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.

On January 10, 2025 Intensity Therapeutics, Inc. ("Intensity" or the "Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported a business update highlighting key achievements with its lead drug candidate INT230-6 (Press release, Intensity Therapeutics, JAN 10, 2025, View Source [SID1234649604]).

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Business Development

Discussions with multiple companies regarding potential strategic collaborations and licenses in various territories for INT230-6 initiated in 2024. While term sheets may be negotiated, there is no assurance that any ongoing discussions, negotiations, or due diligence processes will result in definitive agreements, partnerships, collaborations, or relationships.

Sarcoma INVINCIBLE-3

In July 2024, the Company initiated and dosed its first patient in a Phase 3 open-label, randomized study (the "INVINCIBLE-3 Study") testing INT230-6 as a monotherapy compared to the standard of care ("SOC") drugs in second-and third-line treatment for certain soft tissue sarcoma subtypes. This study has been authorized by the US FDA, Health Canada, the European Medicines Authority, and Australia’s Therapeutics Goods Administration. The trial is enrolling and being conducted in eight countries: the US, Australia, Canada, France, Germany, Italy, Poland, and Spain. Up to 62 sarcoma-focused hospitals and other centers are expected to participate from these countries.

In November 2024, the Company presented INT230-6 Phase 1/2 data in a late-breaking session at the 2024 Annual Connective Tissue Oncology Society Meeting (CTOS). These data showed a median overall survival ("mOS") of 21.3 months versus a synthetic control of 6.7 months, an increase in T-cell activation, and favorable safety profile for patients receiving INT230-6 alone. INVINCIBLE-3 continues recruiting with an expected enrollment of 333 patients with leiomyosarcoma, liposarcoma and undeferential pleomorphic sarcoma.

Breast Cancer INVINCIBLE-2 and INVINCIBLE-4

In October 2024, the Company, in collaboration with the Swiss Group for Clinical Cancer Research SAKK ("SAKK") in the INVINCIBLE-4 Study, a Phase 2 trial to treat patients with localized triple-negative breast cancer ("TNBC"), announced that the first patient has been dosed in the study.

In December 2024, Phase 2 data in presurgical breast cancer from the completed INVINCIBLE-2 study along with an overview of the ongoing INVINCIBLE-4 (SAKK 66/22), was presented at the 2024 San Antonio Breast Cancer Symposium (SABCS).

The Company’s completed INVINCIBLE-2 Study, where INT230-6 was given alone in multiple tumor types including TNBC, showed the following:

Tumor-killing properties at levels greater than 95% in some patients on a single intratumoral dose with systemic immune activation.
Tumors larger than 2 cm showed significant necrosis in 74% of subjects at the time of surgery.
Gene expression analysis showed a significant difference between baseline biopsies and surgical specimens. Pathway analysis identified genes associated with TCR signaling, B-cell and T-cell activation, with increasing effects in post-treatment samples (SABCS 2023 #PS16-03).
The study demonstrated pathologic and immune priming effects of intratumoral cytotoxicity in traditional immune quiescent breast cancers, with a treatment that showed favorable safety and was well tolerated.
INT230-6 patients had increases in CD4 T cells and NK cells within the tumor and associated changes in the diversity of T cell repertoire.
The INVINCIBLE-4 Study is a randomized open-label, multicenter study to determine the clinical activity, safety, and tolerability of INT230-6 in patients with tumors greater than two centimeters having early-stage, operable Triple Negative Breast Cancer ("TNBC"). These patients undergo standard-of-care neoadjuvant immunochemotherapy ("SOC") treatment, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel (i.e. the Keynote-522 regimen). The primary endpoint is pathological complete response ("pCR") in the primary tumor and affected lymph nodes. Patients will be randomized one to one to receive a regimen of two doses of INT230-6 followed by SOC, or SOC alone. The study is expected to enroll 54 patients in up to 16 centers in Switzerland and France.

"The data from our prior studies and trial design has allowed INT230-6 to be authorized by the leading regulatory agencies globally to move into late-stage clinical trials. INT230-6 is being tested in metastatic and pre-surgical cancers, which highlights the broad potential for our new cancer treatment," said Lewis H. Bender, President and CEO of Intensity Therapeutics, "There are many risks and hurdles in drug development and advancing programs into phase 3 trials is an important achievement and a testament that reflects the expertise and dedication of our team. We are excited that contracts exist with nearly two dozen top sarcoma-centric hospitals in our Phase 3 study and nine sites in our Phase 2 presurgical breast cancer trial with seven activated. Several sites are enrolling and continue to recruit patients for both studies. Given the potential benefit of our new drug, we are working to establish partnerships that expedite product development and ultimate market access in the US and abroad."

About Soft Tissue Sarcoma
Soft tissue sarcoma is a broad term for cancers that start in soft tissues (muscle, tendons, fat, lymph and blood vessels, and nerves). These cancers can develop anywhere in the body but are found mainly in the arms, legs, chest, and abdomen. There are many types of sarcomas; however, the four most common are bone sarcoma (referred to as osteosarcoma), leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), and liposarcoma. According to SEER estimates, approximately 14,500 patients have metastatic liposarcoma, leiomyosarcoma, and undifferentiated pleomorphic disease at any one time in the US. When sarcoma is metastatic, the prognosis is poor, even with systemic chemotherapy.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

About Triple Negative Breast Cancer in the Presurgical Setting
Approximately 11-17% of breast cancers test negative for estrogen receptors (ER), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 (HER2) protein, qualifying them as triple negative. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immune/chemotherapy before surgery. Since the publication of Keynote-522, standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates are 65%, with rates lower in the larger-sized tumors. The toxicity of the Keynote-522 regimen is high, with 80% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients.

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.

On January 10, 2025 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for TYRA-300 allowing the company to proceed with a Phase 2 clinical trial of TYRA-300 in low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC) (Press release, Tyra Biosciences, JAN 10, 2025, View Source [SID1234649605]). This program will be led by newly appointed Dr. Erik Goluboff, SVP, Clinical Development of TYRA, who brings more than thirty years of experience as an academic urologic oncologist, principal investigator, practicing urologist and most recently Principal Medical Lead for GU/GI cancers at Genentech/Roche.

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TYRA-300 is a potential first-in-class, investigational, oral, FGFR3-selective inhibitor designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for the FGFR3 gatekeeper mutations. FGFR3 is the most frequently altered gene in NMIBC, with 60-80% of IR NMIBC showing alterations. TYRA-300 is expected to be evaluated in three Phase 2 studies: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia (ACH) and SURF301 for metastatic urothelial carcinoma (mUC).

SURF302 will be an open-label Phase 2 clinical study evaluating the efficacy and safety of TYRA-300 in participants with FGFR3-altered low-grade, IR NMIBC. The study will enroll up to 90 participants at multiple sites primarily in the United States. Participants will be randomized initially to treatment with TYRA-300 at 50 mg once-daily (QD) (Cohort 1) or treatment with TYRA-300 at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival (RFS), progression free survival (PFS), safety and tolerability.

"Receiving FDA IND clearance is an important milestone in the advancement of TYRA-300 and for patients with NMIBC who urgently need better tolerated therapeutic options," commented Doug Warner, Chief Medical Officer of TYRA. "We look forward to leveraging Erik’s impressive background to guide our development plans in NMIBC. We expect to initiate patient dosing in the second quarter of this year, with initial three-month CR data to follow."

Dr. Goluboff joins TYRA from Genentech/Roche, where he was Principal Medical Lead for GU/GI cancers and was responsible for driving business and pipeline opportunities in those indications. Prior to Genentech/Roche, Dr. Goluboff held positions of increasing responsibility at AstraZeneca, including most recently as Global Clinical Head for IMFINZI (durvalumab) and tremelimumab for GU, GYN and tumor agnostic. Before joining industry, he held urology professorships at Columbia and Mount Sinai and managed thousands of patients from diagnosis to late line disease, medically and surgically, with bladder, prostate, and kidney cancers. He was a principal investigator for multiple clinical trials and has published over 100 peer-reviewed papers. He received his B.A. from Columbia University, an M.D. from Johns Hopkins, and an M.B.A. from NYU’s Stern School of Business. Dr. Goluboff completed his surgical internship at Johns Hopkins Hospital and his urology residency and urologic oncology fellowship at Columbia-Presbyterian Medical Center.

"For the last thirty years, I have dedicated my career to helping patients with bladder cancer as a urologic oncologist, a principal investigator running clinical trials, and as a drug developer seeking new and more effective therapies for patients with urologic cancers," added Dr. Goluboff. "I believe that TYRA-300 is the most compelling agent in development for the treatment of IR NMIBC, with a proven mechanism of action and more attractive tolerability profile than pan-FGFR inhibitors, which made joining TYRA a very exciting opportunity. I look forward to advancing TYRA-300 through the Phase 2 SURF302 study and delivering benefit to patients in need."

About Non-Muscle Invasive Bladder Cancer

In the United States, it is estimated that there are more than 730,000 people living with bladder cancer. Many of these patients have intermediate risk non-muscle invasive bladder cancer (IR NMIBC) and experience recurrence episodes throughout the course of their disease. Treatment for IR NMIBC and disease recurrence is a surgical procedure called transurethral resection of bladder tumor (TURBT) combined with intravesical-administered chemotherapy. Repeat TURBT procedures and intravesical-administered chemotherapy can impact patients’ quality of life and overall health, leading to a significant unmet medical need for better tolerated therapeutic options. TYRA-300 is the only orally administered investigational agent in clinical development for IR NMIBC.

About TYRA-300

TYRA-300 is the Company’s lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasia, including achondroplasia and hypochondroplasia. In oncology, TYRA-300 is being evaluated in metastatic urothelial cancer (mUC) and intermediate risk non-muscle invasive bladder cancer (IR NMIBC). In mUC, TYRA-300 is being evaluated in a multi-center, open label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors) (NCT05544552). The study is designed to determine the optimal and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. In October 2024, TYRA reported interim clinical proof-of-concept data in mUC from SURF301. TYRA has received IND clearance from the U.S. FDA to proceed with its SURF302 clinical trial in patients with IR NMIBC. In skeletal dysplasia, TYRA-300 has demonstrated positive preclinical results in achondroplasia and hypochondroplasia, and TYRA has received IND clearance from the U.S FDA to proceed with its BEACH301 clinical trial in children with achondroplasia.

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.