On August 12, 2019 Zai Lab Limited (NASDAQ: ZLAB), a Shanghai-based innovative commercial stage biopharmaceutical company, and Novocure (NASDAQ: NVCR), a global oncology company with a proprietary platform technology called Tumor Treating Fields, reported that the China National Medical Products Administration (NMPA) granted Innovative Medical Device Designation for Optune, a Tumor Treating Fields delivery system that uses electric fields tuned to specific frequencies to disrupt cancer cell division, inhibiting tumor growth and causing affected cancer cells to die (Press release, Zai Laboratory, AUG 12, 2019, View Source [SID1234538601]).

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"We are excited that Optune has been granted the Innovative Device Designation as it will allow our team to accelerate dialogue with the NMPA and bring us closer to commercializing Optune in China," said Dr. Samantha Du, Founder and CEO of Zai Lab. "Our launch in Hong Kong has provided valuable insight into the impact that this device can have on patients with GBM, which is an area of high unmet clinical need in China and globally. We look forward to working closely with the NMPA as Optune advances through the regulatory process in China."

The Innovative Device Designation allows Zai Lab to take advantage of an expedited approval procedure for Optune that offers opportunities for pre-consultation with and input from the NMPA throughout the approval process. Novocure granted Zai Lab an exclusive license for Tumor Treating Fields, including the brand name Optune, in Greater China in September 2018 and Zai Lab successfully launched the product in Hong Kong for the treatment of glioblastoma (GBM) late last year. Novocure markets Optune in the United States, European Union, Japan and certain other countries for the treatment of GBM and the NovoTTF-100L System, another Tumor Treating Fields delivery system, in the U.S. for the treatment of malignant pleural mesothelioma. Tumor Treating Fields is in late stage clinical development for four solid tumor indications including non-small cell lung cancer, brain metastases, pancreatic and ovarian cancers. Tumor Treating Fields was included and recommended with Level 1 evidence as a treatment for GBM in China’s Glioma Treatment Guideline published in 2018.

"We are committed to bringing Optune to as many patients who may benefit as possible," said Novocure’s Executive Chairman Bill Doyle. "Zai Lab has been an excellent partner as we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing Tumor Treating Fields therapy. We are pleased that together with our partners at Zai Lab we are one step closer to commercializing Optune in China."

About Tumor Treating Fields

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

On August 12, 2019 TScan Therapeutics reported the publication in the scientific journal Cell describing the invention of a breakthrough technology that enables the rapid and unbiased discovery of the physiologic targets of any T cell (Press release, TScan Therapeutics, AUG 12, 2019, View Source [SID1234538600]). This work is the foundation for development efforts at TScan Therapeutics to discover new TCR immunotherapies for cancer and infectious disease. The work described in the Cell article is based on research and discoveries by scientific founders of TScan, Stephen Elledge, PhD of Harvard Medical School and Tomasz Kula, PhD. TScan Therapeutics has an exclusive world-wide license to use the technology to discover and develop novel therapies based on T cell receptors (TCRs).

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"Although cytotoxic T cells are the primary cells in the human immune system that are responsible for detecting and eliminating cancer cells, there has been no thorough and systematic way to determine what peptide antigens those T cells are recognizing until now," commented Dr. Elledge. "The TScan technology provides a method to better understand the natural T cell response to cancer and how we might use that information to design safer and more effective T cell therapies."

Dr. Tomasz Kula, a recent graduate from the Elledge Laboratory at Harvard Medical School, worked with Dr. Elledge and his team to develop the TScan technology. In the Cell paper, researchers from the Elledge Laboratory describe how the technology can be used in the areas of cancer and infectious disease to discover new targets for TCR therapy. The authors also demonstrate how tumor-derived TCRs can be fully characterized to reveal both their primary targets and any potential off-targets that may affect their safety profile as therapeutics.

"The TScan technology has advantages over previous approaches to TCR target identification because it relies on natural processes in both the T cells and their target cells to capture physiologically relevant and functional interactions," commented Dr. Kula. "I am excited to now apply this technology to the discovery of new targets for cancer therapy."

"I am thrilled that Tomasz has elected to join the TScan team," commented Gavin MacBeath, PhD, CSO of TScan Therapeutics. "Tomasz and I share the same vision for TCR therapeutics. His ingenuity and insight will be invaluable as we further develop the TScan technology platform and use it to discover and develop life-changing therapies for patients."

The paper, T-Scan: A Genome-wide Method for the Systematic Discovery of T Cell Epitopes, was published online in the Journal Cell by Tomasz Kula, Mohammad H. Dezfulian, Charlotte I. Wang, Kai W. Wucherpfennig, Herbert Kim Lyerly, Stephen J. Elledge.

Having recently graduated from the Elledge lab, Dr. Kula has joined TScan Therapeutics. Both Stephen Elledge, Professor of Genetics at Harvard Medical School and Kai Wucherpfennig, Professor of Cancer Immunology and Virology at Dana-Farber Cancer Institute and co-author on the Cell paper, are actively engaged with TScan Therapeutics as members of the Scientific Advisory Board.

On August 12, 2019 PharmaMar (MSE:PHM) reported that the International Association for the Study of Lung Cancer (IASLC) has published the list of abstracts titles to be presented during the congress that will take place from September 7th to 10th in Barcelona (Press release, PharmaMar, AUG 12, 2019, View Source [SID1234538599]). Three abstracts will be presented on lurbinectedin for the treatment of small cell lung cancer.

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Targeting Transcription (Including Lurbinectedin)
Mini Symposium Oral Session: "Molecular Subsets and Novel Targeted Approaches to Small Cell and Neuroendocrine Cancers," on September 10th, 2019, from 12:00 to 12:15 in the Colorado Springs Room
Presenter: Dr. Camilla L. Christensen, Harvard University

Antitumor Activity of Single Agent Lurbinectedin in Patients with Relapsed SCLC Occurring ≥30 Days After Last Platinum Dose. (Abstract 1710).
Poster: September 8th, 2019, from 8:00 to 18:00 in the Exhibit Hall
Session: P1.12 – Small Cell Lung Cancer/NET
Lead author: José Manuel Trigo, Hospital Universitario Virgen de la Victoria.

Lurbinectedin (L) Combined with Paclitaxel (P) or Irinotecan (I) in Relapsed SCLC. Results from Two Phase Ib Trials. (Abstract 1588).
Poster: September 9th, 2019, from 8:00 to 18:00 in the Exhibit Hall
Session: P2.12 – Small Cell Lung Cancer/NET
Lead author: Santiago Ponce, Hospital Universitario 12 de Octubre.

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On August 12, 2019 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biopharmaceutical company developing PTI-125 for Alzheimer’s disease, reported financial results for the second quarter ended June 30, 2019 (Press release, Pain Therapeutics, AUG 12, 2019, View Source [SID1234538598]). Net loss for the second quarter 2019 was $1.1 million, or $0.06 per share, as compared to a net loss of $2.5 million for the same period in 2018. Net cash use was $0.6 million during the second quarter of 2019.

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Cassava Sciences ended the second quarter 2019 with $18.5 million of cash and cash equivalents, and no debt.

About PTI-125
PTI-125 is an investigational drug candidate for Alzheimer’s disease. We developed this small molecule drug to target a process known as "protein misfolding." PTI-125 has a novel mechanism of action: it stabilizes a critical protein that is otherwise altered and misfolded in the Alzheimer’s brain. PTI-125 has demonstrated both cognitive improvement and slowing of disease progression in animal models of disease. We are also developing a blood-based diagnostic to detect Alzheimer’s disease, called PTI-125Dx. The goal of PTI-125Dx is to make the detection of Alzheimer’s disease as simple as getting a blood test.

The underlying science for our scientific programs is published in prestigious peer-reviewed technical journals, including Journal of Neuroscience, Neurobiology of Aging, and Journal of Biological Chemistry. The National Institutes of Health (NIH) has awarded us several research grants following an in-depth, confidential review of our science and technology. In 2019-2020, these NIH grants may represent up to $6.7 million of non-dilutive financing.

Financial Highlights for Second Quarter 2019

At June 30, 2019, cash and cash equivalents were $18.5 million, compared to $19.8 million at December 31, 2018. Net cash utilized during the second quarter 2019 was $0.6 million. We have no debt.
Net loss was $1.1 million compared to $2.5 million for the same period in the prior year, representing a 57% decrease. Net loss per share was $0.06 compared to $0.36 for the same period in the prior year.
We received research grant funding reimbursements of $1.4 million from NIH and recorded this as a reduction in research and development expenses ("R&D"). This compared to $0.4 million of NIH grant receipts received for the same period in the prior year.
Net R&D expenses were $0.3 million. This compared to $1.5 million for the same period in the prior year, representing a 79% decrease. The decrease was due primarily to the increase in NIH grant funding in 2019 compared to the prior year combined with a decrease in non-cash stock-based compensation expense. R&D expenses included non-cash stock related compensation costs of $0.1 million compared to $0.3 million for same period in the prior year.
General and administrative ("G&A") expenses were $0.8 million. This compared to $1.0 million for the same period in 2018, representing a 15% decrease. G&A expenses included non-cash stock-based compensation costs of $0.2 million compared to $0.4 million for the same period in the prior year.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Eventually, a person with Alzheimer’s disease may be unable to carry out even simple tasks. Currently, there are no drug therapies to halt Alzheimer’s disease, much less reverse its course.

An estimated 5.8 million Americans of all ages are living with Alzheimer’s disease in 2019.

On August 12, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), and Mission Bio, the pioneer in targeted single-cell DNA analysis and precision genomics, reported that they have formed a collaboration to utilize the Mission Bio TapestriⓇ Platform for targeted single-cell DNA analysis to study Onconova’s novel cancer therapy, rigosertib, through clinical trials (Press release, Onconova, AUG 12, 2019, View Source [SID1234538597]).

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With the growing complexity of clinical trials, precision biomarkers are needed to reduce the time and costs associated with the drug development cycle. Broad-based sequencing technologies lack the sensitivity to identify the earlier initial single cell events that contain the driver mutations that initiate the oncologic disease. With the Mission Bio Tapestri Platform, researchers can detect rare cancer subclones and co-occurring cancer mutations at the single-cell level, offering a precise way to measure therapy response and disease progression. Supporting the pharma and biopharma industries through clinical trials and commercialization continues to be a focus for Mission Bio.

Ras proteins control cell proliferation, and mutation of this protein can lead to cancer in affected individuals. Ras is mutated in over 30 percent of patients with cancer, making it one of the most sought-after targets. Onconova is developing rigosertib, a first-in-class, small molecule Ras mimetic, to target this mutation. Rigosertib blocks the activation of Ras effector proteins, thus modulating the Ras pathway. Onconova’s goal is to fully enroll INSPIRE, its phase 3 clinical trial studying rigosertib in higher-risk MDS patients who fail the current standard of care, by year-end.

"Through single-cell genomics, we can identify mutations with far better resolution than that of traditional sequencing methods. This allows a view into each patient’s disease at a level never before achieved," explained Darrin Crisitello, CCO of Mission Bio. "The Tapestri Platform can identify subclones that help monitor a patient’s response to research drugs in clinical trials, supporting the advancement of rigosertib to the clinic."

"Rigosertib has the potential to be the first new higher-risk MDS treatment in more than 15 years, for a condition affecting an estimated 59,000 patients with low and higher-risk MDS in the United States alone," said Dr. Steve Fruchtman, CEO of Onconova. "In adding the Tapestri Platform to our research and development program, we are including the opportunity to study single cell clones in MDS and determine the sequence of genetic events and the influence of rigosertib on these events along with clinical outcomes. These studies have the potential to make a meaningful difference in the lives of patients in need."