On June 17, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that it has entered into a mutual agreement with Celgene Corporation to terminate the parties’ global collaboration for tislelizumab, BeiGene’s investigational anti-PD-1 antibody, in advance of the pending acquisition of Celgene by Bristol-Myers Squibb (Press release, BeiGene, JUN 17, 2019, View Source [SID1234537119]). In connection with the termination, Celgene has agreed to pay $150 million to BeiGene.

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"Our collaboration with Celgene was instrumental for the late-stage clinical development of tislelizumab and has provided us with significant resources to continue our broad clinical program," said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. "As we have been leading most of the ongoing Phase 3 or potentially registration-enabling trials with a global development organization of over 800 people, we believe that we are well-positioned to continue the development of tislelizumab. I am proud of the work that we have accomplished in collaboration with Celgene and am excited by the tremendous opportunity that we have ahead now that we’ve regained full global rights to tislelizumab."

Tislelizumab has been dosed in over 2,950 patients globally. With two new drug applications under review in China, BeiGene expects tislelizumab to receive its first regulatory approval later this year.

In July 2017, BeiGene and Celgene announced a global strategic collaboration in which Celgene obtained exclusive rights to develop and commercialize tislelizumab in solid tumor cancers in the United States, Europe, Japan and the rest of world outside of Asia. BeiGene retained rights in hematology indications globally and in solid tumor cancers in Asia (ex-Japan). In connection with that agreement, BeiGene also acquired Celgene’s commercial operations in China and an exclusive license to Celgene’s cancer commercial portfolio in China (ABRAXANE, REVLIMID, VIDAZA). BeiGene’s commercial license from Celgene is not affected by the termination of the tislelizumab agreement. In the almost two years since the transaction, BeiGene has grown its commercial organization in China to more than 600 people.

About Tislelizumab

Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug candidate produced from BeiGene’s immuno-oncology biologic program, and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab is being studied in a broad clinical program. BeiGene has completed a pivotal Phase 2 clinical trial in patients with relapsed or refractory (R/R) classical Hodgkin’s lymphoma (cHL). Ongoing clinical trials of tislelizumab include a Phase 3 clinical trial in patients with second-line or third-line non-small cell lung cancer (NSCLC); a Phase 3 clinical trial in first-line patients with hepatocellular carcinoma (HCC); a Phase 3 clinical trial in second-line patients with esophageal squamous carcinoma (ESCC); a Phase 3 clinical trial in first-line patients with gastric cancer (GC); a Phase 3 clinical trial in first-line patients with ESCC; a Phase 2 clinical trial in second- or third-line patients with HCC; and a Phase 1 clinical trial in patients with R/R NK/T-cell lymphomas. The aforementioned studies are enrolling patients in multiple countries, including the U.S., Europe, and China.

Additionally, BeiGene is conducting a Phase 3 clinical trial in first-line patients with non-squamous NSCLC; a Phase 3 clinical trial in first-line patients with squamous NSCLC; a Phase 3 clinical trial in patients with nasopharyngeal cancer (NPC); a Phase 3 clinical trial in first-line patients with urothelial carcinoma (UC); a pivotal Phase 2 clinical trial in patients with locally advanced or metastatic urothelial cancer; and a pivotal Phase 2 trial in patients with MSI-H or dMMR solid tumors. These studies are enrolling patients in China.

New drug applications (NDA) for tislelizumab in patients with R/R cHL and in patients with locally advanced or metastatic UC have been accepted by the China National Medical Products Administration (NMPA, formerly known as CFDA) and the R/R cHL filing has been granted priority review.

On June 17, 2019 T Medical Technologies, Inc., a company dedicated to improving the lives of patients with brain tumors, reported the presentation of clinical data from a prospective study of GammaTile Therapy in patients with previously irradiated intracranial neoplasms (brain tumors) at the American Brachytherapy Society (ABS) 2019 Annual Meeting in Miami (Press release, GT Medical Technologies, JUN 17, 2019, View Source [SID1234537120]). These data reinforce the safety profile of GammaTile Therapy, a surgically targeted radiation therapy (STaRT) that is designed to delay tumor regrowth for patients with recurrent intracranial neoplasms (brain tumors).

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The company also announced that David Brachman, M.D., co-founder and CTO of GT MedTech, received the prestigious Judith Stitt Best Abstract Award for his abstract Surgically Targeted Radiation Therapy: Safety Profile of Collagen Tile Brachytherapy in 79 Recurrent, Previously Irradiated Intracranial Neoplasms on a Prospective Clinical Trial. Only four abstracts every year – out of hundreds of submissions – are selected by the ABS’s scientific committee for this recognition.

GammaTile is an FDA-cleared therapy for patients with recurrent intracranial neoplasms (brain tumors) including primary (benign or malignant) and metastatic tumors. Placed directly at the site of the tumor cavity during the last few minutes of excision surgery, GammaTile Therapy is a new approach that immediately begins targeting residual tumor cells, before they can replicate. Designed to help protect healthy brain tissue and facilitate rapid, accurate placement during the procedure, the therapy features a bioresorbable, conformable, 3D-collagen tile and uniform radiation source.

The prospective, single-arm study evaluated the safety profile of GammaTile Therapy in combination with tumor resection surgery in 79 recurrent brain tumors of various types, including gliomas, meningiomas, and brain metastases. Results from the study showed that GammaTile Therapy improves local tumor control compared to currently available treatments. The study also showed a low rate of adverse events, with wound infection occurring in 2.5% of tumors and radiation-related brain changes occurring in 8% of treated patients during the follow-up period. These findings suggest that GammaTile Therapy is a viable radiation therapy option for the challenging cohort of patients with recurrent brain tumors.

"These data further support the safety profile and efficacy of GammaTile Therapy for patients with brain tumors," said Dr. Brachman. "This therapy is designed to meet a significant unmet need for patients who may not be candidates for other forms of radiation therapy, or for whom surgery is not a viable option without effective adjuvant therapy. We are encouraged by these data, which build on our body of evidence supporting the safety and efficacy of this therapy."

GammaTile Therapy offers advantages over the most common treatment for patients undergoing surgery for recurrent brain tumors: a course of External Beam Radiation Therapy (EBRT), which requires daily treatments for up to six weeks. Some patients may not be candidates for EBRT. Once the disease has returned, many people with recurrent brain tumors have already received levels of radiation therapy that make the risk of additional external beam radiation outweigh the potential benefits. Additionally, those patients who are potentially candidates for EBRT typically have to wait two weeks or more for surgical wound healing before beginning treatment, giving any residual tumor cells a chance to replicate.

Initial data from this study were published this year in the Journal of Neurosurgery (JNS) demonstrating that GammaTile therapy is a safe and effective new option proven to delay tumor progression in patients with previously treated, aggressive meningiomas, the most common type of primary brain tumor. Additional data from this study supporting the safety and efficacy of GammaTile Therapy for various tumor types were presented in April at the American Association of Neurological Surgeons Annual Meeting, affirming that this therapy could help expand options for brain tumors that are challenging to treat.

About GammaTile Therapy

GammaTile Therapy is an FDA-cleared, surgically targeted radiation therapy (STaRT) that is designed to delay tumor regrowth for patients with brain tumors. Featuring a bioresorbable, conformable, 3D-collagen tile and uniform radiation source, GammaTile Therapy is placed at the end of excision surgery so that it immediately begins to target residual tumor cells while limiting the impact of radiation on healthy brain tissue. Because the therapy is implanted at the end of surgery, patients treated with GammaTile Therapy require no additional trips to the hospital or clinic for radiation therapy.

On June 17, 2019 Pfizer Inc. (NYSE: PFE) and Array BioPharma Inc. (NASDAQ: ARRY) reported that they have entered into a definitive merger agreement under which Pfizer will acquire Array, a commercial stage biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need. Pfizer has agreed to acquire Array for $48 per share in cash, for a total enterprise value of approximately $11.4 billion (Press release, Array BioPharma, JUN 17, 2019, View Source [SID1234537105]). The Boards of Directors of both companies have approved the merger.

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This press release features multimedia. View the full release here: View Source

Array’s portfolio includes the approved combined use of BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) for the treatment of BRAFV600E or BRAFV600K mutant unresectable or metastatic melanoma. The combination therapy has significant potential for long-term growth via expansion into additional areas of unmet need and is currently being investigated in over 30 clinical trials across several solid tumor indications, including the Phase 3 BEACON trial in BRAF-mutant metastatic colorectal cancer (mCRC).

In the U.S., colorectal cancer is the third most common type of cancer in men and women. An estimated 140,250 patients were diagnosed with cancer of the colon or rectum in 2018, and approximately 50,000 are estimated to die of their disease each year.1BRAF mutations are estimated to occur in up to 15% of colorectal cancer cases and represent a poor prognosis for these patients.

"Today’s announcement reinforces our commitment to deploy our capital to bring breakthroughs that change patients’ lives while creating shareholder value," said Albert Bourla, chief executive officer of Pfizer. "The proposed acquisition of Array strengthens our innovative biopharmaceutical business, is expected to enhance its long-term growth trajectory, and sets the stage to create a potentially industry-leading franchise for colorectal cancer alongside Pfizer’s existing expertise in breast and prostate cancers."

In addition to the combination therapy for BRAF-mutant metastatic melanoma, Array brings a broad pipeline of targeted cancer medicines in development, as well as a portfolio of out-licensed potentially best-in-class and/or first-in-class medicines, which are expected to generate significant royalties over time.

"We are incredibly proud that Pfizer has recognized the value Array has brought to patients and our remarkable legacy discovering and advancing molecules with great potential to impact and extend the lives of patients in critical need," said Ron Squarer, Array chief executive officer. "Pfizer shares our commitment to patients and a passion for advancing science to develop even more options for individuals with unmet needs. We’re excited our team will have access to world-class resources and a broader research platform to continue this critical work."

In May 2019, Array announced results from the interim analysis of the Phase 3 BEACON mCRC trial: The second-or-third-line treatment with the BRAFTOVI triplet combination (BRAFTOVI + MEKTOVI + cetuximab) showed statistically significant improvement in overall response rate and overall survival compared to the control group, reducing the risk of death by 48%. The triplet combination could be the first chemotherapy-free, targeted regimen for patients with BRAF-mutant mCRC. Array intends to submit these data for regulatory review in the United States in the second half of 2019.

"We are very excited by Array’s impressive track record of successfully discovering and developing innovative small-molecules and targeted cancer therapies," said Mikael Dolsten, Pfizer chief scientific officer and president, Worldwide Research, Development and Medical. "With Array’s exceptional scientific talent and innovative pipeline, combined with Pfizer’s leading research and development capabilities, we reinforce our commitment to advancing the most promising science, regardless of whether it is found inside or outside of our labs."

Upon the close of the transaction, Array’s employees will join Pfizer and continue to be located in Cambridge, Massachusetts and Morrisville, North Carolina, as well as Boulder, Colorado, which becomes part of Pfizer’s Oncology Research & Development network in addition to La Jolla, California and Pearl River, New York.

Pfizer expects to finance the majority of the transaction with debt and the balance with existing cash. The transaction is expected to be dilutive to Pfizer’s Adjusted Diluted EPS by $0.04 -$0.05 in 2019, $0.04 -$0.05 in 2020, neutral in 2021, and accretive beginning in 2022, with additional accretion and growth anticipated thereafter. Pfizer will provide any appropriate updates to its current 2019 guidance in conjunction with its third quarter 2019 earnings release.

Under the terms of the merger agreement, a subsidiary of Pfizer will commence a cash tender offer to purchase all outstanding shares of Array common stock for $48 per share in cash for a total enterprise value of approximately $11.4 billion. The closing of the tender offer is subject to customary closing conditions, including regulatory approvals and the tender of a majority of the outstanding shares of Array common stock (on a fully-diluted basis). The merger agreement contemplates that Pfizer will acquire any shares of Array that are not tendered into the offer through a second-step merger, which will be completed promptly following the closing of the tender offer. Pfizer expects to complete the acquisition in the second half of 2019.

Pfizer’s financial advisors for the transaction were Guggenheim Securities, LLC, and Morgan Stanley & Co. LLC, with Wachtell, Lipton, Rosen & Katz acting as its legal advisor. Centerview Partners served as Array’s exclusive financial advisor, while Skadden, Arps, Slate, Meagher & Flom LLP served as its legal advisor.

Conference Call

Pfizer Inc. invites investors and the general public to view and listen to a webcast of a live conference call with investment analysts at 9:00 a.m. EDT on Monday, June 17, 2019.

To view and listen to the webcast visit Pfizer’s web site at www.pfizer.com/investorsor directly at View Source Information on accessing and pre-registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to pre-register in advance of the conference call.

You can listen to the conference call by dialing either (855) 895-8759 in the United States or Canada or (503) 343-6044 outside of the United States and Canada. The password is "Analyst Call." Please join the call five minutes prior to the start time to avoid operator hold times.

Pfizer Inc.: Breakthroughs that change patients’ lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

On June 17, 2019 Resolution Bioscience, Inc., reported the publication of a blinded performance evaluation between two cell-free DNA (cfDNA) next-generation sequencing (NGS) assays (Press release, Resolution Bioscience, JUN 17, 2019, View Source [SID1234537121]). The publication reports that the team of scientists, led by lung cancer researchers and clinicians at Dana-Farber Cancer Institute, found that the Resolution ctDx-Lung assay identified more actionable gene fusion mutations than Guardant Health’s Guardant360 test. The peer-reviewed manuscript, "Sensitivity of next-generation sequencing assays detecting oncogenic fusions in plasma cell-free DNA," was released online ahead of publication in Lung Cancer.

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Plasma genotyping has shown the ability to identify actionable, targetable mutations to drive personalized therapy for patients with advanced non-small cell lung cancer (NSCLC). However, leading commercial platforms have generated variable results when detecting complex variations, such as oncogenic gene fusions or copy number variations. In this comparison study, a cohort of 169 NSCLC patients with Guardant360 plasma results was screened for the presence of gene fusions based on previous tumor tissue analysis. Scientists at Dana-Farber used the Resolution kit in their lab to analyze the plasma of 16 patients who had a rearrangement in their tumor. All personnel involved in sample analysis were blinded to tumor genotype and Guardant360 results.

The Resolution assay detected 13 out of 16 (81.3%) fusions (allele frequency range 0.17-62.8%), while the Guardant360 test detected only seven (43.8%) fusions (allele frequency range 0.3-8.2%). For cases detected by both assays, the Resolution technology identified the mutation at a median of 7% higher allele frequency, which is indicative of a higher capture rate of breakpoint bearing cfDNA that increases overall sensitivity. For the six patients in which a fusion was detected by the Resolution assay but not by Guardant360, the average time to treatment discontinuation was 15.2 months (full range of 3-34 months).

"The Resolution liquid biopsy platform is designed to provide a fast, accurate, and non-invasive solution for mutationally comprehensive tumor genotyping," said Mark Li, CEO of Resolution Bioscience. "While this was a small study, we measure our success one patient at a time. Two patients with a fusion undetected by Guardant360 were on treatment for more than 30 months."

Dana-Farber scientists hypothesized that the Resolution assay offers more efficient hybridization to cfDNA fragments due to its use of tiled, short (˜40 nt) capture probes rather than more common 120 nt probes.

"Our targeted sequencing platform was designed from the ground up for analysis of cfDNA fragments. The shorter probes maintain high specificity while allowing better detection of the low amounts of mutation-bearing fragments often found in plasma," said Li. "Importantly, scientists at the Dana-Farber Cancer Institute performed the assay within their lab, demonstrating the potential of a distributed model."

Scientists presented the early results of this retrospective liquid biopsy comparison study between Resolution’s ctDx-Lung assay and Guardant Health’s Guardant360 test at this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. To view the full manuscript, please visit View Source

About Resolution Bioscience’s Technology

The Resolution liquid biopsy assays are powered by the company’s patented cfDNA NGS analysis platform, which includes proprietary targeted capture NGS chemistry and tightly coupled, cloud-based bioinformatics. Resolution’s technology has now been recognized as novel by the US Food and Drug Administration and has been cited in several important research publications and presentations. For example:

The Resolution HRD assay was recently granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).
The company was the first to demonstrate detection of all four major types of mutations in a blinded clinical study led by scientists at Dana-Farber Cancer Institute. The team determined the assay has the potential to be implemented broadly for patient care and translational research.
Resolution was also the first company to demonstrate gene deletion detection in cfDNA in a study led by scientists at Vanderbilt University in small cell lung cancer. The team determined that cfDNA sequencing allows for improved monitoring of disease burden, depth of response to treatment, and timely warning of disease relapse in patients.
Resolution recently published 97% clinical response data with Memorial Sloan Kettering Cancer Center for non-small cell lung cancer patients who received plasma-directed therapy selection from Resolution’s assay. With more than 950 patients enrolled, the ongoing study is the largest prospective study of stage II, III, or IV NSCLC aimed at demonstrating clinical response and outcomes based upon plasma-directed therapy selection.
In a recent AstraZeneca publication, Resolution had the highest positive predictive value (PPV) and lowest false positive rate amongst four leading NGS liquid biopsy companies in a blinded comparison study.

On June 16, 2019 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.("Fosun Pharma; stock code: 600196.SH, 02196.HK)), a leading healthcare group in China reported that its investigational drug ORIN1001 has received Fast Track designation (FTD) from U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed, refractory and metastatic breast cancer (including triple-negative breast cancer [TNBC]) (Press release, Fosun Pharma, JUN 16, 2019, View Source [SID1234556449]).

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ORIN1001 is an investigational first-in-class small molecule drug that has a novel molecular target, novel mechanism of action and novel chemical structural class and identity, and is independently developed by Fosun Orinove, a subsidiary of Fosun Pharma. The new drug is for the treatment of advanced solid tumors and relapsed refractory metastatic breast cancer. As of May 2019, Fosun Pharma has invested RMB 45.47 millions in this investigational drug.

Established in July 2017 by Fosun Pharma and a team of American scientists, Fosun Orinove focuses on cancer cell metabolism-related small molecule anticancer drugs, and has set up R&D locations both in Suzhou and Los Angeles.

Dr. Qingping Zeng, CEO of Fosun Orinove said, "The fast track designation of ORIN1001 reflects a recognition for our R&D aspirations of getting novel therapeutics to patients and addressing unmet medical needs. The molecular target is related to a stress mitigation mechanism for diseased cells, and has commonality for various therapeutic indications. We will accelerate ORIN1001 development in multiple indications in the near future and reach the global market expeditiously."

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious or life-threatening disease or condition and fill an unmet medical need. A therapeutic that receives Fast Track designation may be eligible for frequent communication with the FDA, priority review, potential accelerated approval according to data, and rolling submission, which allows a company to submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be submitted for review.

Dr. Aimin Hui, the Senior Vice President and Chief Medical Officer of Fosun Pharma said, "We are thrilled to treat cancer patients in the United States and receive FDA Fast Track Development Program designation within six months since initial IND submission. It implies that the research and development for innovative medicine and globalization at Fosun Pharma is moving to a new stage."

Breast cancer is one of the major cancer-caused deaths for women nowadays. TNBC refers to breast cancer tumors that do not express the estrogen receptor (ER), progesterone receptor (PR) and Her2/neu, and is diagnosed more frequently in younger and premenopausal women under 40 years old. TNBC accounts for about 15 to 25% of breast cancer patients, and because of the high heterogeneity of its tumor cells, triple-negative breast cancer has very high invasiveness, recurrence rate and metastasis. Due to the lack of effective targeted therapy, there is a huge unmet clinical need for TNBC.

"Receipt of FDA Fast Track designation has marked another innovative breakthrough of Fosun Pharma in oncology treatment area." Executive Director and Co-President of Fosun International, Chairman of Fosun Pharma, Mr. Chen Qiyu said, "In the future, we’ll continue to innovate in unmet medical needs, to find treatment for refractory diseases, and to provide more accessible, more qualified, and more affordable products and services to global patients."

Cancer severely threats human health. Tradition treatment could hardly curing cancer. In recent years, Fosun Pharma continues to expand investment on innovation and oncology research, and has layout on small molecular innovative drugs, biologics and cellular immunotherapy. Now, Fosun Pharma owns a rich pipeline, with more than 30 projects on clinical development stage in oncology. In February 2019, its independent innovative product HLX01(trademark: 汉利康) which is developed by Henlius, Fosun Pharma’s biologics platform has been approved by NMPA as the first biosimilar in China. It helps to increase the accessibility of high-quality biosimilar, and would benefit more lymphoma patients. Facing with unmet medical needs, Fosun Pharma also introduces a number of advanced and cutting-edge products and technologies via corporate cooperation and license-in. Fosun Kite’s first product FKC876 was accepted in the clinical trial and registration review of the NMPA, with an aim to provide advanced treatment to Chinese cancer patients. In the future, Fosun Pharma will leverage on the advantages and stick to independent innovation and internationalization benefiting from industry and market opportunities, to contribute better and more affordable medicines for society.