On November 20, 2019 Novocure (NASDAQ: NVCR) reported 43 presentations on Tumor Treating Fields, including three oral presentations, will be featured at the 24th Annual Meeting of the Society for Neuro-Oncology (SNO) on Nov. 20 through Nov. 24 in Phoenix (Press release, NovoCure, NOV 20, 2019, View Source [SID1234551540]). Presentations on Tumor Treating Fields cover a broad and growing range of topics. External authors prepared 34 of the 43 presentations.

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The oral presentations on Tumor Treating Fields include an EF-14 post hoc subgroup analysis on tumor growth rates, and the pilot study results of Tumor Treating Fields combined with radiotherapy and temozolomide for the treatment of newly diagnosed glioblastoma.

Highlights among poster presentations include the combinations of Tumor Treating Fields with other therapies such as radiation and immunotherapies, simulations, health economics and outcomes research, patient advocacy, and research on the mechanism of action.

"Year after year, it is amazing to see the continued focus on Tumor Treating Fields at the SNO Annual Meeting," said Novocure CEO Asaf Danziger. "From our first presentation at SNO in 2008 to today, more than 250 abstracts on Tumor Treating Fields have been included at one of the most important conferences in neuro-oncology worldwide. I am proud of our team for their relentless focus on innovative research and for their consistent drive in raising awareness of our therapy among the scientific community. We look forward to another productive year at SNO."

Oral Presentations

(Abstract #: ACTR-46) Tumor Treating Fields combined with radiotherapy and temozolomide for the treatment of newly diagnosed glioblastoma: Final results from a pilot study. R. Grossman. 2:45 to 2:50 p.m. MST Nov. 22.

(Abstract #: RTHP-28) TTFields treatment affects tumor growth rates: A post-hoc analysis of the pivotal phase 3 EF-14 trial. Z. Bomzon. 4:05 to 4:10 p.m. MST Nov. 22.

(Abstract #: QOLP-24) Patients’/parents’ experiences of receiving Optune delivered tumor treatment fields: A Pediatric Brain Tumor Consortium Study: PBTC-048. J. Lai. 7:50 to 7:54 p.m. MST Nov. 22.

Poster Presentations

(Abstract #: RDNA-10) TTFields treatment planning for targeting multiple lesions spread throughout the brain. Z. Bomzon. 7:30 to 9:30 p.m. MST Nov. 22. (Radiation Biology and DNA Repair/Basic Science)

(Abstract #: NIMG-20) Evaluation of head segmentation quality for treatment planning of tumor treating fields in brain tumors. Z. Bomzon. 7:30 to 9:30 p.m. MST Nov. 22. (Neuro-Imaging/Clinical Research)

(Abstract #: HOUT-24) Challenges and successes in the global reimbursement of a breakthrough medical technology for treatment of glioblastoma multiforme. C. Proescholdt. 7:30 to 9:30 p.m. MST Nov. 22. (Health Outcome Measures/Clinical Research)

(Abstract #: EXTH-02) The blood brain barrier (BBB) permeability is altered by Tumor Treating Fields (TTFields) in vivo. E. Schulz. 7:30 to 9:30 p.m. MST Nov. 22. (Experimental Therapeutics/Basic Science)

(Abstract #: IMMU-06) TTFields induces immunogenic cell death and STING pathway activation through cytoplasmic double-stranded DNA in glioblastoma cells. D. Chen. 7:30 to 9:30 p.m. MST Nov. 22. (Immunology/Basic Science)

(Abstract #: DRES-06) Prostaglandin E Receptor 3 mediates resistance to Tumor Treating Fields in glioblastoma cells. D. Chen. 7:30 to 9:30 p.m. MST Nov. 22. (Drug Resistance/Basic Science)

(Abstract #: EXTH-34) In vitro tumor treating fields (TTFields) applied prior to radiation enhances the response to radiation in patient-derived glioblastoma cell lines. S. Mittal. 7:30 to 9:30 p.m. MST Nov. 22. (Experimental Therapeutics/Basic Science)

(Abstract #: CSIG-20) Effect of tumor-treating fıelds (TTFields) on EGFR phosphorylation in GBM cell lines. M. Reinert. 7:30 to 9:30 p.m. MST Nov. 22. (Cell Signaling and Signaling Pathways/Basic Science)

(Abstract #: CBMT-14) The dielectric properties of brain tumor tissue. M. Proescholdt. 7:30 to 9:30 p.m. MST Nov. 22. (Cell Biology and Metabolism/Basic Science)

(Abstract #: CSIG-26) Is intrinsic apoptosis the signaling pathway activated by tumor-treating fields for glioblastoma. K. Carlson. 7:30 to 9:30 p.m. MST Nov. 22. (Cell Signaling and Signaling Pathways/Basic Science)

(Abstract #: ATIM-08) Trial in Progress: CA209-9Y8 phase 2 trial of tumor treating fields (TTFs), nivolumab plus/minus ipilimumab for bevacizumab-naïve, recurrent glioblastoma. Y. Odia. 7:30 to 9:30 p.m. MST Nov. 22. (Adult Clinical Trials – Immunologic/Clinical Research)

(Abstract #: ACTR-60) A phase 2, historically controlled study testing the efficacy of TTFields with adjuvant temozolomide in high-risk WHO grade II and III astrocytomas (FORWARD). A. Allen. 7:30 to 9:30 p.m. MST Nov. 22. (Adult Clinical Trials – Non-Immunologic/Clinical Research)

(Abstract #: TMIC-54) Comparison of cellular features at autopsy in glioblastoma patients with standard treatment of care and tumor treatment fields. A. Lowman. 7:30 to 9:30 p.m. MST Nov. 22. (Tumor Microenvironment/Basic Science)

(Abstract #: ACTR-26) Safety and efficacy of bevacizumab plus Tumor Treating Fields (TTFields) in patients with recurrent glioblastoma (GBM): data from a phase II clinical trial. J. Fallah. 7:30 to 9:30 p.m. MST Nov. 22. (Adult Clinical Trials – Non-immunologic/Clinical Research)

(Abstract #: RBTT-02) Radiosurgery followed by Tumor Treating Fields for brain metastases (1-10) from NSCLC in the phase 3 METIS trial. V. Gondi. 7:30 to 9:30 p.m. MST Nov. 22. (Randomized Brain Tumor Trials in Development/Clinical Research)

(Abstract #: INNV-16) Complete response of thalamic IDH wildtype glioblastoma after proton therapy followed by chemotherapy together with Tumor Treating Fields. M. Stein. 7:30 to 9:30 p.m. MST Nov. 22. (Innovations in Patient Care/Clinical Research)

(Abstract #: INNV-20) A systematic review of tumor treating fields therapy for primary for recurrent and glioblastoma. P. Shah. 7:30 to 9:30 p.m. MST Nov. 22. (Innovations in Patient Care/Clinical Research)

(Abstract #: STEM-16) Dual Inhibition of Protein Arginine Methyltransferase 5 and Protein Phosphatase 2a Enhances the Anti-tumor Efficacy in Primary Glioblastoma Neurospheres. H. Sur. 7:30 to 9:30 p.m. MST Nov. 22. (Stem Cells/Basic Science)

(Abstract #: CBMT-13) 3DEP system to test the electrical properties of different cell lines as predictive markers of optimal tumor treating fields (TTFields) frequency and sensitivity. M. Giladi. 5 to 7 p.m. MST Nov. 23. (Cell Biology and Metabolism/Basic Science)

(Abstract #: EXTH-37) A novel transducer array layout for delivering Tumor Treating Fields to the spine. Z. Bomzon. 5 to 7 p.m. MST Nov. 23. (Experimental Therapeutics/Basic Science)

(Abstract #: NIMG-41) Rapid and accurate creation of patient-specific computational models for GBM patients receiving Optune therapy with conventional imaging (T1w/PD). Z. Bomzon. 5 to 7 p.m. MST Nov. 23. (Neuro-Imaging/Clinical Research)

(Abstract #: HOUT-17) Utilities of rare cancers like malignant pleural mesothelioma and glioblastoma multiforme – do they compare? C. Proescholdt. 5 to 7 p.m. MST Nov. 23. (Health Outcome Measures/Clinical Research)

(Abstract #: INNV-17) Innovative educational approaches to enhance patient and caregiver understanding of Optune for glioblastoma. M. Shackelford. 5 to 7 p.m. MST Nov. 23. (Innovations in Patient Care/Clinical Research)

(Abstract #: EXTH-05) Therapeutic implications of TTFields induced DNA damage and replication stress in novel combinations for cancer treatment. N. Karanam. 5 to 7 p.m. MST Nov. 23. (Experimental Therapeutics/Basic Science)

(Abstract #: EXTH-31) Combination of tumor treating fields (TTFields) and paclitaxel produces additive reductions in proliferation and clonogenicity in patient-derived metastatic non-small cell lung cancer (NSCLC) cells. S. Michelhaugh. 5 to 7 p.m. MST Nov. 23 (Experimental Therapeutics/Basic Science)

(Abstract #: EXTH-53) Tumor Treating Fields leads to changes in membrane permeability and increased penetration by anti-glioma drugs. E. Chang. 5 to 7 p.m. MST Nov. 23. (Experimental Therapeutics/Basic Science)

(Abstract #: RDNA-01) Tubulin and microtubules as molecular targets for TTField therapy. J. Tuszynski. 5 to 7 p.m. MST Nov. 23. (Radiation Biology and DNA Repair/Basic Science)

(Abstract #: SURG-01) OptimalTTF-1: Final results of a phase 1 study: First glioblastoma recurrence examining targeted skull remodeling surgery to enhance Tumor Treating Fields strength. A. Korshoej. 5 to 7 p.m. MST Nov. 23. (Surgical Therapy/Clinical Research)

(Abstract #: ATIM-39) Phase 2 open-labeled study of adjuvant temozolomide plus Tumor Treating Fields plus Pembrolizumab in patients with newly diagnosed glioblastoma (2-THE-TOP). D. Tran. 5 to 7 p.m. MST Nov. 23. (Adult Clinical Trials – Immunologic/Clinical Research)

(Abstract #: ACTR-49) Initial experience with scalp preservation and radiation plus concurrent alternating electric tumor-treating fields (SPARE) for glioblastoma patients. A. Song. 5 to 7 p.m. MST Nov. 23. (Adult Clinical Trials – Non-Immunologic/Clinical Research)

(Abstract #: RTHP-25) TTFields dose distribution alters tumor growth patterns: An imaging-based analysis of the randomized phase 3 EF-14 trial. M. Ballo. 5 to 7 p.m. MST Nov. 23. (Radiation Therapy/Clinical Research)

(Abstract #: ACTR-19) Report on the combination of Axitinib and Tumor Treating Fields (TTFields) in three patients with recurrent glioblastoma. E. Schulz. 5 to 7 p.m. MST Nov. 23. (Adult Clinical Trials – Non-Immunologic/Clinical Research)

(Abstract #: PATH-47) TTF may apply selective pressure to glioblastoma clones with aneuploidy: a case report. M. Ruff. 5 to 7 p.m. MST Nov. 23. (Molecular Pathology and Classification – Adult and Pediatric/Clinical Research)

(Abstract #: RARE-39) Combination of Tumor Treating Fields (TTFields) with lomustine (CCNU) and temozolomide (TMZ) in newly diagnosed glioblastoma (GBM) patients – a bi-centric analysis. L. Lazaridis. 5 to 7 p.m. MST Nov. 23. (Rare Tumors/Clinical Research)

(Abstract #: ACTR-31) The use of TTFields for newly diagnosed GBM patients in Germany in routine clinical care (TIGER: TTFields in Germany in routine clinical care). O. Bahr. 5 to 7 p.m. MST Nov. 23. (Adult Clinical Trials – Non-Immunologic/Clinical Research)

(Abstract #: INNV-09) Clinical efficacy of tumor treating fields for newly diagnosed glioblastoma. Y. Liu. 5 to 7 p.m. MST Nov. 23. (Innovations in Patient Care/Clinical Research)

(Abstract #: EXTH-61) Celecoxib Improves Outcome of Patients Treated with Tumor Treating Fields. K. Swanson. 5 to 7 p.m. MST Nov. 23. (Experimental Therapeutics/Basic Science)

(Abstract #: INNV-23) Glioblastoma and Facebook: An Analysis Of Perceived Etiologies and Treatments. N. Reddy. 5 to 7 p.m. MST Nov. 23. (Innovations in Patient Care/Clinical Research)

(Abstract #: INNV-12) Outcomes in a Real-world Practice For Patients With Primary Glioblastoma: Impact of a Specialized Neuro-oncology Cancer Care Program. N. Banerji. 5 to 7 p.m. MST Nov. 23. (Innovations in Patient Care/Clinical Research)

(Abstract #: RBTT-11): NRG Oncology NRG-BN006: A Phase II/III Randomized, Open-label Study of Toca 511 and Toca FC With Standard of Care Compared to Standard of Care in Patients With Newly Diagnosed Glioblastoma. M. Ahluwalia. 5 to 7 p.m. MST Nov. 23. (Randomized Brain Tumor Trials Development/Clinical Research)

On November 19, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported that Bill Newell, CEO of Sutro Biopharma, will present a corporate overview and business update at the Stifel 2019 Healthcare Conference on Wednesday, Nov. 20, 2019, at 9:10 a.m. EST at the Lotte New York Palace hotel in New York City (Press release, Sutro Biopharma, NOV 19, 2019, View Source [SID1234551460]).

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A live webcast of the presentation will be accessible through the Events and Presentations page of the Investor Relations section of the company’s website at www.sutrobio.com. A replay of the webcast will be available for approximately 30 days following the event.

On November 19, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported financial results for the quarter ended September 30, 2019 and provided an update on clinical and corporate developments (Press release, Affimed, NOV 19, 2019, View Source [SID1234551478]).

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"We are excited to commence patient dosing in our Phase 2 study of AFM13 in support of registration, bringing us one step closer to delivering a potential new treatment for pTCL patients, who have very few treatment options," said Dr. Adi Hoess, Affimed’s CEO. "In addition, the IND for the first ever clinical trial bringing together an innate cell engager (AFM13) and adoptive NK cell transfer has cleared. This study of AFM13 and MD Anderson’s NK cell product could address a much broader group of patients with CD30-expressing lymphomas, including Hodgkin lymphoma, cutaneous T-cell lymphoma and diffuse large B-cell lymphoma."

Program Updates
AFM13 (CD30/CD16A)

In November 2019, the first patient was dosed in a Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with CD30-positive peripheral T cell lymphoma (pTCL). The results of the study, if positive, could form the basis for a Biologics License Application submission and support an accelerated approval given the unmet medical need for safe and effective new treatments in this hard-to-treat patient population. The study will also enroll a cohort of patients with transformed mycosis fungoides, an aggressive subtype of cutaneous T cell lymphoma.
The U.S. Food and Drug Administration (FDA) cleared an investigational new drug application (IND) for an investigator-sponsored Phase 1 study, in which the University of Texas MD Anderson Cancer Center (MDACC) plans to investigate the combination of AFM13 with allogeneic NK cells. MDACC intends to administer a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells in different doses (numbers of pre-loaded NK cells) to patients with relapsed/refractory CD30-positive lymphoid malignancies. The combination represents a novel approach to further improve response rates and durability of responses in this patient population.
AFM24 (EGFR/CD16A)

In October 2019, Affimed received clearance of its IND for AFM24 from the FDA, enabling the company to proceed with its planned Phase 1/2a clinical study of the tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding innate cell engager in patients with advanced cancers known to express EGFR. The clearance of the IND follows the company’s IND submission in late-September 2019. Affimed expects the study, which is aimed at establishing safety and identifying initial signals of efficacy of AFM24, to initiate in the first quarter of 2020.
Pipeline Updates
Affimed selected two new CD16A-binding innate cell engager candidates (AFM28 and AFM32) from our ROCK platform for undisclosed targets that the company plans to advance into preclinical studies in 2020 with the aim of supporting future IND submissions. The selection of the new development candidates follows Affimed’s evaluation of innate immune cell activity versus a number of potential targets that are expressed in multiple hematological and solid tumor malignancies.
Genentech Collaboration
In November 2019, Genentech exercised its final option for an exclusive target under the ongoing, multi-program strategic oncology collaboration agreement to develop and commercialize novel NK cell engager-based immunotherapeutics generated from Affimed’s ROCK platform to treat multiple cancers. The target selection triggers a payment in an undisclosed amount to Affimed from Genentech.
Management Changes
Affimed announced the appointment of Cassandra Choe-Juliak, MD, MS as Acting Chief Medical Officer to succeed Dr. Leila Alland, effective November 30, 2019. Dr. Alland will transition out of her current role and will serve as a consultant for the company. Dr. Choe-Juliak has over 13 years of experience in drug development and medical affairs in immuno-oncology/oncology for both hematological and solid tumor malignancies. Since joining Affimed in July 2017, she has served as the clinical leader for the AFM13 development program.
Dr. Hoess commented, "Cassandra’s deep expertise in drug development and strong leadership skills have been, and will continue to be, a tremendous asset to Affimed and our clinical team as we advance our pipeline of innate cell engagers. I would also like to thank Leila for her many contributions to Affimed and wish her success in her future endeavors."

Financial Highlights
(Figures for the third quarter and nine months ended September 30, 2019 and 2018 are unaudited.)
Cash, cash equivalents and current financial assets totaled €76.5 million as of September 30, 2019, compared to €108.8 million as of December 31, 2018. In November 2019, Affimed completed a public equity offering with net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses, of approximately $32 million (€29 million). Based on its current operating and budget assumptions, the company anticipates that its cash, cash equivalents and current financial assets as of September 30, 2019, together with the proceeds from the stock offering, will enable the Company to fund its planned clinical development and early development activities at least into the fourth quarter of 2021.

Net cash used in operating activities was €30.6 million for the nine months ended September 30, 2019, compared to net cash used in operating activities of €24.9 million for the nine months ended September 30, 2018. The increase is primarily due to higher cash expenditure for research and development efforts.

Total revenue was €2.1 million for the three months ended September 30, 2019 compared to €0.3 million for the three months ended September 30, 2018. The increase in revenue is attributable to the recognition of €1.9 million as revenue from the Genentech collaboration in the third quarter of 2019.

Research and development (R&D) expenses for the third quarter of 2019 were €11.7 million, compared to R&D expenses for the third quarter of 2018 of €9.8 million. The increase was primarily related to higher expenses related to manufacturing activities for clinical study material for AFM13, startup activities for the AFM13 registration study in pTCL and early stage development and discovery activities.

General and administrative expenses for the third quarter of 2019 were €2.8 million compared to €2.4 million for the third quarter of 2018.

Net loss was €10.9 million, or €0.17 per common share, for the third quarter of 2019, compared to a net loss of €12.0 million, or €0.19 per common share, for the third quarter of 2018.

Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports the consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles 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, Tuesday, November 19, 2019 at 8:30 a.m. Eastern time to discuss the company’s financial results and recent corporate developments. To access the call, please dial +1 (631) 510-7495 for U.S. callers, or +44 (0) 2071 928000 for international callers, and reference conference ID 8758067 approximately 15 minutes prior to the call. An audio webcast of the conference call can be accessed in the "Webcasts" section on the "Investors" 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 for 30 days following the call.

On November 19, 2019 Stealth BioTherapeutics Corp (NASDAQ: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, reported that Reenie McCarthy, CEO, will present at the Jefferies 2019 London Healthcare Conference in London, UK, on Wednesday, November 20, 2019 at 8:00 am GMT (Press release, Stealth Biotech, NOV 19, 2019, View Source [SID1234551494]).

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A live audio webcast of the event will be available on the Investors & News section of Stealth’s website at https://investor.stealthbt.com/. A replay of the webcast will be archived on Stealth’s website for 30 days following the event.

On November 19, 2019 LabCorp (NYSE: LH) reported that it has provided notice of its intention to redeem all of its outstanding Zero Coupon Convertible Subordinated Notes due 2021 (Zero Coupon Notes) for cash on Dec. 19, 2019, (Redemption Date) in accordance with the terms of the Indenture, dated as of Oct. 23, 2006, (Indenture), between LabCorp and The Bank of New York Mellon, as trustee (Trustee) and the conversion agent (Press release, LabCorp, NOV 19, 2019, View Source [SID1234552831]). The redemption price will be equal to $966.20 per $1,000 principal amount of Zero Coupon Notes at maturity, plus accrued and unpaid contingent cash interest to the Redemption Date (Redemption Price). The current outstanding aggregate principal amount at maturity of the Zero Coupon Notes is approximately $935,000.

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As a result of the issuance of the notice of redemption, the Zero Coupon Notes are convertible into cash and Common Stock of LabCorp, if any, subject to the terms of the Zero Coupon Notes and the Indenture. Zero Coupon Notes may be converted at any time before the close of business on Dec. 17, 2019, at the current conversion rate of 13.4108 shares of Common Stock per $1,000 principal amount of Zero Coupon Notes at maturity.

In order to exercise the option to convert all or a portion of the Zero Coupon Notes, holders must validly surrender their Zero Coupon Notes at any time through the close of business at 5:00 p.m., New York City time, on Dec. 17, 2019. The Trustee has informed LabCorp that, as of this date, all custodians and beneficial holders of the Zero Coupon Notes hold the Zero Coupon Notes through Depository Trust Company (DTC) accounts and that there are no certificated Zero Coupon Notes in non-global form. Accordingly, all Zero Coupon Notes surrendered for conversion must be delivered through the transmittal procedures of DTC.

Should Zero Coupon Notes be converted, LabCorp would be required to pay holders in cash for the accreted principal amount of the securities to be converted, with the remaining amount, if any, to be satisfied with shares of Common Stock. The shares required for settlement of the Zero Coupon Notes are included in LabCorp’s computation of fully diluted earnings per share.

Original issue discount and contingent cash interest on the Zero Coupon Notes will cease to accrue on and after the Redemption Date, and the only remaining right of holders of the Zero Coupon Notes will be to receive payment of the Redemption Price.