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Puma Biotechnology to Host Conference Call to Discuss Second Quarter Financial Results

On July 24, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 8, 2019 following release of its second quarter 2019 financial results (Press release, Puma Biotechnology, JUL 24, 2019, View Source [SID1234537713]).

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The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least ten 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 approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

City of Hope Study Finds a Novel Mechanism of Action for Natural Killer Cells in Checkpoint Inhibitor Therapy for Cancer

On July 24, 2019 City of Hope reported that PD-L1 checkpoint inhibitors are a powerful and growing form of immunotherapy used to treat melanoma, kidney cancer, head and neck cancers, Hodgkin’s lymphoma and other cancers (Press release, City of Hope, JUL 24, 2019, View Source [SID1234537712]). The PD-L1 protein is expressed on tumor cells and aids the cancer by signaling to immune cells, such as T cells, to stop working against tumors.

"We have provided a scientific explanation as to how checkpoint inhibitor therapy can work when there’s no checkpoint expressed on a patient’s cancer cells"

Checkpoint inhibitors, also called anti-PD-L1 monoclonal antibodies, block the PD-L1 protein to help the immune system and, specifically, T cells, do what they’re designed to do, eradicate cancer. However, in some instances, anti-PD-L1 antibodies show anti-tumor activity in patients whose tumors do not express PD-L1.

Now, for the first time, City of Hope scientists have discovered that natural killer (NK) cells provide one reason why anti-PD-L1 antibodies might work when tumor cells do not express PD-L1. The study, published today in Cancer Discovery, found that NK cells can also express PD-L1 in some cancer patients. PD-L1 expression on the NK cells identifies them as charged or highly activated and can demonstrate anti-tumor activity.

Further, when bound by the anti-PD-L1 antibody, the NK cells can kill the tumor cell better regardless of PD-L1 expression on the tumor cells. If an NK cell expressing PD-L1 is treated with a PD-L1 antibody, the interaction activates PD-L1+ NK cells to control the growth of tumors by killing those tumors and by the secretion of cytokines. This demonstrates a novel mechanism of action that provides a significant role for the NK cell and the anti-PD-L1 antibody in anti-tumor activity especially in instances where the tumor cell does not express PD-L1.

"We have provided a scientific explanation as to how checkpoint inhibitor therapy can work when there’s no checkpoint expressed on a patient’s cancer cells," said Jianhua Yu, Ph.D., one of the study’s senior authors, City of Hope professor in the Department of Hematology & Hematopoietic Cell Transplantation, and a Scholar of The Leukemia & Lymphoma Society. "Using checkpoint inhibitors for NK cells with PD-L1 expression can lead to stronger anti-cancer activity, providing us with another powerful therapy against even more cancers."

Michael Caligiuri, M.D., the study’s other senior author, president of City of Hope National Medical Center and Deana and Steve Campbell Physician-in-Chief Distinguished Chair, M.D., noted that NK cells comprise a group of innate immune cells that can attack cancer and viral infections. But there’s been no research on how PD-L1 and NK cells interact against cancer.

"Natural killer cells are the body’s first line of defense against cancer and viral infections," Caligiuri said. "When NK cells detect tumor or viral cells in the body, they have the potential to kill them immediately. But in those with cancer, tumors have developed mechanisms to circumvent NK cells and T cells. We believe PD-L1 expression on NK cells identifies tumors that could be susceptible to destruction by NK cells, thereby providing a new immunotherapeutic avenue to explore."

The scientists studied PD-L1+ and PD-L1- NK cells in both humans and mice with PD-L1- tumors. PD-L1+ NK cells, upon encountering and being activated by NK-susceptible tumor cells, secreted more cytokines and cytolytic granules, which both increased the immune cells’ effectiveness. PD-L1+ NK cells, which can also be generated in the laboratory by culturing with some tumor cells or with cytokines, killed more tumor cells in vitro than NK cells that were PD-L1- or than NK cells that do not see tumor cells or cytokines. These results were able to be repeated in an in vivo mouse model containing human NK cells.

Researchers also found that NK cells from a majority of 79 AML patients examined had expressed moderate to high levels of PD-L1, and those who entered a complete remission from their leukemia had a higher percentage of PD-L1+ NK cells at the time of remission when compared to diagnosis. In contrast, patients who failed to enter a complete response had no change in the percentage of PD-L1+ NK cells at remission when compared to diagnosis.

Because the percentage of PD-L1+ NK cells following chemotherapy correlated with a positive clinical response – in contrast to those AML patients whose NK cells did not express PD-L1 – the study’s authors believe a next step could be a clinical trial for particular AML patients displaying an increase in PD-L1+ NK cells at the time of remission. The trial would include anti-PD-L1 monoclonal antibodies with or without NK cell-activating cytokines, thereby exploiting a novel pathway that is independent of T cells and PD-1, the other target for checkpoint inhibitor therapy.

City of Hope is also planning similar clinical trials for patients with other cancers such as lung cancer.

Freenome Closes $160 Million Series B Financing to Advance Its Multiomics Blood Testing Platform for Early Cancer Detection

On July 24, 2019 Freenome, a biotechnology company that has pioneered the most comprehensive multiomics platform for early cancer detection through a routine blood draw, reported the close of its $160 million Series B financing, bringing its total financing to $238 million to date (Press release, Freenome, JUL 24, 2019, View Source [SID1234537711]). Freenome will use the proceeds to further the development of its early cancer detection blood test powered by its platform. The Company plans to conduct a pivotal validation study and submit to the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) under the Parallel Review Program the first application of its platform in colorectal cancer screening and expand its laboratory infrastructure and software to support its continued growth.

The Series B financing was led by RA Capital Management and Polaris Partners. They were joined by other new investors including Perceptive Advisors, funds and accounts advised by T. Rowe Price Associates, Inc., Roche Venture Fund, Kaiser Permanente Ventures, and the American Cancer Society’s BrightEdge Ventures. Freenome’s existing investors also participated in the financing including Andreessen Horowitz, GV (formerly Google Ventures), Data Collective Venture Capital, Section 32, and Verily Life Sciences (a subsidiary of Alphabet focused on life sciences and healthcare).

"We are fortunate to have an experienced and proven group of biotech and healthcare investors who share our mission of making early detection of cancer a routine part of patient care," said Gabe Otte, Chief Executive Officer of Freenome, "In addition, we are excited to welcome several strategic investors who are committed to our mission. Each brings insight, expertise, and partnership opportunities to accelerate our path to positively impacting patient care."

"Freenome’s work holds much promise and potential," said Bob Crutchfield, Managing Director of the American Cancer Society’s philanthropic impact fund, BrightEdge. "We hope our investment will help lead to accelerated patient access to this technology and better outcomes for cancer patients."

Mr. Otte added, "Since our founding in 2014, we have been focused on building a multi-disciplinary team to achieve our vision of a future where cancer mortality is significantly reduced through early detection matched with the right treatment informed by our blood test. We have already demonstrated promising clinical results at Digestive Disease Week this year, where our cell-free DNA (cfDNA) assay and machine learning approach enabled high sensitivity and specificity in a cohort of mostly early stage colorectal cancer patients. This funding will allow us to execute the necessary validation study for approval and reimbursement coverage of our colorectal cancer screening test, as well as expand our platform to other forms of cancer or immune-driven disease areas in the future."

Freenome’s multiomics platform detects key biological signals from a routine blood draw. The platform integrates assays for cell-free DNA, methylation, and proteins with advanced computational biology and machine learning techniques to identify additive signatures that improve the accuracy for early cancer detection given the molecular subtypes of cancer are heterogeneous in nature. This strategy incorporates a multidimensional view of both tumor- and immune-derived signatures that enables the early detection of cancer, instead of relying only on tumor-derived markers, which may miss the early signs of cancer. Freenome’s first cancer test is for the screening of colorectal cancer, the second deadliest form of cancer in the U.S. When identified early, colorectal cancer has a 90 percent five-year relative survival rate compared to 14 percent when detected at a more advanced stage according to data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program.

"The most affordable and effective treatment for metastatic cancer is to detect it early, when the tumor is still small and local, and we can cure it with surgery. It’s with that vision that we have invested in Freenome," said Peter Kolchinsky, Managing Partner of RA Capital. "Freenome’s multiomics platform is unlike anything we’ve seen, and we believe it can unlock the promise of using blood tests to detect and treat cancer early."

"The only way to achieve meaningful progress against cancer is to interweave normally disparate fields towards a single mission. And the leadership team at Freenome has built a world-class, multi-disciplinary team of molecular biologists, computational biologists, machine learning scientists, and engineers," said Amir Nashat, Managing Partner of Polaris Partners. "Having seen the tremendous progress Freenome has made in early cancer detection, we are excited to continue charting that path together."

X4 Pharmaceuticals to Attend Two Upcoming Investor Conferences

On July 24, 2019 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, reported that the management team is scheduled to present at the 39th Annual Canaccord Genuity Growth Conference, and to conduct one-on-one meetings at the BTIG Biotechnology Conference 2019 (Press release, X4 Pharmaceuticals, JUL 24, 2019, View Source [SID1234537710]).

Details related to the team’s participation are as follows:

Conference:

39th Annual Canaccord Genuity Growth Conference

Location:

Boston, MA

Presentation Date & Time:

August 7th at 3 pm EDT

Conference:

BTIG Biotechnology Conference 2019

Location:

New York, NY

Date:

August 12th

TScan Therapeutics Formed to Overcome Challenges of Current Immunotherapies with Novel TCR Discovery Platform and $48 Million in Funding

On July 24, 2019 TScan Therapeutics, dedicated to unleashing the power of the immune system through life-changing T cell therapies, reported its Series B financing, with over $48 million raised since the company’s inception (Press release, TScan Therapeutics, JUL 24, 2019, View Source [SID1234537709]). An experienced executive team has been built consisting of David P. Southwell, Chief Executive Officer; Gavin MacBeath PhD, Chief Scientific Officer; Henry Rath, Chief Business Officer; and Robert Crane, Chief Financial Officer. TScan is dedicated to realizing the true potential of T-cell receptor (TCR) therapy for patients suffering from a broad range of cancers.

"TScan is committed to unleashing the immune system in patients with the only genome-wide, high-throughput and unbiased system to discover the natural targets of TCRs. Through the pioneering work of Dr. Elledge, TScan’s technology platform has the potential to uncover new targets in a variety of diseases, including cancer, autoimmunity, and infectious disease. We have made significant progress in discovering novel targets which are shared across cancers and look forward to bringing TCR therapies to patient suffering from both liquid and solid tumors," commented David Southwell, Chief Executive Officer of TScan.

"Further, I am proud that we have assembled an outstanding team of executives, including Gavin, Henry and Bob, and scientists from leading cell therapy companies – along with top-tier investors – to drive development of these products internally and to work externally with corporate partners," continued Southwell. "We are pleased to welcome Novartis Institutes for BioMedical Research to our Series B financing, as they join the strong core of investors from our Series A round of financing."

Dr. Stephen Elledge, Professor of Genetics and of Medicine at Harvard Medical School and Brigham and Women’s Hospital, spearheaded the development of the TScan system utilizing ground-breaking technology developed in his lab. Dr. Elledge is internationally recognized for his pioneering work in DNA damage repair and was the recipient of the 2015 Lasker Prize in Basic Medicine and the 2017 Breakthrough Prize in the life sciences.

TScan’s approach is comprehensive, unbiased, and relies on natural processes in both T cells and cancer cells to identify physiologically relevant targets and to develop effective T cell therapies for patients.

"Within the tumors of cancer patients are T cells with the potential to recognize and eliminate those cancer cells," said Gavin MacBeath, PhD, Chief Scientific Officer of TScan. "We are identifying tumor-reactive T cells in patients that are winning their fight against cancer in order to discover the targets of their T cells and develop innovative, cell-based therapies for the many patients that are not so fortunate. Importantly, we believe the TScan technology will enable us to expand the currently limited range of targets for T cell therapy."

About the TScan Leadership Team

David Southwell, Chief Executive Officer
David Southwell is the Chief Executive Officer of TScan and also serves as a member of the Company’s Board of Directors. Previously, David served as President and Chief Executive Officer of Inotek Pharmaceuticals through Inotek’s merger with Rocket Pharmaceuticals, a gene therapy-based biotechnology company. Previously, Mr. Southwell served as Executive Vice President, Chief Financial Officer of Human Genome Sciences, until its merger with GlaxoSmithKline plc. and as Executive Vice President and Chief Financial Officer of Sepracor Inc., sold to Dainippon Sumitomo. Mr. Southwell is a member of the Board of Directors of Rocket Pharmaceuticals and PTC Therapeutics, and has also served on the Boards of Directors of Human Genome Sciences, THL Credit Inc., Inventiv Health, Biosphere Medical, Inotek Pharmaceuticals and Spero Therapeutics. In addition, Mr. Southwell serves on the Board of Advisers at the Tuck School at Dartmouth College, from which he received an MBA, and has a BA from Rice University.

Gavin MacBeath, PhD, Chief Scientific Officer
Gavin MacBeath joined TScan from AbPro where he served as the Chief Scientific Officer. Gavin has two decades of experience in academia and industry, founding companies and driving research from early-stage discovery through drug approval. Previously, Dr. MacBeath served as Co-founder and SVP of Discovery at Merrimack Pharmaceuticals. Dr. MacBeath began his career in academia, where he served as the first fellow at Harvard’s Bauer Center for Genomics Research, as an Assistant and later Associate Professor in the Department of Chemistry & Chemical Biology at Harvard University, and as a Lecturer and Principal Investigator at Harvard Medical School. Dr. MacBeath received his undergraduate degree from the University of Manitoba, his Ph.D. from The Scripps Research Institute, and postdoctoral training with Dr. Stuart Schreiber at Harvard University.

Henry Rath, Chief Business Officer
Henry Rath joined TScan from Seres Therapeutics where he served as Senior Vice President of Corporate Development. Henry has over 25 years of experience in the biotechnology industry with roles spanning corporate finance, strategy, and business development. Prior to joining Seres, Henry served in various leadership roles at Amgen, Catabasis Pharmaceuticals, and Baxter BioScience Mr. Rath began his career with roles in the banking and consulting industries focusing on biotechnology with Oppenheimer & Co. Inc. and LEK Consulting. Mr. Rath earned his undergraduate degree from Harvard College and his M.B.A. from the Wharton School of the University of Pennsylvania.

Robert Crane, Chief Financial Officer
Robert Crane has served as Chief Financial Officer from company formation in April 2018. Mr. Crane has served as Chief Financial Officer and other senior roles in over 30 companies including Sirtris (acquired by GSK); I-STAT (acquired by Abbott); InKine (acquired by Salix); Seragen (acquired by Ligand), deCODE (acquired by Amgen) and Circe (acquired by ICN Pharmaceuticals). Mr. Crane was previously a partner at venture capital firm Montgomery Ventures and chairman of the American Bicycle Group. Mr. Crane holds a Bachelor of Science from MIT and an MBA from Stanford.