On January 25, 2022 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, reported that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for Pidnarulex, a first-in-class G-quadruplex stabilizer, for the treatment of patients with breast and ovarian cancers BRCA1/2, PALB2, or other HRD mutations (Press release, Senhwa Biosciences, JAN 25, 2022, View Source [SID1234606791]).

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"We are excited to receive Fast Track Designation and look forward to working closely with the US FDA to accelerate the development of Pidnarulex, aiming to bring a meaningful treatment to patients with breast and ovarian cancer whose tumors have BRCA1/2. PALB2, or other HRD mutations," said Mei-Hui Kuo, Acting Chief Executive Officer of Senhwa Biosciences. FTD expedites the review of new drugs for serious conditions to fill an unmet medical need. Through Fast Track, Senhwa is eligible to apply for Accelerated Approval and Priority Review upon reaching relevant criteria with the US FDA.

Currently, Pidnarulex is tested in a Phase 1b Open-label, Multi-center Expansion Study (in both US and Canada) to determine a tolerable dose in patients with selected solid tumors (such as Breast Cancer, Ovarian Cancer, Pancreatic Cancer and Prostate Cancer) with BRCA2 and PALB2, and Ovarian Cancer with BRCA1 and other HR gene mutations. This dose will be used in future Phase II trials.

In a previous Phase 1 trial, Pidnarulex demonstrated clinically significant and lasting benefits in patients with BRCA1/2, and PALB2 mutations and that were also resistant to platinum and other chemotherapeutics. Due to a DNA repair defect, BRCA1/2 deficient tumor cells are more sensitive to PARPi through the mechanism of synthetic lethality. However, PARPi resistance is not uncommon in clinical use. According to an article published on Molecular Cancer in 2020, more than 40% of BRCA1/2 deficient patients fail to respond to PARPi alone.

Addressing treatment resistant tumors continues to be an unmet medical need in cancer treatment. Pidnarulex has proven human efficacy across certain tumor types by accelerating dsDNA breaks. By targeting the G-quadruplex DNA structure instead, Senhwa’s Pidnarulex has great potential as an alternative treatment for patients who have developed resistance to PAPRi or other chemotherapies.

About Pidnarulex (CX-5461)

Specific mutations within the Homologous Recombination (HR) pathway may be exploited by Pidnarulex through a "synthetic lethality" approach by targeting the DNA repair defects in HR Deficient tumors. Specifically, Pidnarulex is designed to stabilize DNA G-quadruplexes of cancer cells, which leads to disruption of the cell’s replication fork. While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death.

On January 25, 2022 Evotec reported that the Company has entered a target and drug discovery partnership with Boehringer Ingelheim, focusing on induced pluripotent stem cell ("iPSC")-based disease modelling for ophthalmologic disorders (Press release, Evotec, JAN 25, 2022, View Source [SID1234606760]). Millions of people are affected by vision-related diseases worldwide, and there is a high unmet need for novel therapeutic solutions.

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Through phenotypic screening of human iPSC-derived cells, supported by Evotec’s PanOmics platform, Evotec will identify small molecules able to modulate disease phenotypes, and then validate the underlying promising targets for potential therapeutic interventions. Boehringer Ingelheim will then continue with the discovery and development of potential therapeutic candidates. Besides an undisclosed upfront and FTE-based research payment, Evotec will continue to benefit from the successful further development of the candidates in the form of milestones and layered royalties.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We are excited to utilise our unique iPSC- and PanOmics-based approaches to ophthalmologic diseases in this new partnership with Boehringer Ingelheim. Phenotypic screening approaches have a long history of delivering highly effective drugs based on novel molecular mechanisms. Phenotypic screens based on human iPSC-derived disease models combined with our unbiased PanOmics readouts are more likely to deliver disease relevant drugs than any other cell-based screening approach."

On January 25, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.69 per share of the company’s common stock for the second quarter of 2022 (Press release, Merck & Co, JAN 25, 2022, View Source [SID1234606776]). Payment will be made on April 7, 2022 to shareholders of record at the close of business on March 15, 2022.

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On January 25, 2022 ViewRay, Inc. (NASDAQ: VRAY) reported that the Company will participate in the B. Riley Securities Oncology Conference. Scott Drake, President and Chief Executive Officer, and Zach Stassen, Chief Financial Officer, will participate in a fireside chat at 1:00 p.m. Eastern Time on Friday, January 28, 2022 (Press release, ViewRay, JAN 25, 2022, View Source [SID1234606792]).

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An audio webcast of the Company’s presentation will be available on the investor relations section of ViewRay’s website at View Source A replay of the webcast will be available for 7 days after the date of the presentation.

On January 25, 2022 AmerisourceBergen, a global healthcare solutions leader, and TrakCel, the leading innovator of cellular orchestration solutions, reported an integrated technology platform designed to accelerate patient access to prescribed cell and gene therapies and deliver complete visibility throughout the treatment journey (Press release, TrakCel, JAN 25, 2022, View Source [SID1234607618]). The enhanced offering combines two platforms—OCELLOS, TrakCel’s advanced therapy orchestration platform, and Fusion, a customer relationship management and patient support ecosystem powered by AmerisourceBergen’s Lash Group, a market leader in patient support services.

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The platform increases connectivity between hub patient services and providers, resulting in a seamless and timely exchange of benefits and eligibility information which expedites patient enrollment and support, ultimately helping patients start on therapies sooner. The new offering adds to AmerisourceBergen’s robust portfolio of services and solutions that support the needs of cell and gene therapy innovators, providers and patients throughout the product and treatment journey—from pre-clinical and commercial logistics to market access and reimbursement consulting and patient support services.

"The fast-growing pipeline of cell and gene therapies represents immense hope for patients around the world, but their unique nature can pose challenges throughout the patient journey, such as eligibility and coverage barriers that can delay access to the treatment," said Willis Chandler, president of Manufacturer Services and Commercial Solutions at AmerisourceBergen. "By combining the capabilities of Fusion and OCELLOS, we’re streamlining the path to care, improving speed-to-therapy and creating a heightened level of connectivity across the supply chain. This represents an important step in AmerisourceBergen’s ongoing commitment to build an end-to-end service offering that supports innovators in enhancing patient access to these critical therapies."

TrakCel’s OCELLOS streamlines the orchestration of clinical and commercial stage therapies, from subject enrollment to treatment and administration, ensuring chain of custody and chain of identity are managed at each step of the patient journey. Fusion leverages emerging technologies, such as artificial intelligence and machine learning, for benefit verification, prior authorization, and multi-channel communication between payers, providers, and patients.

Through this integrated platform, the bi-directional flow of data starts when a provider creates a patient account and captures enrollment information within OCELLOS. The data is then securely delivered to the patient hub, where Fusion’s advanced technology begins to determine patients’ eligibility through benefits verification. If needed, a Lash Group coordinator will initiate benefits investigation and prior authorization. Providers receive a near real-time response of the patient’s coverage determination in OCELLOS and can take the next steps to move the prescribed treatment process forward.

"Ensuring that medicines are delivered efficiently and safely to patients is of utmost priority and progressing treatment pathways smoothly and quickly is critical both to successful treatment and to a good patient experience," said Ravi Nalliah, Chief Product and Strategy Officer for TrakCel. "These goals can only be achieved if data is shared securely, accurately and in real-time."

The integrated platform serves as the latest collaboration between AmerisourceBergen and TrakCel to support advanced therapy developers. AmerisourceBergen’s global specialty logistics provider, World Courier, collaborates with multiple orchestration platform providers, including TrakCel, to deliver systems that enable stakeholders to maintain chain of custody, chain of identity and traceability throughout shipments.

For more information on the integrated platform and AmerisourceBergen’s solutions to support cell and gene therapy manufacturers, visit View Source