Pharma’s commitment to advancing new treatments for patients with cancer," said Michael C. Cox, PharmD, MHSc, BCOP, SVP, and head of early development of Circle Pharma. "CID-078 has shown strong single-agent activity in tumor models with dysregulated cell cycle pathways, where activity has been linked to specific molecular features such as RB1 mutations and high E2F pathway scores. We believe CID-078 has the potential to be a new treatment option for patients with solid tumors such as small-cell lung cancer or triple-negative breast cancer which are known to harbor these alterations, or solid tumors harboring an RB mutation identified through comprehensive genomic profiling. We are encouraged by the progress of the CID-078 phase 1 study, and we’re excited to share early clinical insights at ASCO (Free ASCO Whitepaper) 2025."

Contributing Authors:
William McKean, Ildefonso Rodriguez Rivera, Antonio Giordano, Timothy Yap, Afshin Dowlati, Vivek Subbiah, Judy Wang, Manali Bhave, Kyaw Thein, Jinshu Fang, Eric Connor, Li-Fen Liu, Peadar Cremin, Lukas Makris, Li-Pen Tsao, Lisa Kopp, Michael Cox, and Shivaani Kummar.

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.

On May 12, 2025 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, reported financial results for the first quarter 2025, ending March 31, 2025, and provided a business update (Press release, Cellectis, MAY 12, 2025, View Source [SID1234652871]).

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« We are making progress in our wholly-owned clinical studies and in the three programs under our strategic partnership with AstraZeneca. We will continue to focus our efforts and resources on advancing these core programs and are looking forward to the results expected over the next few months » said André Choulika, Ph.D., Chief Executive Officer at Cellectis.

Pipeline Highlights

UCART Clinical Programs

BALLI-01 study evaluating lasme-cel (UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)

On April 15, 2025, the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) selected lasmecabtagene timgedleucel (lasme-cel) as recommended international non-proprietary name of UCART22 drug substance.
Cellectis continues to focus on the enrollment of patients in the BALLI-01 study and expects to present the Phase 1 dataset and late-stage development strategy for lasme-cel in r/r B-ALL in the third quarter of 2025.

NATHALI-01 study evaluating eti-cel (UCART20x22) in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r NHL)

On April 15, 2025, the INN Expert Committee of the WHO selected etivelcabtagene erigedleucel (eti-cel) as recommended international non-proprietary name of UCART20x22 drug substance.
Cellectis continues to focus on the enrollment of patients in the NATHALI-01 study and expects to present a Phase 1 readout for eti-cel in r/r NHL in late 2025.
Research Data & Preclinical Programs

Novel Non-Viral Gene Editing and Base Editing Research

On April 28, 2025, Cellectis announced the presentation of research data on TALEN-mediated non-viral transgene insertion for advancing cellular and gene therapies, and advancements in genetic editing using TALE base editors (TALEB), at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting that will be held on May 13-17, 2025 in New Orleans. The data will be presented in two posters:
TALEN- Mediated non-viral Transgene Insertion for the Advancement of Cellular and Gene Therapies

In this work, Cellectis combines TALEN-mediated gene editing with non-viral transgene insertion for advancing cellular and gene therapies and explores gene insertion-efficacy and cellular health using single-stranded DNA (ssDNA) for payload delivery in different cell types.
This innovative approach has the potential to address the challenges associated with traditional lentiviral viral methods or AAV-mediated transgene insertion such as manufacturing constraints, potential genomic toxicities or limited payload size.
High fidelity C-to-T editing with TALE base editors

TALE base editors (TALEB) are fusions of a transcription activator-like effector domain (TALE), split-DddA deaminase halves, and an uracil glycosylase inhibitor (UGI). The C-to-T class of TALEB edits double-stranded DNA by converting a cytosine (C) to a thymine (T) and does not involve a DNA strand nick. Cellectis has developed a method to evaluate TALEB activity, analyzing factors affecting its efficiency. Using precise ssODN knock-in in primary T cells, the method assesses how target sequence composition and spacer variations impact TALEB performance.
Overall, the results of this study enhance the control and use of TALEB, allowing for the design of highly efficient and specific TALEB compatible with future potential therapeutic applications.
The abstracts are live on the ASGCT (Free ASGCT Whitepaper) website. The posters will be available on Cellectis’ website the first day of the event.

Partnerships

AstraZeneca Joint Research and Collaboration Agreement

Research and development activities are ongoing under three cell and gene therapy programs under the joint research and collaboration agreement entered into by Cellectis and AstraZeneca in November 2023: one allogeneic CAR T for hematological malignancies, one allogeneic CAR T for solid tumors, and one in vivo gene therapy for a genetic disorder.

On May 12, 2025 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the first quarter ended March 31, 2025, and provided a business update (Press release, Bolt Biotherapeutics, MAY 12, 2025, View Source [SID1234652870]).

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"We continue to make progress advancing our pipeline of first-in-class, novel immunotherapies," said Willie Quinn, Chief Executive Officer. "We recently presented promising early clinical data for BDC-3042 at AACR (Free AACR Whitepaper) and launched a process to find a partner to accelerate BDC-3042 development. We also just opened enrollment for the first next-generation Boltbody ISAC in our pipeline, BDC-4182. We are excited to see what our ISAC platform technology can do for gastric and gastroesophageal cancer patients. We continue to be good stewards of capital as we execute against our mission to deliver new treatment options to patients with cancer."

Recent Highlights and Anticipated Milestones

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Clinical data from Phase 1 dose-escalation study of BDC-3042 presented at AACR (Free AACR Whitepaper) Annual Meeting 2025 in April 2025. BDC-3042 is a proprietary agonist antibody that targets dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). This single-agent, dose-escalation Phase 1 clinical study is evaluating BDC-3042 in patients with metastatic or unresectable solid tumors including non-small cell lung cancer (NSCLC). The dose-escalation data support the selection of 10 mg/kg q2w as a recommended Phase 2 dose (RP2D), alongside potential exploration of other doses and schedules. The results support further clinical development in NSCLC and other post-immunotherapy settings, as patients previously treated with PD-(L)1 inhibitors appear to have more dectin-2 expression and may experience improved outcomes. Bolt is running a process to find a partner with resources to accelerate development and optimize commercialization.
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BDC-4182 Phase 1 study for patients with gastric and gastroesophageal cancer opened for enrollment in April 2025. BDC-4182 is a next-generation BoltbodyTM ISAC clinical candidate targeting claudin 18.2, a clinically validated target in oncology with expression in gastric/gastroesophageal junction cancer, pancreatic cancer, and other tumor types. Preclinically, monotherapy treatment with BDC-4182 generated complete regressions in multiple models and BDC-4182 was tolerated in toxicology studies. BDC-4182 outperformed cytotoxic claudin 18.2 ADCs, using MMAE or TOPO1, in multiple preclinical studies.
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Presented preclinical results for next-generation Boltbody ISACs targeting CEA and PD-L1 at AACR (Free AACR Whitepaper) Annual Meeting 2025 in April 2025.

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Bolt’s lead CEA-targeting ISAC comprises a novel, fully human antibody with high affinity and selectivity to CEACAM5 (CEA), and not to other members of the CEACAM family, conjugated to a propriety TLR7/8 agonist via a non-cleavable linker. This ISAC drives enhanced phagocytosis of CEA-positive tumor cells and stimulates production of critical immune-activating cytokines including IL-12p70, IFNg, and TNFa. The next-generation CEA ISAC induced complete and durable anti-tumor responses in mice and was well-tolerated in NHPs.
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Bolt’s PD-L1 ISAC utilizes a novel human anti-PD-L1 antibody conjugated to a TLR7/8 agonist via a non-cleavable linker. This ISAC leverages a unique mechanism of action due to its ability to target both tumor and immune cells that express PD-L1. Preclinical results demonstrated that PD-L1 ISACs represent a compelling new approach to treat cancer, leveraging mechanisms that are distinct from and potentially complementary to conventional PD-1/PD-L1 blockade.
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Collaborations with Genmab and Toray continue to progress. Genmab and Bolt have now selected a second product to advance into development, while the companies also continue research and development on additional programs. The Toray collaboration combines the Company’s immunostimulatory linker-payloads with Toray antibodies targeting Caprin-1, a tumor-specific antigen that is strongly expressed on the cell membrane in multiple solid tumor types.
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Cash, cash equivalents, and marketable securities were $58.0 million as of March 31, 2025. Cash on hand is expected to fund multiple milestones and operations through mid-2026.

First Quarter 2025 Financial Results

• Collaboration Revenue – Total collaboration revenue was $1.2 million for the quarter ended March 31, 2025, compared to $5.3 million for the same quarter in 2024. Revenue in the comparative periods was generated from services performed under the R&D collaborations as we fulfill our performance obligations. The decrease in revenue in the comparative period was mainly due to the $3.5 million revenue recognized under the Amended Innovent Agreement, as we completed our performance obligation to Innovent.

• Research and Development (R&D) Expenses – R&D expenses were $9.5 million for the quarter ended March 31, 2025, compared to $16.5 million for the same quarter in 2024. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses, a decrease in clinical expenses primarily related to the discontinued development of trastuzumab imbotolimod, formerly known as BDC-1001 in May 2024.

• General and Administrative (G&A) Expenses – G&A expenses were $3.8 million for the quarter ended March 31, 2025, compared to $5.8 million for the same quarter in 2024. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of the May 2024 restructuring.

• Loss from Operations – Loss from operations was $12.1 million for the quarter ended March 31, 2025, compared to $17.1 million for the same quarter in 2024.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer.

On May 12, 2025 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported financial results for the first quarter ended March 31, 2025, and provided a corporate update (Press release, Black Diamond Therapeutics, MAY 12, 2025, View Source [SID1234652869]).

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"We continue to execute on enrollment in our BDTX-1535 Phase 2 trial for the treatment of newly diagnosed patients with EGFRm NSCLC and look forward to providing a clinical update in the fourth quarter of 2025," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "Our recently announced global licensing agreement with Servier for BDTX-4933 provides us with a strong cash position and runway into the fourth quarter of 2027. Pending FDA feedback in the fourth quarter of 2025, we believe we are well-positioned to begin pivotal development of BDTX-1535 in the first half of 2026."

Recent Developments & Upcoming Milestones:

BDTX-1535:

In the fourth quarter of 2025, Black Diamond expects to disclose initial Phase 2 clinical data for BDTX-1535 in newly diagnosed patients with non-classical epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) (NCT05256290) and plans to solicit U.S. Food and Drug Administration (FDA) feedback on a potential pivotal registrational path.
In April 2025, investigators at the Ivy Brain Tumor Center presented a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting titled: A Phase 0/1 ‘trigger’ trial of BDTX-1535 in recurrent glioblastoma (GBM) patients with EGFR alterations or fusions. The data showed encouraging pharmacokinetic and safety data for BDTX-1535 in recurrent EGFR-positive GBM patients, providing a strong rationale for the program’s continued expansion into newly diagnosed EGFR-positive GBM patients.
In March 2025, the investigator sponsored Phase 0/1 trial was expanded into newly diagnosed GBM patients with epidermal growth factor receptor (EGFR) alterations. The trial is sponsored by the Ivy Brain Tumor Center in Phoenix, Arizona (NCT06072586).
Corporate

In March 2025, Black Diamond announced a global licensing agreement with Servier Pharmaceuticals LLC (Servier) for BDTX-4933, a small molecule designed by Black Diamond to address unmet medical needs in RAF/RAS-mutant solid tumors. Pursuant to the terms of the agreement, Servier will lead the development activities and the worldwide commercialization of BDTX-4933 across multiple indications, including NSCLC, with potential applications in other solid tumors. Under the agreement, Black Diamond received an upfront payment of $70.0 million in March 2025 and will be eligible to receive up to $710.0 million in development and commercial sales milestone payments, along with tiered royalties based on global net sales.
Financial Highlights

Cash Position: Black Diamond ended the first quarter of 2025 with approximately $152.4 million in cash, cash equivalents, and investments compared to $98.6 million as of December 31, 2024. Net cash provided by operations was $53.4 million for the first quarter of 2025 compared to net cash used in operations of $21.2 million for the first quarter of 2024.
Research and Development Expenses: Research and development (R&D) expenses were $10.5 million for the first quarter of 2025, compared to $13.5 million for the same period in 2024. The decrease in R&D expenses was primarily due to workforce efficiencies and increased focus on advancing and optimizing development plans for BDTX-1535.
General and Administrative Expenses: General and administrative (G&A) expenses were $5.0 million for the first quarter of 2025, compared to $6.7 million for the same period in 2024. The decrease in G&A expenses was primarily due to the restructuring announced in October 2024.
Net Income/Loss: Net income for the first quarter of 2025 was $56.5 million, as compared to a net loss of $18.2 million for the same period in 2024.
Financial Guidance

Black Diamond ended the first quarter of 2025 with approximately $152.4 million in cash, cash equivalents and investments, which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the fourth quarter of 2027.

On May 12, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported it will showcase its latest spatial biology and cell and gene therapy workflow solutions at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2025 meeting taking place in New Orleans between May 13th – 17th at the New Orleans Ernest N. Morial Convention Center (Press release, Bio-Techne, MAY 12, 2025, View Source [SID1234652866]).

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Bio-Techne will feature its cutting-edge advancements for cell and gene therapy development and manufacturing at booth 1537. Highlights include the new RNAscope protease-free workflow for visualization of biodistribution of AAV vectors, transgene mRNA, small RNAs (ASO, siRNA, miRNA) along with functional RNA and protein markers. Bio-Techne’s booth will also showcase its solutions to improve cell therapy workflows, including the ProPak GMP cytokines in dose-optimized, single-use bags with weldable tubing for closed-system cell therapy manufacturing, and new AI-modified, designer proteins. The next-generation Simple Western Leo System will also be featured, with this state-of-the-art instrument enabling the simultaneous processing of up to 100 samples in a single 3-hour run.

Leading researchers along with Maithreyan Srinivasan, PhD, Chief Scientific Officer, Advanced Cell Diagnostics (ACD), a Bio-Techne brand, will present the latest innovations with RNAscope technology at ACD’s symposium on Wednesday, May 14th at 8:30 am in room 383-385. This session will highlight NextGen RNAscope Multiomics Solutions for Spatial Precision: AAV, small RNA, CAR-T, and Beyond. Our distinguished guest speakers include:

Adrian Veres, MD, PhD, Cofounder & Chief Scientific Officer at Dyno Therapeutics will present on "In Vivo Validation of AI-designed AAV Capsids for Targeted Gene Delivery to NHPs."
William (Wes) Salomon, PhD, Senior Director, Delivery Biology, Tessera Therapeutics will speak on "Visualizing RNA Gene Writer Activity in Mouse Liver for the Potential Therapeutic Correction of Monogenic Disease Mutations."
Another talk, moderated by Edward Pavina (Bio-Techne) will be presented on Thursday, May 15th from 12:15 – 1:15 PM in Room 383: "Protein Quantitation Applications to Advance Gene Therapy Development – From Discovery Through Analytical Development" with guest Speakers Julyana Acevedo PhD, Analytical Development Scientist, Sangamo Therapeutics and Nicolas Tricaud PhD, Co-founder, CEO/CS, Nervosave Therapeutics.

"Bio-Techne is leading the forefront of advancing cell and gene therapy development with cutting edge tools and technologies," commented Kim Kelderman, President and Chief Executive Officer of Bio-Techne. "This conference highlights the frontier of pre-clinical and clinical advanced therapeutic development and paves the way for building safe and effective therapies for a multitude of disorders."

For Research Use Only. Not for use in diagnostic procedures.