On July 5, 2024 Kura Oncology, Inc. (the "Company") (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that on July 1, 2024, the Compensation Committee of the Company’s Board of Directors (the "Compensation Committee") granted inducement awards consisting of nonstatutory stock options to purchase 128,700 shares of common stock to eight (8) new employees under the Company’s 2023 Inducement Option Plan (Press release, Kura Oncology, JUL 5, 2024, View Source [SID1234644685]). The Compensation Committee approved the stock options as an inducement material to such employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4).

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Each stock option has an exercise price per share equal to $21.20 per share, the Company’s closing sales price on July 1, 2024, and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employees’ continued service relationship with the Company through the applicable vesting dates. The stock options are subject to the terms and conditions of the Company’s 2023 Inducement Option Plan and the terms and conditions of an applicable stock option agreement covering the grant.

On July 5, 2024 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases, reported that on July 2, 2024, the compensation committee of BridgeBio’s board of directors approved equity grants to 25 new employees in restricted stock units for an aggregate of 123,070 shares of the Company’s common stock (Press release, BridgeBio, JUL 5, 2024, View Source [SID1234644684]). One-fourth of the shares underlying each employee’s restricted stock units will vest on August 16, 2025, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the "Plan").

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The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio’s board of directors in November 2019, and amended and restated on February 10, 2023 and on December 13, 2023.

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.