On March 20, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the Phase III IMpower131 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone in the initial (first-line) treatment of people with advanced squamous non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, MAR 20, 2018, View Source [SID1234525401]). Safety for the TECENTRIQ and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. At this interim analysis a statistically significant overall survival (OS) benefit was not observed and the study will continue as planned. These data will be presented at an upcoming oncology congress.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Squamous non-small cell lung cancer is difficult to treat and there have been limited new treatment options over the last few decades," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We will share the IMpower131 results with global health authorities and we look forward to seeing more mature overall survival data."

As per the statistical analysis plan in IMpower131, Arm B (TECENTRIQ plus carboplatin and nab-paclitaxel) must demonstrate a statistically significant OS result vs. Arm C (carboplatin and nab-paclitaxel), before an analysis between Arm A (TECENTRIQ plus carboplatin and paclitaxel) and Arm C can be made for PFS and OS.
Currently, Roche has eight Phase III lung cancer studies underway evaluating TECENTRIQ alone or in combination with other medicines and five are expected to report this year.

About the IMpower131 study
IMpower131 is a Phase III, open-label, multicentre, randomised study evaluating the efficacy and safety of TECENTRIQ in combination with carboplatin and nab-paclitaxel or TECENTRIQ in combination with carboplatin and paclitaxel versus chemotherapy (carboplatin and nab-paclitaxel) alone in people with stage IV squamous NSCLC who have not been previously treated with chemotherapy. The study enrolled 1,021 people who were randomised equally (1:1:1) to receive:
TECENTRIQ plus carboplatin and paclitaxel (Arm A), or
TECENTRIQ plus carboplatin and nab-paclitaxel (Arm B), or
Carboplatin and nab-paclitaxel (Arm C, control arm)
During the treatment-induction phase, people in Arm A received four or six cycles of TECENTRIQ plus carboplatin and paclitaxel , given on day one of each 21-day cycle. This was followed by maintenance therapy with TECENTRIQ every three weeks until progression of the cancer, or for as long as clinical benefit was observed.
During the treatment-induction phase, people in Arm B received four or six cycles of TECENTRIQ, carboplatin and nab-paclitaxel. TECENTRIQ and carboplatin were administered on day one of each 21-day cycle. Nab-paclitaxel was administered on days one, eight and 15 of each 21-day cycle. This was followed by maintenance therapy with TECENTRIQ every three weeks until progression of the cancer, or for as long as clinical benefit was observed.
During the treatment-induction phase, people in Arm C received four or six cycles of carboplatin and nab-paclitaxel. Carboplatin was administered on day one of each 21-day cycle, and nab-paclitaxel was administered on days one, eight and 15 of each 21-day cycle. In the maintenance phase, participants received best supportive care.
The co-primary endpoints were:
PFS as determined by the investigator using RECIST v1.1 in the intention-to-treat (ITT) population (Arm B vs. Arm C)
Overall survival (OS) in the ITT population (Arm B vs. Arm C)
IMpower131 met its PFS co-primary endpoint per study protocol. This analysis of IMpower131 evaluated Arm B vs. Arm C.
About NSCLC
Lung cancer is the leading cause of cancer death globally.1 Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.2 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.2 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope. The squamous form tends to grow near the centre of the lung, and accounts for approximately 25-30% of all NSCLC cases.3

About TECENTRIQ (atezolizumab)
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines.
TECENTRIQ is already approved in the European Union, United States and more than 60 countries for people with previously treated metastatic NSCLC and for people with locally advanced or metastatic urothelial cancer (mUC) who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy.

Abraxane is a registered trademark of Abraxis Bioscience, LLC, a wholly owned subsidiary of Celgene Corporation.
About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with TECENTRIQ to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.
To learn more about the Roche approach to cancer immunotherapy please follow this link:
View Source

On March 20, 2018 – Crescendo Biologics Limited (Crescendo), the drug developer of novel,
targeted T-cell engaging therapeutics, announces that Dr Brian McGuinness, Head of New Product and
Business Development, Phil Bland-Ward (CSO) and James Legg (VP R&D) will be presenting a poster at
AACR (American Association for Cancer Research) Annual Meeting in Chicago, USA on 18 April 2018 (Press release, Crescendo Biologics, MAR 20, 2018, View Source [SID1234525091]). The Crescendo team will be available to discuss the poster entitled "Multifunctional biologics for
targeted T-cell therapy based on in vivo matured fully human VH domains" within the "Antibodies,
Fusion Proteins and Related Biologics session". This will cover the beneficial characteristics of
Humabodies and their enhanced therapeutic potential over traditional monoclonal antibodies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Poster details

Title: Multifunctional biologics for targeted T-cell therapy based on in vivo matured fully human VH
domains
Authors: J. Legg, B. McGuinness, P. Bland-Ward, P. Pack
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibodies, Fusion Proteins, and Related Biologics
Session Date and Time: Wednesday Apr 18, 2018 8:00 AM – 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 35
Poster Board Number: 11
Permanent Abstract Number: 5766

There will also be a poster by Eleven Biotherapeutics in the same session which includes data from
Crescendo. This poster, entitled ‘Engineering and characterization of anti-PSMA humabody-deBouganin
fusion proteins’, will be at Board Number 15.

AACR’s Annual Meeting is being held in Chicago, Illinois from 14 – 18 April. The theme is ‘Driving
Innovative Cancer Science to Patient Care’. Presentations at the Annual Meeting will cover the latest
basic, translational, clinical, and prevention-focused research in the field, including important areas such
as early detection, cancer interception, and survivorship in all populations.

On March 20, 2018 Surface Oncology, an immuno-oncology company developing next-generation antibody therapies that target the tumor microenvironment, reported that the first patient was treated in its Phase I trial of SRF231, the company’s lead product candidate (Press release, , 20 20, 2018, View Source [SID1234524906]). SRF231 is a fully human antibody that inhibits the activity of CD47, a protein overexpressed on many types of cancer cells which prevents them from being engulfed and eliminated by macrophages.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The initiation of this clinical trial is a milestone for Surface and demonstrates the outstanding progress we’ve made in advancing our innovative oncology pipeline," said Rob Ross, M.D., chief medical officer of Surface Oncology. "SRF231 is the first of what we expect will be multiple novel agents that we bring into clinical development to help patients suffering from cancer."

Initially, this multi-center, open-label Phase I trial will evaluate the safety and tolerability of SRF231 in multiple ascending doses in patients with advanced solid tumors and hematologic malignancies with the objective of establishing a recommended dose for further study. Following the dose escalation component of the trial, Surface intends to evaluate the safety and efficacy of SRF231 in cohorts of patients with specific types of cancer.

"Targeting the tumor microenvironment has tremendous therapeutic potential," said Amita Patnaik, M.D., F.R.C.P.C., Associate Director of Clinical Research at South Texas Accelerated Research Therapeutics and an investigator on the trial. "Our team is eager to evaluate the role of macrophage activation through SRF231 to expand the opportunities for patients with cancer to benefit from immunotherapy."

ABOUT SRF231

SRF231 is a fully human monoclonal antibody therapeutic targeting CD47, a protein overexpressed on many cancer cells which prevents them from being engulfed and eliminated by macrophage mediated phagocytosis. SRF231 preclinical results presented at the 2016 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and the American Society of Hematology (ASH) (Free ASH Whitepaper) meetings demonstrated that SRF231 has potent anti-tumor activity preclinically in several different tumor models and in combination with existing cancer modalities. Importantly, preclinical studies also showed that SRF231 does not induce hemagglutination, an important potential safety advantage.

On March 20, 2018 Athersys, Inc. (NASDAQ:ATHX) announced today that Gil Van Bokkelen, Chairman and CEO, will present a corporate overview at the 17th Annual Needham Healthcare Conference at The Westin Grand Central Hotel in New York City. The presentation is scheduled for Wednesday, March 28, 2018 at 9:30 am ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Investors interested in arranging a meeting with the Company’s management during this conference should contact the conference coordinator.

A live webcast of the presentation can be accessed by visiting ‘Events & Presentations’ in the Investors Section on the Company’s website at www.athersys.com. An archived replay of the webcast will be available on the Company’s website after the conference for a limited time.

On March 20, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported financial results for the quarter and year ended December 31, 2017 (Press release, Affimed, MAR 20, 2018, View Source [SID1234524902]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our approach of harnessing the power of innate and adaptive immunity showed its first clinical potential in 2017 and early 2018 with very encouraging data becoming available for AFM13 as monotherapy in Hodgkin and CD30-positve lymphomas as well as for AFM13 in combination with Keytruda in Hodgkin lymphoma," said Dr. Adi Hoess, CEO of Affimed. "In addition, we were able to hire outstanding executive managers with Leila Alland as CMO and Wolfgang Fischer as COO, who will be instrumental to the further development of our pipeline towards marketed therapies."

Corporate Updates

· In 2017 and early 2018, Affimed has made important additions to its management team. The Company entered into an agreement with Leila Alland, M.D. who will join Affimed as CMO effective March 26, 2018. Dr. Leila Alland brings to the Company more than 20 years of oncology experience, having held leadership roles in drug development at Tarveda Therapeutics, AstraZeneca, Bristol-Myers Squibb and Novartis. Further strengthening Affimed’s U.S. presence, Dr. Alland will be based in the Company’s New York location along with Cassandra Choe-Juliak, M.D., Vice President, Clinical U.S. and Denise Mueller, Head of Commercial Strategy and Business Development of Affimed.

· In September 2017, Dr. Wolfgang Fischer, former Global Head of Program and Project Management of Sandoz Biopharmaceuticals (Novartis Group) joined Affimed as Chief Operating Officer (COO). Dr. Fischer has over 20 years of R&D experience with a focus on oncology, immunology and pharmacology, as well as a proven track record in drug development.

· In February 2018, Affimed completed an underwritten public offering on the Nasdaq Global Market, raising a total of approximately $24.5 million (€19.7 million) in net proceeds. Proceeds from this transaction, together with existing cash on the balance sheet, are expected to fund operations, including clinical development and early development activities, at least until the fourth quarter of 2019.

Pipeline Updates
NK-cell engager programs

· Enrollment has been completed into Affimed’s Phase 1b combination study of AFM13, a CD30/CD16A-targeting NK cell engager, with Merck’s Keytruda (pembrolizumab) in relapsed/refractory Hodgkin lymphoma (r/r HL) and treatment is ongoing. A total of 24 patients are being treated at the highest AFM13 dose level. In February 2018, Affimed presented interim data from a total of 9 patients in this cohort, demonstrating that AFM13 in combination with Keytruda is well-tolerated, with a 3-month objective response rate (ORR) of 89% comparing favorably to historical ORR of anti-PD-1 antibodies as monotherapy in a similar patient population (58-63%). Furthermore, 4 out of 9 patients (44%) showed complete metabolic responses, compared to complete response rates of 9-22% reported for anti-PD-1 monotherapy in a similar patient population. Affimed expects full 3-month data by mid-year 2018 and intends to provide regular updates at scientific or medical conferences.

· Affimed is supporting an investigator-sponsored translational Phase 1b/2a study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation led by Columbia University. The study is designed to allow for serial cutaneous biopsies, thereby enabling assessment of NK cell biology and tumor cell killing within the tumor microenvironment. The second cohort has been fully enrolled and recruitment into the third cohort is ongoing. In February 2018, the Company reported an analysis of the first dose cohort (3 patients dosed at 1.5 mg/kg), demonstrating that AFM13 could be safely administered and showed therapeutic activity as a single agent, with an ORR of 66% (2 out of 3 patients). One complete response, one partial response and one stable disease were observed, as determined by global response score. These early data confirm the single-agent activity observed in a previous Phase 2a trial, and further suggest a new opportunity for AFM13 in CD30-positive lymphoma.

· The Company’s investigator-sponsored Phase 2a monotherapy study of AFM13 in HL led by the German Hodgkin Study Group (GHSG) is open and recruiting, including patients pre-treated with both brentuximab vedotin (B.V.) and anti-PD1. In May 2017 Affimed reported data from a subset of patients enrolled under the original study protocol (minimum of 3 lines of treatment including B.V., anti-PD-1-naïve) suggesting that AFM13 is efficacious as single agent in this heavily pre-treated group of patients.

· In Affimed’s collaboration with The University of Texas MD Anderson Cancer Center (MDACC), evaluating the Company’s NK cell engager AFM13 in combination with MDACC’s NK cell product, preclinical research activities are progressing. These are intended to be followed by a Phase 1 clinical trial.

· Affimed has generated tetravalent bispecific NK cell engager product candidates for AFM24 (EGFR/CD16A) with different pharmacokinetic profiles. Differentiating from current EGFR-targeted therapeutics, the Company’s molecules are designed with the potential to widen the therapeutic window in solid tumor therapy and to address patient populations that are resistant to EGFR-targeting agents. Affimed anticipates completing IND-enabling studies by mid-year 2019.

· The NK cell engager AFM26 (BCMA/CD16A), is designed to address the medical need of eliminating minimal residual disease (MRD) in multiple myeloma. In particular, Affimed aims to leverage BCMA as a target in autologous stem cell transplant (ASCT)-eligible patients. Affimed is developing different tetravalent bispecific antibody formats and continues to advance its lead candidate in IND-enabling studies.

· Discovering and assessing additional opportunities to harness innate and adaptive immunity, Affimed recently published data in Cancer Immunology Research, together with its collaboration partner, the German Cancer Research Center (DKFZ). The Company presented evidence of AFM13 sensitizing NK cells to IL-2 and/or IL-15 stimulation. In this study, after exposure to AFM13, the NK cells showed enhanced IL-2- and IL-15-mediated proliferation and cytotoxicity. These data corroborate initial findings the Company had presented at the AACR (Free AACR Whitepaper) Annual Meeting in April 2017 and support the approach of combining Affimed’s NK cell engagers with IL-2- or IL-15 to potentially achieve deeper clinical responses.

T-cell engager programs

· Affimed is conducting two clinical Phase 1 dose-escalation trials with AFM11, a CD3/CD19-targeting tetravalent bispecific T cell engager, in patients with r/r acute lymphocytic leukemia (ALL) and with r/r non-Hodgkin lymphoma (NHL), respectively. In the Company’s NHL study, the third dose cohort has recently been completed and Affimed’s ALL trial is currently recruiting patients into the fifth dose cohort.

· Amphivena Therapeutics, Inc. continues to recruit patients into its first-in-human Phase 1 dose escalation study of AMV564 in r/r acute myeloid leukemia (AML). Amphivena also plans to launch a Phase 1 clinical study in patients with myelodysplastic syndrome (MDS) and is

exploring the utility of AMV564 in solid tumors. AMV564 is a CD33/CD3-specific T cell engagers based on Affimed’s technology platform. Affimed owns approximately 18.5% of Amphivena (fully diluted).

Financial Highlights

(Figures for the fourth quarter of 2017 and 2016 represent unaudited figures)

Cash and cash equivalents and financial assets totaled €39.8 million as of December 31, 2017 compared to €44.9 million as of December 31, 2016. Affimed was able to fund its operational expenses in 2017 with existing cash, the issuance of new shares and the usage of an additional loan tranche.

Net cash used in operating activities for the fourth quarter of 2017 was €4.9 million compared to €6.6 million for the fourth quarter of 2016. Net cash used in operating activities was €25.5 million for the twelve months ended December 31, 2017 compared to €32.1 million for the twelve months ended December 31, 2016. The year-over-year decrease was primarily related to lower cash expenditure for research and development (R&D) in connection with our development and collaboration programs.

Revenue for the fourth quarter of 2017 was €0.6 million compared to €1.4 million for the fourth quarter of 2016. Revenue for the full year 2017 was €2.0 million compared to €6.3 million for the full year 2016. Revenue for the full year and the fourth quarter 2017 was primarily derived from AbCheck services. Revenue for the full year 2016 related to a large extent to Affimed’s collaborations with Amphivena and LLS while revenue for the fourth quarter 2016 was derived from AbCheck services.

R&D expenses for the fourth quarter of 2017 were €4.6 million compared to €5.7 million for the fourth quarter of 2016. For the full year 2017, R&D expenses were €21.5 million compared to €30.2 million for the full year 2016. The decrease was primarily related to lower expenses for AFM13 related CMC activities, preclinical programs and infrastructure.

G&A expenses for the fourth quarter of 2017 were €1.9 million compared to €2.1 million for the fourth quarter of 2016. For the full year 2017, G&A expenses were slightly lower with €8.0 million compared to €8.3 million for the full year 2016.

Net loss for the fourth quarter of 2017 was €6.4 million, or €0.14 per common share, compared to a net loss of €5.4 million, or €0.19 per common share, for the fourth quarter of 2016. Net loss for the full year 2017 was €30.2 million, or €0.69 per common share, compared to a net loss of €32.2 million, or €0.97 per common share, for the full year 2016. The decrease in net loss for the full year 2017 was primarily related to decreased spending on R&D for AFM13 related CMC

activities, preclinical programs and infrastructure, partially offset by lower revenue and higher finance costs. Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2017 and "Item 5. Operating and Financial Review and Prospects," which will be included in Affimed’s Annual Report on Form 20-F as filed with the SEC.

Including the proceeds from the equity offering in February 2018, the Company’s operations, including clinical development and early development activities, are expected to be funded at least until the fourth quarter of 2019.

Note on IFRS Reporting Standards

Affimed prepares and reports the consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles (GAAP) in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information

Affimed’s management will host a conference call to discuss the company’s financial results and recent corporate developments today at 8:30 a.m. ET. A webcast of the conference call can be accessed in the "Events" section on the "Investors & Media" page of the Affimed website at View Source A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived on the Affimed website for 30 days following the call.