BullFrog AI to Present at Biotech Showcase and RESI JPM During JP Morgan Week

On January 10, 2025 BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, reported its participation in the TechBio track at Biotech Showcase and RESI JPM, both taking place during the annual JP Morgan Healthcare Conference in San Francisco, January 13–16, 2025 (Press release, Bullfrog AI, JAN 10, 2025, View Source [SID1234649590]).

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At both Biotech Showcase and RESI JPM, BullFrog AI will highlight its proprietary BullFrog Data Networks, a data insights tool powered by the bfLEAP platform. BullFrog Data Networks evaluate high-dimension, multi-modal data in specific disease indications, providing a customized, visual representation of previously unknown relationships and pathways. The networks leverage a wide range of data inputs, including publicly available datasets such as the Human Cell Atlas (HCA), The Cancer Genome Atlas (TCGA), and Gene Expression Omnibus (GEO), as well as proprietary or custom data sources.

BullFrog Data Networks address a key challenge faced by pharmaceutical and biotechnology companies: turning vast and complex datasets into actionable insights. The platform uses machine learning to holistically analyze data, revealing hidden insights that manual methods cannot uncover. These insights are presented in an intuitive visual format that enables users to explore individual nodes or clusters, examine relationships, and derive actionable conclusions.

BullFrog AI has demonstrated proof of concept for BullFrog Data Networks in its own research and development pipeline, focusing on colorectal cancer and multiple neuropsychiatric indications. These networks have a wide range of applications, including target identification and validation, understanding mechanisms of action, optimizing clinical trials, and drug repurposing. By accelerating the generation of novel insights, BullFrog Data Networks aim to transform approaches to drug development by reducing timelines and improving outcomes.

Powered by the bfLEAP platform, BullFrog Data Networks are purpose-built to deliver answers to critical questions throughout the drug development lifecycle. From early target discovery to understanding drug safety and tolerability, the networks can help streamline development processes and optimize clinical trial design by identifying suitable patient populations for the appropriate trials. BullFrog Data Networks represent an advancement in the Company’s mission to revolutionize drug discovery and development.

Bio-Techne Expands R&D Systems AI-Engineered Designer Protein Portfolio to Advance Cell Therapy and Regenerative Medicine

On January 10, 2025 Bio-Techne (NASDAQ: TECH), a global leader in life science tools and reagents, reported the launch of new designer proteins engineered using advanced Artificial Intelligence (AI) based design platforms and protein evolutionary workflows (Press release, Bio-Techne, JAN 10, 2025, View Source [SID1234649589]). This expanded portfolio from Bio-Techne’s R&D Systems brand includes IL-2 Heat Stable Agonist, Activin A Hyperactive, FGF basic Heat Stable (available both for research use only (RUO) and made under good manufacturing processes (GMP) for therapeutic development), as well as Wnt/RSPO1 Agonist, Wnt/RSPO2 Agonist, and Wnt/RSPO3 Agonist proteins.

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These innovative recombinant proteins are designed and engineered to address critical needs in cellular therapy workflows and research applications, including improved cell culture performance and optimized cell expansion. Leveraging generative AI trained on data developed over almost five decades of proteomic leadership, protein library evolution, and rational design, Bio-Techne’s expanded portfolio delivers next-generation cytokines and growth factors with tailored functionalities such as hyperactivity, enhanced receptor affinities, and improved heat stability.

"Our growing portfolio of designer proteins combine cutting-edge AI technology and innovative protein engineering," said Will Geist, President, Protein Sciences Segment. "This expanded portfolio empowers our customers with versatile, high-performance solutions to boost the production of immune cells and enhance regenerative medicine cell therapies. Bio-Techne remains committed to developing the tools and workflow solutions our customers need to advance innovative cell therapies in both clinical and research settings."

The new products include:

IL-2 Heat Stable Agonist: Engineered with enhanced thermal stability and altered receptor affinity for improved biological activity, ideal for cellular therapy applications such as CAR T-cell or Tumor-infiltrating lymphocytes (TIL) expansion.

Activin A Hyperactive: Optimized for superior performance in regenerative medicine cell differentiation applications.

FGF basic Heat Stable: A robust and versatile growth factor designed for improved protein stability and performance for stem cell culture applications, available in both RUO and GMP formats to support cell therapy manufacturing and advanced research.

Wnt/RSPO1, Wnt/RSPO2, and Wnt/RSPO3 Agonists: Key reagents for advancing stem cell research, organoid development, and regenerative medicine.

Bio-Path Holdings Provides 2025 Clinical and Operational Update

On January 10, 2025 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer and obesity drugs, reported a clinical development and operational update for 2025 (Press release, Bio-Path Holdings, JAN 10, 2025, View Source [SID1234649588]).

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"The important work we conducted throughout 2024 has led us into what we believe is an exciting 2025 as we build off positive data generated in oncology and the addition of a new application for BP1001-A in the treatment of obesity for Type 2 Diabetes. This new application compels us to advance these studies as quickly as possible and to file for regulatory designations that could accelerate our path to approval," said Peter H. Nielsen, President and Chief Executive Officer of Bio-Path. "There is no greater challenge than the battle against cancer, and developing effective new medicines for patients suffering with few treatment options is what drives us every day. The addition of development of a potential treatment for obesity in Type 2 Diabetes patients follows this pathway as these patients need treatment beyond current weight loss drugs to support needed therapy for reducing glucose levels, which has positive impact across a number of different health-related conditions. The substantial progress we have made gives us further confidence that our DNAbilize platform is ushering in a new path of DNA-powered medicines that can make a difference in the lives of these patients."

Clinical Program Overview

Bio-Path’s clinical development program consists of one Phase 2 clinical trial, two Phase 1 or 1/1b clinical trials, and two preclinical programs. Bio-Path has developed a molecular biomarker package for its Phase 2 clinical trial in acute myeloid leukemia (AML) that was developed to identify patients that potentially have a higher propensity to respond to prexigebersen treatment. Bio-Path expects to utilize the biomarker package to accompany prexigebersen treatment in 2025 and expects to evaluate prexigebersen for the treatment of obesity. In addition, BP1001-A is in preclinical development for treatment of obesity in Type 2 Diabetes patients, which may be submitted to the U.S. Food and Drug Administration (FDA) later in the year in an Investigational New Drug (IND) application.

Development of Molecular Biomarkers – Bio-Path has developed a molecular biomarker package to accompany prexigebersen treatment, the goal of which is to identify patients with a genetic profile more likely to respond to treatment thereby improving probability of success for this program. The emerging role of biomarkers has been enhancing cancer development over the past decade and has become a more common companion to many cancer development programs. Bio-Path expects to utilize the prexigebersen biomarkers in 2025 in the Phase 2 AML clinical trial and to develop additional molecular biomarker packages to accompany its new programs.

Prexigebersen Phase 2 Clinical Trial – Bio-Path’s Phase 2 clinical trial for the treatment of AML is comprised of three cohorts of patients and treatments, each separately approvable by the FDA as a new indication. The first two cohorts are treating patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort includes untreated AML patients, and the second cohort includes relapsed/refractory AML patients. Finally, the third cohort is treating relapsed/refractory AML patients who are venetoclax-resistant or intolerant with the two-drug combination of prexigebersen and decitabine. Outcomes for these older patients who are unable to receive intensive chemotherapy due to the challenging side effect profile, remain suboptimal with a median survival of only 5 to 10 months. Bio-Path also expects to utilize an advisory panel of AML experts to assist in the design of the final clinical development plans through potential FDA approval. Other significant milestones expected during 2025 include the completion of Cohort 2 and an interim analysis for Cohort 3.

Phase 1/1b Clinical Trial in BP1001-A in Advanced Solid Tumors – A Phase 1/1b clinical trial of BP1001-A in patients with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer, is ongoing. BP1001-A is a modified product candidate that incorporates the same drug substance as prexigebersen but has a slightly modified formulation designed to enhance nanoparticle properties. The Phase 1 study has advanced to the second, higher dose level and the first patient in the second dose cohort continued experiencing a positive response which may signal that this analog of prexigebersen has potential as a new treatment for advanced solid tumors. The patient continues to be doing well after ten months on study after failing extensive chemotherapy and surgical treatment for gynecologic cancer, demonstrating a 15% reduction in her primary tumor through nine cycles of treatment. Moreover, it appears that these positive outcomes may have contributed to allowing her to continue with rigorous exercise and improved quality of life. Completion of the second and third dosing cohorts are expected in 2025.

The Phase 1b portion of the study is expected to commence after successful completion of the three BP1001-A monotherapy dose level cohorts and is intended to assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Phase 1b studies are also expected to be initiated in combination with gemcitabine in Stage 4 pancreatic cancer and combination therapy in breast cancer.

Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML – A Phase 1/1b clinical trial for BP1002 to treat relapsed/refractory AML patients, including venetoclax-resistant patients, is ongoing. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. Venetoclax treats AML patients by blocking the activity of the Bcl-2 protein in AML patients. However, over time patients become resistant to venetoclax. BP1002 treats the Bcl-2 target by blocking the cell’s ability to produce Bcl-2 and could provide benefit for these venetoclax resistant patients. AML patients that fail frontline venetoclax-based therapy have very poor prognosis with median overall survival of less than three months. The first dose cohort consisted of a starting dose of 20 mg/m2, the second dose cohort of 40 mg/m2 and there were no dose limiting toxicities. The third dosing cohort of 60 mg/m2 is open and enrollment closed faster than expected which Bio-Path believes reflects the need for additional treatment options.

Prexigebersen as Potential Treatment for Obesity in Type 2 Diabetes Patients – BP1001-A downregulates Grb2 expression to increase insulin sensitivity and helps lower blood glucose level in Type 2 diabetes patients. Scientific evidence suggests that by downregulating Grb2 expression, BP1001-A could help lower blood glucose levels by affecting insulin signaling. Bio-Path conducted preclinical studies that confirmed the effectiveness of BP1001-A in affecting insulin signaling and its potential efficacy as a therapeutic treatment for obese patients who have Type 2 diabetes. In 2025, Bio-Path expects to complete preclinical testing and to file an IND.

Intellectual Property Protection

Bio-Path’s composition of matter patents are designed to protect encroachment from third parties on its proprietary products. These composition patents allow the Company to apply its core technology to new protein targets and receive new 20-year patents. Bio-Path’s patent portfolio is as follows:

Composition and methods of use patents issued cover DNAbilize technology, solely owned by Bio-Path.
Seven patents issued in the U.S. with one additional application allowed; 61 foreign patents issued across 24 countries; five additional foreign patent applications allowed; three applications pending in the U.S. along with more than 30 applications pending in foreign jurisdictions.

Arvinas Updates Guidance for First- and Second-Line Phase 3 Combination Trials with Vepdegestrant, Highlights Upcoming Milestones, and Provides Corporate Update

On January 10, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported updated guidance for the planned first- and second-line combination clinical trials for vepdegestrant in patients with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer, highlighted key upcoming milestones and provided a corporate update (Press release, Arvinas, JAN 10, 2025, View Source [SID1234649587]).

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"We are on the cusp of a major transformation in 2025, with the potential to provide significant benefit to patients and meaningful value to our stockholders," said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. "We are on track to report topline results from our first Phase 3 trial in the first quarter and to initiate two additional Phase 3 trials by the end of the year. In the first half of 2025, we plan to present the first-in-human data from ARV-102, our PROTAC LRRK2 degrader, which we believe will highlight the potential value that our PROTAC degraders may offer for patients with neurodegenerative diseases. And finally, we plan to share initial data from our Phase 1 trial with ARV-393, our PROTAC BCL6 degrader, which will provide an early look the tolerability and efficacy in patients with B-cell lymphomas."

Select milestones anticipated in 2025

Vepdegestrant: Oral PROTAC ER degrader

As part of Arvinas’ global collaboration with Pfizer, in 2025 the companies plan to:

Announce topline data for the VERITAC-2 Phase 3 monotherapy clinical trial in patients with second-line-plus ER+/HER2- metastatic breast cancer (mBC) (1Q25).
Initiate two new Phase 3 combination trials in patients with ER+/HER2- mBC (pending emerging data and regulatory feedback):
First-line Phase 3 combination trial with Pfizer’s novel investigational CDK4 inhibitor, atirmociclib.
Second-line Phase 3 combination trial with a CDK4/6 inhibitor.
With the prioritization of the vepdegestrant plus atirmociclib combination for the first-line setting, the VERITAC-3 trial evaluating vepdegestrant plus palbociclib in the first-line will not proceed beyond the study lead-in.

ARV-102: Oral PROTAC LRRK2 degrader

Present single-ascending dose data from the ongoing Phase 1 clinical trial in healthy volunteers in an oral session at the Alzheimer’s Disease/Parkinson’s Disease (AD/PD) conference in Vienna, Austria (April 1-4, 2025).
Complete enrollment and present initial data from the ongoing Phase 1 clinical trial in patients with Parkinson’s disease.
ARV-393: Oral PROTAC BCL6 degrader

Present initial data from the ongoing Phase 1 clinical trial in patients with B-cell lymphomas (NCT06393738).
Novel PROTAC KRAS G12D degrader

File an Investigational New Drug (IND) application.
Corporate update
Alex Santini, Arvinas’ Senior Vice President, Global and U.S. Market Access, has been appointed interim Chief Commercial Officer, effective January 17, 2025. Mr. Santini joined Arvinas in 2023 with more than 30 years of experience managing and leading commercial organizations. Previously, he was Executive Vice President, Chief Commercial Officer, at Lexicon Pharmaceuticals. Prior to Lexicon, Mr. Santini was Executive Vice President, U.S. Market Access at Bayer, where he served on the U.S. Executive Committee. Mr. Santini’s prior experience also includes serving as Senior Vice President, Market Access at Nektar Therapeutics, and he began his career at Berlex Laboratories, where he served in roles of increasing responsibility in the commercial organization.

John Northcott, Chief Commercial Officer, is leaving the Company for personal reasons, effective January 17, 2025.

"Our commercial organization couldn’t be in a better position, and I look forward to working closely with Alex," continued Dr. Houston. "He has been a highly valued member of the Arvinas team for multiple years, and his well-established ability to build and lead an outstanding commercial team will be invaluable as we prepare for our potential first launch alongside our partners at Pfizer. We thank John for his contributions to the business, particularly his efforts to begin building a strong commercial organization for launch."

About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER positive (ER+)/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential monotherapy and as part of combination therapy across multiple treatment settings for ER+/HER2- metastatic breast cancer.

In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits.

The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- locally advanced or metastatic breast cancer previously treated with endocrine-based therapy.

Quanterix to Acquire Akoya Biosciences, Creating the First Integrated Solution for Ultra-Sensitive Detection of Blood- and Tissue-Based Protein Biomarkers

On January 10, 2025 Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultra-sensitive biomarker detection, and Akoya Biosciences (NASDAQ: AKYA), The Spatial Biology Company, reported a definitive merger agreement under which Quanterix will acquire Akoya in an all-stock transaction (Press release, Akoya Biosciences, JAN 10, 2025, View Source [SID1234649586]). The transaction will create the first integrated solution for ultra-sensitive detection of blood- and tissue-based protein biomarkers.

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"Liquid biopsy will eventually surpass the market size of all other diagnostics testing combined. Enabling early disease detection, before symptoms appear, using non-invasive methods is our mission and will be the majority of Quanterix’s long-term value," said Masoud Toloue, PhD, Chief Executive Officer of Quanterix. "This transaction accelerates our progress by creating the first platform that lets researchers and clinicians track disease progression from tissue to blood. By starting with tissue and detecting early signs of complementary proteins in blood using leading ultra-sensitive SIMOA technology, we are uniquely positioned to speed up market development of new liquid biopsy tests."

Brian McKelligon, Chief Executive Officer of Akoya, said, "Joining forces with Quanterix marks a pivotal step in our journey to revolutionize the way we understand and treat disease. We are thrilled to be part of an established leader in the life science tools and diagnostics market that not only strengthens our presence in critical markets but also accelerates our ability to scale, innovate and ultimately bring to market products that impact human health. With the capital structure and significant synergies facilitated through this transaction, the combined company is well-positioned for future growth and profitability. We look forward to being part of the Quanterix team to better serve the needs of researchers and clinicians and bring substantial value to our customers and shareholders."

Strategic and Financial Benefits of the Combination

Creates first integrated solution for liquid and tissue proteomic biomarkers: The integration of Akoya’s spatial biology capabilities in tissue with Quanterix’s advanced tools for the ultra-sensitive detection of biomarkers in blood will establish the first fully integrated technology ecosystem to identify and measure biomarkers across tissue and blood. Quanterix will be better positioned to serve research customers and ultimately clinicians with a broader set of technologies to improve diagnostic relevance and accuracy and enhance patient outcomes through biomarker-driven treatment decisions.
Expands technology offering across high growth markets in neurology, oncology and immunology: With Quanterix’s industry-leading position in neurology and Akoya’s focus within oncology and immunology, Quanterix will expand its technology offerings across these high-growth markets. The addition of Akoya’s cutting-edge spatial biology capabilities will enable Quanterix to capitalize on growth opportunities in a $5 billion serviceable addressable market.
Expanded lab services and clinical diagnostic market opportunity: Leveraging Akoya’s established clinical partnerships and CLIA-certified lab services, Quanterix is now strategically positioned to drive significant value creation through an expanded portfolio of lab service offerings. This collaboration establishes a clear path for Quanterix to participate in the rapidly emerging spatial biology clinical market, particularly in oncology.
Increases commercial reach and maximizes cross-selling opportunities: Quanterix and Akoya have complementary offerings and deep customer relationships across discovery, translational, and clinical research. When offered as an integrated solution, Quanterix expects significant cross-selling opportunities to a combined 2,300 instrument install-base driving strong double-digit organic revenue growth in 2026.
Accelerates path to profitability through realization of substantial cost savings: The transaction is expected to generate approximately $40 million in annual cost synergies by the end of 2026, with $20 million expected to be realized within the first year following close. These cost savings will be driven primarily by the elimination of duplicative corporate structures, streamlined commercial infrastructure, increased operational efficiencies, process improvements and footprint optimization. The synergies will be additive to the cost savings initiatives already implemented by the two organizations. Quanterix’s previous cost initiatives combined with the expected cost synergies from the transaction are expected to accelerate its path to profitability, including generating positive free cash flow in 2026.
Significant combined cash balance: For the trailing 12 months ending September 30, 2024, the combined company generated revenue of approximately $220 million. With more than $300 million in combined cash today, Quanterix expects to have approximately $175 million in cash with no expected debt at the time of closing, after accounting for debt repayment, transaction costs, and a $20 million payment for its recently announced EMISSION acquisition. Quanterix will have financial flexibility to advance the Company’s global diagnostic testing infrastructure, including for Alzheimer’s disease and other growth opportunities such as Akoya’s advancement into the companion diagnostics segment.
Transaction Terms

Under the terms of the agreement, which was approved by the Boards of Directors of both companies, Akoya shareholders will receive 0.318 shares of Quanterix common stock for each share of Akoya common stock owned. This represents a 19% premium to Akoya’s unaffected stock price on November 14, 2024, the last full trading day prior to Akoya’s announcement of its review of strategic alternatives.

Following the close of the transaction, Quanterix shareholders will own approximately 70% of the combined company and Akoya shareholders will own approximately 30%, on a fully diluted basis.

Timing, Approvals and Governance

The transaction is expected to close in the second quarter of 2025, subject to approval by both companies’ shareholders, expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and satisfaction of other customary closing conditions.

Quanterix has entered into voting agreements supporting the transaction with certain shareholders owning more than 50% of Akoya’s common stock.

Following close, Masoud Toloue will serve as Chief Executive Officer and Vandana Sriram will serve as Chief Financial Officer. The combined company will continue to operate under the Quanterix name.

Upon closing, the Quanterix Board will consist of nine members. Two current Quanterix directors will resign, and Quanterix will appoint two directors designated by Akoya from their current Board.

Conference Call and Webcast

Quanterix will host a conference call and webcast today at 8:30 a.m. E.T. to discuss the transaction. For audio, use the following dial-in number and passcode: USA & Canada – Toll-Free (800) 715-9871 Conference ID: 9092934. Interested investors can also access the live webcast from the News & Events page within the Investors section of the Quanterix website at View Source

Advisors

Goldman Sachs & Co. LLC is serving as financial advisor to Quanterix and Covington & Burling LLP is serving as its legal counsel. Perella Weinberg Partners LP is serving as financial advisor to Akoya and DLA Piper LLP is serving as its legal counsel.