On January 21, 2020 SHINE Medical Technologies LLC, the Institute of Organic Chemistry and Biochemistry (IOCB Prague) and GE Healthcare reported the production of patient dose quantities of the therapeutic isotope lutetium-177 (Lu-177) (Press release, Shine Medical Technologies, JAN 21, 2020, View Source;pk_kwd=shine-iocb-deliver-lu-177-doses-to-ge [SID1234553393]). The lot passed GE Healthcare’s quality control testing, including internationally recognized radionuclide purity (RNP) standards. The delivery of Lu-177 in this quantity and purity demonstrates the suitability of the IOCB technology for Lu-177 production. It is a major step toward commercial production of the therapeutic isotope by SHINE.

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Last May, SHINE entered an agreement with IOCB Prague that granted the company exclusive access to IOCB Prague’s novel technology, which is used to separate lutetium from enriched ytterbium targets. The technology enabled the production of the non-carrier-added (nca) Lu‑177 supplied to GE Healthcare. The isotope was produced in collaboration with the Nuclear Physics Institute in Czechia. The Nuclear Physics Institute and IOCB Prague are members of the Czech Academy of Sciences.

Lu-177 is used to treat neuroendocrine cancers. It also shows promise for the treatment of metastatic prostate and other cancers. The isotope is a low-energy beta-particle emitter that works by directly irradiating cancer cells after being delivered to the cancer site by a targeting molecule.

"Non-carrier-added Lu-177 at the dosage and purity delivered to us bodes well for the potential to provide physicians and patients with a vital, highly effective therapeutic isotope," said Charles Shanks, GE Healthcare’s principal engineer, Life Sciences. "Lu-177 is one of the key drivers of growth in the medical isotope market. It represents a major opportunity to better serve the market."

"The delivery of patient dose quantities of Lu-177 to GE Healthcare is a significant step forward for SHINE Therapeutics," said Katrina Pitas, the vice president and general manager of SHINE Therapeutics. "Together with our collaborators from the Czech Academy of Sciences, we have demonstrated the capability to produce Lu-177 at a very high standard of purity. We look forward to continuing to work with GE Healthcare to move Lu-177 closer to commercialization and the patients who will benefit from it most."

"Producing clinically relevant doses of any therapeutic radionuclide is not easy and we have demonstrated that our technology can meet the challenge for nca Lu-177," said Dr. Miloslav Polasek of IOCB Prague. "I am very grateful to the SHINE, IOCB and NPI teams for the progress we are making together."

On January 21, 2020 Adaptive Biotechnologies Corporation (Nasdaq:ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported the commencement of a proposed underwritten public offering of 8,000,000 shares of its common stock by certain selling shareholders (Press release, Adaptive Biotechnologies, JAN 21, 2020, View Source [SID1234553523]). In addition, certain selling shareholders expect to grant the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of its common stock in the offering. Adaptive will not receive any of the proceeds from the sale of the shares of its common stock being offered by the selling shareholders. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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J.P. Morgan, Goldman Sachs & Co. LLC and BofA Securities are acting as joint lead book-running managers for the offering. Cowen, Guggenheim Securities and William Blair are acting as book-running managers for the offering. BTIG is acting as co-manager for the offering.

A registration statement on Form S-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) but has not yet become effective. These securities may not be sold nor may offers to buy these securities be accepted prior to the time the registration statement becomes effective. The offering will be made only by means of a prospectus. A copy of the preliminary prospectus relating to this offering may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at [email protected]; or BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On January 21, 2020 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 the pivotal Phase 3 trial evaluating its anti-PD-1 antibody tislelizumab in combination with two chemotherapy regimens for the first-line treatment of patients with squamous non-small cell lung cancer (NSCLC), met the primary endpoint of improved progression-free survival (PFS) at the planned interim analysis, as assessed by independent review committee (IRC) (Press release, BeiGene, JAN 21, 2020, View Source [SID1234553359]). In this study, patients with previously untreated advanced squamous NSCLC were randomized to receive either tislelizumab in combination with paclitaxel and carboplatin, tislelizumab in combination with nanoparticle albumin-bound (nab) paclitaxel (ABRAXANE) and carboplatin, or paclitaxel and carboplatin alone. Based on the pre-planned interim analysis, both tislelizumab treatment arms crossed the pre-specified efficacy boundary compared to chemotherapy alone. The safety profile of tislelizumab in both combinations in this trial was consistent with the known risks of each study treatment, and no new safety signals were identified.
"Tislelizumab was recently approved in China for patients with relapsed or refractory classical Hodgkin’s lymphoma, and we have a broad development program with more than 5,000 patients enrolled in over 25 tislelizumab studies, including 15 potentially registration-enabling trials," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "We are extremely excited about the compelling results that tislelizumab demonstrated in this Phase 3 trial and for its potential use as a first-line treatment for patients in China with advanced squamous NSCLC. We look forward to continuing the development program for tislelizumab in lung cancer, which includes three other Phase 3 trials, and reporting additional data."
The company plans to discuss its plans for filing a supplemental new drug application (sNDA) for tislelizumab as a first-line treatment for squamous NSCLC with the Center for Drug Evaluation (CDE) at the National Medical Products Administration (NMPA) in China and to present these data at an upcoming medical meeting.
This trial (NCT 03594747, known as BGB-A317-307) is a Phase 3, randomized, open-label, multi-center trial investigating tislelizumab combined with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE, which is commercialized by BeiGene in China) and carboplatin compared with paclitaxel and carboplatin alone in patients with

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a317307readoutenimage1.jpg

untreated stage IIIB or IV squamous NSCLC from mainland China, regardless of PD-L1 expression. The primary endpoint is PFS per IRC. Key secondary endpoints include overall survival and safety. The study began enrolling patients in July 2018, and 360 patients were randomized 1:1:1 to receive tislelizumab (200mg every three weeks) in combination with each of the chemotherapy regimens or chemotherapy only, until disease progression, unacceptable toxicity, physician decision or consent withdrawal. Patients on the chemotherapy-only control arm who experienced disease progression, verified by central independent review, were eligible to cross over to receive tislelizumab monotherapy.
"Squamous NSCLC remains a significant unmet need, representing approximately 30 percent of patients with NSCLC in China. This Phase 3 study was designed to assess the impact of tislelizumab given in combination with chemotherapy as a potential treatment to improve outcomes in patients with advanced squamous NSCLC, for whom prognoses are typically quite poor. These results give us hope that we could have a new treatment option for these patients," commented Jie Wang, M.D., Professor at the Cancer Hospital Chinese Academy of Medical Sciences, in Beijing, China and lead investigator for the trial.
About Non-Small Cell Lung Cancer
In contrast to most Western countries where lung cancer death rates are decreasing, lung cancer incidence rate is still increasing in China.12 There were approximately 770,000 new cases of lung cancer in China in 2018 and it is the leading cause of cancer-related death in both men and women, with approximately 690,500 deaths in China in 2018.3 Non-small cell lung cancer (NSCLC) comprises the most common form of lung cancer in China.4
About Tislelizumab
Tislelizumab (BGB-A317) is a 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 from BeiGene’s immuno-oncology biologics 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 approved by the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin’s lymphoma who received at

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least two prior therapies. A supplemental new drug application (sNDA) for tislelizumab in patients with previously treated locally advanced or metastatic urothelial carcinoma has been granted priority review by the Center for Drug Evaluation at the NMPA and is currently under review.
Tislelizumab is being studied in a broad clinical program as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 11 Phase 3 trials and four pivotal Phase 2 trials.
Tislelizumab is not approved for use outside of China.

On January 21, 2020 Novigenix SA, a leading Immuno-Transcriptomics company that develops and commercializes solutions for early cancer detection and precision medicine, reported that a consortium, including Maastricht University (The Netherlands), Biolizard and the KU Leuven (Belgium), in addition to Novigenix, has been awarded a grant up to €1 million to develop a blood based multi-omics colorectal cancer (CRC) test (Press release, Novigenix, JAN 21, 2020, View Source [SID1234553375]).

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The aim of the consortium is to develop a blood based test based on transcriptomic and epigenetic biomarkers for early detection and relapse monitoring in CRC patients. The biomarker development strategy will leverage transcriptome profiling of whole blood and candidate tumor DNA methylation markers in cell free-DNA. Moreover, the consortium will develop an automated and structured data analysis process, including the most advanced machine learning methods, and validate multi-omics signatures.

The members of consortium balanced between industrial and academic partners. Novigenix’s will leverage its core competencies of the Immuno-Transcriptomics technology and Biolizard will focus on biological data integration, bioinformatics analysis, pipeline implementation and will provide artificial intelligence solutions. The group of Prof. dr. Manon van Engeland at Maastricht University brings unique expertise on CRC DNA methylation, whereas the Molecular Digestive Oncology group of Prof. dr. Sabine Tejpar at KU Leuven adds a clinical network for prospective collection of biological specimens and data interpretation.

"This Eurostars project combines excellent, world-leading science and technologies in a consortium dedicated to making significant advances in how colorectal cancer is detected and its treatment monitored," said Dr. Jan Groen, CEO of Novigenix. "We believe the outcome of this project, a potential omics-based test, will be important for the diagnosis and disease management of CRC patients."

About Eurostars

Eurostars supports international innovative projects led by research and development- performing small- and medium-sized enterprises (R&D-performing SMEs). With its bottom-up approach, Eurostars supports the development of rapidly marketable innovative products, processes and services that help improve the daily lives of people around the world. Eurostars is a joint program between EUREKA and the European Commission, co-funded from the national budgets of 36 Eurostars Participating States and Partner Countries and by the European Union through Horizon 2020. For more information visit View Source

On January 21, 2020, Vaccinex, Inc. (the "Company"), reported that it has entered into a stock purchase agreement (the "Stock Purchase Agreement") with certain investors as indicated on Exhibit A to the Stock Purchase Agreement (the "Investors"), pursuant to which the Company agreed to issue and sell to the Investors, and the Investors agreed to purchase from the Company, an aggregate of 1,468,563 shares (the "Shares") of common stock, par value $0.0001 per share, of the Company (the "Common Stock"), at a purchase price of $5.09 per Share (the average closing price for the common stock for the five trading days immediately preceding the date of the Stock Purchase Agreement) (the "Private Placement") (Filing, 8-K, Vaccinex, JAN 21, 2020, View Source [SID1234553464]). The Stock Purchase Agreement contains customary representations and warranties of the parties. The closing of the Private Placement occurred on January 23, 2020.

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The aggregate gross proceeds for the sale of the Shares was $7,474,985.67. The Company intends to use the net proceeds from the Private Placement to fund the ongoing development of pepinemab, the Company’s lead product candidate, and for working capital and general corporate purposes.

FCMI Parent Co., one of the Investors, is the Company’s majority stockholder and is controlled by Albert D. Friedberg, the Company’s chairman. Vaccinex (Rochester), L.L.C., of which Dr. Maurice Zauderer, the Company’s president, chief executive officer and a member of its board of directors, is the president and a majority owner, is another Investor. Jacob Frieberg, a third Investor, is one of the Company’s current directors.

The Shares have not been registered under the Securities Act of 1933, as amended (the "1933 Act"), and were issued and sold in a private placement pursuant to Section 4(a)(2) of the 1933 Act and Rule 506 of Regulation D as promulgated by the Securities and Exchange Commission (the "SEC") under the 1933 Act. Each of the Investors represented that it is an "accredited investor" within the meaning of Rule 501 of Regulation D, and is acquiring the Shares for investment only and not with a view towards, or for resale in connection with, the public sale or distribution thereof. The Shares were offered without any general solicitation by the Company or its representatives.

On January 23, 2020, the Company entered into a registration rights agreement (the "Registration Rights Agreement") with the Investors that affords the Investors certain registration rights with respect to the Shares. Under the Registration Rights Agreement, the Company has agreed, among other things, to use its reasonable best efforts to file with the SEC a registration statement covering the resale of the Shares by the later of 60 days from the closing of the Private Placement and March 31, 2020 and commercially reasonable efforts to cause such registration statement to become effective on or prior to 90 calendar days (or, in the event of a substantive review by the SEC, 135 calendar days) from the closing date. In addition, the Company agreed to use commercially reasonable efforts to keep the registration statement effective until the Shares have been sold thereunder or until the Shares can be sold without restriction. If the Company fails to meet the specified deadlines for the effectiveness of the registration statement, the Company will be required to pay liquidated damages to the Investors, subject to maximum aggregate liquidated damages of 8.0% of the aggregate purchase price paid for the Shares. Interest on any unpaid

liquidated damages will accrue at a rate of 1.0% per month. In addition, the Company agreed to provide Investors with certain "piggy-back" registration rights that may require the Company to effect certain registrations to register the Shares for resale in the event that no registration statement registering the Shares is effective and the Company is otherwise filing a registration statement under the 1933 Act.

The Registration Rights Agreement also contains certain indemnification and contribution provisions under which the Company and the Investors have agreed to indemnify each other against certain liabilities.

The foregoing summaries of the Stock Purchase Agreement and the Registration Rights Agreement do not purport to be complete and are subject to and qualified in their entirety by the terms of the Stock Purchase Agreement and the Registration Rights Agreement, copies of which are attached hereto as Exhibit 10.1 and Exhibit 10.2, respectively, and are incorporated by reference herein.