Novartis Scemblix® Phase III data first to show superior efficacy with a favorable safety and tolerability profile vs. standard-of-care TKIs in adults with newly diagnosed CML

On May 31, 2024 Novartis reported positive results from the pivotal Phase III ASC4FIRST trial as a late-breaking abstract at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting. Scemblix (asciminib) demonstrated superior major molecular response (MMR) rates at week 48 compared to investigator-selected standard-of-care (SoC) tyrosine kinase inhibitors (TKIs) imatinib, nilotinib, dasatinib and bosutinib, and compared to imatinib alone in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) (Press release, Novartis, MAY 31, 2024, View Source [SID1234643905]). Scemblix also showed a numerical improvement in MMR at week 48 vs. second generation (2G) TKIs (nilotinib, dasatinib and bosutinib)1. Additionally, Scemblix demonstrated a favorable safety and tolerability profile, with fewer adverse events (AEs) and treatment discontinuations vs. both imatinib and 2G TKIs1.

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"Scemblix is the first CML treatment to show significantly better efficacy compared to investigator-selected standard-of-care TKIs," said Prof. Tim Hughes, MD, South Australian Health & Medical Research Institute (SAHMRI). "When you combine superior response with the excellent safety and tolerability profile of Scemblix, we have a very promising potential frontline option for newly diagnosed patients to support them in achieving their treatment goals."

The median follow-up was 16.3 and 15.7 months for Scemblix and investigator-selected SoC TKIs, respectively1. Nearly 20% more patients treated with Scemblix achieved MMR at week 48 vs. investigator-selected SoC TKIs and nearly 30% more patients achieved MMR at week 48 vs. imatinib alone1. Patients treated with Scemblix also achieved deeper rates of molecular responses (MR4 and MR4.5) compared with investigator-selected SoC TKIs and imatinib alone1.

Overalla
Scemblix (n=201)
vs. investigator-selected SoC TKIs (n=204) Imatinib stratumb
Scemblix (n=101)
vs. imatinib (n=102) 2G TKI stratumc
Scemblix (n=100) vs. 2G TKIs (n=102)

Primary endpoints Week 48 MMR rates 67.7% vs. 49.0% 69.3% vs. 40.2% –
Week 48 MMR Treatment difference (95% CI) 18.9%
(9.6%–28.2%) 29.6%
(16.9%–42.2%)

Adjusted 1-sided
p-value <.001 <.001 –

Secondary endpointsd Week 48 MMR rates – – 66.0% vs. 57.8%
Week 48 MR4 39% vs. 21% 43% vs. 15% 35% vs. 26%
Week 48 MR4.5 17% vs. 9% 18% vs. 5% 16% vs. 13%
a All patients receiving Scemblix (n=201) or investigator-selected SoC TKIs (n=204). Treatment difference after adjusting for pre-randomization selected TKI and EUTOS long-term survival (ELTS) risk groups at baseline.
b The 203 patients within the pre-randomization-selected imatinib stratum were randomized to receive either Scemblix (n=101) or imatinib (n=102). Treatment difference after adjusting for ELTS risk groups at baseline.
c The 202 patients within the pre-randomization selected 2G TKIs stratum were randomized to receive either Scemblix (n=100) or 2G TKIs (n=102: nilotinib, 48%; dasatinib, 41%; bosutinib, 11%).
d Secondary endpoints were not powered for statistical significance.

In newly diagnosed patients, the safety profile was consistent with previous registration studies with no new safety concerns observed1. Fewer grade ≥3 AEs, dose adjustments to manage AEs, and half the rate of AEs leading to treatment discontinuation were reported for Scemblix vs. both imatinib and 2G TKIs1.

Scemblix Imatinib 2G TKIs
Grade ≥3 AEsa 38% 44% 55%
AEs leading to treatment discontinuationa 5% 11% 10%
AEs leading to dose adjustments/ interruptionsa 30% 39% 53%
a In patients who experienced ≥1 adverse event.

"Patients living with CML need efficacious and well-tolerated treatment options that help them achieve meaningful outcomes as they manage their chronic condition," said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. "The compelling ASC4FIRST data highlight the potential of Scemblix to achieve better results than standard-of-care in newly diagnosed adults, while maintaining a favorable safety and tolerability profile. These results reinforce Scemblix as a proven treatment in Ph+CML-CP, as we continue to build on our 20-year legacy in CML innovation."

"CML is a chronic condition and the side effects of standard-of-care can be challenging for patients. They often affect their daily life and can lead to high rates of treatment switching," said Gerald Clements, CML caregiver, patient advocate and Steering Committee Treasurer at CML Advocates Network. "Effective care that can be tolerated long-term is a key unmet need. By potentially bringing Scemblix to patients when they are first diagnosed, they may have an opportunity to be on a highly effective treatment while also maintaining their day-to-day from the start."

The trial remains ongoing, with the next scheduled analysis at week 96 to evaluate the key secondary endpoint (MMR at week 96) and additional secondary endpoints18.

These results have been submitted to the US Food and Drug Administration (FDA) via the Oncology Center of Excellence Real-Time Oncology Review (RTOR) program and Scemblix has been granted Breakthrough Therapy Designation. They will also be presented as a plenary at the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Congress in June.

About ASC4FIRST Phase III Clinical Trial
ASC4FIRST (NCT04971226) is a Phase III, head-to-head, multi-center, open-label, randomized study of oral Scemblix 80 mg QD vs. investigator-selected first- or second-generation TKIs (imatinib, nilotinib, dasatinib or bosutinib) in 405 adult patients with newly diagnosed Ph+ CML-CP18. The two primary endpoints of the study are to compare efficacy of asciminib vs. investigator-selected SoC TKIs and to compare efficacy vs. that of TKI within the stratum of participants with imatinib as pre-randomization selected TKI, based on proportion of patients that achieve MMR at week 4818.

The study remains ongoing with key secondary endpoints of proportion of patients that achieve MMR at week 96 and a safety endpoint of discontinuation of study treatment due to an AE (TTDAE) by week 9618. The study also assesses additional secondary safety and efficacy endpoints, including MMR, MR4, MR4.5, complete hematological response (CHR) and BCR::ABL1 ≤1% at and by all scheduled data collection time points; duration of and time to first MMR, MR4 and MR4.5; time to treatment failure; event-free survival, failure-free survival, progression-free survival and overall survival18.

About Scemblix (asciminib)
Scemblix is the first CML treatment that works by Specifically Targeting the ABL Myristoyl Pocket (referred to as a STAMP inhibitor in scientific literature)19-21. The current approved CML treatments are TKIs that target the ATP-binding site (ATP-competitive) 21.

Scemblix is approved in more than 70 countries, including the US and the EU, to treat adults with Ph+ CML-CP who have previously been treated with two or more TKIs22-24. In some countries, including the US, Scemblix is also approved in patients with Ph+ CML-CP with the T315I mutation23-25.
Scemblix is an important treatment option for patients who experience resistance and/or intolerance after two prior TKI therapies2-17, and it is being studied across multiple treatment lines for Ph+ CML-CP, both as a monotherapy and in combination.

Latest analysis of Novartis NATALEE study shows Kisqali® reduces risk of cancer recurrence for early breast cancer patients with high-risk node-negative disease

On May 31, 2024 Novartis reported results from a subgroup analysis of patients with high-risk, node-negative (N0) hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) from the Phase III NATALEE trial (Press release, Novartis, MAY 31, 2024, View Source [SID1234643906]). The latest analysis demonstrated that Kisqali (ribociclib) plus endocrine therapy (ET), compared to ET alone, showed an improvement in rates of invasive disease-free survival (iDFS), distant recurrence-free survival (DRFS), and distant disease-free survival (DDFS) in high-risk EBC patients with N0 disease1,2. These data are being presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting today and are consistent with the significant benefits observed in the broad population of patients with stage II and III HR+/HER2- EBC in the pivotal NATALEE trial, initially presented at ASCO (Free ASCO Whitepaper) 20231,2.

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Kisqali iDFS, DRFS and DDFS rates in key pre-specified subgroup1:

Subgroup 3-year iDFS rate, % 3-year DRFS rate, % 3-year DDFS rate, %
High-risk node-negative (N0) Kisqali + ET: 93.2
ET alone: 90.6
(HR=0.72; 95% CI: 0.41, 1.27) Kisqali + ET: 96.3
ET alone: 92.5
(HR=0.58; 95% CI: 0.29, 1.17) Kisqali + ET: 94.3
ET alone: 91.5
(HR=0.70; 95% CI: 0.38, 1.29)
"More than 1 in 3 patients diagnosed with early-stage breast cancer, regardless of nodal involvement, are at risk of experiencing recurrent disease despite treatment with standard chemotherapy and/or endocrine therapy," said Denise A. Yardley, MD, Associate Director, Breast Cancer Research; Executive Member, Breast Cancer Research Executive Committee, Sarah Cannon Research Institute; and Principal Investigator of the NATALEE clinical trial. "Notably, the NATALEE trial has shed light on the node-negative patient population, an important at-risk subgroup that could benefit from more options to reduce their risk of their cancer returning. The findings from this trial underscore the efficacy of ribociclib in early-stage node-negative breast cancer, highlighting its role as a viable and well-tolerated treatment intervention that could significantly diminish the recurrence risk for this particular group."

The safety profile of Kisqali at the 400 mg dose in the high-risk, N0 subgroup remains consistent with the well-tolerated profile previously demonstrated in the intent-to-treat population with generally low-grade adverse events (AEs), other than laboratory findings. In the N0 subgroup, the rate of discontinuation due to all grade AEs was 24% vs 8% with Kisqali plus ET vs ET alone1,2. No new safety signals were identified1,2.

"Currently available targeted therapies are approved only for a small proportion of patients, leaving a large number of people diagnosed with HR+/HER2- early breast cancer at risk of cancer returning, particularly those with high-risk N0 tumors," said Jeff Legos, Executive Vice President, Global Head of Oncology Development, Novartis. "Our robust body of data continues to support the potential for Kisqali to benefit many more patients as they seek to reduce the likelihood of their cancer coming back with the addition of a CDK4/6 inhibitor to their endocrine treatment."

Novartis submitted NATALEE data to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in 2023, and further submissions to global authorities are ongoing.

About NATALEE
NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali (ribociclib) with ET as an investigational adjuvant treatment versus ET alone in patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO5. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable5. The primary endpoint of NATALEE is iDFS as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria5. A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial5.

Results previously announced at the San Antonio Breast Cancer Symposium (SABCS) in December 2023 showed Kisqali plus ET, compared to ET alone, lowered the risk of cancer recurrence by 25.1% (HR=0.749; 95% CI: 0.628, 0.892; p=0.0006), along with consistent clinically meaningful iDFS benefit across key pre-specified subgroups5.

NATALEE explored a lower starting dose (400 mg) of Kisqali than the dose approved for treatment in metastatic breast cancer (MBC) (600 mg) with the goal to minimize disruptions to patient quality of life without compromising efficacy. Compared to the 600 mg dose, the safety profile of Kisqali at 400 mg was observed to have lower rates of symptomatic AEs and less need for dose modifications when administered up to three years5. AEs of special interest (grade 3 or higher) are neutropenia (44.3%), liver-related AEs (e.g., elevated transaminases) (8.6%), and QT interval prolongation (1.0%)1,5.

About Early Breast Cancer
More than 90% of patients diagnosed with breast cancer have EBC7. Despite adjuvant ET or being declared on remission, patients with EBC remain at risk for cancer recurrence, peaking within the first three years after initial diagnosis2. Patients with negative-node disease face a risk of recurrence up to 11% within the first three years after diagnosis, and 29% expect to recur within 20 years2.

About Kisqali (ribociclib)
Kisqali (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.

In MBC, Kisqali has consistently demonstrated statistically significant OS benefit across three Phase III trials8-19. Updates to the NCCN Guidelines for breast cancer, released in January 2023, recommend ribociclib (Kisqali) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of patients with HR+/HER2- when combined with an aromatase inhibitor (AI), making Kisqali the preferred first-line treatment of choice for US prescribers in HR+/HER2- in MBC20. Additionally, Kisqali has the highest rating of any CDK4/6 inhibitor on the ESMO (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale, achieving a score of five out of five for first-line pre-menopausal patients with HR+/HER2- advanced breast cancer21. Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6 inhibitors, received a score of four out of five for post-menopausal patients with HR+/HER2- advanced breast cancer treated in the first line22.

Kisqali has been approved in 99 countries worldwide, including by the United States Food and Drug Administration (FDA) and the European Commission. In the U.S., Kisqali is approved for the treatment of adult patients with HR+/HER2- advanced or MBC in combination with an AI as initial ET or fulvestrant as initial ET or following disease progression on ET in post-menopausal women or in men. In the EU, Kisqali is approved for the treatment of women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist23.

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

Please see full Prescribing Information for Kisqali, available at www.Kisqali.com.

Results of the Phase III PIVOTAL trial of Nidlegy in melanoma to be presented at ASCO 2024

On May 31, 2024 Philogen S.p.A. (BIT:PHIL) and Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma")) reported that the primary results of the Nidlegy Phase III PIVOTAL trial (NCT02938299) will be the object of an oral presentation at ASCO (Free ASCO Whitepaper) by Prof. Dr. Axel Hauschild (Abstract #LBA9501) (Press release, Philogen, MAY 31, 2024, View Source [SID1234643907]).

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PIVOTAL (NCT02938299) is an open label, randomized, multicenter, Phase III trial evaluating Nidlegy as a neoadjuvant intralesional therapy for fully resectable, locally advanced melanoma. The primary endpoint of the study was recurrence-free survival (RFS), assessed by investigators and confirmed by retrospective Blinded Independent Central Review (BICR) of PET/CT scans. The study was conducted at 22 sites in 4 European countries and enrolled a total of 256 patients randomized 1:1 to the treatment (neoadjuvant Nidlegy followed by surgery) and to the control arm (surgery). More than 90% of the enrolled patients had received previous treatments, including surgery, systemic therapy or radiotherapy.

"We look forward to Axel Hauschild’s presentation of the PIVOTAL primary results. These are exciting days for the Company: while PIVOTAL is the most advanced Phase III trial to be completed, we expect the readout of at least six additional ongoing studies with registration potential in the near future", commented Alfredo Covelli, M.D., Chief Medical Officer, Philogen. Hellen De Kloet, Business Head-Western Europe and ANZ, Sun Pharma, said "Sun and Philogen have had a fruitful partnership over the past year, wherein Nidlegy has continued to progress in its journey towards the market. Upon approval, Nidlegy is expected to address a significant unmet clinical need for patients suffering from this life-threatening disease. We are looking forward to the data presentation of the PIVOTAL results."

The primary outcome analysis shows that the RFS HR between the treatment and the control arm is 0.59 [95% CI 0.41-0.86; log-rank p=0.005] as per BICR assessment and 0.61 [0.41-0.92; p=0.018] as per investigator assessment (power = 85%; two-sided α = 0.05). Median RFS was 16.7 months in the treatment and 6.9 months in the control arm as per BICR. Moreover, distant metastasis-free survival (DMFS) was significantly improved by the neoadjuvant treatment, with an HR between the two arms of 0.60 [0.37-0.95; p=0.029]. The safety profile of Nidlegy was characterized mostly by low-grade, local adverse events (12.7% grade 3 TEAEs). No Grade 3-4 immune-related Adverse Events and no drug-related death recorded.

Collectively, the analysis of primary (RFS) and secondary (DMFS and safety) endpoints show that neoadjuvant Nidlegy is an effective therapeutic option for this patient population.

Philogen and Sun Pharma entered into a distribution, license and supply agreement in May 2023 for commercializing Nidlegy in Europe, Australia and New Zealand for the treatment of skin cancers. In October 2023, both companies announced that PIVOTAL met the primary endpoint of recurrence-free survival. Nidlegy is the first immunocytokine product for which positive Phase III data have been reported.

Nidlegy data accepted by ASCO (Free ASCO Whitepaper) include: Abstract Title Authors Abstract Number/Presentation details Phase 3 study (PIVOTAL) of neoadjuvant intralesional Daromun versus immediate surgery in fully resectable melanoma with regional skin and/or nodal metastases Hauschild A., Hassel J.C., Ziemer M., Rutkowski P., Meier F., Flatz L., GaudyMarqueste C., Santinami M., Russano F., von Wasielewski I., Eigentler T., Maio M., Zalaudek I., Haferkamp S., Quaglino P., Ascierto P.A., Garbe C., Robert C., Schadendorf D., Kähler C.K.. Abstract #LBA9501 Oral presentation: Friday, May 31, 2024, 2:45 – 5:45pm CDT * * *

About Nidlegy (Daromun)

Nidlegy is a biopharmaceutical product, proprietary to Philogen, designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF which are manufactured independently, and which are mixed prior to intralesional administration. The L19 antibody is specific to the Extra Domain B of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are pro-inflammatory cytokines with anti-tumor activity. Nidlegy is currently being investigated in two Phase III clinical trials for the treatment of locally advanced melanoma, and in Phase II clinical trials for the treatment of High-Risk Basal Cell Carcinoma and other non-melanoma skin cancers.

About PIVOTAL Phase III study

PIVOTAL is a phase III, international, multi-center, randomized, comparator-controlled, parallel-group study evaluating the efficacy and safety of intratumoral injections of Nidlegy as a neoadjuvant treatment, followed by standard-of-care treatment (surgery), as opposed to standard-of-care treatment (i.e., surgery alone), in melanoma patients with locally advanced, fully resectable cutaneous, sub-cutaneous (including satellite/in transit metastases), or nodal metastases accessible to intratumoral injection. For both arms, adjuvant treatment with approved drugs was allowed. Nidlegy was injected intralesionally up to four times, once a week before surgery. The trial enrolled 256 patients in Europe across 22 clinical centers in Germany, Italy, France and Poland.

About locally advanced fully resectable melanoma

Melanoma is skin tumor which begins when melanocytes start growing without control. Melanocytes are found in the basal layer of the epidermis at the boundary with the next layer (the dermis). Locally advanced melanoma is a metastatic cancer in which neoplastic lesions have spread to drainage area of regional lymph nodes and can appear as micrometastases, satellite/in transit metastases, and/or lymph node metastases. To date, these patients with resectable disease receive surgery, possibly followed by approved adjuvant systemic therapies. There is no approved drug for the treatment of locally advanced fully resectable melanoma in the neoadjuvant setting.

Adaptimmune and Galapagos sign clinical collaboration agreement with an option to exclusively license Adaptimmune’s TCR T-cell therapy candidate, uza-cel, in head & neck cancer and potential future solid tumor indications

On May 30, 2024 Adaptimmune Therapeutics plc (NASDAQ: ADAP), and Galapagos NV (Euronext & NASDAQ: GLPG) reported that they have entered into a clinical collaboration agreement with an option to exclusively license Adaptimmune’s next-generation TCR T-cell therapy (uza-cel) targeting MAGE-A4 for head & neck cancer and potential future solid tumor indications, using Galapagos’ decentralized cell manufacturing platform (Press release, Adaptimmune, MAY 30, 2024, View Source [SID1234643841]).

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Uza-cel is a next-generation clinical-stage engineered TCR T-cell therapy developed by Adaptimmune, targeting the MAGE-A4 cancer antigen expressed in various solid tumors. Uza-cel is engineered to express the CD8α co-receptor alongside the engineered TCR that targets MAGE-A4. Data indicate that co-expression of CD8α may broaden and increase the immune response against solid tumors.1

The Adaptimmune sponsored Phase 1 SURPASS trial with centrally manufactured uza-cel has shown encouraging results in head & neck cancer with an overall response rate of 80%. Initial in vitro results suggest that uza-cel, produced on Galapagos’ decentralized manufacturing platform, yields early phenotype T-cells that could improve efficacy and durability compared to uza-cel centrally manufactured on Adaptimmune’s platform.2 In addition, Galapagos’ decentralized manufacturing platform offers the potential for the delivery of fresh, fit cells with a vein-to-vein time of seven days in a patient population in which rapid access to treatment is vital.

1 Poster presentation ESMO (Free ESMO Whitepaper) 2021: Safety and efficacy from the SURPASS trial with ADP-A2M4CD8, a SPEAR T-cell therapy incorporating a CD8α co-receptor and an affinity optimized TCR targeting MAGE-A4, Annals of Oncology, vol. 32, suppl. 5, pp. S604-S605. Poster presentation SITC (Free SITC Whitepaper) 2021: Enhancement of TCR-engineered T-cells targeting MAGE-A4 antigen by co-expression of CD8α and inhibition of AKT signaling during ex vivo T-cell expansion. SITC (Free SITC Whitepaper) Annual Meeting. Nov. 10-14, 2021. Washington, DC and virtual. Emily Schmidt, PhD, et al.

2 Data on file

Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "Data with uza-cel from our Phase 1 SURPASS trial has demonstrated compelling early results in ovarian, bladder, and head & neck cancers. In head & neck cancer, we have seen reductions in target lesions across all five patients treated to date, and there have been four confirmed partial responses. Combining uza-cel with Galapagos’ unique decentralized manufacturing platform is a natural synergy and has the potential to deliver an even more effective TCR T-cell therapy for people with critical late-stage cancers."

Dr. Paul Stoffels3, Galapagos’ Chief Executive Officer and Chairman: "We are excited to partner with Adaptimmune, a pioneer in TCR T-cell therapy, as this fully aligns with our strategic vision to advance novel cell therapies. This collaboration enables us to expand our oncology cell therapy portfolio to include treatments for solid tumors and next-generation therapies, leveraging our innovative, decentralized cell therapy manufacturing platform. For patients with head & neck cancer, an area with significant unmet medical needs, this collaboration offers the promise for faster access to a potentially transformative treatment."

Under the terms of the agreement, Adaptimmune will receive an upfront exclusivity payment of $70 million, plus $15 million in R&D funding at signing. A further $15 million in R&D funding will follow subject to the start of dosing in the proof-of-concept trial. Adaptimmune will be responsible for the clinical proof-of-concept trial in head & neck cancer and the supply of the vector for the manufacturing of uza-cel. Galapagos will be responsible for the delivery of fresh uza-cel product for the head & neck cancer proof-of-concept trial using its innovative, decentralized cell therapy manufacturing platform.

Adaptimmune will retain the right to develop, manufacture, commercialize, and otherwise exploit uza-cel for platinum-resistant ovarian cancer (currently being developed in the SURPASS-3 trial).

Following completion of the proof-of-concept trial, Galapagos has an exclusive option to license global rights to uza-cel for a maximum of $100 million, depending on the number of indications in relation to which the option is exercised. In addition, Adaptimmune is eligible to receive development, regulatory and sales milestone payments of up $465 million, unless the agreement is terminated, and tiered royalties on net sales in the mid-single to low-double digit range.

Conference call / webcast details – 8 a.m. EDT May 31st

A live webcast and replay can be accessed at View Source . Call in information is as follows: 1-844-763-8274 (US or Canada) or +1-647-484-8814. Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.

Genprex to Present at the 2024 BIO International Convention

On May 30, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its President, Chief Executive Officer and Chief Financial Officer, Ryan Confer, will be providing an overview of the Company’s gene therapies for cancer and diabetes at the upcoming 2024 BIO International Convention (Press release, Genprex, MAY 30, 2024, View Source [SID1234643857]).

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Event: 2024 BIO International Convention

Conference Dates: June 3-6, 2024

Presentation Date: Monday, June 3, 2024

Presentation Time: 2:00 p.m. PT

Venue: San Diego Convention Center in Theater 1

Presenter: Ryan Confer, Genprex’s President, Chief Executive Officer and Chief Financial Officer

Mr. Confer will deliver an overview of the Company’s pioneering gene therapies for cancer and diabetes and will be available for in-person one-on-one meetings with participating attendees through the conference platform.

For those interested in meeting Genprex management during the conference, please request a meeting through the conference portal or reach out to Investor Relations at [email protected].