On September 7, 2022 Lytix Biopharma ("Lytix") (Euronext Growth Oslo: LYTIX), a Norwegian immuno-oncology company, reported the regulatory approval from European authorities to commence the ATLAS-IT-05 study in three European countries (Press release, Lytix Biopharma, SEP 7, 2022, View Source [SID1234619222]).

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ATLAS-IT-05 is a Phase II combination study evaluating LTX-315 and pembrolizumab in patients with advanced melanoma. The study was initiated at MD Anderson Cancer Center in 2021 and is currently ongoing in the US. The objective of the study is to document whether LTX-315 in combination with pembrolizumab is effective in inducing responses in patients who have failed prior anti PD 1/PD L1 immune checkpoint therapy.

The clinical trial application (CTA) has now been approved according to the European Clinical Trial Regulation, and the national authorities in Spain, France and Norway have commended the CTA for ATLAS-IT-05.

The approval will enable the expansion of the site network and clinical impact field for LTX-315, mitigate recruitment challenges and drive enrollment in the ATLAS-IT-05 Phase II trial towards completion. The study will be performed at highly recognized sites with intratumoral immunotherapy expertise in the three European countries. It will be led by melanoma experts at each site and follow the same protocol as in the US.

The regulatory application in Europe was submitted in Q2 2022 and six leading clinical sites in Europe are expected to open during the 4th quarter of 2022. Efforts to prepare the sites for initiation of the study and recruitment of patients is ongoing with the aim to complete enrollment in the study in early 2023.

"We are very pleased to have received the regulatory approval to commence studies in three European countries. Lytix has mobilized internal resources and moved extraordinary fast in the face of the need to broaden the impact of this study among clinicians and key opinion leaders. The speed with which we were able to move from the start of this expansion program to this approval speaks to the high level of engagement from the team at Lytix. Now that the European approval has been granted, we are looking forward to and actively preparing for the upcoming start of this clinical study at the European sites," says CEO and Co-founder of Lytix Biopharma, Øystein Rekdal.

On September 7, 2022 Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL) reported data from the AGENT study that formed the basis for its assessment that it was not justified to continue the study (Press release, Isofol Medical, SEP 7, 2022, View Source [SID1234619221]). Isofol will continue to collect and review data related to, among other areas, subgroups and gene expression, in order to identify possible commercial value. Data has so far failed to show any concrete results of value, which means severely limited commercial potential. The AGENT study will be terminated in accordance with applicable ethical considerations and regulatory requirements, which will occur during the autumn. Parallel to this, Isofol’s Board of Directors will evaluate possible courses of action to secure the greatest possible value for Isofol’s shareholders.

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The information in this press release is intended for investors.

On August 3, 2022 Isofol presented top-line results showing that the AGENT study met neither its primary endpoint nor its key secondary endpoints. On August 31, 2022 the company announced that based on available data[1], it was not justified to continue conducting the AGENT study further. Today, Isofol is able to present data from the AGENT study that formed the basis for this assessment and that indicate a severely limited clinical and commercial value for Isofol:

The P-value[2] for the primary endpoint of objective response rate (ORR) was approximately 0.85 and the study arms displayed no difference in outcome. Data for this endpoint is deemed to be final.
Progression-free survival (PFS) was approximately 12.8 months for the arfolitixorin arm and 11.6 months for the control arm, with a P-value of 0.76. Data for this endpoint is not final but it is not deemed to change significantly moving forward.
Analysis of overall survival (OS), one of the AGENT study’s safety endpoints, showed a preliminary indication of a non-significant detrimental trend for the experimental arm of the study compared with the control arm.
There was no difference between the study arms with regards to key safety data.
No significant differences between the study arms in any subgroups have been identified so far.
Isofol will continue to collect and analyze study data throughout the autumn so that the final study report can be compiled. This work will cover final analysis of subgroups, gene expression and additional safety data to identify possible clinical and commercial value. Parallel to this, work continues to close down the AGENT study in line with applicable ethical aspects and regulatory requirements for termination of phase III studies. This process will require both company time and resources during the autumn. Moreover, Isofol must take into consideration patients who are still undergoing treatment and follow up and this process must be completed in an ethically sound way. The AGENT study will be concluded when all patients have been taken care of, all data is available, and all analyses are finalized.

"The clinical results that we have access to right now point to a severely limited clinical and commercial value. This is a huge disappointment given the large medical need for new treatments of advanced colorectal cancer. Even if the opportunities of finding results that indicate commercial value are limited, we will continue to analyze the AGENT study’s data as it becomes available. At the same time, we are focusing on closing down the study appropriately with regards to ethics and regulations, as well as optimizing the company’s resources as new information becomes available," said Ulf Jungnelius, CEO of Isofol.

Isofol is actively implementing measures to decrease costs and thereby protect the company’s financial position. Isofol’s current assessment is that additional in-house studies cannot be justified.

As communicated on August 31, Isofol’s Board of Directors has taken the decision to investigate potential courses of action to secure the greatest possible value for Isofol’s shareholders. These options can consist of, among others, structural deals such as clinical collaborations or a potential merger with another company. The Board of Directors will consider additional options should they arise.

[1] Final clinical data is not yet available but Isofol’s assessment is that the current data will not change significantly moving forward.

[2] The P-value describes the probability that the result is a matter of chance. Values close to 1 do not indicate statistical difference, while a low value (often below 0.05) indicates a statistically significant difference.

The information was submitted for publication, through the agency of the contact person set out above, at  12.00 CEST on September 7, 2022.

About the AGENT Study
The Phase III AGENT Study is the first to evaluate a meaningful alternative to the standard of care for most patients with metastatic colorectal cancer (mCRC) in 20 years and involves approximately 90 clinics in the U.S., Canada, Europe, Australia, and Japan. The Phase III randomized, controlled, multi-center study of 490 patients assessed the efficacy and safety of arfolitixorin, [6R]-5,10 methylene-THF (MTHF), compared to leucovorin, both used in combination with 5-U, oxaliplatin, and bevacizumab, in first line mCRC patients.

The study was designed to show that arfolitixorin was better than leucovorin and that the results would be statistically significant. Patients were randomized in a 1:1 ratio with the primary endpoint being an overall response rate (ORR) >10 percent improvement vs. the control arm. The key secondary endpoint is a clinically meaningful positive trend in progression free survival (PFS). Other secondary endpoints include duration of response (DOR), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumor cells.

In the AGENT study, patients with non-resectable mCRC treated with arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab did not achieve a statistically significant overall response rate of ≥ 10% as compared to patients treated with the standard of care (leucovorin + 5-FU, oxaliplatin and bevacizumab).

On September 7, 2022 ViewRay, Inc. (NASDAQ: VRAY) reported that the company’s MRIdian MRI-Guided Radiation Therapy System has received approval from the Chinese regulatory authority National Medical Products Administration (NMPA), allowing for its sale and utilization throughout China (Press release, ViewRay, SEP 7, 2022, View Source [SID1234619220]). This approval expands MRIdian’s global reach and offers cancer patients a new radiation therapy option, MRIdian Stereotactic MRI-Guided Adaptive Radiotherapy (SMART), allowing treatment that integrates diagnostic-quality MR imaging, on-table adaptive replanning, and continuous, real-time, soft tissue tracking and automated beam gating.

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Recognizing the need to improve both social and economic development, China has put health at the core of policy making. Healthy China 2030 lays out China’s long-term approach to healthcare and shows its commitment to improving healthcare services across the country.1 There are about 4.6 million new cases of cancer diagnosed annually in China.2 The Healthy China 2030 initiative aims to increase the five-year survival rate of cancer patients by 15%.1

"With the increasing burden of cancer prevalence in China, we are excited to bring the benefits of MRIdian SMART to these patients," said Paul Ziegler, ViewRay Chief Commercial Officer. "The availability of more treatment options, excellent treatment outcomes, reduced toxicity, and improved quality of life is an important advance for this market. The China NMPA approval not only supports our global expansion but also our goal of changing the paradigm of care in radiation oncology."

The MRIdian system provides oncologists outstanding anatomical visualization through diagnostic-quality MR images and the ability to adapt a radiation therapy plan to the targeted cancer with the patient on the table. This combination allows physicians to define tight treatment margins to avoid unnecessary radiation exposure of vulnerable organs-at-risk and healthy tissue and allows the delivery of ablative radiation doses in five or fewer treatment sessions, without relying on implanted markers. By providing real-time continuous tracking of the target and organs-at-risk, MRIdian enables automatic gating of the radiation beam if the target moves outside the user-defined margins. This allows for delivery of the prescribed dose to the target, while sparing surrounding healthy tissue and critical structures, which results in minimizing toxicities typically associated with conventional radiation therapy.

To date, nearly 25,000 patients have been treated with MRIdian. Currently, 53 MRIdian systems are installed at hospitals around the world where they are used to treat a wide variety of solid tumors and are the focus of numerous ongoing research efforts. MRIdian has been the subject of hundreds of peer-reviewed publications, scientific meeting abstracts, and presentations. For a list of treatment centers, please visit: View Source

Xiaodong, tan. (2017). Healthy china 2030: A Vision for Health Care – ISPOR. Retrieved August 11, 2022, from View Source
Incidence rates: 2020 GLOBOCAN database
Disclaimer:
Nothing in this material is intended to provide specific medical advice or to take the place of written law or regulations.

Safety Statement
The MRIdian Linac System is not appropriate for all patients, including those who are not candidates for magnetic resonance imaging. Radiation treatments may cause side effects that can vary depending on the part of the body being treated. The most frequent ones are typically temporary and may include, but are not limited to, irritation to the respiratory, digestive, urinary, or reproductive systems; fatigue; nausea; skin irritation; and hair loss. In some patients, side effects can be severe. Treatment sessions may vary in complexity and duration. Radiation treatment is not appropriate for all cancers. You should discuss the potential for side effects and their severity as well as the benefits of radiation and magnetic resonance imaging with your doctor to make sure radiation treatment is right for you.

On September 7, 2022 Nuvalent, Inc. ( Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported it will present preliminary dose escalation data from its ongoing ARROS-1 Phase 1/2 clinical trial of NVL-520 for patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors during an oral plenary session at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium taking place October 26-28, 2022 in Barcelona, Spain (Press release, Nuvalent, SEP 7, 2022, View Source [SID1234619219]). In addition, new preclinical data will be presented in poster sessions for its ALK-selective inhibitor NVL-655 and its recently nominated HER2-selective inhibitor, NVL-330.

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The NVL-520 oral presentation represents the first report of preliminary safety and clinical activity data from the dose-escalation portion of the company’s ongoing Phase 1/2 ARROS-1 study, evaluating NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors. NVL-520 has been designed to address the clinical challenges of emergent treatment resistance, off-target central nervous system (CNS) adverse events, and brain metastases that may limit the use of currently available ROS1 kinase inhibitors. The ARROS-1 clinical trial is continuing to enroll patients in the Phase 1 portion of the study.

The NVL-655 poster presentation will describe new preclinical data demonstrating activity of NVL-655 in additional models derived from patients who have progressed on treatment with earlier-generation ALK inhibitors. NVL-655 has previously demonstrated the potential for a best-in-class profile through broad preclinical activity across diverse ALK oncoproteins, single and compound resistance mutations, and tumor types while maintaining strong selectivity for ALK over TRKB and CNS penetrance.

Clinical investigation of NVL-655 is currently ongoing in the Phase 1 portion of the ALKOVE-1 Phase 1/2 study of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors. Nuvalent also continues to advance a discovery program for ALK IXDN compound mutations and plans to leverage insights from the ALKOVE-1 clinical trial to guide development candidate selection, which is no longer planned for 2022.

Nuvalent recently selected NVL-330 as the development candidate from its HER2 exon 20 insertion discovery program. Preclinical characterization of NVL-330 as a HER2-selective, brain-penetrant, small molecule inhibitor with activity against HER2 exon 20 insertion mutations will be shared in a poster presentation.

Nuvalent plans to host a conference call and webcast in conjunction with the data presentation on October 28, 2022. Details for the conference call will be provided at a future date, and, once available, presentation and poster information will be archived on the Nuvalent website at www.nuvalent.com.

Details for the presentations are as follows:
Title: Safety and preliminary clinical activity of NVL-520, a highly selective ROS1 inhibitor, in patients with advanced ROS1 fusion-positive solid tumors
Abstract Number: ENA22-0275
Session Topic: Molecular Targeted Agents
Session Title: New Drugs on the Horizon, Plenary Session 6
Session Date and Time: October 28, 2022, 1:00 p.m. – 1:10 p.m. CEST
Presenter: Alexander Drilon, M.D. (Memorial Sloan Kettering Cancer Center, New York, USA)

Title: Preclinical activity of NVL-655 in patient-derived models of ALK cancers, including those with lorlatinib-resistant G1202R/L1196M compound mutation
Abstract Number: ENA22-0105
Session Title: Poster Session, Molecular Targeted Agents 2
Session Date and Time: October 27, 2022, 10:00 a.m. – 5:00 p.m. CEST
Presenter: Anupong Tangpeerachaikul, Ph.D. (Nuvalent, Cambridge, USA)

Title: NVL-330 is a selective, brain-penetrant inhibitor of oncogenic HER2 exon 20 insertion mutations in preclinical models
Abstract Number: ENA22-0150
Session Title: Poster Session, Molecular Targeted Agents 2
Session Date and Time: October 27, 2022, 10:00 a.m. – 5:00 p.m. CEST
Presenter: Kristin L. Andrews, Ph.D. (Nuvalent, Cambridge, USA)

About NVL-520
NVL-520 is a novel brain-penetrant ROS1-selective inhibitor designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with the prevalent G2032R resistance mutation and those with the S1986Y/F, L2026M, or D2033N resistance mutations. NVL-520 has been optimized for brain penetrance to potentially improve treatment options for patients with brain metastases. NVL-520 has been observed in preclinical studies to selectively inhibit wild-type ROS1 and its resistance variants over the structurally related tropomyosin receptor kinase (TRK) family to potentially avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and drive more durable responses for patients. NVL-520 is currently being investigated in the ARROS-1 study (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors.

About NVL-655
NVL-655 is a novel brain-penetrant ALK-selective inhibitor created to overcome limitations observed with currently available ALK inhibitors. NVL-655 is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with the solvent front G1202R mutation or compound mutations G1202R / L1196M ("GRLM"), G1202R / G1269A ("GRGA"), or G1202R/L1198F ("GRLF"). NVL-655 has been optimized for CNS penetrance to improve treatment options for patients with brain metastases. NVL-655 has been observed in preclinical studies to selectively inhibit wild-type ALK and its resistance variants over the structurally related tropomyosin receptor kinase (TRK) family to potentially avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and drive more durable responses for patients. NVL-655 is currently being investigated in the ALKOVE-1 study (NCT05384626), a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors.

About NVL-330
NVL-330 is a novel, selective, brain-penetrant HER2 inhibitor designed to treat patients with HER2 exon 20 insertion-positive tumors, including those with brain metastases, and to minimize adverse events and dose-limiting toxicities related to off-target inhibition of epidermal growth factor receptor ("EGFR" or "ErbB1"), a HER2 family member.

On September 7, 2022 CASI Pharmaceuticals, Inc. ( Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported the first-patient-in in China Phase 1 dose-escalation and expansion study of BI-1206, a first-in-class fully human monoclonal antibody (mAb) that targets FcγRIIB, in combination with rituximab in patients with relapsed/refractory Non-Hodgkin’s Lymphoma (NHL) (Press release, CASI Pharmaceuticals, SEP 7, 2022, View Source [SID1234619218]). The study design is to assess the safety, tolerability, pharmacology, and clinical activity of BI-1206. The patient was enrolled at Henan Cancer Hospital.

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Wei-Wu He, Ph.D., CASI’s Chairman, and Chief Executive Officer, commented, "We are excited to dose the first patient in the continued evaluation of BI-1206. BI-1206 has previously shown encouraging early signs of efficacy in Phase 1, a tolerable safety profile, and the potential to be used with multiple therapeutic mAbs that rely on ADCC/CDC* for efficacy. This Phase 1 trial in China will generate valuable information and has the potential to provide early evidence of clinical activity in the treatment of relapsed or refractory Non-Hodgkin’s Lymphoma."

Martin Welschof, CEO of BioInvent, said: "The initiation of this Phase I trial in China is an important milestone for BioInvent as it marks the expansion of the clinical program of our lead drug candidate, BI-1206. The clinical results have been very promising, and we are looking forward to generating additional data together with our partner CASI Pharmaceuticals with the aim of improving treatment for patients with NHL and addressing this significant unmet medical need."

About BI-1206 (Anti-FcyRIIB antibody)
The National Medical Products Administration (NMPA) granted BI-1206 Clinical Trial Application (CTA) approval in December 2021. Ethics committee approval from a leading investigational site was granted in January 2022. BI-1206 is currently being investigated outside of China in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of non-Hodgkin lymphoma (NHL), which includes patients with follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL) who have relapsed or are refractory to rituximab. A second Phase 1/2 trial is investigating BI-1206 in combination with anti-PD1 therapy Keytruda (pembrolizumab) in solid tumors. Earlier this year, the U.S. FDA granted Orphan Drug Designation, for BI-1206, for the treatment of follicular lymphoma, the most common form of slow-growing non-Hodgkin lymphoma.