On July 5, 2023 Pheon Therapeutics (Pheon), a leading Antibody-Drug Conjugate(ADC) specialist developing next generation ADCs for a wide range of hard-to-treat cancers, reported an exclusive licence agreement with Biocytogen Pharmaceuticals (Beijing) Co. Ltd. (Biocytogen), a global biotech company focused on the discovery of novel antibody therapeutics (Press release, Pheon Therapeutics, JUL 5, 2023, View Source [SID1234633053]). Under the terms of the agreement, Pheon will develop and commercialize an antibody developed using Biocytogen’s proprietary RenMiceTM platforms. Biocytogen will receive an upfront payment and is eligible for development and commercial milestone payments as well as single-digit royalties on net sales.

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The new agreement expands Pheon’s ADC pipeline which boasts first-in-class and best-in-class ADCs to meet significant unmet clinical needs in oncology. Pheon launched in March 2022 with a $68 million Series A financing led by a strong leadership team of specialists in targeted oncology therapies and ADCs.

Biocytogen’s proprietary RenMiceTM platforms feature the complete replacement of human antibody variable genes in situ. The platforms together with target knock-out strategy empower the generation of fully human antibodies with low immunogenicity, great diversity, species cross-reactivity, high affinity and good developability. RenMice platforms and derived antibodies have been recognized by many renowned biotech and biopharmaceutical companies.

Bertrand Damour, Chief Executive Officer of Pheon Therapeutics, said: "This license agreement represents a significant expansion of Pheon’s pipeline, and it enhances our ability to successfully develop the next generation of ADCs. Biocytogen is a fantastic partner with groundbreaking technology that is well suited to our needs. We look forward to working with them and helping to find powerful therapies that can address the significant unmet patient need in solid tumours across a broad range of hard-to-treat cancers."

Dr. Yuelei Shen, President and CEO of Biocytogen, said: "We are glad to collaborate with Pheon Therapeutics. Using RenMiceTM, we have launched Project Integrum which aims to develop fully human therapeutic antibody molecules for 1000+ targets for the development of drugs in different modalities. The combination of our strengths in fully human antibody discovery with Pheon’s strengths in ADC technologies may accelerate the generation of differentiated novel therapeutics that can bring benefits to patients."

On July 5, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company granted an aggregate of 171,400 restricted stock units (RSUs) to 11 newly-hired employees (Press release, Karyopharm, JUL 5, 2023, View Source [SID1234633052]). These RSU awards were granted as of June 30, 2023 pursuant to the Company’s 2022 Inducement Stock Incentive Plan, as amended, as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

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Each RSU award will vest over three years, with 33 1/3% of the shares underlying the RSU award vesting on each of the three consecutive anniversaries of the applicable employee’s employment commencement date or June 30, 2023, as applicable. The vesting of each RSU award is subject to the employee’s continued service as an employee of, or other service provider to, Karyopharm through the applicable vesting dates. In addition, each RSU award will be immediately exercisable in full if, on or prior to the first anniversary of the consummation of a "change in control event," the employee’s employment is terminated for "good reason" by the employee or terminated without "cause" by Karyopharm (as such terms are defined in the applicable RSU agreement).

On July 5, 2023 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 the China National Intellectual Property Administration has granted Genprex China Patent No: 201780076886.X (Press release, Genprex, JUL 5, 2023, View Source [SID1234633051]). The broad patent covers the use of Genprex’s lead drug candidate, REQORSA Immunogene Therapy, in combination with PD1 antibodies through 2037.

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"This is a very important patent because it provides Genprex with additional protection for our REQORSA gene therapy in combination with PD1 antibodies, such as Keyruda, which is the subject of our ongoing Acclaim-2 clinical trial for the treatment of lung cancer," said Thomas Gallagher, Esq., Senior Vice President of Intellectual Property and Licensing at Genprex. "Genprex has already received this patent protection in the U.S., Japan, Australia, Russia and Mexico. Now with the same patent protection in China, we have secured exclusivity for this drug combination for the treatment of cancer in many of the largest markets. This patent protection prevents others from making, using or selling this drug combination."

Acclaim-2 is an open-label, dose escalation and clinical response study of REQORSA in combination with Keytruda in patients with advanced, metastatic non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda. More information on Acclaim-2 can be found at www.clinicaltrials.gov Identifier NCT05062980.

In 2022, Genprex received a U.S. patent granting protection for the combination of REQORSA with PD1 antibodies for the treatment of cancer. In 2021, Genprex received U.S. Food and Drug Administration’s (FDA) Fast Track Designation for treatment of the Acclaim-2 patient population.

About Acclaim-2

The Acclaim-2 trial is a Phase 1/2 open-label, dose-escalation and clinical response study of REQORSA in combination with Keytruda in patients with advanced, metastatic non-small-cell lung cancer who have progressed after treatment with Keytruda. The Company anticipates enrolling patients at approximately 10 clinical sites and estimates that the Phase 1 dose escalation portion of the Acclaim-2 trial will enroll up to 18 patients, the Phase 2 expansion portion will enroll approximately 36 patients, and the Phase 2 randomized portion will enroll approximately 126 patients. Patients enrolled in the Phase 2 randomized portion of the study will be randomized 2:1 to either REQORSA and Keytruda combination therapy or to chemotherapy (docetaxel with or without ramucirumab). Patients will be treated until disease progression or unacceptable toxicity is experienced. Patients must have histologically confirmed unresectable stage III or IV NSCLC (any histology) with radiological progression on Keytruda and an ECOG performance status of 0 to 1. Genprex expects to complete enrollment for the Phase 1 dose escalation portion of Acclaim-2 by the first quarter of 2024.

On July 5, 2023 Cardinal Health (NYSE: CAH) reported plans to release fourth-quarter and year-end financial results for its fiscal year 2023 on August 15, prior to the opening of trading on the New York Stock Exchange (Press release, Cardinal Health, JUL 5, 2023, View Source [SID1234633050]). The company will webcast a discussion of these results beginning at 8:30 a.m. Eastern.

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To access the webcast and corresponding slide presentation, visit Cardinal Health’s Investor Relations page. No access code is required. Presentation slides and a webcast replay will be available on the Investor Relations page for 12 months.

On July 5, 2023 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science to develop a new generation of small-molecule medicines and transform how disease is treated, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for CFT8919, an orally bioavailable BiDAC degrader designed to be potent and selective against EGFR L858R for non-small cell lung cancer (NSCLC) patients (Press release, C4 Therapeutics, JUL 5, 2023, View Source [SID1234633049]).

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This milestone marks C4T’s fourth IND clearance from its proprietary TORPEDO platform. In May 2023, C4T and Betta Pharmaceuticals entered into an exclusive licensing agreement for the development and commercialization of CFT8919 in Greater China, including Hong Kong SAR, Macau SAR and Taiwan. In China, approximately 693,000 patients were diagnosed with NSCLC in 2020 and approximately 40% of these cases are driven by the EGFR mutation. The L858R mutation is the second most common EGFR mutation, found in approximately 40% of NSCLC patients with EGFR mutations in China. Betta Pharmaceuticals is responsible for preparing and submitting a Clinical Trial Application to the National Medical Products Administration in China and plans to commence a first-in-human clinical trial of CFT8919 in China. C4T expects to initiate clinical trial activities outside Greater China following the completion of Betta Pharmaceuticals’ Phase 1 dose escalation study in Greater China.

About CFT8919
CFT8919 is an orally bioavailable allosteric BiDAC degrader that is designed to be potent and selective against EGFR bearing an oncogenic L858R mutation. In preclinical studies, CFT8919 is active in in vitro and in vivo models of L858R driven non-small cell lung cancer. Importantly, in preclinical studies, CFT8919 retains full activity against additional EGFR mutations that confer resistance against approved EGFR inhibitors including L858R-C797S, L858R-T790M, and L858R-T790M-C797S. In 2023, C4T and Betta Pharmaceuticals entered into an exclusive licensing agreement for the development and commercialization of CFT8919 in Greater China, including Hong Kong SAR, Macau SAR and Taiwan.