Labcorp Launches New Test for People With Skin Cancer

On May 18, 2022 LabCorp reported that Finding treatment options for skin cancer may become easier with the launch of a new test by Labcorp (NYSE: LH), a leading global life sciences company (Press release, LabCorp, MAY 18, 2022, View Source [SID1234614803]). The new test measures Lymphocyte-activation gene 3 (LAG-3) expression levels by immunohistochemistry (IHC) in tumor tissue. LAG-3 is an immune-oncology target with demonstrable clinical benefit in patients with melanoma. The test is available for use in both clinical trials and for the care and treatment of patients.

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"Our goal is to provide diagnostic solutions that can help guide the clinical application of new cancer treatments, improving the lives of those living with cancer," Prasanth Reddy, M.D., MPH, senior vice president and oncology head at Labcorp. "The LAG-3 IHC assay provides physicians with actionable information to evaluate the best treatment options, including newly approved treatments and clinical trials, for their patients."

The LAG-3 IHC assay was developed by Labcorp Drug Development for use in a clinical trial studying dual checkpoint inhibitors that included a LAG-3 immunotherapy. As is published in the Journal of Clinical Pathology, this assay will enable the analysis of LAG-3 status in the tumor and the correlation between expression status and response to LAG-3 immunotherapy. This assay is also being used in other ongoing clinical trials evaluating clinical response to LAG-3-directed cancer treatments.

According to the National Cancer Institute, skin cancer is the most common form of cancer in the United States. While melanoma is one of the rarer types, it poses a greater risk of spreading to other parts of the body. One of the first signs of melanoma is a change to the appearance of an existing mole. Anyone noticing a new mole or changes to existing moles should speak to health care provider. A tissue biopsy is the only way to diagnose melanoma and can be performed in most health care settings.

The development of the LAG-3 IHC assay coupled with its availability for clinical use, demonstrates Labcorp’s unique leading capabilities in diagnostic testing and comprehensive drug development services. By delivering targeted biomarker solutions to power better decisions by clinicians, Labcorp is helping to improve patient outcomes.

Verastem Oncology Awarded Pancreatic Cancer Action Network’s First Therapeutic Accelerator Award to Evaluate the Combination of VS-6766 and Defactinib in Front-Line Metastatic Pancreatic Cancer

On May 18, 2022 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported that it has received the first "Therapeutic Accelerator Award" from the Pancreatic Cancer Network (PanCAN) (Press release, Verastem, MAY 18, 2022, View Source [SID1234614819]). The Award will support a Phase 1b/2 clinical trial of the Company’s lead investigational candidates, RAF/MEK Clamp, VS-6766, with FAK inhibitor, defactinib, to evaluate whether a more complete blockade of KRAS signaling, which is mutated in more than 95% of pancreatic cancer tumors, will improve outcomes for patients with front-line metastatic pancreatic cancer.

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"The goal of the Therapeutic Accelerator Award is ultimately to develop new drugs for patients with metastatic pancreatic cancer faster and more efficiently than standard clinical trials," said Julie Fleshman, president and CEO of PanCAN. "We are delighted that Verastem, with rigorous scientific and clinical evidence for addressing this critical pathway, will be the inaugural awardee for this grant. We are looking forward to partnering with them to determine whether their investigational treatment combination will be beneficial to patients."

"We are honored to have been selected for this important award that will expand our development program for VS-6766 and defactinib to evaluate the combination in patients with metastatic pancreatic cancer," said Louis Denis, Chief Medical Officer at Verastem Oncology. "We look forward to a strong collaboration with PanCAN and applaud its commitment to bring patients, academia and industry together to advance the science and accelerate development of much needed novel treatment options for patients."

PanCAN created the Therapeutic Accelerator Award as part of its innovative approach to pancreatic cancer research. This includes grants for scientists across the country as well as large-scale research initiatives such as PanCAN’s Precision PromiseSM Clinical Trial, which seeks to accelerate the approval of new treatment options for pancreatic cancer patients and PanCAN’s Early Detection Initiative, with a goal of developing a strategy to diagnose pancreatic cancer early when surgery is still possible.

Verastem Oncology was selected to receive the 2022 PanCAN Therapeutic Accelerator Award of $3.8M through a rigorous, competitive process involving scientific, business and programmatic review from leading experts in the field.

KRAS is mutated in more than 95% of pancreatic cancers and Verastem Oncology’s RAF/MEK clamp VS-6766 blocks tumorigenic signaling downstream of mutant KRAS. Verastem’s selective FAK inhibitor, defactinib, is included in the trial as FAK has been identified preclinically and clinically as a potential resistance mechanism to RAF and MEK inhibition. FAK inhibition has been shown to reduce stromal density in pancreatic cancer both preclinically and clinically which may enhance anti-tumor immunity and efficacy of the standard gemcitabine/nab-paclitaxel regimen.

About the Pancreatic Cancer Action Network

The Pancreatic Cancer Action Network (PanCAN) leads the way in accelerating critical progress for pancreatic cancer patients. PanCAN takes bold action by funding life-saving research, providing personalized patient services and creating a community of supporters and volunteers who will stop at nothing to create a world in which all pancreatic cancer patients will thrive.

About VS-6766

VS-6766 (formerly known as CH5126766 and RO5126766) is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. VS-6766 is currently in late-stage development.

In contrast to other MEK inhibitors, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

Verastem Oncology is conducting Phase 2 registration-directed trials of VS-6766 alone and with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS G12V-mutant NSCLC as part of its RAMP (Raf And Mek Program) clinical trials, RAMP 201 and RAMP 202, respectively. Verastem Oncology has also established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and adagrasib in combination with VS-6766 in KRAS G12C-mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively.

Laekna Therapeutics Raises $61 Million in Series D financing

On May 18, 2022 Laekna Therapeutics ("Laekna"), a clinical-stage global biotechnology company dedicated to developing next generation medicines to treat cancer and liver diseases, reported that it has raised $61 million in Series D financing led by CS Capital with support from Worldstar, and Infinity Capital (Press release, Laekna Therapeutics, MAY 18, 2022, View Source [SID1234614835]). Yanchuang Capital as the existing investor continued to support the company with additional funding.

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Laekna’s robust infrastructure has enabled the rapid development of 14 innovative drug candidates. The company has initiated six clinical programs, three of which are multi-regional clinical trials (including one pivotal trial) to address urgent, unmet medical needs in the standard of care-resistant cancers.

In the four rounds of financing to date, Laekna has been supported by leading healthcare-focused institutional investment firms. In addition to CS Capital, most recently, SCGC led the company’s $61 Series C financing in October 2020, after GP Healthcare Capital and OrbiMed Healthcare Fund Management led the Series B and Series A financing rounds, respectively.

Proceeds from the Series D financing will be used to accelerate the clinical development of Laekna’s two core product candidates, AKT kinase inhibitor afuresertib (LAE002) and the world’s first clinical-stage CYP17/CYP11B2 dual inhibitor (LAE001). Both product candidates cover three differentiated key mechanisms, namely targeted therapy, hormonal therapy, and immuno-oncology therapy. Laekna’s most advanced clinical trial is an open-label, randomized, multi-regional Phase 2 PROFECTA-II clinical trial of afuresertib, the world’s first registration-directed clinical trial of an AKT kinase inhibitor to treat platinum-resistant ovarian cancer.

"As Laekna celebrates its fifth anniversary in April, I would like to thank our new and existing investors. Over the past five years, it has been our honor to be recognized and supported by all of our partners. I believe that the time has come for Laekna as we work together with like-minded partners towards a better future," said Dr. Chris Lu, Chairman and CEO of Laekna. "We have arrived at a critical stage, and we understand that drug discovery and development is a long and often arduous journey. We remain committed to our vision to cure for a better future."

CS Capital life science investment team said, "The global biopharmaceutical industry is booming and has a myriad of thriving players. We decided to invest in Laekna as its R&D pipeline, innovation capabilities and management team deeply impressed us. We will work together with Laekna to help it become a partner and a leader in the industry to benefit patients worldwide."

Outlook Therapeutics to Present at the H.C. Wainwright Global Investment Conference

On May 18, 2022 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, reported that Lawrence Kenyon, Chief Financial Officer of Outlook Therapeutics, will present at the H.C. Wainwright Global Investment Conference being held May 23-26, 2022 in Miami, FL and virtually (Press release, Outlook Therapeutics, MAY 18, 2022, View Source [SID1234616060]).

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In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website.

A video webcast of the presentation will be accessible for viewing on-demand beginning on Tuesday, May 24, 2022, at 7:00 AM ET for those registered for the event and will be available on the Events page in the Investors section of the Company’s website (outlooktherapeutics.com). The webcast replay will be archived for 90 days following the event.

iBio to Participate in the H.C. Wainwright Global Investment Conference

On May 18, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable, plant-based FastPharming Manufacturing System, reported that it will participate virtually in the H.C. Wainwright Global Investment Conference (Press release, iBioPharma, MAY 18, 2022, View Source [SID1234614787]). The hybrid conference will take place May 23-26, 2022.

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iBio’s pre-recorded presentation will be available on demand during the event for all registered attendees. Beginning on Tuesday, May 24, 2022, the presentation will also be available on the Company’s website at www.ibioinc.com under "News & Events" in the Investors section.