On November 19, 2019 Torque, a clinical-stage immuno-oncology company developing Deep Primed T cell immunotherapy to direct immune power deep within the tumor microenvironment, reported additional preclinical data for its lead Deep IL-15 Primed T cell, Deep IL-12 Primed T cell, and Deep TLR Primed T cell therapeutics programs (Press release, Torque Therapeutics, NOV 19, 2019, View Source [SID1234551493]). The data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy taking place November 17–20, 2019 in Boston.

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"IL-15 and IL-12 are potent cytokines with complementary tumor-attacking capabilities that have been explored as cancer immunotherapies, but severe side effects have limited their clinical success. The preclinical data we presented at this year’s AACR (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy demonstrate that co-administering Deep IL-12 Primed and Deep IL-15 Primed T cells directs the stimulatory activity of these cytokines to the tumor microenvironment and leverages their complementary biology to prime and boost the immune response of T cell therapies to achieve superior efficacy, with limited systemic exposure and toxicity," said Thomas Andresen, PhD, Chief Scientific Officer of Torque. "In addition, we presented data demonstrating that Deep TLR Primed T cells leverage the immune-stimulating potential of TLR agonists to achieve superior anti-tumor efficacy while avoiding systemic exposure and toxicities, the key current bottlenecks to successful TLR therapy."

Highlights of the two preclinical presentations follow, and copies of the posters are available on the Torque website: https://bit.ly/34yZnTU

Poster A68: "Combining Deep IL-12 Primed and Deep IL-15 Primed T cells induces potent antigen-dependent in vitro cytotoxicity and in vivo antitumor activity"
Presenter: Elena Geretti, PhD, Torque
Date & Time: Monday, November 18, 12:30 p.m.–3:00 p.m.
Key findings from the study:

In preclinical models, co-administration of Deep IL-12 and Deep IL-15 T cells leveraged their complementary immunodulatory functions and elicited superior anti-tumor activity and was well tolerated, without notable toxicity.
Poster B66: "Deep TLR Primed T cells induce potent antitumor activity without systemic toxicity"
Presenter: Nathan Westcott, Torque
Date & Time: Tuesday, November 19, 4:30 p.m.–7:00 p.m.
Key findings from the study:

In preclinical models, Deep TLR Primed T cells released a potent small-molecule TLR agonist over an extended period of time and increased anti-tumor activity while avoiding systemic exposure and toxicities.
About Deep-Primed T Cell Therapeutics
Torque is developing a new class of Deep-Primed cellular immunotherapy designed to overcome the key challenges limiting broad use of cellular therapy in oncology, including the ability to target tumors that express multiple heterogeneous antigens, the ability to overcome the immunosuppressive tumor microenvironment that shuts down T cell function, and the need for cost-effective outpatient treatment with a high margin of safety. Deep-Priming is a unique technology platform that harnesses natural T cell biology and the power of cytokine activation to prime and boost a full immune response in the tumor microenvironment. Deep-Primed T cells are designed to:

1. Activate a Deep Immune Response Against Solid Tumors & Hematologic Cancers: Natural T cell receptors are primed to target multiple tumor antigens and retain their natural ability to integrate with the full immune system to direct a deep and comprehensive immune response against cancer.
2. Prime and Boost Broad Immune Cell Engagement to Overcome Immunosuppression in the Tumor Microenvironment: Deep-Primed T cells carry surface-anchored cytokines and immunomodulators to jump-start the engagement and coordination of the full network of immune cells to direct immune power in the tumor microenvironment, without significant systemic exposure.

Torque’s first clinical program, TRQ-1501 (Deep IL-15 Primed T cells), has received FDA Fast Track designation for the treatment of relapsed or refractory solid tumors and lymphomas and is currently in a Phase 1/2 clinical trial for this indication.

On November 19, 2019 Oncoceutics, Inc. reported a publication in the journal Nature Communications demonstrating selective antagonism of the G-protein coupled receptor (GPCR) dopamine receptor D2 (DRD2) by Oncoceutics’ lead candidate imipridone, ONC201 (Press release, Oncoceutics, NOV 19, 2019, View Source [SID1234558321]).

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ONC201 was found to specifically bind and antagonize DRD2, and its functionally redundant family member DRD3, without affecting other dopamine receptors, other GPCRs, nuclear hormone receptors, kinases, or other drug targets of FDA-approved cancer therapies. Additionally, a biologically inactive isomer of ONC201 did not antagonize DRD2, indicating that antagonism of this receptor may be linked to anti-cancer efficacy as shown in other publications (Clinical Cancer Research and Neoplasia).

The publication also describes the novel approach taken by Oncoceutics collaborators in the laboratory of Olivier Elemento, PhD, Director of the Englander Institute for Precision Medicine at Weill Cornell Medicine. The researchers used a novel machine-learning platform, called BANDIT, created in the Elemento Lab that suggested DRD2 as a target of ONC201. This method used the molecular structure of ONC201, its in vitro efficacy profile, and its publicly available bioactivity assay results as inputs to compare ONC201 against all small molecules with known targets.

"This publication represents years of collaborative work that uncovered DRD2 as the first known binding target of ONC201," said Joshua Allen, PhD and Senior Vice President of R&D of Oncoceutics. "Along with downstream biomarkers, the dopamine pathway has guided tumor type selection and interpretation of activity of ONC201 in clinical trials. So far, we have observed the most robust single agent efficacy in malignancies that exhibit dysregulation of the dopamine pathway and grow in a dopamine-rich microenvironment, such as midline gliomas."

"Our findings have helped uncover imipridone small molecules as a unique chemical scaffold for targeting GPCRs," said Dr. Elemento. "We are pleased to see the clinical translation of our precision medicine efforts in ONC201 clinical trials and hope this information can be used to identify additional indications for this new therapy."

"The unique mechanism of action of ONC201 is now well defined," said Martin Stogniew, PhD and Chief Development Officer of Oncoceutics. "The most conserved downstream effect of ONC201 in tumor cells is activation of the integrated stress response. Several additional downstream effects, such as dual inactivation of Akt/ERK, induction of TRAIL and DR5, and degradation of Myc also occur in many tumor models, along with immunostimulatory effects involving NK cells and cancer stem cell depletion. These effects aggregately explain the broad antitumor activity observed in multiple models and are likely trigged by the interaction ONC201 with DRD2 and/or ClpP, a recently uncovered additional binding target of the molecule."

For further reference, please refer to additional publications on ONC201 and imipridone small molecules.

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.