On April 3, 2023 Novocure (NASDAQ: NVCR) reported that it will report financial results for the first quarter 2023 on Thursday, May 4, 2023, before the U.S. financial markets open (Press release, NovoCure, APR 3, 2023, View Source [SID1234629782]). Novocure management will host a conference call and webcast to discuss the company’s financial results for the three months ended March 31, 2023, at 8:00 a.m. ET on Thursday, May 4, 2023. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

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The slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On April 3, 2023 Scorpion Therapeutics, Inc. ("Scorpion"), a clinical-stage biotechnology company redefining the frontier of precision medicine through its Precision Oncology 2.0 strategy, reported that it has named STX-241 as its next development candidate (Press release, Scorpion Therapeutics, APR 3, 2023, View Source [SID1234629781]). STX-241 is the third development candidate nominated by Scorpion in less than three years, and the second highly selective epidermal growth factor receptor ("EGFR") development candidate from the Company’s franchise of next-generation mutant EGFR inhibitors for the treatment of non-small cell lung cancer ("NSCLC"). STX-241 is an orally bioavailable, highly selective, central nervous system ("CNS")-penetrant, and potentially best-in-class fourth generation EGFR tyrosine kinase inhibitor ("TKI") designed to inhibit C797S mutations with a co-occurring EGFR exon 19 deletion or exon 21 mutation ("double mutant") in NSCLC.

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NSCLC is the most common form of lung cancer and EGFR mutations are one of its most common disease drivers. The current standard-of-care therapy for NSCLC patients with EGFR exon 19 or 21 mutations is osimertinib; however, up to 12.5 percent of treated patients, or approximately 3,000 people each year in the United States, acquire resistance mutations at C797S, for which there are currently no approved therapies.1 As osimertinib use in first line EGFR-mutated NSCLC increases, mutations at C797S are expected to increase in parallel, creating a growing need for a fourth-generation EGFR TKI that can be used to treat this patient population.

"We are excited to name STX-241 as our next development candidate, as we believe it holds immense potential to improve the lives of a growing group of patients who invariably develop resistance to the standard-of-care," said Axel Hoos, M.D., Ph.D., Chief Executive Officer of Scorpion Therapeutics. "We are particularly proud to introduce our third internally discovered development candidate in less than three years after the founding of Scorpion. This is a testament to the expertise of our scientific team, the capabilities of our platform, and the resulting speed and quality of our Precision Oncology 2.0 strategy. We look forward to sharing preclinical data for STX-241 later this year, and to submitting an IND application to the U.S. Food and Drug Administration ("FDA") in the first half of 2024."

Scorpion Therapeutics is developing STX-241 as an orally bioavailable, highly selective, potent inhibitor of double mutant NSCLC with the potential to deliver promising safety, tolerability, and efficacy, while exhibiting excellent CNS penetrance. In preclinical studies, STX-241 demonstrated potential best-in-class mutant vs. wild-type selectivity for the EGFR exon 19/C797S and EGFR exon 21/C797S double mutations when compared to key reference benchmarks, including approved first- and third-generation EGFR TKIs, gefitinib and osimertinib, which could translate into a wide therapeutic index. In addition, treatment with STX-241 demonstrated tumor regressions in animal models and favorable CNS penetration. Scorpion expects to present these data in the second half of 2023 and to submit an IND filing in the first half of 2024.

"Despite recent progress in the treatment of NSCLC, there is a need for new options that can address the resistance mutations that arise following front-line therapies," said Darrin Stuart, Ph.D., Chief Scientific Officer of Scorpion Therapeutics. "While osimertinib has delivered tremendous benefit for people living with EGFR mutation driven NSCLC, we are hopeful that STX-241 can fill the treatment gap for the growing number of patients that develop ‘double mutant’ disease."

STX-241 is the second highly selective EGFR product candidate to emerge from Scorpion’s franchise of next-generation mutant EGFR inhibitors for the treatment of NSCLC. Scorpion is also developing STX-721, a potentially best-in-class exon 20 mutant EGFR inhibitor, for which an IND application is expected in 2023.

On April 3, 2023 Mercy BioAnalytics, Inc., a pioneer in extracellular vesicle-based liquid biopsies for the early detection of cancer, reported it has closed a $41 million Series A financing round (Press release, Mercy BioAnalytics, APR 3, 2023, View Source [SID1234629780]). The oversubscribed financing was led by Novalis LifeSciences, with participation from Sozo Ventures, Hatteras Venture Partners, iSelect Fund, American Cancer Society BrightEdge, and Broadway Angels, an all-women venture capital group. The round also included strategic investments from Labcorp and Bruker, in addition to strong participation from existing investors.

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"Liquid biopsy is an important advance in clinical testing that has not yet been fully realized. Mercy is taking a unique approach designed to address the challenges that have plagued early cancer detection liquid biopsy tests that seek to measure tumor-derived DNA"

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The company’s novel Mercy Halo platform unlocks high clinical sensitivity and specificity through the simultaneous detection of multiple cancer-related biomarkers co-localized on the surface of individual tumor-derived extracellular vesicles. The abundance of extracellular vesicles in circulation enables the Mercy Halo test to be run on a very small volume of serum or plasma with a simple PCR-based read-out.

Proceeds from the financing will be used to advance development and commercialization of the Mercy Halo test for high-risk lung cancer screening, the company’s lead clinical indication. Lung cancer is the leading cause of cancer death globally, with more than 350 Americans dying from lung cancer every day. There are currently more than 14 million Americans recommended for annual lung cancer screening, but less than six percent of those eligible engage in imaging-based screening programs. An easy-to-administer blood test like Mercy Halo could help to address this challenge.

Funds will also be used to advance clinical programs in additional indications, including ovarian cancer, for which 80 percent of cases are diagnosed at Stage III or Stage IV with poor long-term survival. Mercy intends to leverage its Mercy Halo liquid biopsy platform technology to develop a broad portfolio of tests for the early detection of cancer.

"Cancer remains a leading cause of death globally, and liquid biopsy-based screening represents a meaningful opportunity to address barriers that contribute to disparities in early cancer detection, including in medically underserved populations. We believe the Mercy Halo testing platform is uniquely capable of delivering high-performing, broadly accessible cancer screening across all communities. A simple, inexpensive blood-based screening test could be a vital new tool to significantly increase patient engagement in lung cancer screening, creating the opportunity to save lives through early detection," said Mercy BioAnalytics CEO Dawn Mattoon, PhD. "We are grateful for the support from Novalis, the American Cancer Society BrightEdge and others, and are humbled by their belief in our mission to relieve suffering and save lives through our unique Mercy Halo technology."

"Liquid biopsy is an important advance in clinical testing that has not yet been fully realized. Mercy is taking a unique approach designed to address the challenges that have plagued early cancer detection liquid biopsy tests that seek to measure tumor-derived DNA," said Paul Meister, Partner at Novalis LifeSciences, and member of Mercy’s Board of Directors. "We have been impressed with Mercy’s early clinical data, their relentless focus on scientific rigor, and thoughtful approach to commercialization. We are excited to partner with the company to further validate their Mercy Halo test portfolio across the most challenging cancers we face."

Data presented last year at the annual meetings of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and American Association for Cancer Research (AACR) (Free AACR Whitepaper), and at the Early Detection of Cancer Conference (EDCC), demonstrated promising preliminary performance for Mercy Halo assays in detecting Stage I and II lung cancer and ovarian cancer. The company is currently planning and executing studies to validate assay performance in larger independent patient cohorts in these and other indications.

Mercy will be presenting additional new data at the upcoming AACR (Free AACR Whitepaper) conference in Orlando, Florida this month, and at the upcoming International Society for Extracellular Vesicles (ISEV) annual meeting in Seattle, Washington in May.

On April 3, 2023 Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing novel, multifunctional biotherapeutics, reported that management will participate in the following upcoming investor conferences (Press release, Zymeworks, APR 3, 2023, View Source [SID1234629779]):

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2023 Bloom Burton & Co. Healthcare Investor Conference. Zymeworks’ management will participate in one-on-one meetings and present on April 25th in Toronto, CA.

Stifel 2023 Targeted Oncology Days. Zymeworks’ management will participate virtually in one-on-one meetings and present on April 26th.

All presentations and webcasts will be available on Zymeworks’ website at View Source

On April 3, 2023 Sunovion Pharmaceuticals Inc., an indirect, wholly owned subsidiary of Sumitomo Pharma Co. Ltd, announced today that it will combine with affiliate companies Sumitomo Pharma America Holdings, Inc., Sumitovant Biopharma Ltd., Myovant Sciences, Inc., Urovant Sciences, Inc., Enzyvant Therapeutics, Inc., and Sumitomo Pharma Oncology, Inc. to form Sumitomo Pharma America, Inc. effective July 1, 2023 (Press release, Sumitomo Pharmaceuticals, APR 3, 2023, View Source [SID1234629778]). Spirovant Sciences, Inc., Sumitovant’s remaining wholly owned subsidiary, will operate as a standalone company under Sumitomo Pharma America. Sumitovant’s current CEO Myrtle Potter will serve as President and CEO of Sumitomo Pharma America upon completion of the combination.

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Sumitomo Pharma America will establish a science-based, technology-driven biopharmaceutical company focused on addressing unmet patient needs in the critical areas of central nervous system, oncology, urology, women’s health, and cell and gene therapies. Sumitomo Pharma America will house a diverse portfolio of commercialized products and robust pipeline of early- to late-stage assets leveraging proprietary technology platforms and advanced computational analytics capabilities to accelerate research, development, and potential commercialization of new therapies. Each subsidiary will continue to operate independently until the combination is complete but are collaborating on key integration efforts in the interim to allow for a smooth transition for all stakeholders in preparation for Day 1 of Sumitomo Pharma America.

Hiroshi Nomura, President and CEO of Sumitomo Pharma, said, "We remain deeply committed to addressing pressing health challenges and believe Sumitomo Pharma America will serve as a valuable growth engine. Sumitomo Pharma America will have increased scale and a combined network of resources and talent to accelerate a diverse portfolio of commercial and investigational programs for critical indications while creating a sustainable platform for growth."

"Sumitomo Pharma America represents an exciting opportunity to leverage each subsidiary’s competitive strengths to create an innovative biopharma company with the scale, agility and efficiency needed for accelerated impact and patient-focused outcomes," said Myrtle Potter, current CEO of Sumitovant and future President and CEO of Sumitomo Pharma America. "We will combine our deep R&D and life sciences expertise with unparalleled advance technology platforms, DrugOME and Digital Innovation, to underpin growth of existing product lines and pipeline efforts. Sumitomo Pharma America will build on the group’s mission and bring needed therapies to patients sooner in key areas where treatment options remain limited or non-existent."

"Sunovion is proud to have brought forward important therapies over the last decade, which have improved the lives of people worldwide. In addition, Sunovion’s R&D pipeline includes promising new compounds being developed for the treatment of patients suffering from serious neuropsychiatric conditions," said Antony Loebel, M.D., President and CEO, Sunovion. "We look forward to bringing together our strengths with other Sumitomo Pharma Group companies to create new synergies that will contribute to the betterment of healthcare for all.