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.

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 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 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial (first-line) treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer, did not meet its primary endpoints of progression-free survival (PFS) at its primary analysis with a hazard ratio (HR) of 1.27 [95% CI: 1.02,1.57] and overall survival (OS) at its first interim analysis with a HR of 1.33 [95% CI: 1.02, 1.73], which was immature (Press release, Hoffmann-La Roche, JUL 4, 2024, View Source [SID1234644669]). The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat population, which includes the phase II and phase III cohorts. The overall safety profile remains consistent with the safety profile previously observed for the combination of tiragolumab plus Tecentriq and chemotherapy, and no new or unexpected findings were identified. Based on these results, patients and investigators will be unblinded and we intend to halt the study. A communication will be sent to the investigators and results will be shared with health authorities and subsequently presented at an upcoming medical meeting.

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"These results are disappointing as it was our hope that this combination might yield improved outcomes for people living with metastatic non-squamous lung cancer," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. "We are thankful to all of the patients and healthcare professionals involved in the study, and we will leverage the learnings to inform our scientific understanding of the anti-TIGIT pathway and new avenues in cancer research."

Ongoing phase III studies are investigating treatment settings and indications distinct from SKYSCRAPER-06. Based on today’s results, we will evaluate any relevant changes needed to the ongoing tiragolumab programme.

About SKYSCRAPER-06 study
SKYSCRAPER-06 is a global phase II/III, randomised, placebo-controlled and double-blinded study evaluating tiragolumab plus Tecentriq (atezolizumab) and chemotherapy as an initial (first-line) treatment versus pembrolizumab and chemotherapy in 542 people with non-squamous non- small cell lung cancer. Primary endpoints are overall survival (OS) and progression-free survival (PFS).

About tiragolumab
Tiragolumab is an investigational novel immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint which suppresses the immune response to cancer. Based on preclinical research, tiragolumab is thought to work as an immune amplifier with other cancer immunotherapies such as Tecentriq (atezolizumab). The TIGIT pathway is distinct but complementary to the PD-L1/PD-1 pathway. Dual blockade with tiragolumab and Tecentriq may help overcome immune suppression and restore the immune response.

About Tecentriq (atezolizumab)
Tecentriq is a cancer immunotherapy approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer (mUC), PD-L1-positive metastatic triple-negative breast cancer (TNBC), BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma (ASPS).

Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted therapies and various chemotherapies across a broad range of cancers.

In addition to intravenous infusion, Tecentriq has been approved as a subcutaneous formulation in over 40 countries. The approved indications for Tecentriq SC mirror those of Tecentriq IV.

On July 3, 2024 ImmuneOnco Biopharma reported that Timdarpacept (IMM01) combined with Tislelizumab for refractory cHL Phase III clinical trial successfully completed the first patient enrollment on July 1, 2024 (Press release, ImmuneOnco Biopharma, JUL 3, 2024, View Source [SID1234655701]).

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IMM01 is the first SIRP-α-FC fusion protein to enter the clinical stage in China and is developed to use in combination with other drugs to treat a variety of blood and solid tumors. The results of two Phase II clinical trials of IMM01 were released in oral presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 annual meeting. One is the new updated data of Phase II trial for IMM01 combined with Tislelizumab in cHL patients who have failed prior PD-(L)1 antibody therapy, after 6.87 months of follow-up, ORR reached 66.7%, CR 24.2%, DCR 93.9%, median PFS and median DOR were not reached. In addition, IMM01 combined with Tislelizumab was well tolerated. Another is the phase 2 study of IMM01 combined with azacitidine (AZA) as the first-line treatment in adults with higher risk myelodysplastic syndromes (MDS). After 12.8 months follow-up, ORR reached 64.7%, including 29.4% CR), 15.7% mCR with hematologic improvement (HI): 5.9% HI and 13.7% mCR alone. 12-month PFS reached 54.4%. The updated data show that MM01 combined with AZA were well tolerated and effective in patients with treatment-naive higher-risk MDS.

Founder and chairman of ImmuneOnco Dr. Tian, Wenzhi said: "We are very pleased to see the completion of the first patient enrollment in our Phase III registration clinical trial of Timdarpacept (IMM01) combined with Tislelizumab for cHL refractory to PD-(L)1 monoclonal antibody. This therapy tries to meet ’unmet clinical need’ since there is very limit treatment options for those young-age onset patients. Timdarpacept activates macrophages to turn "cold tumors" into "hot tumors", and macrophages will present more tumor antigens to T lymphocytes to induce tumor-specific T cell responses, thereby restoring and expanding the sensitivity and therapeutic response to Tislelizumab This is well supported by our clinical data. In contrast, PD-1 antibody combined with another T cell-associated immune checkpoint antibody is difficult to achieve such clinical manifestations. We firmly believe that the development of Timdarpacept in combination with Tislelizumab for refractory cHL will have great market competitiveness. We will quickly advance the phase III registered clinical trial and strive to bring benefits to cHL cancer patients as soon as possible."

Chief Medical Officer/Senior Vice President of ImmuneOnco, Dr. Lu, Qiying, said: "the project of IMM01, the company’s key product, combined with Tislelizumab successfully completed the enrollment of the first patient in phase III clinical trial for the cHL patients refractory to PD1/PD-L1 therapy. this is another important milestone indicating that the clinical development of IMM01 has fully entered the registered clinical trial stage. This is globally first registration of trial large molecule drug against CD47 for cHL. From approval of CDE on May 16 to First Patient in on July 1, our team took one and half month to get the work done , indicating that the team had strong execution ability and worked efficiently. We are confident that we can quickly promote the clinical development of IMM01 products to bring new treatment options for cancer patients to solve the unmet clinical needs."