On September 20, 2022 ExThera Medical reported that published data from a preliminary European study demonstrating in vitro adsorption of human circulating tumor cells (CTC) has been corroborated at a major US cancer center (Press release, ExThera Medical, SEP 20, 2022, View Source [SID1234619707]). CTCs are responsible for the often-fatal spread or metastasis of localized cancers to other parts of the body.

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This earlier German study confirmed that cultured neuroblastoma, prostate, and leukemia CTCs bind to the adsorption media in the company’s Seraph 100 Microbind Affinity Blood Filter (Seraph 100), which was developed to remove bacteria and viruses, often in immunocompromised patients. The recent USA study reconfirmed prostate CTC binding, and demonstrated binding of metastatic pancreatic, breast, lung and colon cancer CTCs isolated from the blood of patients who underwent conventional cancer therapies.

"These results await a peer-reviewed publication, but they are encouraging and warrant clinical study ASAP," said Robert Ward, CEO for ExThera Medical. "If clinical research confirms safety and efficacy, we see the possibility of a dialysis-like therapy that might prevent metastasis or extend the life of patients with existing metastatic cancer. Based on our experience treating COVID-19 and sepsis, we expect that even repeated and/or regular treatments with Seraph 100, would be well tolerated by patients, compared to chemo-radiation therapies." CTC levels in blood drawn from cancer patients can be monitored by existing diagnostic tests and help predict Overall Survival (OS) of cancer patients. However, no therapy is currently available to remove CTCs directly from the blood in quantities that could extend OS.

The European results were first presented in Sept 2021 at the Deutsche Gesellschaft für Nephrologie (DGfN) conference in Berlin as part of a scientific collaboration with University Hospital Frankfurt to evaluate clinical feasibility of metastatic cancer cell removal from the bloodstream: "Absorption of Circulating Tumor Cells by Hemoperfusion." (View Source). Other results also demonstrated reduction in cancer exosomes (CE’s).

"We are extremely excited by the results because these data suggest that Seraph 100 filter could make an impact on the outcomes of patients with metastatic cancer. We do not have effective treatments for many cancers after metastasis, and these data suggest that we can use a filter technology to perform ‘oncopheretic treatment,’ which could be a candidate therapy for the National Foundation for Cancer Research (NFCR) Cancer Moonshot program." said Lakhmir Chawla, MD and Medical Advisory Chair for ExThera Medical.

Based on these datasets, ExThera Medical plans to open a cancer hemadsorption Investigational Device Exemption (IDE) trial with the FDA by Q2, 2023.

Metastatic cancer research is a critical area of clinical research and represents a significant patient population. It is estimated that more than 600,000 patients in the United States will die from cancer in 20221, of which 90% will be from metastatic causes2. Metastatic cancer lacks effective therapies as it is often resistant to chemotherapy, radiation, and immunotherapy. Published studies show that the concentration of CTC’s and CEs in a patient’s blood is linked to outcomes in metastatic cancer. Higher counts of CTC and CE cells in the blood are linked to higher probability of death. Experimental methods which remove both CTCs and CEs have been shown to improve outcomes in animals. CTCs and CEs are key pathways for cancer progression and metastasis. Effective removal of CTCs and CEs is therefore likely to impact outcomes in patients with metastatic cancer.

Ward continued, "The observed rapid removal of CTCs and CEs from blood appears similar to the reduction rate we’ve seen for bacterial and viral pathogens when treating bloodstream infections with Seraph 100. We are committed to additional testing of this novel treatment to support the vision of a new therapy for late stage/metastatic cancer patients."

On September 20, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that it will present the Company’s foundational guideposts – exceptional employees, continuous evolution and improvement, and customer and solution centric – as well as three-year financial targets (Press release, Castle Biosciences, SEP 20, 2022, View Source [SID1234619706]).

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"The guideposts presented today – exceptional employees, continuous evolution and improvement, and customer and solution centric – are firmly grounded in Castle’s mission, vision and values, and are foundational to how we operate our business," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We expect these principles to drive continued value creation and allow us to continue to meet the evolving needs of clinicians and their patients to improve shared decision-making."

"With Castle’s strong balance sheet, focused investments in our growth plans, and innovative portfolio of tests, we believe we are well-positioned to achieve our three-year financial targets, including anticipated total revenue of $255-$330 million for the year ending December 31, 2025," said Frank Stokes, chief financial officer of Castle Biosciences. "Additionally, we expect we will continue to see strong top-line growth and gross margins, balanced by disciplined capital allocation, which should contribute to our anticipated net operating cash flow positivity by 2025."

Maetzold and Stokes will be joined by the following Castle leaders and key opinion leader discussing the Company’s dermatology, gastroenterology and mental health tests, as well as its inflammatory skin disease pipeline program: Robert Cook, Ph.D., Castle Biosciences’ senior vice president, research and development; Matthew Goldberg, M.D., F.A.A.D., Castle Biosciences’ medical director; Craig Munroe, M.D., Castle Biosciences’ gastroenterology medical director; and Brent Moody, M.D., F.A.C.P., F.A.A.D., dermatologist and Mohs surgeon at Skin Cancer Surgery Center in Nashville, Tennessee.

Prepared remarks for Castle’s Investor Day will begin today at 4:00 p.m. Eastern time, followed by a Question & Answer session. During the webcast, Castle will present a slide deck associated with the event, which has been posted to the Investor Relations page of the Company’s website (View Source).

To register for the virtual event, please visit the Events & Presentations section of the Company’s investor relations page (View Source). A replay of the webcast will be available following the conclusion of the broadcast.

On September 20, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported an agreement with Takeda to license the worldwide research and development and commercial rights to alisertib, a selective, small-molecule, orally administered inhibitor of aurora kinase A (Press release, Puma Biotechnology, SEP 20, 2022, View Source [SID1234619705]). Alisertib is an adenosine triphosphate–competitive and reversible inhibitor of aurora kinase A and results in disruption of mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on aurora kinase A. Alisertib has been tested in clinical trials in patients with metastatic cancers including breast cancer, small cell lung cancer, head and neck cancer, ovarian cancer, peripheral T cell lymphoma and acute myeloid leukemia.

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Under the terms of the agreement, Puma will assume sole responsibility for the global development and commercialization of alisertib. Takeda will receive an upfront license fee of $7 million and is eligible to receive potential future milestone payments of up to $287.3 million upon Puma’s achievement of certain regulatory and commercial milestones over the course of the agreement, as well as tiered royalty payments for any net sales of alisertib.

Puma initially intends to focus the development of alisertib on the treatment of patients with metastatic estrogen receptor-positive (ER-positive) HER2-negative breast cancer, triple-negative breast cancer and small cell lung cancer. In ER-positive HER2-negative breast cancer, alisertib has previously been tested in a Phase II clinical trial as a single agent (Lancet Oncology 2015), in a Phase II randomized clinical trial as a single agent compared to a combination with fulvestrant (SABCS 2020) and in a Phase II randomized clinical trial in combination with paclitaxel compared to paclitaxel monotherapy (JAMA Network Open 2021). In triple-negative breast cancer, alisertib has previously been tested in a Phase II clinical trial as a single agent (Lancet Oncology 2015) and in a randomized clinical trial in combination with paclitaxel compared to paclitaxel monotherapy (JAMA Network Open 2021). Alisertib has demonstrated meaningful clinical activity in these populations and most notably in ER-positive breast cancer patients who have been previously treated with a CDK4/6 inhibitor (JAMA Network Open 2021). Alisertib has also been previously tested in small cell lung cancer in a Phase II clinical trial as a single agent (Lancet Oncology 2015) and in a Phase II randomized clinical trial in combination with paclitaxel compared to paclitaxel monotherapy (Journal of Thoracic Oncology 2020).

"There continues to be a need for new drugs for the treatment of metastatic ER- positive, HER2-negative breast cancer and triple negative breast cancer," said Joyce A. O’Shaughnessy, M.D., the Celebrating Women Chair in Breast Cancer Research at Baylor University Medical Center, Texas Oncology, and Chair of Breast Cancer Research for the US Oncology Network in Dallas, Texas. "The results from the clinical trials of alisertib in these two indications are encouraging and suggest that the drug may be able to provide a clinical benefit to these patient populations, and, due to its novel mechanism, alisertib may be able to provide a benefit in patients who have developed resistance to other treatments modalities," said Dr. O’Shaughnessy.

"Treatment options for patients with small cell lung cancer that has progressed on or after platinum-based chemotherapy are limited, and there is an urgent need for new drugs to treat this patient population," said Taofeek K. Owonikoko, MD, PhD, Chief of the Division of Hematology/Oncology and Associate Director for Translational Research and Co-Leader of the Cancer Therapeutics Program at the UPMC Hillman Cancer Center. "The results from the clinical trials of alisertib in small cell lung cancer suggest that the drug may represent a potentially promising treatment option for these patients and more specifically for patients with molecularly defined tumors that are likely to respond to an aurora kinase A inhibitor such as alisertib," said Dr. Owonikoko.

Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma stated, "We are pleased to be able to complete this licensing agreement with Takeda for alisertib. To date, alisertib has demonstrated strong evidence of antitumor activity, both as a single agent and in combination with other anticancer drugs, in patients with metastatic ER-positive and triple negative breast cancer, as well as in small cell lung cancer. We look forward to the continued development of alisertib."

Puma will host a conference call today at 2:00 p.m. PDT/5:00 p.m. EDT to discuss the alisertib licensing agreement. The call may be accessed by dialing (877) 709-8150 (domestic) or (201) 689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On September 20, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported a shift in focus to advance its core technology. Pulse Biosciences is expanding strategic opportunities within healthcare, and anticipates a concentrated focus on cardiovascular applications, with potential expansion in oncology, gastroenterology, and other sectors where the Company has established key opinion leader relationships and emerging preclinical evidence (Press release, Pulse Biosciences, SEP 20, 2022, View Source [SID1234619704]).

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To support the realignment, Pulse Biosciences has made several executive team changes. Kevin Danahy, who served as Chief Commercial Officer since February, is succeeding Darrin Uecker as President and Chief Executive Officer. The Company is very pleased to announce that Mr. Uecker will devote his full time to the newly created role of Chief Technology Officer where he will be responsible for technology advancement and product development. Joe Talarico, who currently serves as Vice-President of North American Sales, will become Vice-President of Business Development where he will leverage his significant experience in the commercial introduction of new disruptive technologies. Board Chairman, Robert Duggan, will assume a newly created leadership role as the Company’s Executive Chairman.

"During his time at Pulse, Kevin has demonstrated strong leadership and operational skills. The Board of Directors believes he is the right person to lead Pulse during this next pivotal phase. I am confident in NPS technology and its potential," said Robert Duggan, Executive Chairman of Pulse Biosciences. "We have positioned the Company to now focus on high opportunity application areas."

Implementing the present time strategic opportunities does not require the significant sales, marketing and related administrative support team that has been in place. Accordingly, headcount now stands at 66 employees principally focused on engineering, business development and related new product support personnel. In June of 2022, Pulse Biosciences employed 121 employees. The vast majority of present time reduction in personnel mainly impacts dermatological sales, marketing and related support activities. Along with minimizing commercial activities, the Company plans to evaluate potential partners in the dermatology space. Additionally, the Company plans to hold an Investors Day in the next 60 days to show progress and highlight the promising opportunities in other health care verticals.

In support of the change in strategy, Mr. Duggan, the majority shareholder and Executive Chairman, and the Company have entered into a loan agreement in which Mr. Duggan has agreed to loan the Company $65 million to fund its product development operations.

"With the full backing of our board to make the shift in strategy at this time, I look forward to expanding into other areas of healthcare that can leverage our unique NPS technology," said Kevin Danahy, Pulse Biosciences President and Chief Executive Officer. "Shifting our strategy aligns with our ability to demonstrate our proven mechanism of action and the safety and efficacy of our technology as it relates to other markets. I am excited to have the opportunity to collaborate with this top-quality executive team through our next phase of growth."

Mr. Danahy has more than 20 years of senior management experience at medical technology companies. Most recently, Mr. Danahy served as President of Solmetex, driving revenue growth for the company through the implementation of innovative and scalable solutions, while overseeing strategy, sales, marketing, operations, engineering, and service efforts. Previously, at Zimmer Biomet, Mr. Danahy held roles of increasing responsibility, most recently as Vice President of Global Emerging Technologies and Specialty Sales. Before his time at Zimmer, Mr. Danahy served as Sr. Director at Intuitive Surgical, where he successfully transformed the sales leadership training program. Early in his career, he served in commercial leadership roles at both Medtronic and Johnson & Johnson. Mr. Danahy received a Master of Science from Tufts University.

"In conclusion, you can expect Team Pulse Biosciences to stiffen execution, measure what matters, economize wherever possible and do what it takes to achieve a dynamic, expanding and viable organization that delivers patients, physicians and caregivers products and services that significantly improve quality of life," said Robert Duggan, Executive Chairman of Pulse Biosciences.

On September 20, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported the completion of the previously announced transaction to acquire MiroBio, a privately held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, for approximately $405 million in cash (Press release, Gilead Sciences, SEP 20, 2022, View Source [SID1234619703]). The acquisition provides Gilead with MiroBio’s proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio’s lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA) and has entered Phase 1 clinical trials, with the first patient dosed in early August 2022. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.

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"Inflammation is a key area of focus for Gilead, and MiroBio’s novel discovery platform technology and pipeline provides the opportunity to develop potentially best-in-class large molecule therapeutics to help patients with currently unmet medical needs," said Flavius Martin, Executive Vice President, Research, Gilead Sciences. "This novel approach to inflammatory diseases has the potential to be an important part of providing durable remission for patients living with complex and chronic immune-mediated conditions."