On July 5, 2024 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported that the China National Medical Products Administration (NMPA) has approved a new indication of XPOVIO (selinexor) as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) (Press release, Antengene, JUL 5, 2024, View Source [SID1234644689]).

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A Novel Therapy Bringing Long-awaited Clinical Breakthrough to the Treatment of R/R DLBCL

DLBCL is one of the most common subtypes of non-Hodgkin lymphoma (NHL) in adults and is highly heterogeneous malignancy in both clinical manifestations and prognosis. The current standard treatment, immunotherapy, offers patients with DLBCL a five-year progression-free survival rate of 60%-65% and curative outcomes for 40%-50% of treated patients. However, 10%-15% of DLBCL patients do not respond to standard first-line treatment, and 20%-25% experience relapses after achieving initial responses, leading to a poor prognosis and enormous unmet clinical needs.

The Clinically Validated Efficacy and Convenience of Oral Administration of Selinexor Offer Benefits to a Broad Spectrum of Patients

The approval for the new indication was supported by data from the registrational SEARCH study in China. Results from the study, which enrolled a total of 60 Chinese patients with DLBCL, showed that patients treated in the trial achieved a central radiological review assessed overall response rate (ORR) meeting the pre-specified primary endpoint. The SEARCH study demonstrated clear efficacy of orally-administered selinexor monotherapy in Chinese patients, exhibiting significant response rates, durable responses, long survival.

Prof. Jun Zhu, principal investigator of the SEARCH study from Peking University affiliated Beijing Cancer Hospital, said, "DLBCL is the most common subtype of NHL in adults and accounts for 40% of all NHL cases in China. The incidence of NHL has been steadily rising year over year, while patients with third- and later-lines relapsed or refractory disease lack effective and convenient therapies. As a nuclear export protein inhibitor with a novel mechanism of action (MOA), selinexor offers patients a new treatment option that is efficacious and easy to use, with oral availability that can reduce hospitalization and financial burden on patients by allowing them to receive treatment at home. Overall, the approval for this new indication of selinexor is indeed a great news for Chinese patients with R/R DLBCL."

Approved in 40+ Markets Globally with Expanding Insurance Coverage Across APAC

With a novel mechanism of action, XPOVIO is the world’s first approved orally-available, selective XPO1 inhibitor. XPOVIO has a global commercial presence with approvals in over 40 countries and regions. To date, XPOVIO has already been included for health insurance coverage in the mainland of China, Australia, Singapore and South Korea. Antengene has also submitted the NDAs in additional ASEAN markets, including Thailand, Malaysia and Indonesia, where approvals are expected in the H2 of 2024.

About XPOVIO (selinexor)

XPOVIO is the world’s first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses.

By blocking the nuclear export protein XPO1, XPOVIO can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. XPOVIO delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumor suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. To utilize its unique mechanism of actions, XPOVIO is being evaluated for use in multiple combination regimens in a range of indications. At present, Antengene is conducting multiple clinical studies of XPOVIO in the mainland of China for the treatment of relapsed/refractory hematologic malignancies and solid tumors (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]).

On July 5, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, and IASO Biotechnology ("IASO Bio"), a biopharmaceutical company engaged in discovering, developing, manufacturing, and marketing innovative cell therapies and antibody products, reported the agreement on a series of cooperation, including IASO Bio’s purchase from Innovent regarding its relevant right of FUCASO (Equecabtagene Autoleucel) and obtaining license from Innovent regarding the intellectual property related to FUCASO, as well as Innovent’s equity investment in IASO Bio (Press release, Innovent Biologics, JUL 5, 2024, View Source [SID1234644690]).

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According to the agreement, IASO Bio will purchase Innovent’s relevant rights of FUCASO under the original "BCMA CAR-T Cell Therapy Cooperation Agreement" at the agreed price and Innovent will use the proceeds to acquire an 18% stake in IASO Bio. Under the new strategic cooperation framework, the parties will achieve high-level integration in the field of cellular immunotherapy. IASO Bio obtains global commercial rights and the intellectual property license for FUCASO and will be fully responsible for development, manufacturing and commercialization of the product, while Innovent becomes a strategic shareholder of IASO Bio.

FUCASO was jointly developed by Innovent and IASO Bio and was approved by the National Medical Products Administration (NMPA) on June 30, 2023 to treat relapsed and/or refractory multiple myeloma (RRMM) patients who have undergone at least 3 lines of prior treatment and progressed. FUCASO is the world’s first approved fully human CAR-T product, as well as the first approved BCMA CAR-T product in China. On March 28, 2024, FUCASO received the investigational new drug (IND) application for treating RRMM patients who have undergone 1-2 lines of prior therapies and are refractory to lenalidomide. In 2024, its IND application for the treatment of autoimmune diseases such as refractory generalized myasthenia gravis (gMG) has also been approved in both China and the United States.

Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "We appreciate IASO Bio for their expertise, innovation, and strong execution capability in the field of cell therapy. We believe that the new collaboration model will better leverage our mutual strengths and resources. The new model will endow more integrated resources and dedicated team in the full chain of manufacturing, development and commercial operation of CAR-T cell therapy as a special novel modality. Also, we will continue to support IASO Bio as a strategic shareholder. We look forward to working with IASO Bio to improve the accessibility of medications and bring hope to patients worldwide."

Ms. Zhang Jinhua, Founder, Chairwoman and CEO of IASO Bio, stated: "We extend our gratitude to Innovent for their recognition and trust in our research and development capabilities as well as our commercialization strength. Over the past six years, we have built a solid partnership with Innovent and witnessed each other’s innovation and growth in the biopharmaceutical field. We firmly believe that this new strategic alliance will bring significant synergistic effects to both parties. We can fully leverage our strengths and work together to advance innovative therapeutic solutions. We will remain committed to our original mission of bringing more innovative treatments to patients and look forward to achieving mutual success in our future strategic partnership with Innovent."

On July 4, 2024 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that the New Drug Application ("NDA") for tazemetostat for the treatment of adult patients with relapsed or refractory ("R/R") follicular lymphoma ("FL") has been accepted for review and granted Priority Review by the China National Medical Products Administration ("NMPA") (Press release, Hutchison China MediTech, JUL 4, 2024, View Source [SID1234644677]).

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Tazemetostat is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme, Inc. ("Epizyme"), an Ipsen company. Tazemetostat is approved by the U.S. Food and Drug Administration ("FDA") for the treatment of certain patients with R/R FL and certain patients with advanced epithelioid sarcoma ("ES") under the FDA accelerated approval program. It is also approved by the Japan Ministry of Health, Labour and Welfare (MHLW) for certain patients with R/R FL. HUTCHMED entered into a strategic collaboration to research, develop, manufacture and commercialize tazemetostat in China, Hong Kong, Macau and Taiwan.

This China NDA is supported by results from a multicenter, open-label, Phase II bridging study in China, and clinical studies conducted by Epizyme outside China.

Tazemetostat was approved for use in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (Hainan Pilot Zone) in May 2022, under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with ES and FL consistent with the label as approved by the FDA. Tazemetostat was approved in the Macau Special Administrative Region ("SAR") in March 2023 and in the Hong Kong SAR in May 2024.

About Follicular Lymphoma
FL is a subtype of non-Hodgkin’s lymphoma ("NHL"). FL accounts for approximately 17% of NHL. In 2020, there were an estimated 16,000 and 13,000 new cases of FL in China and the U.S., respectively.[1],[2],[3]

About Tazemetostat Clinical Development in China
Tazemetostat is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme, an Ipsen company. HUTCHMED entered into a strategic collaboration to research, develop, manufacture and commercialize tazemetostat in China, Hong Kong, Macau and Taiwan.

42 patients were enrolled in the Phase II bridging study in China. The primary objective was to evaluate the objective response rate ("ORR") of tazemetostat for the treatment of patients with R/R FL whose disease harbor EZH2 mutations. The secondary objectives included duration of response ("DoR"), progression-free survival (PFS), overall survival (OS), safety and pharmacokinetics of tazemetostat for the treatment of R/R FL patients whose disease do or do not harbor EZH2 mutations. Results of the study will be submitted for presentation at an upcoming medical conference (NCT05467943).

HUTCHMED is participating in Ipsen’s SYMPHONY-1 study, leading it in China. This is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase Ib/III study, which is designed to evaluate the safety and efficacy of tazemetostat in combination with rituximab and lenalidomide (R²) in patients with R/R FL after at least one prior line of therapy (NCT04224493).

About Tazemetostat approval in the United States
Tazemetostat is a methyltransferase inhibitor indicated in the United States for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced ES not eligible for complete resection.
Adult patients with R/R FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with R/R FL who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval by the U.S. FDA based on ORR and DoR. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
The most common (≥20%) adverse reactions in patients with ES are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with FL are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

Please see the U.S. Full Prescribing Information for TAZVERIK (tazemetostat).

TAZVERIK is approved in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive FL (only when standard treatment is not applicable).

TAZVERIK is a registered trademark of Epizyme Inc., an Ipsen company.

On July 4, 2024 NH TherAguix (NHT), a phase II clinical-stage biotechnology company specializing in the development of novel nanomedicine solutions for precision radiotherapy in oncology, reported the publication of a pioneering study in American Chemical Society (ACS) Nano, a high impact factor journal (Press release, NH TherAguix, JUL 4, 2024, View Source [SID1234644679]). The study, titled "Theragnostic gadolinium-based nanoparticles safely augment X-ray radiation effects in patients with cervical cancer", provides compelling evidence supporting the use of AGuIX nanoparticles to selectively enhance the effectiveness of radiotherapy in cervical cancer treatment.

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AGuIX: A nanodrug capable of improving the precision and effectiveness of radiotherapy

The culmination of over a decade of research, AGuIX nanoparticles are designed to meet the critical medical need for more effective cancer treatments, including advanced cervical cancer. These gadolinium-based nanoparticles enhance MRI contrast, allowing for precise tumor visualization, and significantly amplify the radiation dose delivered to tumor tissues, thereby improving the efficacy of radiotherapy.

Study Highlights:
Safety and Tolerance: The Phase I clinical trial involving 12 patients with locally advanced cervical cancer demonstrated that AGuIX nanoparticles have an excellent safety profile, with no dose-limiting toxicities and no severe side effects observed, especially when combined with brachytherapy or cisplatinum-based chemoradiation.

Enhanced Imaging and Treatment: Based on AGuIX quantification through MRI, treating physicians can determine the optimal radiotherapy dose for each patient.

Efficacy: All patients (n=12) achieved complete remission of the primary tumor, with only one instance of distant tumor recurrence, i.e. 8% compared to 30-40% recurrence according to historical studies. The study confirms the relationship between tumor accumulation, quantification, and encouraging tumor response signals: an estimated dose enhancement factor of about 15% at 2 Gy per tumor has been observed, a meaningful increase that generates a biological response sufficient to achieve tumor control and improved outcomes for patients.

Rapid Clearance: The nanoparticles are rapidly cleared from the body, minimizing potential side effects and allowing for efficient imaging and treatment cycles.

Dr. Olivier de Beaumont, CMO of NH TherAguix, emphasized the significance of these findings: "This study marks a significant advancement in the use of AGuIX as a novel option for cancer treatment. The ability to quantify AGuIX concentration in correspondence with tumor response signals with high precision opens new avenues for personalized medicine in oncology using companion MRI-based information."

Vincent Carrère, CEO of NH TherAguix, commented: "We are thrilled to announce this important publication in ACS Nano. I would like to thank the teams at IGR, especially Professors C. Chargari and E. Deutsch, for this remarkable clinical and translational work. It highlights the transformative potential of AGuIX in enhancing radiotherapy for cervical cancer patients. These promising results reinforce our commitment to advancing innovative cancer treatments and improving patient outcomes."

On 4 July, 2024 Philogen 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 on June 20th the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for Nidlegy , which was finalized on June 3rd (Press release, Philogen, JUL 4, 2024, View Source [SID1234644680]).

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"The validation of the dossier by EMA represents the first important milestone for the MAA review process," commented Dario Neri, chief executive officer and chief scientific officer at Philogen. "Our group is committed to working with EMA throughout the review process with the goal of making Nidlegy available to patients in need."

Nidlegy is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and Australia. Both companies jointly made the following announcements:

– October 23, 2023 – Phase III PIVOTAL trial met the primary endpoint (link)
– May 31, 2024 – Primary results of PIVOTAL presented at ASCO (Free ASCO Whitepaper) (link)
– June 4, 2024 – MAA submission to EMA (link)

The data of the Phase III Nidlegy trial are expected to be published in a peer-reviewed scientific journal in 2024.