On April 23, 2025 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported it will present data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Corcept Therapeutics, APR 23, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-present-late-breaking-data-pivotal-phase-3-rosella-trial [SID1234652052]). The data will be presented in a late-breaking oral presentation on Monday, June 2, 2025.

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Title: ROSELLA: A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Patients with Platinum-Resistant Ovarian Cancer​ (GOG-3073, ENGOT-ov72)
Oral Abstract Session – Gynecologic Cancer
June 2, 2025, 8:00 AM – 11:00 AM CDT
Abstract Number: LBA5507
The ROSELLA trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).

About Relacorilant

Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to ovarian cancer, including endogenous hypercortisolism (Cushing’s syndrome) and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

About Cortisol’s Role in Oncology

Cortisol helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response, which weakens its ability to fight disease.

On April 23, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that an abstract was accepted for an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30 to June 3, 2025, in Chicago, IL (Press release, Candel Therapeutics, APR 23, 2025, View Source [SID1234652051]). The oral presentation will feature data from the Company’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high risk localized prostate cancer.

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Details are as follows:

CAN-2409 – Localized Prostate Cancer

•
Abstract Title: Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard-of-care external beam radiation therapy (EBRT) for newly diagnosed localized prostate cancer
•
Presenter: Theodore DeWeese, M.D. *, the Francis Watt Baker, M.D., and Lenox D. Baker Jr., M.D., Dean of the Medical Faculty and CEO, Johns Hopkins Medicine

•
Session Title: Oral Abstract Session – Genitourinary Cancer – Prostate, Testicular, and Penile

•
Session Date/Time: Tuesday, June 3, 2025; 9:45 AM – 12:45 PM CT

•
Location: Hall A, McCormick Place Convention Center, Chicago, IL

Full abstracts will be released by ASCO (Free ASCO Whitepaper) on Thursday, May 22, 2025, at 5:00 PM ET. Details from the presentations will be available following the event on the Candel website at Candel Media.

Dr. DeWeese has no relationship with Candel, other than serving as the national principal investigator for Candel’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high risk localized prostate cancer. He has never received reimbursements, consulting fees, or EAB fees from Candel, and he has no shares of common stock, options to purchase common stock or other stake in Candel.

About CAN-2409

CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus engineered to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic nucleotide analogue that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of the patient’s own tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity, as well as combination activity with standard of care (SoC) radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors, have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile reported to date, supporting the potential for combination with other therapeutic strategies.

Candel’s clinical development program for CAN-2409 includes completed positive phase 2a clinical trials in both non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), as well as a positive pivotal randomized, placebo-controlled phase 3 clinical trial of CAN-2409 in localized, non-metastatic prostate cancer. In December 2024, Candel announced that CAN-2409 achieved its primary endpoint in this phase 3 clinical trial in men with intermediate-to-high-risk, localized prostate cancer, demonstrating statistically significant and clinically meaningful improvement in disease-free survival when added to SoC radiation therapy +/- androgen deprivation therapy.

In the Company’s randomized controlled phase 2a clinical trial of CAN-2409 in borderline resectable PDAC, positive survival data showed notable improvement with an estimated median overall survival of 31.4 months after experimental treatment with CAN-2409 plus SoC versus 12.5 months in the control group in patients with PDAC who only received SoC. Median survival post-progression was 21.2 months in patients who received CAN-2409 compared to 6.4 months in the control arm. The final survival data from the phase 2a clinical trial of CAN-2409, in patients with stage III/IV NSCLC, showed an mOS of 24.5 months in 46 evaluable patients receiving 2 courses of CAN-2409 (per protocol population; cohort 1 and 2) and 21.5 months in evaluable patients from cohort 2 (n=41) that had progressive disease at baseline, despite Immune Checkpoint Inhibitor treatment. CAN-2409 plus prodrug has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy and localized prostate cancer. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC. Candel’s pivotal phase 3 clinical trial in newly diagnosed, localized prostate cancer was conducted under a Special Protocol Assessment agreed with the FDA.

On April 23, 2025 Boston Scientific Corporation (NYSE: BSX) reported net sales of $4.663 billion during the first quarter of 2025, growing 20.9 percent on a reported basis, 22.2 percent on an operational1 basis and 18.2 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, APR 23, 2025, View Source [SID1234652050]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $674 million or $0.45 per share (EPS), compared to $495 million or $0.33 per share a year ago, and achieved adjusted3 EPS of $0.75 for the period, compared to $0.56 a year ago.

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"We delivered an exceptional quarter to start the year, reflecting the effectiveness of our highly engaged global team and the strength of our product portfolio," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We remain well-positioned for the future as we continue to focus on meaningful innovation, clinical science and the execution of our category leadership strategy to drive differentiated growth and performance for the long-term."

First quarter financial results and recent developments:

Reported net sales of $4.663 billion, representing an increase of 20.9 percent on a reported basis, compared to the company’s guidance range of 17 to 19 percent; 22.2 percent on an operational basis; and 18.2 percent on an organic basis, compared to the company’s guidance range of 14 to 16 percent, all compared to the prior year period.

Reported GAAP net income attributable to Boston Scientific common stockholders of $0.45 per share, compared to the company’s guidance range of $0.43 to $0.45 per share, and achieved adjusted EPS of $0.75 per share, compared to the guidance range of $0.66 to $0.68 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 11.7 percent reported, 12.8 percent operational and 5.3 percent organic
Cardiovascular: 26.2 percent reported, 27.6 percent operational and 25.6 percent organic

Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 31.1 percent reported and operational
Europe, Middle East and Africa (EMEA): 5.5 percent reported and 7.9 percent operational
Asia-Pacific (APAC): 8.2 percent reported and 10.6 percent operational
Latin America and Canada (LACA): 4.4 percent reported and 14.1 percent operational
Emerging Markets4: 6.5 percent reported and 9.8 percent operational

Commenced enrollment in the ELEVATE-PF clinical trial to evaluate the safety and effectiveness of the FARAFLEX Mapping and Pulsed Field Ablation (PFA) Catheter for treatment of persistent atrial fibrillation (AF).

Began the OPTION-A clinical trial in the Asia-Pacific region to evaluate the safety and effectiveness of catheter ablation with the FARAPULSE PFA System and subsequent implant of the WATCHMAN Left Atrial Appendage Closure Device in a concomitant procedure.

Published in The New England Journal of Medicine and presented as late-breaking science at the 2025 European Heart Rhythm Association annual meeting were results from the investigator-sponsored SINGLE SHOT CHAMPION clinical trial which demonstrated the FARAPULSE PFA System achieved superior effectiveness for the treatment of symptomatic paroxysmal AF versus the Arctic Front Advance cardiac cryoablation catheter (Medtronic).

Presented late-breaking findings from the VITALYST Early Feasibility Study at the Technology and Heart Failure Therapeutics conference which demonstrated successful early experience with the investigational VITALYST Temporary Percutaneous Transvalvular Circulatory Support System in patients undergoing elective high-risk percutaneous coronary intervention.

Published in JAMA Network Open real-world data demonstrating that patients with prostate cancer treated with SpaceOAR Hydrogel showed a 25% reduction in bowel disorder risk and a 46% decrease in procedures like colonoscopies four years post-radiation therapy.

Completed the acquisition of Bolt Medical, Inc., the developer of an intravascular lithotripsy advanced laser-based platform for the treatment of coronary and peripheral artery disease.

Announced agreement to acquire SoniVie Ltd., the developer of the TIVUS Intravascular Ultrasound System, an investigational nerve denervation technology designed to treat hypertension — such as renal artery denervation in the kidneys — subject to customary closing conditions.
1. Operational net sales growth excludes the impact of foreign currency fluctuations.

2. Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales.

3. Adjusted EPS excludes the impacts of certain charges (credits) which may include amortization expense, goodwill and other intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio net losses (gains) and impairments, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), European Union (EU) Medical Device Regulation (MDR) implementation costs, debt extinguishment net charges, deferred tax expenses (benefits) and certain discrete tax items.

4.Our Emerging Markets countries include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada.

Net sales for the first quarter by business and region:

View News Release Full Screen

Increase/(Decrease)

Three Months Ended

March 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

Impact of
Certain
Acquisitions/Divestitures

Organic
Basis

(in millions)

2025

2024

Endoscopy

$ 673

$ 642

4.7 %

1.2 %

5.9 %

(0.4) %

5.5 %

Urology

633

513

23.5 %

1.0 %

24.5 %

(20.1) %

4.4 %

Neuromodulation

271

256

5.8 %

0.9 %

6.8 %

— %

6.8 %

MedSurg

1,577

1,412

11.7 %

1.1 %

12.8 %

(7.5) %

5.3 %

Cardiology

2,429

1,872

29.8 %

1.4 %

31.2 %

— %

31.2 %

Peripheral Interventions

656

573

14.4 %

1.4 %

15.8 %

(8.4) %

7.4 %

Cardiovascular

3,085

2,445

26.2 %

1.4 %

27.6 %

(2.0) %

25.6 %

Net Sales

$ 4,663

$ 3,856

20.9 %

1.3 %

22.2 %

(4.0) %

18.2 %

View News Release Full Screen

Increase/(Decrease)

Three Months Ended
March 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

(in millions)

2025

2024

U.S.

$ 2,960

$ 2,258

31.1 %

— %

31.1 %

EMEA

846

803

5.5 %

2.4 %

7.9 %

APAC

701

647

8.2 %

2.4 %

10.6 %

LACA

155

149

4.4 %

9.6 %

14.1 %

Net Sales

$ 4,663

$ 3,856

20.9 %

1.3 %

22.2 %

Emerging Markets4

$ 690

$ 648

6.5 %

3.3 %

9.8 %

Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Net sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of certain acquisitions/divestitures are not prepared in accordance with U.S. GAAP.

Guidance for Full Year and Second Quarter 2025

The company estimates net sales growth for the full year 2025, versus the prior year period, to be approximately 15 to 17 percent on a reported basis and 12 to 14 percent on an organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $1.86 to $1.93 and estimates adjusted EPS, excluding certain charges (credits), of $2.87 to $2.94.

The company estimates net sales growth for the second quarter of 2025, versus the prior year period, to be in a range of approximately 17.5 to 19.5 percent on a reported basis, and 13 to 15 percent on an organic basis. Second quarter organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $0.45 to $0.47 and estimates adjusted EPS, excluding certain charges (credits), of $0.71 to $0.73.

Conference Call Information
Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. ET. The company will webcast the call to interested parties through its website: investors.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.

On April 23, 2025 Arvinas, Inc. (Nasdaq: ARVN) reported that data from the global Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant versus fulvestrant in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer will be presented as a late-breaking oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30 – June 3 in Chicago, IL (Press release, Arvinas, APR 23, 2025, View Source [SID1234652048]). The presentation includes the first pivotal data for vepdegestrant, a potential first-in-class investigational oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader.

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Vepdegestrant is being jointly developed by Arvinas and Pfizer for the treatment of patients with advanced or metastatic ER+/HER2- breast cancer.

Presentation details are as follows:

Title: Vepdegestrant, a PROTAC estrogen receptor (ER) degrader, vs. fulvestrant in ER-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (aBC): results of the global, randomized, phase 3 VERITAC-2 study
Presenting Author: Erika P. Hamilton, MD, Breast Cancer Research Program, Sarah Cannon Research Institute
Abstract Number: LBA1000
Session Date, Time and Location: Saturday, May 31, 2025, 1:15 PM-4:15 PM CT in Hall B1
Session Type and Title: Oral Abstract Session – Breast Cancer—Metastatic

Late-breaking abstracts will be released at 7:00 am CT / 8:00 am ET on the day of the scientific presentation. Additional information can be found at www.asco.org.

About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROTAC (PROteolysis TArgeting Chimera) 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- advanced or metastatic breast cancer previously treated with endocrine-based therapy.

On April 23, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that it will present updated data from the completed Phase 1 TRAVERSE trial of ALLO-316 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29-June 2 in Chicago, Illinois (Press release, Allogene, APR 23, 2025, View Source [SID1234652047]). The trial evaluated ALLO-316 in patients with advanced or metastatic renal cell carcinoma (RCC) who had progressed following immune checkpoint inhibitor and VEGF-targeted therapies. In addition, a trial-in-progress poster is also being presented to highlight the ongoing pivotal Phase 2 ALPHA3 trial, which is evaluating cemacabtagene ansegedleucel (cema-cel) as part of first-line (1L) treatment for patients with large B-cell lymphoma (LBCL).

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ALLO-316 is an allogeneic, "off-the-shelf" CAR T product targeting CD70 and is the only allogeneic CAR T product to demonstrate potential in solid tumors. Data from the Phase 1 TRAVERSE trial previously showed a manageable safety profile and encouraging anti-tumor activity in heavily pretreated patients with advanced or metastatic CD70+ RCC. Enrollment is now complete in the Phase 1b expansion cohort, which evaluated the safety and efficacy of ALLO-316 at dose level 2 (80M CAR T cells) following a standard lymphodepletion regimen of cyclophosphamide and fludarabine.

The ALPHA3 trial is the first pivotal study to evaluate an allogeneic CAR T product as a consolidation strategy aimed at eradicating minimal residual disease (MRD) following 1L treatment in LBCL. It is assessing cema-cel in patients with MRD after standard 1L chemoimmunotherapy, such as R-CHOP, with the goal of improving 1L cure rates. The trial identifies patients at high risk for relapse after 1L treatment by utilizing Foresight CLARITY, powered by PhasED-Seq, a novel Investigational Use Only (IUO) test for MRD. This randomized trial will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation).

Allogene Presentations at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting:

ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC): Updated results from the phase 1 TRAVERSE study.
Presenter: Samer A. Srour, M.D., The University of Texas MD Anderson Cancer Center
Session Title: Oral Abstract Session – Genitourinary Cancer – Kidney and Bladder
Abstract: #4508
Location: Hall D2
Presentation Date and Time: Sunday, June 1, 9:45AM – 12:45PM CT

ALPHA3: A pivotal phase 2 study of first-line (1L) consolidation with cemacabtagene ansegedleucel (cema-cel) in patients (pts) with large B-cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard therapy.

Presenter: Jason Westin, MD, MS, FACP, The University of Texas MD Anderson Cancer Center
Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Abstract: TPS7085
Poster Board: #267a
Location: Hall A
Poster Session Display Date and Time: Sunday, June 1, 9:00AM – 12:00PM CT

About Cemacabtagene Ansegedleucel (cema-cel)
Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T investigational product for the treatment of large B cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan.

About ALLO-316 (TRAVERSE)
ALLO-316 is an AlloCAR T investigational product targeting CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic CD70+ RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced a $15 million award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC.

About the ALPHA3 Trial
Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% who initially respond will relapse and require subsequent treatment. The current standard of care (SOC) after 1L treatment has been simply to "watch and wait" to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, "off-the-shelf" treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard "7th cycle" of frontline treatment available to all eligible patients with MRD.