On November 7, 2018 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases, reported that it will participate in the following investor conferences in November (Press release, Audentes Therapeutics, NOV 7, 2018, View Source [SID1234530902]):

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Credit Suisse 27th Annual Healthcare Conference Natalie Holles, President and Chief Operating OfficerFormat: 1×1 Investor MeetingsWednesday, November 14, 2018Scottsdale, Arizona
Evercore ISI HealthConX Conference Matthew R. Patterson, Chairman and Chief Executive OfficerFormat: Fireside ChatTuesday, November 27, 2018, 10:35am ESTBoston, Massachusetts
Piper Jaffray 30th Annual Healthcare Conference Matthew R. Patterson, Chairman and Chief Executive OfficerFormat: Fireside ChatWednesday, November 28, 2018, 11:30am ESTNew York, New York
Barclays Gene Editing & Gene Therapy SummitMatthew R. Patterson, Chairman and Chief Executive OfficerFormat: Corporate PresentationThursday, November 29, 2018, 10:15am ESTNew York, New York
To access live webcasts of the fireside chats and presentation please visit the Events & Presentations page within the Investors + Media section of the Audentes website. Following each conference, a replay of the live webcast will be available on the Audentes website for approximately 30 days.

On November 7, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that the first patient has been treated in KEYNOTE-890, a Phase 2 clinical trial for the treatment of late-stage triple negative breast cancer (TNBC) with TAVO (intratumoral plasma encoded IL-12, or tavokinogene telseplasmid, plus electroporation) in combination with Merck’s KEYTRUDA (pembrolizumab) (Press release, OncoSec Medical, NOV 7, 2018, View Source [SID1234530901]).

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KEYNOTE-890 is designed as a multicenter Phase 2 open-label trial focusing on patients with a histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC and at least 1 prior line of approved systemic chemotherapy or immunotherapy. 25 patients are expected to be enrolled. Each patient will undergo 3-week treatment cycles with pembrolizumab administered as a 30-minute IV infusion day 1 of every cycle (flat dose of 200 mg) and treated with TAVO on days 1, 5 and 8 every six weeks.

"Treating the first patient in our KEYNOTE-890 clinical trial is an important milestone for OncoSec as we seek to rapidly advance this program," said Kellie Malloy Foerter, Chief Clinical Development Officer of OncoSec. "Additionally, this study is important for patients with metastatic triple negative breast cancer given the lack of treatment options currently available. Prior clinical observations suggest that TAVO in combination with pembrolizumab is a valid therapeutic approach for TNBC. Based on the outcome of the study and feedback from FDA, we may choose to expand the study and seek accelerated approval with the FDA for this patient population."

Breast cancer cells that test negative for estrogen receptors (ER-), progesterone receptors (PR-), and HER2 (HER2-) means the cancer is triple negative.1 Approximately 10-20 percent of U.S. breast cancer cases are triple negative breast cancer (TNBC),1 which disproportionately affects younger women, as well as African-American women,2 followed by Hispanic women.3

TNBC remains a poor-prognosis breast cancer subtype,2 with limited treatment options for patients with advanced, recurrent disease. In the recurrent disease setting, chemotherapy remains the standard of care, and median survival is approximately 13 months from the time of disease recurrence.4 Emerging evidence shows immunotherapy options may play an important role in the treatment paradigm for TNBC.5-8 Preliminary data from early-phase studies demonstrated the anti-PD-1 antibody pembrolizumab led to an objective response in 18 to 19 percent of TNBC patients;5-7 and median overall survival was 8.9 months in a pretreated cohort.6 The anti-PD-L1 antibody atezolizumab (MPDL3280A) achieved an objective response in 25 percent of patients in the first-line and 11 percent of patients in the second-line setting.8 There is increasing evidence that tumors need TILs for anti-PD-1/PD-L1 therapies to be most effective.9-12 Data also show TILs promote better responses to chemotherapy and improve clinical outcomes in breast cancer, including TNBC.13-17

On November 7, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies that harness the power of innate and adaptive immunity (NK cells, macrophages and T cells), reported financial and operational results for the quarter ended September 30, 2018 (Press release, Affimed, NOV 7, 2018, View Source [SID1234530900]).

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"Our progress in the third quarter is highlighted by the exciting strategic collaboration that we entered into with Genentech based on our proprietary ROCK platform," said Dr. Adi Hoess, Affimed’s CEO. "This partnership is a transformational accomplishment for Affimed, and is based on both our technology platform and expertise in innate immunity. Separately, at the 2018 ASH (Free ASH Whitepaper) Annual Meeting, we look forward to sharing updated clinical data of AFM13 showing continued promising signs of therapeutic efficacy both in combination with Keytruda in Hodgkin lymphoma and as monotherapy in CD30-positive lymphoma. We are working toward finalizing our plans for a registrational clinical study for AFM13 and will provide an update in early December."

Investor Meeting on Friday, December 7, 2018

Affimed will host a meeting with the investment community to review the clinical development strategy for AFM13 on Friday, December 7, 2018 in New York City. Topics will include future planned clinical activities for AFM13 as monotherapy treatment and in rational combinations. Further details will be announced closer to the date of the meeting.
Collaboration Agreement with Genentech

During the quarter, Affimed entered into a strategic collaboration agreement with Genentech, a member of the Roche Group, to develop and commercialize novel NK cell engager-based immunotherapeutics based on Affimed’s proprietary Redirected Optimized Cell Killing (ROCK) platform to treat multiple cancers. On October 31, 2018, Affimed received $96 million in upfront and committed funding, and may be eligible to receive up to an additional $5 billion including payments on achievement of certain development, regulatory and commercial milestones, plus royalties on sales.
Third Quarter and Recent Pipeline Progress

CD16A innate immune cell engager programs

AFM13 (CD30/CD16A)

Data from Phase 1b Combination Study of AFM13 with Merck’s Keytruda (pembrolizumab) to be Presented at 2018 ASH (Free ASH Whitepaper). Affimed will present data on all 30 patients (pts) administered the combination of AFM13 with pembrolizumab at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Key clinical outcomes, including objective response rate (ORR) and complete response (CR) rate will be released. An ASH (Free ASH Whitepaper) abstract released on November 1, 2018 highlighted early data that showed an 87% ORR and a 39% CR rate in 23 evaluable pts from the highest dose cohort as of a June 29, 2018 data cut-off. Updated data for all pts (24 pts from the highest dose cohort plus 6 pts treated at lower doses) will be presented at ASH (Free ASH Whitepaper).

Clinical and Biological Evaluation of AFM13 as Monotherapy in Relapsed or Refractory CD30-Positive Lymphoma to be Presented at 2018 ASH (Free ASH Whitepaper). A poster presentation by Ahmed Sawas, MD, Assistant Professor of Medicine at the Columbia University College of Physicians and Surgeons and the New York-Presbyterian Hospital and Principal Investigator of the study, will describe the ability of AFM13 to engage innate immunity through specific activation of NK cells in tumors expressing CD30 and the impact of these effects on clinical outcome. Updated data from this study with AFM13 monotherapy in relapsed or refractory CD30-positive lymphoma with cutaneous lesions showed a 50% ORR in three dose cohorts (n=8), including one CR (13%) and three partial responses, or PRs (38%). The presentation will also discuss the immunologic changes in the tumor and peripheral blood over time.

Cord Blood Derived Natural Killer Cells Loaded with a Tetravalent Bispecific Antibody Construct (AFM13) As Off-the-Shelf Cell Therapy for CD30+ Malignancies to be Highlighted in Oral Presentation at 2018 ASH (Free ASH Whitepaper). The combination of expanded allogeneic cord-blood derived Natural Killer cells preloaded with AFM13 to redirect the specificity of NK cells against CD30-positive malignancies in preclinical models will be discussed in an oral presentation. The data provide a strong rationale for testing this combined, redirected off-the-shelf cellular product to further increase response rates and durability of responses in patients with relapsed/refractory CD30+ lymphoma. This new approach was led by Katy Rezvani, MD, PhD and her team at the Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center (MDACC) under Affimed’s multi-year sponsored research collaboration with MDACC.

Following discussions with the U.S. Food and Drug Administration on future development plans for AFM13, Affimed is working with clinical experts to finalize the registrational study designs for AFM13 and will provide an update in early December.
AFM24 (EGFR/CD16A)

Affimed selected the development candidate in its AFM24 program and successfully completed a toxicology assessment in cynomolgus monkeys at a range of dose levels up to 75mg/kg over 4 weeks with no observed toxicities even at high dose levels. AFM24 is designed to treat patients with a variety of EGFR expressing solid tumors with the potential for better efficacy and safety as compared to current therapeutic anti-EGFR monoclonal antibodies that are associated with significant toxicities. Affimed continues to anticipate completing IND-enabling studies by mid-2019.
Other Innate Immunity Engager Opportunities and AFM26 (BCMA/CD16A)

Additional abstracts to be presented at the 2018 ASH (Free ASH Whitepaper) Annual Meeting include an update on Affimed’s research on the role of CD16A specific immune cell engagers and activation of CD16A expressing macrophages to eliminate tumor cells, as well as preclinical data regarding its partnered program for AFM26 (BCMA/CD16A) in multiple myeloma.
T cell engager programs

AFM11 (CD19/CD3)

Preliminary Results from Phase 1 Study of AFM11 in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) to be Presented at 2018 ASH (Free ASH Whitepaper). Data will be presented on the clinical activity and safety of AFM11, a CD19/CD3-targeting tetravalent bispecific T cell engager in Affimed’s Phase 1 dose escalation trial in relapsed/refractory ALL. An ASH (Free ASH Whitepaper) abstract released on November 1, 2018 showed two complete responses with complete hematological recovery, including one pt achieving minimal residual disease (MRD) negativity.

In October, Affimed announced that AFM11 is on clinical hold after the occurrence of Serious Adverse Events (SAEs) in three patients. Affimed is assessing all of the data from the AFM11 program and will be working with global health authorities to determine next steps for the program. Affimed intends to provide an update on AFM11 upon completion of the evaluation.
Financial Highlights
(Figures for the third quarter and nine months ended September 30, 2018 and 2017 represent unaudited figures)

Cash and cash equivalents totaled €37.1 million as of September 30, 2018 compared to €39.8 million as of December 31, 2017. Affimed’s operational expenses were largely offset by net proceeds of €19.7 million from the public offering in February 2018. Pro forma cash and cash equivalents as of September 30, 2018, including the $96.0 million (€82.9 million) payment received from Genentech at the end of October 2018, would have been €120.0 million ($138.9 million).

Net cash used in operating activities was €24.9 million for the nine months ended September 30, 2018 compared to €20.7 million for the nine months ended September 30, 2017. The increase was primarily related to higher cash expenditure for research and development (R&D) in connection with Affimed’s clinical development programs and early stage development activities.

Revenue for the third quarter of 2018 was €0.3 million compared to €0.5 million for the third quarter of 2017. Revenue in both periods was solely derived from AbCheck services.

R&D expenses for the third quarter of 2018 were €9.8 million compared to €6.0 million for the third quarter of 2017. The increase was primarily related to higher expenses for early stage development and discovery activities.

G&A expenses for the third quarter of 2018 were higher at €2.4 million compared to €1.9 million for the third quarter of 2017.

Net loss for the third quarter of 2018 was at €12.0 million, or €0.19 per common share, compared to a net loss of €8.1 million, or €0.18 per common share, for the third quarter of 2017. The increase in operating expenses was primarily related to higher R&D expenses.

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 will host a conference call and webcast today, Wednesday, November 7, 2018 at 8:30 a.m. Eastern time to discuss the company’s financial results and recent corporate developments. To access the call, please dial (323) 794-2588 for U.S. callers, or +44 (0)330 336 9125 for international callers, and reference conference ID 6650897 approximately 15 minutes prior to the call. An audio webcast of the conference call can be accessed in the "Events" section on the "Investors & Media" page of Affimed’s 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 for 30 days following the call.

On November 7, 2018 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported a collaboration with The Leukemia & Lymphoma Society (LLS), to accelerate the development of duvelisib for the treatment of patients with peripheral T-cell lymphoma (PTCL), an aggressive type of non-Hodgkin lymphoma (NHL) (Press release, Verastem, NOV 7, 2018, View Source;p=irol-newsArticle&ID=2375824 [SID1234530899]). Verastem Oncology’s duvelisib was selected for the LLS’s Therapy Acceleration Program (TAP) which provides additional resources to support the development of therapies for patients with blood cancers. The Company plans to use the funds to conduct certain translational and clinical activities relating to the development of duvelisib for the treatment of PTCL. LLS and Verastem Oncology will share the cost of the development program, portions of which will be conducted in collaboration with Memorial Sloan Kettering Cancer Center, The Dana-Farber Cancer Institute, The Washington University in St. Louis and Stanford University.

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"The selection of duvelisib for a TAP collaboration with the LLS underscores the potential of this innovative, oral monotherapy for patients with relapsed or refractory PTCL," said Robert Forrester, President and Chief Executive Officer of Verastem Oncology. "This collaboration provides important funding to accelerate the advancement of duvelisib as a potential new treatment for patients battling PTCL, either as a monotherapy or in combination with other anti-cancer agents. We look forward to collaborating with the LLS team on the exciting work ahead in order to advance duvelisib through the clinic and ultimately to the patients and families suffering from this devastating cancer."

Duvelisib is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, that has demonstrated clinical activity in a Phase 1 clinical trial in 16 heavily pre-treated patients with relapsed or refractory PTCL (Horwitz, et al. Blood. Feb 2018). Results from the study showed duvelisib demonstrated a 50% overall response rate, including 19% complete responses.

Verastem Oncology is currently conducting an open-label, multicenter, Phase 2 clinical trial (the PRIMO study) evaluating the efficacy and safety of duvelisib monotherapy in adult patients with histologically confirmed relapsed or refractory PTCL. This study is expected to enroll approximately 120 patients.

In addition, funds from the TAP will be used to support the expansion of an investigator-sponsored study being conducted by Steven Horwitz, MD, Medical Oncologist, Memorial Sloan Kettering Cancer Center and NYC Health + Hospitals/Bellevue. This study is evaluating the combination of duvelisib with romidepsin, an HDAC inhibitor, with a goal to create deeper and more durable responses for patients with relapsed or refractory PTCL. Initial data on the combination as presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2017 Annual Meeting, demonstrated a 64% overall response rate including 34% complete responses.

"The mission of our TAP program is to identify and fund the most promising investigational therapies that have the potential to change the standard of care for patients with blood cancers, with a particular focus on areas of the highest unmet medical need, such as relapsed or refractory PTCL," Lee Greenberger, PhD, Chief Scientific Officer of LLS, commented. "Our partnership with Verastem Oncology is an excellent fit with our key initiative to accelerate development of new and cutting edge therapies like duvelisib, which specifically inhibits only certain PI3K family members, that have shown promising early clinical results in PTCL."

* Duvelisib’s use in patients suffering from PTCL is solely investigational in nature; its use has not been deemed safe and effective by the U.S. Food and Drug Administration.

About the Therapy Acceleration Program

The Leukemia & Lymphoma Society’s Therapy Acceleration Program (TAP) identifies and funds innovative projects related to therapies, supportive care or diagnostics that have the potential to change the standard of care for patients with blood cancer, especially in areas of high unmet medical need. TAP funding assists both clinical investigators and companies in gaining critical clinical proof of concept data that better enables them to obtain the resources they need or a partner to complete the testing, registration and marketing of new treatments, supportive care and diagnostics for leukemia, lymphoma and myeloma. TAP funding is different from the traditional grant at LLS. The TAP review process is separate from the grant process and each approved project is closely monitored by TAP staff. To learn more about how TAP works, please click here.

About Peripheral T-Cell Lymphoma

Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma (NHL) that develops in mature white blood cells called "T cells" and "natural killer (NK) cells"1 which circulate with the lymphatic system.2 PTCL accounts for between 10-15% of all non-Hodgkin lymphomas (NHLs) and generally affects people aged 60 years and older.1 Although there are many different subtypes of peripheral T-cell lymphoma, they often present in a similar way, with widespread, enlarged, painless lymph nodes in the neck, armpit or groin.2 There is currently no established standard of care for patients with relapsed or refractory disease.1

On November 7, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that it will report its financial results for the first nine months of 2018 on Tuesday, 13 November 2018 (Press release, Evotec, NOV 7, 2018, View Source;announcements/press-releases/p/evotec-ag-to-report-first-nine-month-2018-results-on-13-november-2018-5741 [SID1234530884]).

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The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

Conference call details

Date: Tuesday, 13 November 2018

Time: 02.00 pm CET (08.00 am EST, 01.00 pm GMT)

From Germany: +49 69 20 17 44 220

From France: +33 170 709 502

From Italy: +39 023 600 6663

From UK: +44 20 3009 2470

From USA: +1 877 423 0830

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