On July 5, 2023 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, reported the grant of a restricted stock unit (RSU) award for 9,000 shares of Syros common stock to one newly hired employee in connection with commencing employment with Syros (Press release, Syros Pharmaceuticals, JUL 5, 2023, View Source [SID1234633055]). This RSU was granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

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The award was granted on June 30, 2023, and vests as to one-quarter of the shares on June 30, 2024, and as to an additional one-quarter of the shares at the end of each successive year thereafter, subject to the employee’s continued service with Syros. This award is subject to the terms and conditions of a restricted stock unit agreement covering the award and Syros’ 2022 Inducement Stock Incentive Plan.

On July 5, 2023 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that synthetic recombinant proenzymes trypsinogen and chymotrypsinogen were successfully produced via the Proenzyme Optimization Project 1 (POP1) joint research and drug discovery program with the Universities of Jaén and Granada, Spain (Press release, Propanc, JUL 5, 2023, View Source [SID1234633054]). The POP1 project is led by Mr. Aitor González, whose doctoral thesis is focused on the "synthetic development of PRP and its subsequent biological validation," conducted at the laboratory of Professor Macarena Perán, PhD, University of Jaén, Granada, Spain, and in collaboration with Professor Diethard Mattanovich at the Institute of Microbiology and Microbial Biotechnology, University of Natural Resources and Life Sciences, Vienna, Austria. The program is designed to produce a backup clinical compound to the Company’s lead product candidate, PRP, which is from bovine origin, targeting metastatic cancer from solid tumors. According to Emergen Research, the global metastatic cancer market is projected to be worth over $111 Billion by 2027.

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Key findings from the research conducted by Mr. González determined that it is possible to scale up production of both proenzymes trypsinogen and chymotrypsinogen using recombinant technology, resulting in stable, purified proteins that are biologically active and have a similar anti-tumoral effect when compared with PRP. Furthermore, cell viability assays on pancreatic cancer stem cells (Bx PC3-CSCs) suggest that recombinant proenzymes may possess an even stronger anti-tumor effect than pancreatic proenzymes from bovine origin.

Dr Julian Kenyon, MD, MB, ChB, Propanc’s Chief Scientific Officer, said, "The work undertaken by Aitor is masterfully brilliant. I read his thorough work producing recombinant proenzymes in detail. It started with a comprehensive assessment of our current level of understanding of proenzymes and then describes in detail recombinant technology, culminating in the successful production of a completely synthetic recombinant product. As a result, we now have a viable way forward to developing a recombinant product, ultimately into the clinic."

The recombinant proenzyme product candidate, designated the label, rec-PRP, is set to enter preclinical pharmacology and safety toxicology studies to compare the safety and efficacy profile to the naturally derived formula in 2023 and 2024 calendar years.

A recombinant version of PRP could have additional benefits to the global healthcare system that could further capitalize on a new therapeutic approach to treating cancer that the Company’s lead product candidate offers sufferers. For example, both proenzymes are synthesized by an in vivo (living organism) system to produce crystallized proteins that could be maintained for long periods without suffering degradation in the absence of refrigeration. This will be useful for a longer shelf life as well as global distribution of the product, particularly in warmer climates and developing regions where refrigeration may not be available.

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include pancreatic, ovarian, kidney, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers. Orphan Drug Designation status of PRP has been granted from the US Food and Drug Administration (US FDA) for treatment of pancreatic cancer.

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.