On August 27, 2025 Wugen, Inc., a clinical-stage biotechnology company pioneering the next generation of allogeneic, off-the-shelf CAR-T cell therapies, reported the closing of $115 million equity financing led by Fidelity Management & Research Company, with participation from RiverVest Venture Partners, Lightchain Capital, Abingworth, ICG, LYZZ Capital, Tybourne Capital Management, Aisling Capital Management, and other leading life sciences investors (Press release, Wugen, AUG 27, 2025, View Source [SID1234655521]). The proceeds will advance the ongoing pivotal T-RRex study of WU-CART-007 in relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T‑LBL).

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WU-CART-007, also known as soficabtagene geleucel, is a CD7-targeted, CRISPR-edited allogeneic CAR-T cell therapy with potential to be the first approved "off-the-shelf" CAR-T for T-cell malignancies. In a completed global Phase 1/2 study, WU-CART-007 achieved an overall response rate (ORR) of 91% and a composite complete remission (CRc) rate of 73% at the recommended Phase 2 dose. The median duration of response exceeded six months with manageable safety. These data, presented at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, substantially surpass the outcomes achieved with current standard-of-care therapies.

"This financing comes at a decisive time for Wugen as we advance WU-CART-007 through our ongoing pivotal study with a clear path to a BLA filing in 2027," said Kumar Srinivasan, Ph.D., MBA, president, and chief executive officer of Wugen. "Relapsed and refractory T-ALL/T-LBL are aggressive malignancies resistant to current treatment options. We are committed to delivering an accessible, off-the-shelf therapy that can significantly improve the trajectory of patients’ care. We are grateful for the support of a world-class syndicate of investors who share our vision of transforming the treatment landscape for T‑cell malignancies."

"WU-CART-007’s robust response in a heavily pretreated patient population—coupled with manageable safety and scalable manufacturing—positions it as a potential first-in-class therapy," said Cherry Thomas, M.D., chief medical officer of Wugen. "Our pivotal T-RRex trial is designed to evaluate WU‑CART-007 in a single study for both pediatric and adult patients, with the goal of offering a potentially curative option where current salvage therapies fail."

"RiverVest has been impressed by the Wugen team’s efforts advancing WU-CART-007 into this pivotal study, and we are pleased that several of the world’s leading cancer centers are participating," said Niall O’Donnell, Ph.D., Managing Director at RiverVest. "We are optimistic about Wugen’s potential to transform care for patients who currently face poor outcomes and limited treatment options, and we look forward to supporting WU-CART-007’s continued progress."

Use of Proceeds and Next Steps
Proceeds from this financing will fund the advancement of the pivotal T-RRex trial in patients with relapsed/refractory or minimal residual disease-positive T-ALL/T-LBL, regulatory engagement with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and preparations for commercial-scale manufacturing. The company anticipates a Biologics License Application (BLA) submission in 2027.

About WU-CART-007

WU-CART-007 is an allogeneic, off-the-shelf, CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat T-cell cancers. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC) genes, thereby preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host disease (GvHD). WU‑CART-007 is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global pivotal clinical trial for relapsed or refractory T-ALL/T-LBL. More information on the Phase 1/2 trial is available on clinicaltrials.gov, identifier NCT04984356 and on the pivotal trial on clinicaltrials.gov, identifier NCT06514794.

WU-CART-007 has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed or refractory T-ALL/T-LBL. RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need.

On August 27, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, and University College London (UCL) reported that data published online in Cell show that the Decipher Prostate Genomic Classifier predicts which patients with metastatic cancer are likely to benefit from treatment intensification with the chemotherapy docetaxel and which are not likely to benefit and can therefore avoid unnecessary toxicity (Press release, Veracyte, AUG 27, 2025, View Source [SID1234655520]). The findings—from the randomized, prospective, Phase 3 STAMPEDE trial—are the first to be published showing that a gene expression test can help clinicians better personalize chemotherapy decisions for patients with metastatic prostate cancer.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Globally, nearly 1.5 million new cases of prostate cancer are diagnosed each year and the disease accounts for a fifth (nearly 400,000) of all cancer-related deaths in men, with these numbers expected to increase over the next two decades.1,2 In the United States, nearly 315,000 patients will be diagnosed with prostate cancer this year and it is the second-leading cause of cancer deaths among men.3 Most prostate cancer deaths occur in patients who first presented with advanced or metastatic disease—a group that has been growing faster in recent years in the U.S., compared to those presenting with localized disease.3

"Our findings suggest that the Decipher Prostate test may provide an important new tool to help guide treatment decisions for the growing population of patients with metastatic prostate cancer," said Professor Gerhardt Attard, director of UCL Cancer Institute and STAMPEDE trial co-investigator. "Treatment intensification with docetaxel, in addition to standard-of-care androgen deprivation therapy, is shown to improve survival for patients with metastatic prostate cancer. However, response rates vary and clinicians have had limited tools to identify who will likely benefit and who will not. Our results demonstrate the Decipher test’s ability to make this distinction."

The study involved 1523 patients with high-risk or metastatic prostate cancer who were randomized to standard-of-care treatment with androgen deprivation therapy (ADT) or to chemotherapy plus ADT. Patients were then followed for a median of 14 years. Among the 832 patients with metastatic prostate cancer, those with higher Decipher Prostate scores had improved survival benefit (HR 0.64, 95% CI 0.48-0.86) from docetaxel, while those with lower Decipher scores did not (HR 0.96, 95% CI 0.71-1.30; biomarker-treatment interaction p=0.039).

The findings remained consistent, regardless of each patient’s metastatic disease volume. This is important because current clinical practice favors use of docetaxel in patients with high- but not low-volume disease.

"The Decipher Prostate test’s ability to help guide treatment for patients with localized prostate cancer has already been established in dozens of peer-reviewed publications and it is the only gene expression test to achieve ‘Level I’ evidence status in the most recent NCCN Guidelines* for prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "This new publication provides important clinical evidence from a Phase 3 trial that supports expanded use of our test to patients with metastatic cancer—an area where there is a clear unmet need."

Veracyte began making the Decipher test for metastatic prostate cancer broadly available to clinicians in the U.S. in June 2025. The expanded-use test was developed through an ongoing collaboration between Veracyte and University College London.

"The recent introduction of the Decipher test for metastatic prostate cancer reinforces the power of our Veracyte Diagnostics Platform. This platform helps harness our whole-transcriptome data-generation capabilities and our commitment to partnering with the research community to advance cancer understanding and innovation. Ultimately, our goal is to further help improve patient care," said Phil Febbo, M.D., Veracyte’s chief scientific officer and chief medical officer.

For the current study, Veracyte performed whole-transcriptome analysis of all prostate samples. In addition to the commercially available Decipher Prostate test, other research-use-only gene signatures were evaluated. One notable finding was that metastatic tumors with both a high Decipher Prostate test score and a PTEN-inactive gene signature had the greatest benefit from the addition of docetaxel, suggesting potential opportunities to enable further-personalized patient care in the future.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients across the full spectrum of prostate cancer. The test is performed on biopsy or surgically resected samples and conveys the aggressiveness of the cancer. For patients with localized or regional prostate cancer, the Decipher score indicates a patient’s risk of metastasis, helping to determine treatment timing and intensity. For patients with metastatic prostate cancer, the Decipher score indicates the likelihood of cancer progression and survival benefit with treatment intensification. Armed with this information, physicians can better personalize their patients’ care. The Decipher Prostate test’s performance and clinical utility has been demonstrated in over 90 studies involving more than 200,000 patients. It is the only gene expression test to achieve "Level I" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.

On August 27, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, and University College London (UCL) reported that data published online in Cell show that the Decipher Prostate Genomic Classifier predicts which patients with metastatic cancer are likely to benefit from treatment intensification with the chemotherapy docetaxel and which are not likely to benefit and can therefore avoid unnecessary toxicity (Press release, Veracyte, AUG 27, 2025, View Source [SID1234655520]). The findings—from the randomized, prospective, Phase 3 STAMPEDE trial—are the first to be published showing that a gene expression test can help clinicians better personalize chemotherapy decisions for patients with metastatic prostate cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Globally, nearly 1.5 million new cases of prostate cancer are diagnosed each year and the disease accounts for a fifth (nearly 400,000) of all cancer-related deaths in men, with these numbers expected to increase over the next two decades.1,2 In the United States, nearly 315,000 patients will be diagnosed with prostate cancer this year and it is the second-leading cause of cancer deaths among men.3 Most prostate cancer deaths occur in patients who first presented with advanced or metastatic disease—a group that has been growing faster in recent years in the U.S., compared to those presenting with localized disease.3

"Our findings suggest that the Decipher Prostate test may provide an important new tool to help guide treatment decisions for the growing population of patients with metastatic prostate cancer," said Professor Gerhardt Attard, director of UCL Cancer Institute and STAMPEDE trial co-investigator. "Treatment intensification with docetaxel, in addition to standard-of-care androgen deprivation therapy, is shown to improve survival for patients with metastatic prostate cancer. However, response rates vary and clinicians have had limited tools to identify who will likely benefit and who will not. Our results demonstrate the Decipher test’s ability to make this distinction."

The study involved 1523 patients with high-risk or metastatic prostate cancer who were randomized to standard-of-care treatment with androgen deprivation therapy (ADT) or to chemotherapy plus ADT. Patients were then followed for a median of 14 years. Among the 832 patients with metastatic prostate cancer, those with higher Decipher Prostate scores had improved survival benefit (HR 0.64, 95% CI 0.48-0.86) from docetaxel, while those with lower Decipher scores did not (HR 0.96, 95% CI 0.71-1.30; biomarker-treatment interaction p=0.039).

The findings remained consistent, regardless of each patient’s metastatic disease volume. This is important because current clinical practice favors use of docetaxel in patients with high- but not low-volume disease.

"The Decipher Prostate test’s ability to help guide treatment for patients with localized prostate cancer has already been established in dozens of peer-reviewed publications and it is the only gene expression test to achieve ‘Level I’ evidence status in the most recent NCCN Guidelines* for prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "This new publication provides important clinical evidence from a Phase 3 trial that supports expanded use of our test to patients with metastatic cancer—an area where there is a clear unmet need."

Veracyte began making the Decipher test for metastatic prostate cancer broadly available to clinicians in the U.S. in June 2025. The expanded-use test was developed through an ongoing collaboration between Veracyte and University College London.

"The recent introduction of the Decipher test for metastatic prostate cancer reinforces the power of our Veracyte Diagnostics Platform. This platform helps harness our whole-transcriptome data-generation capabilities and our commitment to partnering with the research community to advance cancer understanding and innovation. Ultimately, our goal is to further help improve patient care," said Phil Febbo, M.D., Veracyte’s chief scientific officer and chief medical officer.

For the current study, Veracyte performed whole-transcriptome analysis of all prostate samples. In addition to the commercially available Decipher Prostate test, other research-use-only gene signatures were evaluated. One notable finding was that metastatic tumors with both a high Decipher Prostate test score and a PTEN-inactive gene signature had the greatest benefit from the addition of docetaxel, suggesting potential opportunities to enable further-personalized patient care in the future.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients across the full spectrum of prostate cancer. The test is performed on biopsy or surgically resected samples and conveys the aggressiveness of the cancer. For patients with localized or regional prostate cancer, the Decipher score indicates a patient’s risk of metastasis, helping to determine treatment timing and intensity. For patients with metastatic prostate cancer, the Decipher score indicates the likelihood of cancer progression and survival benefit with treatment intensification. Armed with this information, physicians can better personalize their patients’ care. The Decipher Prostate test’s performance and clinical utility has been demonstrated in over 90 studies involving more than 200,000 patients. It is the only gene expression test to achieve "Level I" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.

On August 27, 2025 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, reported that members of the RAPT management team will participate in the following investor conferences in September (Press release, RAPT Therapeutics, AUG 27, 2025, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-participate-multiple-upcoming-investor [SID1234655519]):

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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2025 Wells Fargo Healthcare Conference – Fireside chat on Wednesday, September 3, 2025 at 12:45 p.m. ET
Cantor Global Healthcare Conference 2025 – Fireside chat on Thursday, September 4, 2025 at 1:00 p.m. ET
H.C. Wainwright 27th Annual Global Investment Conference – Fireside chat on Tuesday, September 9, 2025 at 9:00 a.m. ET
Stifel 2025 Virtual Immunology & Inflammation Forum – Presentation on Monday, September 15, 2025 at 9:30 a.m. ET
To access the live webcasts or subsequent archived recordings of the fireside chats and presentation, please visit the RAPT Therapeutics website at https://investors.rapt.com/events-and-presentations.

On August 27, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that management will be participating in the following investor conferences in September (Press release, ORIC Pharmaceuticals, AUG 27, 2025, View Source [SID1234655518]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Citi’s 2025 Biopharma Back to School Summit – Participating in a fireside chat on Wednesday, September 3, 2025, at 4:00 p.m. ET. Management will also be participating in one-on-one meetings.
2025 Wells Fargo Healthcare Conference – Participating in a fireside chat on Thursday, September 4, 2025, at 2:15 p.m. ET. Management will also be participating in one-on-one meetings.
Cantor Global Healthcare Conference 2025 – Participating in a fireside chat on Friday, September 5, 2025, at 8:35 a.m. ET. Management will also be participating in one-on-one meetings.
Morgan Stanley 23rd Annual Global Healthcare Conference – Participating in one-on-one meetings on Tuesday, September 9, 2025.
Baird 2025 Global Healthcare Conference – Participating in a fireside chat on Wednesday, September 10, 2025, at 1:25 p.m. ET. Management will also be participating in one-on-one meetings.
Webcasts of the fireside chat discussions will be available through the investor section of the company’s website at www.oricpharma.com. Replays of the webcasts will be available for 90 days following the event.