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.

On April 3, 2023 Precision Biologics, Inc. ("Precision"), a clinical-stage immunotherapy and targeted oncology company, reported the publication of its first in human Phase I clinical trial with its novel monoclonal antibody, NEO-201, targeting the truncated core-1 O-glycan (Press release, Precision Biologics, APR 3, 2023, View Source [SID1234629777]). This trial was performed in patients with refractory solid tumors and has been published in the Journal of Experimental and Clinical Cancer Research.

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As discussed in the article, based on the safety and activity of NEO-201, a Phase II study is currently enrolling patients with metastatic Non-Small Cell Lung Cancer (NSCLC), Head and Neck Cancers, Endometrial Cancer and Cervical Cancer, who have already been treated with checkpoint inhibitor therapy (including prior Keytruda). (View Source). NEO-201 is a unique monoclonal antibody with multiple mechanisms of action. It has been shown previously to kill cancer cells expressing its target. In the Phase I clinical trial, NEO-201 was found to reduce immune suppressive cells that may be responsible in diminishing cancer-killing activity for checkpoint inhibitors like Keytruda. This ongoing Phase 2 trial is testing to see if combining of NEO-201 with Keytruda can reactivate the effectiveness of checkpoint inhibitors when they don’t work alone.

On April 3, 2023 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the first subject has been dosed in clinical trial of the Company’s novel targeted protein degrader ICP-490 in China (Press release, InnoCare Pharma, APR 3, 2023, View Source [SID1234629776]).

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ICP-490 is developed from InnoCare’s molecular glue platform for the treatment of multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL). It can overcome acquired resistance against earlier-generation of CRBN modulators. Synergizing and enhancing efficacy of monoclonal antibodies (mAbs), ICP-490 provides strong rationale of synergistic combinations in the clinic, and demonstrates immense potential in hematology field.

ICP-490 is expected to demonstrate anti-tumor effects in various MM and diffuse large B cell lymphoma (DLBCL). In addition, by enhancing its ADCC activity, ICP-490 can synergize with InnoCare’s drug pipelines, such as tafasitamab, which provides scientific rationales for combinatory treatment in the clinic.

Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare said, "ICP-490 is a highly potent next generation CRBN Modulator. Developed for the treatment of multi-indications, it has the potential to become a blockbuster in our blood tumor pipeline. We will accelerate its clinical development and explore single or combined therapies, expecting to benefit the blood tumor patients early."

MM accounts for about 10 percent of blood tumors1. NHL is the most common hematological malignancy in the world2, ranking among the top 10 common malignant tumors in China.