On July 14, 2025 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that a real-world, retrospective study demonstrates the benefit of commercial Amtagvi (lifileucel) in real-world clinical settings for patients with advanced (unresectable or metastatic) melanoma previously treated with immune checkpoint inhibitor (ICI) therapy and, if appropriate, targeted therapy (Press release, Iovance Biotherapeutics, JUL 14, 2025, View Source [SID1234654368]).

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!

Among 41 evaluable patients treated at four authorized treatment centers, the physician-assessed objective response rate (ORR) was 48.8% (20/41). Response rates with Amtagvi were higher in third-line or earlier patients (two or fewer prior lines of therapy) with an ORR of 60.9% (14/23). An ORR of 33.3% (6/18) was observed in patients following three or more prior lines of therapy. All evaluable patients received commercial Amtagvi according to the U.S. prescribing information and completed at least one follow-up physician assessment.

Additional results and follow-up from the real-world clinical study will be presented at an upcoming medical meeting this year.

Lilit Karapetyan, MD, MS of H. Lee Moffitt Cancer Center & Research Institute stated, "Lifileucel demonstrates a robust response rate in real-world clinical settings. I am particularly encouraged by the higher response rate in less heavily treated patients. It is remarkable to observe a response in more than half of those patients, supporting consideration of lifileucel as soon as possible after ICI therapy. I am confident in the potential for positive outcomes in more patients as we continue to adopt lifileucel."

In February 2024, the U.S. Food and Drug Administration granted accelerated approval to Amtagvi for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. The approval was based on overall response rate and duration of response from the C-144-01 clinical trial. With this approval, Amtagvi became the first one-time T cell therapy for a solid tumor cancer as well as the first approved treatment option for patients with advanced melanoma after anti-PD-1 and targeted therapy. Iovance is also conducting TILVANCE-301, a Phase 3 trial in frontline advanced melanoma to confirm clinical benefit.

About Amtagvi

Amtagvi is a prescription medicine used to treat adults with a type of skin cancer that cannot be removed surgically or has spread to other parts of the body called unresectable or metastatic melanoma.

Amtagvi is used when your melanoma has not responded or stopped responding to a PD-1 blocking drug either by itself or in a combination, and if your cancer is BRAF mutation positive, a BRAF inhibitor drug with or without a MEK inhibitor drug that has also stopped working.

The approval of Amtagvi is based on a study that measured response rate. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

Important Safety Information

What is the most important information that I should know about Amtagvi?

You will likely be in a hospital prior to and after receiving Amtagvi.

Before taking Amtagvi, tell your healthcare provider about all of your medical conditions, including if you:

Have any lung, heart, liver or kidney problems
Have low blood pressure
Have a recent or active infection or other inflammatory conditions including cytomegalovirus (CMV) infection, hepatitis B or C or human immunodeficiency virus (HIV) infection
Are pregnant, think you may be pregnant, or plan to become pregnant
Are breastfeeding
Notice the symptoms of your cancer are getting worse
Have had a vaccination in the past 28 days or plan to have one in the next few months
Have been taking a blood thinner
Tell your doctor about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive Amtagvi?

Amtagvi is made from your surgically removed tumor. Tumor derived T cells are grown in a manufacturing center at the end of which they number in the billions of cells.
Your tumor tissue is sent to a manufacturing center to make Amtagvi. It takes about 34 days from the time your tumor tissue is received at the manufacturing center until Amtagvi is available to be shipped back to your healthcare provider, but the time may vary. Your Amtagvi will be provided in 1-4 patient-specific infusion bag(s) containing 100 mL to 125 mL of viable (alive) cells per bag.
After your Amtagvi arrives at your treating institution, your healthcare provider will give you lymphodepleting chemotherapy to prepare your body.
Approximately 30 to 60 minutes before you are given Amtagvi, you may be given other medicines including:
Medicines for an allergic reaction (anti-histamines)
Medicines for fever (such as acetaminophen)
Your Amtagvi will be provided in 1 to 4 infusion bag(s) containing 100 mL to 125 mL of viable cells per bag. When your body is ready for Amtagvi infusion, your healthcare provider will give Amtagvi to you by intravenous infusion. This usually takes less than 90 minutes.
After getting Amtagvi

Beginning 3 to 24 hours after Amtagvi is given, you may be given up to 6 doses of IL-2 (aldesleukin) every 8 to 12 hours via intravenous infusion. Your doctor may discontinue IL-2 (aldesleukin) infusion any time if you have severe side effects.

You will have to stay in the hospital until you have completed the IL-2 (aldesleukin) treatment and you have recovered from any serious side effects associated with the Amtagvi treatment.

You should plan to stay within 2 hours of the location where you received your treatment for several weeks after getting Amtagvi. Your healthcare provider will check to see if your treatment is working and help you with any side effects that occur.

What are the possible side effects of Amtagvi?

The most common side effects of the Amtagvi treatment include chills, fever, low white blood cell count (may increase risk of infections), fatigue, low red blood cell count (may cause you to feel tired or weak), fast or irregular heartbeat, rash, low blood pressure, and diarrhea.

These are not all the possible side effects of the Amtagvi treatment. Talk with your healthcare provider for more information about Amtagvi. You can ask your healthcare provider for information about Amtagvi that is written for healthcare professionals.

You may report side effects to Iovance at 1-833-400-4682, or to the FDA, at 1-800-FDA-1088 or at www.fda.gov/medwatch.

Please see Full Prescribing Information and Patient Information, including Boxed Warning, for additional Important Safety Information.

On July 14, 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 that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary, selective cortisol modulator, relacorilant, to treat patients with platinum-resistant ovarian cancer (Press release, Corcept Therapeutics, JUL 14, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-submits-new-drug-application-relacorilant-treatment-0 [SID1234654367]).

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!

Corcept’s filing is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy, with no need for biomarker selection. Relacorilant was well-tolerated, consistent with its known safety profile. Importantly, the type, frequency and severity of adverse events in the combination arms were similar to those in the nab-paclitaxel monotherapy arms. Relacorilant did not increase the safety burden of the patients who received it.

"This submission is an important milestone for Corcept as we now have two New Drug Applications before the FDA: Relacorilant in combination with nab-paclitaxel as a treatment for people with platinum-resistant ovarian cancer and relacorilant as a treatment for patients with hypercortisolism," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. "Better treatment options are needed for the many patients living with these diseases. Our oncology and endocrinology business units are already working to make sure relacorilant is available immediately following regulatory approval."

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 developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism 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. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025 for relacorilant as a treatment for patients with hypercortisolism.

About Cortisol’s Role in Oncology

Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenes in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including 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.

On July 14, 2025 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that it has resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tabelecleucel (EBVALLO or tab-cel) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy (Press release, Atara Biotherapeutics, JUL 14, 2025, View Source [SID1234654366]). There are no FDA approved therapies in this treatment setting.

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!

"The BLA resubmission for tab-cel represents the collaborative efforts with our partner, Pierre Fabre Laboratories, to address the third-party manufacturing facility observations outlined in the January 2025 Complete Response Letter," said Cokey Nguyen, President and Chief Executive Officer of Atara. "We look forward to continued engagement with the FDA throughout its review and with Pierre Fabre Laboratories as they actively prepare for the potential launch of this innovative therapy in the U.S."

Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The BLA is supported by pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple life-threatening diseases, including the latest pivotal ALLELE study data that demonstrated a statistically significant 48.8% Objective Response Rate (ORR) (p<0.0001) and favorable safety profile consistent with previous analyses.

Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disorders.

Corporate Updates

Tab-cel Transition Activities: The company is finalizing the transfer of the following clinical studies associated with tab-cel:

NCT03394365: Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy (ALLELE)
NCT04554914: A Study to Evaluate Tabelecleucel in Participants with Epstein-Barr Virus-associated Diseases. This study is a multicenter, multicohort, open-label, single-arm, Phase 2 study investigating the efficacy and safety of tabelecleucel for the treatment of EBV-associated diseases.
Upon completion substantially all operational activities and associated costs related to tab-cel will transfer to Pierre Fabre Laboratories.

The sponsorship of the BLA continues to be maintained by Atara.

Cash Runway and Future Tabelecleucel (Tab-cel) Milestone and Royalty Income: Atara projects that its cash, cash equivalents and short-term investments of approximately $22M as of June 30, 2025, combined with the cost reduction initiatives implemented in the first half of 2025, will enable funding of all currently planned operations, including one-time restructuring costs, into the first quarter of 2026, that Atara believes will be sufficient to fund the ongoing activities required to achieve potential BLA approval.

Additionally, under its commercialization agreement with Pierre Fabre Laboratories, Atara is eligible to receive a $40 million milestone payment upon FDA approval of the tab-cel BLA, as well as significant double-digit tiered royalties as a percentage of net sales, and milestones related to commercial sales of EBVALLO.

The estimate of our cash, cash equivalents and short-term investments as of June 30, 2025, is preliminary, has not been audited and it is subject to change upon completion of our financial statement closure procedures. Our independent registered public accounting firm has not audited or completed any procedures with respect to this estimate. Such estimates are based on assumptions and plans that are subject to change and such changes could materially impact our expected cash runway. These assumptions include the completion of specific development and regulatory activities by us and actions taken by third parties, and are, therefore, uncertain at this time. Any delay in these activities will create additional expenses and cash needs for us.

We have not yet completed our quarter-end financial close process for the quarter ended June 30, 2025. This estimate of our cash, cash equivalents and short-term investments as of June 30, 2025, is preliminary and is subject to change upon completion of our financial statement closing procedures. Additional information and disclosure would be required for a more complete understanding of our financial position and results of operations as of and for the quarter ended June 30, 2025.

On July 14, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported on the announcement by Shanghai Henlius Biotech, Inc. that it has dosed the first patient in the United States in its global Phase 3 clinical trial (NCT06532006) of HLX22 in combination with trastuzumab and chemotherapy as a first-line treatment for HER2-positive metastatic gastric and gastroesophageal junction (GEJ) cancer (Press release, Alligator Bioscience, JUL 14, 2025, View Source [SID1234654365]).

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!

HLX22 is an anti-HER2 monoclonal antibody being developed by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues.

"We are encouraged to see Henlius dose the first patient in the United States in the Phase 3 trial of HLX22, reflecting continued momentum for this promising program in HER2-positive gastric cancer," commented Søren Bregenholt, CEO of Alligator Bioscience. "While Alligator is not directly involved in the development, we follow it closely as it represents an opportunity for meaningful revenue streams from milestones and royalties upon the future approval of HLX22."

Under the terms of the agreement, Alligator is entitled to 35% of AbClon’s revenue from its sublicense agreement with Henlius.

On July 14, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported exciting new data from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (Press release, Imugene, JUL 14, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/9dcc6e8a-a173-fb47-bc66-6b21c92ab09f/Two_Additional_Complete_Responses_in_azer_cel_Ph1b_trial.pdf [SID1234654361]).

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!

In February 2025, Imugene announced that a total of four out of seven patients had achieved a Complete Response (CR), defined as the disappearance of all signs of cancer in response to treatment. Since then, two additional patients have also achieved a Complete Response, and three patients have achieved Partial Response (cancer reduction by at least 50%) bringing the best overall response rate to 75% and the CR rate to 55%. The duration of response continues to mature. These patients are being treated with azer-cel and interleukin 2 (IL -2).

Evaluable
patients

Treatment

N

Overall Response Rate (ORR)

Complete Response (CR)

At Day 60

Best Durability (Time of response)

DLBCL

Lymphodepletion (LD)1 +azer-cel

+Interleukin-2 (IL-2)

12

9/12 (75%)

6/11 (55%)

>450 days on going

For approved, autologous CD19 CART products, the average time to best response is 2-3 months with some patients taking up to 6 months to achieve their best response.

Azer-cel is being developed as a potential allogeneic, off-the-shelf, CAR T-cell therapy, addressing key limitations of approved autologous CAR T drugs, including geographical access to treatment centres, manufacturing complexity and time to receive treatment (on-demand).

Based on the updated response rate and maturing durability data, as well as having been awarded FDA Fast Track Designation for DLBCL in March 2025, Imugene will request a Type B (End of Phase 1) Meeting in Q4 2025, with the US FDA to present the data and to discuss designs for a pivotal / registrational trial for azer-cel.

Leslie Chong, Managing Director and CEO of Imugene, said:

"We are very pleased with the continued positive data coming from the azer-cel trial, which further reinforces its potential as a treatment for DLBCL patients who have failed several previous lines of therapy. The data also significantly improves our position from both a regulatory and commercial standpoint, and we look forward to expanding on these discussions with the FDA.

Additionally, given the positive results, we are opening the trial to other niche blood cancer indications, such as PCNSL and other subtypes of B Cell Lymphoma, for CAR T naïve patients. This is a high unmet need with potential to expedite and expand the scope of azer-cel."

Dr John Byon, Chief Medical Officer of Imugene, said:

"DLBCL remains one of the most aggressive forms of lymphoma, and despite the existing therapies, there are a large number of patients that still face relapse or resistance. We are seeing significant potential from azer-cel to date in its ability to provide a critical step forward for these patients who have relapsed on multiple therapies, offering deep and durable responses with a one-time treatment.

We remain deeply committed to transforming the standard of care in difficult-to-treat blood cancers, where significant unmet medical need still exists."

The FDA Fast Track Designation for DLBCL received for azer-cel is designed to facilitate the development and expedite the review of drugs that address serious or life-threatening conditions and meet an unmet medical need. Benefits of the designation include more frequent meetings with the FDA to discuss development plans, the option for rolling review of regulatory submissions, and potential eligibility for Accelerated Approval and Priority Review upon meeting relevant criteria.

Imugene continues to actively enrol patients into the Phase 1b azer-cel trial at ten US sites with up to six sites in Australia planned, after the first Australian patient was dosed in January 2025 at Royal Prince Alfred Hospital in Sydney, resulting in a Complete Response.

About the Phase 1b azer-cel trial

The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients with DLBCL. The study has recently expanded to include and treat CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including primary central nervous system lymphoma (PCNSL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM) and follicular lymphoma (FL). Treatment with azer-cel, lymphodepletion (LD) and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated.

About diffuse large B cell lymphoma (DLBCL)

DLBCL is an aggressive and fast-growing type of non-Hodgkin’s lymphoma (NHL), a type of blood cancer. DLBCL is the most common type of NHL, with approximately 160,000[1] global cases per year and approximately 30,000 new cases per year in the U.S. Relapsed/refractory DLBCL has a high unmet medical need; ~60% of patients treated with approved autologous CD19 CAR T relapse.

About primary central nervous system lymphoma (PCNSL)

PCNSL is a rare and aggressive form of non-Hodgkin lymphoma (NHL), a type of blood cancer that originates in the brain, spinal cord, leptomeninges, or eyes, usually without evidence of systemic disease. In the U.S., there are approximately 1,500 to 1,800 new cases per year with limited approved treatment options and is a high unmet need. Currently, there are no CAR T-cell products approved for the treatment of PCNSL providing a unique opportunity for azer-cel to treat CART naïve patients.

About other types of B Cell Lymphoma

Other subtypes of non-Hodgkin lymphoma (NHL) include chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), the most common slow growing leukemia that can become resistant to therapy; marginal zone lymphoma (MZL), a slow-growing B-cell lymphoma that arises in lymphoid tissues associated with mucosal sites like the stomach and lung; Waldenström macroglobulinemia (WM), a rare slow-growing lymphoma characterized by excess IgM production, which can cause multiple complications ; and follicular lymphoma (FL), a common slow-growing NHL that can become more aggressive. While several targeted therapies and monoclonal antibodies are available for these types of B Cell Lymphoma, relapsed or refractory disease remains an ongoing challenge, highlighting the ongoing need for continued innovation and new and better treatments.

About Interleukin 2 (IL-2)

IL-2 is a cytokine (a protein that affects what happens between cells in the immune system) that helps T-cells (which are part of the immune system that help fight cancer) grow and survive. IL-2 has been shown to help T cells live longer and to enhance the cancer killing functions of CAR T cells, making them more effective at targeting and killing cancer cells.