On September 24, 2020 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported that its Board of Directors has approved a $25 million accelerated share repurchase ("ASR") transaction with JPMorgan Chase Bank, National Association ("JP Morgan") as part of the Company’s existing $160 million share repurchase program (Press release, Eagle Pharmaceuticals, SEP 24, 2020, View Source [SID1234565582]).

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The specific number of shares to be repurchased pursuant to the ASR is based on the average of the daily volume weighted average share prices of the Company’s common stock, less a discount, during the term of the ASR program. Based on yesterday’s closing price, the $25 million ASR would represent approximately 5% of the Company’s basic outstanding shares. Upon completion of the ASR, Eagle will have bought back a total of approximately $205 million of its stock since its IPO in 2014.

"The $25 million ASR reflects our ongoing confidence in our pipeline and continued earnings potential. With multiple opportunities to expand our RYANODEX franchise, the anticipated near-term launch of vasopressin, and three potential oncology launches in 2022 including PEMFEXY, fulvestrant and SM-88, along with the recent approval received by our Japanese marketing partner, SymBio, for its ready-to-dilute TREAKISYM product, we remain committed to building shareholder value," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Under the terms of the agreement, Eagle will pay $25 million to JP Morgan on September 24, 2020, and receive 505,817 shares, representing approximately 80% of the notional amount of the ASR, based on the closing price of $39.54 on September 23, 2020. Upon settlement of the ASR, the final number of shares repurchased will be trued up based on the average of the daily volume weighted average share prices of the Company’s common stock, less a discount, during the term of the accelerated share repurchase program. Eagle expects the ASR to be completed in the fourth quarter of 2020. As of September 23, 2020, the Company had 13.5 million common shares outstanding.

The Company intends to use cash on hand to fund the ASR program. As of June 30, 2020, cash and cash equivalents were $108.2 million, net accounts receivable was approximately $46.8 million, and debt was $37 million.

On September 24, 2020 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, reported that it has expanded its clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE: PFE) for an IDEAYA sponsored clinical combination study of IDE196, a Protein Kinase C (PKC) inhibitor, and crizotinib, a cMET inhibitor to which Pfizer has exclusive worldwide rights (Press release, Ideaya Biosciences, SEP 24, 2020, View Source [SID1234565558]). The study will evaluate IDE196 and crizotinib combination therapy in patients with solid tumors having GNAQ or GNA11 mutations (GNAQ/11), including metastatic uveal melanoma (MUM), skin melanoma, lung cancer and colorectal cancer.

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Evaluating MUM patient clinical samples, IDEAYA identified cMET expression or activation as a potentially valuable biomarker that may guide IDE196 clinical treatment in this indication. IDEAYA also demonstrated preclinical synergy in MUM with the combination of IDE196 and crizotinib, which further supports the potential biomarker on cMET expression.

"We are excited to expand our agreement with Pfizer to evaluate the clinical combination of IDE196 and crizotinib in MUM and other solid tumors with GNAQ or GNA11 mutations," said Mick O’Quigley, Vice President, Head of Development Operations, IDEAYA Biosciences. "Through our translational research we have identified cMET expression as a potential biomarker, and we are excited to explore this rational combination between IDE196 and crizotinib clinically," said Mark Lackner, Ph.D., Senior Vice President, Head of Biology and Translational Sciences.

IDEAYA’s clinical development plan in MUM for IDE196 is based on combination therapies, including with binimetinib, a MEK inhibitor, and crizotinib, a cMET inhibitor, enabled through our clinical trial collaboration and drug supply agreement with Pfizer. The company announced First-Patient-In (FPI) for the IDE196 and binimetinib clinical combination in June 2020 and is targeting FPI for the crizotinib clinical trial combination in late 2020 to early 2021. IDEAYA is also evaluating IDE196 as monotherapy in an ongoing GNAQ/11 non-MUM basket trial in additional solid tumor types, including in skin melanoma, where the company announced Phase 2 expansion.

IDEAYA and Pfizer have established a Joint Development Committee (JDC), and there will be joint decision making and data sharing of the clinical trial results between the parties. IDEAYA will sponsor the study and Pfizer will provide the crizotinib drug supply. If there is clinical data from the collaboration studies that could be used to obtain regulatory approvals or label changes, IDEAYA and Pfizer will enter into good faith negotiations to determine a regulatory submission strategy.

On September 24, 2020 TriSalus Life Sciences (TriSalus), an emerging immuno-oncology company committed to transforming outcomes for patients with solid tumors, reported its therapeutic clinical development strategy following the successful acquisition of SD-101, an investigational IND-ready immunotherapy, from Dynavax Technologies on August 3, 2020 (Press release, TriSalus Life Sciences, SEP 24, 2020, View Source [SID1234565583]).

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SD-101 is an investigational toll-like receptor 9 (TLR9) agonist that has been tested in Phase 2 clinical trials for advanced cutaneous melanoma and head and neck cancer, evaluating efficacy, safety, and the ability to increase responsiveness to checkpoint inhibitors in PD-L1 negative tumors. By combining SD-101 with TriSalus’ proprietary FDA cleared, drug delivery technologies, TriSalus will deliver the agent into the local vasculature of solid tumors. The Company intends to begin evaluating SD-101 in patients with uveal melanoma liver metastases followed by testing in patients with pancreatic ductal adenocarcinoma and colorectal cancer liver metastases. In addition, a separate program for locally advanced pancreatic ductal adenocarcinoma is in progress.

Mats Wahlstrom, Chairman of TriSalus Life Sciences, commented, "Our strategy is to develop a portfolio of immuno-oncology therapeutics and innovative infusion technologies to solve the two key reasons for poor outcomes in pancreatic and liver solid tumors ─ immunosuppression and low therapeutic index. The recent acquisition of SD-101 is a strong start to our therapeutics portfolio strategy. We plan to deploy multiple approaches with SD-101 by testing it clinically in a range of liver and pancreatic cancers for which few options currently exist."

Mary Szela, Chief Executive Officer and President of TriSalus Life Sciences, added, "SD-101 represents an important component of the clinical program, studying the safety and effectiveness on activation of the immune system to help attack solid tumors. Building on the acquisition of our first therapeutic candidate, we will seek other immuno-oncology products which could benefit from being delivered directly into the disease site through acquisitions, licenses, and partnerships."

Steven Katz, MD, Chief Medical Advisor of TriSalus and Chairman of its Scientific Advisory Board, said, "As an investigational TLR9 agonist, SD-101 has shown promising immunostimulatory capabilities that promote anti-tumor activity in Phase 1b/2 clinical studies.1 By using Pressure-Enabled Drug Delivery, (PEDD), for intravascular, regional, rather than systemic delivery, our intent is to increase SD-101’s therapeutic index. Our clinical development program will initially evaluate SD-101 delivered with PEDD for treatment of uveal melanoma liver metastases. Concurrently, we will develop three additional programs assessing a combination of SD-101 and other immuno-oncology agents delivered with PEDD."

Richard Carvajal, MD, Director of Experimental Therapeutics and Director of the Melanoma Service at Columbia University Medical Center, concluded, "Based on the biology of uveal melanoma and the clinical results in cutaneous melanoma, delivery of TLR9 agonists into the liver has been quite challenging. I am excited about studying the combination of TriSalus’ delivery technology with SD-101 in uveal melanoma liver metastases."

The Company reported that it will seek a meeting with the Food and Drug Administration to share study designs and clinical plans for the initiation of human clinical studies in uveal melanoma liver metastases, the most common primary intraocular malignancy in adults, representing approximately 85% of all ocular melanomas.2

TriSalus was formed to investigate treatments to help stimulate the immune system to overcome immunosuppression by delivering a combination of immuno-oncology therapies directly to the site of disease. Trisalus is researching this multi-pronged approach to reprogram the immunosuppressive tumor microenvironment, harness the power of tumor killing agents, and deliver these therapies directly to the tumor through its Pressure-Enabled Drug Delivery (PEDD) approach. The Company has identified validated, IND-ready targets to acquire through license agreements, collaborations, or joint ventures. TriSalus is initially focused on the goal of successfully treating intractable solid tumors including uveal melanoma liver metastases and pancreatic cancer.

About SD-101

SD-101 is an investigational proprietary short sequence of synthetic deoxyribonucleic acid (DNA) which binds to the Toll-Like receptor 9 (TLR9) found on suppressive immune cells including myeloid-derived suppressor cells and antigen presenting cells.3 SD-101 has been evaluated in numerous clinical studies to assess safety and efficacy. Investigational studies suggest responsiveness to checkpoint inhibitors in PD-L1 negative tumors as well as inducing an influx of cytotoxic T cells and interferon gamma production.1

SD-101 will be evaluated in multiple visceral organ tumor types to assess its safety and activity via PEDD as well as in combination with other immunotherapies and modalities. For more information on SD-101 clinical trials that are currently recruiting patients, please visit www.clinicaltrials.gov.

About Pressure-Enabled Drug Delivery (PEDD)

Pressure-Enabled Drug Delivery (PEDD) approach with SmartValve technology features a self-expanding, nonocclusive, one-way valve which can infuse therapeutics into solid tumor vasculature 4 The FDA cleared SmartValve devices have been shown to deliver more therapy into the tumor while preventing embolic reflux5.

On September 24, 2020 XiangXue Life Sciences reported that it received US permission to start a Phase I trial of its high affinity specific T-cell receptor candidate, TCRT-ESO-A2 (Press release, Xiangxue Life Sciences, SEP 24, 2020, View Source [SID1234565602]). The molecule is China’s first TCR-T candidate to target solid tumors, aiming at tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients. XLifeSc is a subsidiary of Guangzhou XiangXue Pharma that focuses on TCR therapies for cancer. TCRT-ESO-A2 is being developed globally (ex-China) by Axis Therapeutics, a JV formed by XLifeSc and Athenex, a US-China biopharma.

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On September 24, 2020 Flagship Pioneering reported the launch of Valo Health, LLC (Valo), a drug discovery technology company setting out to transform how oncology, neurodegenerative, and cardiovascular disease drugs are created, developed, and approved (Press release, Flagship Ventures, SEP 24, 2020, View Source [SID1234567634]).

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Founded and initially capitalized by Flagship Pioneering in 2019, Valo received additional funding from investors, bringing total financing to nearly $100m. Valo’s Opal Computational PlatformTM is a first-of-its-kind, end-to-end drug development platform, which integrates machine learning, cloud computing, and data to create an entirely new drug discovery and development process.

"New biological and chemical experimental platforms and the application of advanced computing to integrate human data can shave years off drug development and improve the likelihood of success" said Noubar Afeyan, Ph.D., founder and CEO of Flagship Pioneering. "In a pharmaceutical industry where failure is too often the rule, our goal with Valo is to change how drugs are developed and to bring more predictive confidence to clinical trial design and execution."

Valo’s Opal Computational PlatformTM allows the company’s scientists to analyze human data to uncover previously unsuspected associations between genetic markers and disease with a human-centric framing, enabling the integrated discovery and development of proprietary new molecules.

"At the core of Valo’s approach is a recognition that human-centric data coupled with leading-edge compute can enable a transformation in how drugs are created, reducing cost and time, while increasing confidence," said Valo CEO David Berry, who is also a General Partner at Flagship Pioneering. "We founded Valo with the goal of redefining the drug development process so that we can treat some of the world’s most challenging illnesses more quickly and more effectively than ever before."

During its first year, Valo completed two major acquisitions to help drive the company’s strategy. Numerate, acquired in September 2019, and assets from FORMA Therapeutics, acquired in March 2020. Numerate’s engineers, now part of Valo’s team, created a platform with over 30,000 models and over 70 trillion molecules that powered more than 25 drug programs. Through FORMA Therapeutics, Valo acquired a highly skilled team, research and development compounds and libraries, a global intellectual property portfolio, and two early discovery labs.

"Valo is taking a groundbreaking approach to solving some of the most complex and dynamic issues in drug development," said Ron Hovsepian, Valo Board Chairman, and Flagship Executive Partner. "David Berry’s leadership as an innovator positions Valo to shape how the next generation of drugs will come to market. We are excited to see what comes next."