On January 31, 2018 Oncoceutics, Inc. reported that the first patient has been treated in a clinical trial of ONC201 for pediatric patients with brain tumors that contain a specific mutation called the histone H3 K27M mutation (Press release, Oncoceutics, JAN 31, 2018, View Source [SID1234558373]). The trial, which will treat patients with recurrent high-grade gliomas, including glioblastoma and diffuse intrinsic pontine glioma (DIPG), is led by Sharon Gardner, MD, a pediatric neuro-oncologist at NYU Langone Health’s Stephen D. Hassenfeld Children’s Center for Cancer & Blood Disorders. The study will enroll approximately 45 pediatric patients using ONC201 as a single agent or in combination with radiotherapy for patients with recurrent or newly diagnosed disease, respectively.

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The H3 K27M mutation has been identified as an important prognostic indicator in aggressive midline gliomas that involve specific parts of the brain, including the thalamus, pons, or spinal cord. In 2016, the World Health Organization categorized any midline brain tumor that contains the H3 K27M mutation as the highest grade (IV) because the mutation confers such a poor prognosis. Beyond palliative radiation, no medical therapy has been shown to provide clinical benefit for patients with this mutation in their tumor. Pediatric patients are particularly impacted by this mutation, especially those with DIPG where 70-80% of the patients have the mutation.

As previously announced, the company’s focus on H3 K27M mutual gliomas arose from success with a patient in the first group of its phase II trial for recurrent glioblastoma conducted at Harvard. This patient, a 22-year old woman, had the H3 K27M mutation and has experienced a 96% reduction in tumor size. She remains on therapy today (after 22 months) and has returned to her normal activities. Based on the strong result for this patient, Oncoceutics enrolled additional brain tumor patients with the H3 K27M mutation, and some of these patients have also done well, including a patient whose tumors have completely disappeared. In addition to enrolling more adult patients with the H3 K27M mutation at Harvard (where the trial was limited to adults), we have enrolled a handful of children with brain tumors that have the mutation under compassionate use protocols, special permission from the FDA to enroll patients on a case-by-case when there is no approved clinical trial accessible to the patient. We have also seen signs of efficacy in these children. In total, 14 patients with brain tumors that have the H3 K27M mutation have been treated with single agent ONC201 (7 in formal clinical studies and 7 in compassionate use studies), and five of these patients have demonstrated clinical and/or radiographic benefit from ONC201 therapy. These data will be reported in upcoming scientific conferences and publications. In addition, corroborating preclinical efficacy and mechanistic studies from the lab of Andrew Chi, MD, also at NYU Langone Health, have shown that H3 K27M gliomas cells are extremely sensitive to ONC201.

"The previously reported responses to ONC201 in patients with H3 K27M gliomas, combined with the preclinical results from Dr. Chi’s lab here at NYU, make me excited to offer ONC201 to our patients with this molecularly-defined disease," said Dr. Gardner. "To date, no drugs have proven effective in these tumors, and this patient population is in need of novel therapeutic options.

"We are excited to expand our existing clinical program targeted at patients with the H3 K27M mutation to the pediatric populations," said Lee Schalop, MD, Chief Operating Officer at Oncoceutics. "Based on the results we have seen in patients with the H3 K27M tumor mutation who have received ONC201, as well as the preclinical data generated by Dr. Chi, we believe that ONC201 offers a unique opportunity to eliminate these devastating tumors."

On January 31, 2018, Cascadian Therapeutics, Inc., a Delaware corporation (the " Company "), reported that it has issued a press release announcing the entry into an Agreement and Plan of Merger (the " Merger Agreement "), by and among the Company, Seattle Genetics, Inc., a Delaware corporation (" Parent "), and Valley Acquisition Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of Parent (" Purchaser "), pursuant to which Purchaser will commence a tender offer (the " Offer ") to purchase all of the issued and outstanding shares (the " Shares ") of common stock, par value $0.0001 per share, of the Company at a price of $10.00 per Share in cash, net to the seller, without interest and subject to any required withholding of taxes (Press release, Cascadian Therapeutics, JAN 31, 2018, View Source [SID1234523652]). If successful, the Offer will be followed by the merger of the Company with and into the Purchaser pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with the Company being the surviving corporation (the " Merger "), and becoming a wholly-owned subsidiary of Parent.

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This Schedule 14D-9 filing consists of the following documents related to the proposed Offer and Merger:

(i) Company email to employees

(ii) Company employee presentation

(iii) Letter to HER2CLIMB clinical investigators

(iv) Letter to partners and vendors

(v) Letter to vendors and suppliers

(vi) Email to temporary workers and contractors
The information set forth under Items 1.01, 8.01 and 9.01 of the Current Report on Form 8-K filed by the Company on January 31, 2018 (including Exhibit 2.1 and Exhibit 99.1 attached thereto) is incorporated herein by reference.

Additional Information and Where to Find It

The tender offer described in this communication (the "Offer") has not yet commenced, and this communication is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Cascadian Therapeutics or any other securities. On the commencement date of the Offer, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed with the United States Securities and Exchange Commission (the "SEC") and Cascadian Therapeutics will file a Solicitation/Recommendation Statement on Schedule 14D-9 relating to the Offer with the SEC. The offer to purchase shares of Cascadian Therapeutics common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed with such Schedule TO. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. The tender offer statement will be filed with the SEC by Valley Acquisition Sub, Inc. and Seattle Genetics, Inc., and the solicitation/recommendation statement will be filed with the SEC by Cascadian Therapeutics. Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to Innisfree M&A Incorporated toll-free at (888) 750-5834.

Cautionary Statement Regarding Forward-Looking Statements

This communication may contain, in addition to historical information, certain forward-looking statements, including, without limitation, statements regarding the pending acquisition of Cascadian Therapeutics, Inc. by Seattle Genetics, Inc. and its affiliates, including Valley Acquisition Sub, Inc. (the Offer, the merger and other related transactions are collectively referred to as the "Transactions"). Often, but not always, forward-looking statements can be identified by the use of words such as "believes," "anticipates," "plans," "expects," "expected," "will," "intends," "potential," "project," "possible," "scheduled," "estimates," "intends," "continue," "ongoing," "goal" and similar expressions or variations of such words and phrases or statements that certain actions, events, conditions, circumstances or results "may," "could," "would," "might" or "will" be taken, occur or be achieved. Forward-looking statements involve risks and uncertainties related to Cascadian Therapeutics’ business and the general economic environment, many of which are beyond Cascadian Therapeutics’ control. Such uncertainties and risks include, without limitation: uncertainties as to the timing of the Offer and merger; uncertainties as to how many of the Cascadian Therapeutics’ stockholders will tender their stock in the Offer; the possibility that various closing conditions for the Transactions may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the Transactions; the occurrence of any event, change or

other circumstance that could give rise to the termination of the Merger Agreement; the effects of the Transactions (or the announcement thereof) on relationships with employees, customers, other business partners or governmental entities; transaction costs; the risk that the Transactions will divert management’s attention from Cascadian Therapeutics’ ongoing business operations; and other risks and uncertainties detailed from time to time in documents filed by the Company with the securities regulators in the United States on EDGAR and in Canada on SEDAR, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 to be filed by the Company. These risks, uncertainties and other factors could cause Cascadian Therapeutics’ actual results to differ materially from those projected in forward-looking statements. Although Cascadian Therapeutics believes that the forward-looking statements contained in this communication are reasonable as of the date hereof, it can give no assurance that its expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Cascadian Therapeutics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, conditions, circumstances or otherwise, except as required by applicable law.

On January 31 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that initial results from the company’s ongoing SUMMIT Phase II ‘basket’ clinical trial of PB272 (neratinib) in patients with tumors harboring HER2 or HER3 mutations were published in the journal Nature . The paper, "HER kinase inhibition in patients with HER2- and HER3-mutant cancers," appears in the January 31, 2018 online issue at View Source and will be published in a future print issue of the journal.

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The Phase II SUMMIT trial is a global, multi-histology, open-label, precision-medicine ‘basket’ study evaluating the safety and efficacy of neratinib administered daily to patients with a wide variety of solid tumors with activating HER2 or HER3 mutations. SUMMIT is designed to evaluate the contributions of both genetic mutation and cancer type on individual patients’ response to neratinib. Information generated from the trial will help guide neratinib-based targeted therapy across a broad spectrum of tumor types with HER2 or HER3 mutations, including patients with rare tumors who may not otherwise have access to investigational therapies.

"Publication of the initial SUMMIT data in this prestigious journal reflects the novelty and quality of this precision-medicine trial design, as well as the growing understanding that both tumor type and gene mutations play an important role in individual patients’ response to cancer therapies such as neratinib," said Alan H. Auerbach, Puma’s Chief Executive Officer and President. "The basket trial design utilized for SUMMIT is enabling researchers to evaluate the clinical potential of neratinib in multiple cancer types, rather than limiting exploration to one tumor type at a time. SUMMIT is also significant in that it will provide the largest body of clinical data to date on the use of an irreversible pan-HER inhibitor in patients who have solid tumors with somatic HER2 or HER3 mutations."

The initial SUMMIT results published in Nature comprise data from 141 patients enrolled in the neratinib monotherapy arm of the trial, including 124 patients with HER2 mutations and 17 patients with HER3 mutations. This included patients with 21 unique tumor types, with the most common being breast, lung, bladder and colorectal cancer. Researchers observed 30 distinct HER2 and 12 distinct HER3 mutations among these patients, with the most frequent HER2 variants involving amino acids S310, L755, A755_G776insYVMA and V777.

In the HER2-mutant cohort, clinical responses were observed in tumors with S310, L755, V777, P780_Y781insGSP and A775_G776insYVMA mutations. When stratified by tumor type, responses were observed in patients with breast, cervical, biliary, salivary and non-small-cell lung cancers, which led to cohort expansions in these tumor types. No activity was observed in the HER3-mutant cohort.

The neratinib safety profile observed in the SUMMIT study is consistent with that observed previously in metastatic patients with HER2 amplified tumors. The study showed that the most frequently observed adverse reaction was diarrhea. All patients in the SUMMIT study received prophylactic loperamide (16 mg per day initially) for the first cycle of treatment in order to reduce neratinib-related diarrhea, and with this anti-diarrheal prophylaxis and management, diarrhea was not a treatment-limiting side effect in SUMMIT. For the 141 patients enrolled in the neratinib monotherapy arm with safety data available, 31 patients (22.0%) reported grade 3 diarrhea. The median duration of grade 3 diarrhea for those patients was two days. Four patients (2.8%) permanently discontinued neratinib and 21 patients (14.9%) had dose interruptions due to diarrhea.

"Results to date from the SUMMIT trial validate the ‘next-generation’ basket trial approach, which has enabled us to efficiently and effectively evaluate neratinib across numerous cancer types as well as individual and sometimes entirely novel HER2 mutations," said David Hyman, M.D., Chief of the Early Drug Development Service at Memorial Sloan Kettering Cancer Center (MSK). "We look forward to completing enrollment in the ongoing cohorts in the study and continuing to utilize the basket trial design to explore the most optimal treatment options for these select patient populations."

Dr. Hyman, who helped pioneer the concept of basket trials at MSK, presented the initial findings from the SUMMIT study at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2017.

"We are very pleased with these initial results," said Mr. Auerbach. "We look forward to advancing neratinib into further clinical development in multiple HER2 mutant tumor types, both as monotherapy and in novel combinations."

On January 31, 2018 Seattle Genetics, Inc. (Nasdaq:SGEN) and Cascadian Therapeutics, Inc. (Nasdaq:CASC) reported the signing of a definitive merger agreement under which Seattle Genetics has agreed to acquire Cascadian Therapeutics (Press release, Cascadian Therapeutics, JAN 31, 2018, View Source [SID1234523651]). Under the terms of the agreement, Seattle Genetics will pay $10.00 per share in cash, or approximately $614 million. The transaction was unanimously approved by the Boards of Directors of both companies.

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Cascadian Therapeutics’ most advanced program is tucatinib, an investigational oral, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2, a growth factor receptor that is overexpressed in multiple cancers, including breast, colorectal, ovarian and gastric. Tucatinib is currently being evaluated in a randomized global pivotal trial called HER2CLIMB for patients with HER2-positive (HER2+) metastatic breast cancer, including patients with or without brain metastases. Tucatinib has been evaluated as a single agent and in combination with both chemotherapy and other HER2-directed agents including Herceptin (trastuzumab) and Kadcyla (trastuzumab emtansine). Results from phase 1b trials showed that the combination of tucatinib, capecitabine and trastuzumab was generally well-tolerated and demonstrated clinical activity in patients with and without brain metastases. The data support the ongoing pivotal trial and the potential role of tucatinib in earlier lines of metastatic breast cancer.

"This acquisition would enhance our late-stage clinical pipeline with a potentially best-in-class, orally available and highly selective TKI for patients with HER2-positive metastatic breast cancer," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Tucatinib would complement our existing pipeline of targeted cancer therapies, provide a third late-stage opportunity for a commercial product in solid tumors and expand our global efforts in breast cancer. It also leverages our broad expertise and resources to advance and expand the tucatinib program for patients. Beyond breast cancer, we believe there may be opportunities for tucatinib in other tumor types, such as HER2-positive metastatic colorectal cancer. Cascadian’s pipeline also includes a preclinical immuno-oncology agent. We look forward to welcoming the team at Cascadian Therapeutics and continuing the momentum of the tucatinib development program."

"This agreement represents a very positive outcome for patients with HER2-expressing cancers, our employees and for our stockholders," said Scott D. Myers, President and Chief Executive Officer of Cascadian Therapeutics. "Seattle Genetics has the development and commercial capabilities and the resources needed to more fully realize the potential of tucatinib as a new best-in-class treatment option for metastatic breast cancer, colorectal cancer and potentially for other indications."

Terms of the Transaction

Under the terms of the definitive merger agreement, Seattle Genetics will commence a tender offer on or about February 8, 2018 to acquire all of the outstanding shares of common stock of Cascadian Therapeutics for $10 per share in cash. This represents a 69 percent premium to the closing price of Cascadian Therapeutics’ common stock on Tuesday, January 30, 2018, and a 139 percent premium to its 30-day volume weighted average stock price. The tender offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of Cascadian Therapeutics common stock (on a fully diluted basis) and the expiration or early termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Following the closing of the tender offer, a wholly-owned subsidiary of Seattle Genetics will merge with and into Cascadian Therapeutics, with each share of Cascadian Therapeutics common stock that has not been tendered being converted into the right to receive the same $10 per share in cash offered in the tender offer. The transaction is anticipated to close in the first quarter of 2018.

In connection with the transaction, Seattle Genetics has secured a financing commitment in the amount of $400 million from Barclays and JPMorgan-Chase Bank. The balance of the consideration will be provided from cash on hand.

Leerink Partners LLC is acting as lead financial advisor to Seattle Genetics. Barclays and J.P. Morgan Securities LLC are also acting as financial advisors on the transaction. Perella Weinberg Partners LP is acting as financial advisor to Cascadian Therapeutics. Legal counsel for Seattle Genetics is Sullivan & Cromwell LLP and legal counsel for Cascadian Therapeutics is Reed Smith LLP. Goodwin Procter LLP acted as special counsel for the Cascadian Therapeutics Board of Directors and Board transaction committee.

Seattle Genetics Preliminary Financial Results

In conjunction with today’s announcement, Seattle Genetics separately reported preliminary unaudited consolidated financial results as of and for the quarter and year ended December 31, 2017 as follows:

Three Months Ended December 31, 2017 Year Ended December 31, 2017
Total revenues $128 million to $130 million $481 million to $483 million

ADCETRIS net product sales in the U.S. and Canada $82 million to $84 million $306 million to $308 million

Total revenues increased from the comparable periods in 2016 primarily as a result of increased ADCETRIS net product sales. ADCETRIS net product sales increased from the comparable periods in 2016 primarily due to an increase in sales volume and, to a lesser extent, price increases. The increases in sales volumes in both periods were driven primarily by increased use of ADCETRIS across multiple lines of therapy in Hodgkin lymphoma and for the treatment of other malignancies.

In addition, as of December 31, 2017, Seattle Genetics had approximately $413 million in cash and cash equivalents and short-term investments.

Conference Call Details

Seattle Genetics’ management will host a conference call and webcast to discuss the transaction today at 5:30 a.m. Pacific Time (PT); 8:30 a.m. Eastern Time (ET). The live event will be available from the Seattle Genetics website at www.seattlegenetics.com, under the Investors section, or by calling 800-281-7973 (domestic) or 323-794-2093 (international). The conference ID is 7936538. A replay of the discussion will be available beginning at approximately 8:30 a.m. PT today from the Seattle Genetics website or by calling 888-203-1112 (domestic) or 719-457-0820 (international), using conference ID 7936538. The telephone replay will be available until 5:00 p.m. PT on Friday, February 2, 2018.

On January 31, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported that the first patient was dosed in a global Phase 3 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, as a potential second-line treatment in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) (Press release, BeiGene, JAN 31, 2018, View Source;p=RssLanding&cat=news&id=2329344 [SID1234523649]). Tislelizumab is also being studied in global Phase 3 trials in non-small cell lung cancer and hepatocellular carcinoma and two pivotal Phase 2 trials in China in relapsed/refractory classical Hodgkin lymphoma and urothelial cancer.

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"We are pleased to be leading the third global Phase 3 study of tislelizumab under our strategic collaboration with Celgene. These studies are designed to support regulatory filings both in China and globally, and take advantage of our unique global clinical development organization as well as the recent regulatory reforms in China. In 2018, we look forward to further expanding the development program for tislelizumab and to accomplishing key milestones including a planned NDA submission in China," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

"Patients with advanced unresectable or metastatic esophageal carcinomas face poor prognosis, especially those with squamous histology, due to the extremely aggressive nature of the disease. We are hopeful that this Phase 3 trial will establish safety and efficacy of tislelizumab as an important treatment option for these patients," commented Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene.

The Phase 3, open-label, multi-center, randomized trial is designed to compare the efficacy and safety of tislelizumab compared to investigator-chosen chemotherapy as a second-line treatment in patients with advanced unresectable or metastatic ESCC. Approximately 450 patients are planned to be enrolled in Greater China, Japan, Korea, Belgium, France, Germany, Italy, Spain, the United Kingdom and the United States. Patients will be randomized to receive either tislelizumab at 200 mg every three weeks or one of three single-agent chemotherapies, paclitaxel, docetaxel, or irinotecan, as determined by the investigator.

The trial’s primary endpoint is overall survival, and secondary endpoints include progression-free survival, objective response rate, duration of response, health-related quality of life, safety, and tolerability.

"Treatment options for esophageal squamous cell carcinoma have been limited to chemotherapy. Tislelizumab has shown promising anti-tumor activity and has been generally well-tolerated in clinical trials to date in patients with a variety of cancers, including esophageal cancer, and we are hopeful that data from this Phase 3 trial will lead to a new treatment option where it is so greatly needed," said Professor Lin Shen, M.D., Vice President at the Beijing Cancer Hospital, Beijing, China, and lead investigator of the trial.

For more information about the trial, patients and physicians should email BeiGene at [email protected].

About Esophageal Squamous Cell Carcinoma

Esophageal cancer, which includes squamous cell carcinoma, is considered a serious malignancy with respect to prognosis and a fatal outcome in the great majority of cases. Esophageal carcinoma affects more than 450,000 people worldwide.i Esophageal cancer is the eighth most common cancer worldwide and the sixth most common cause of death from cancer.ii

Esophageal squamous cell carcinoma occurs at a rate 20 to 30 times higher in China than in the United States.i An esophageal "cancer belt," primarily squamous cell cancers, extends from northeast China to the Middle East.i Advanced esophageal cancer is a rapidly fatal disease. More than two-thirds of patients diagnosed with esophageal cancer will have advanced or metastatic disease, with a median survival of 8-10 months and an expected five-year survival rate of less than five percent.iii These data, combined with the relative lack of highly effective treatment, are indicative of the large unmet medical need in patients diagnosed with esophageal cancer.

About Tislelizumab (BGB-A317)

Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. Tislelizumab 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. BeiGene and Celgene Corporation have a global strategic collaboration for tislelizumab for solid tumors outside of Asia (except Japan).