On September 17, 2018 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies based on its novel, universal Antibody-Coupled T cell Receptor (ACTR) technology platform, reported that the Company will be presenting data on the first dose level (40×106 ACTR+ T cells) of its ATTCK-20-03 clinical trial evaluating ACTR707 in combination with rituximab in patients with relapsed or refractory CD20-positive B cell non-Hodgkin Lymphoma (r/r NHL) (Press release, Unum Therapeutics, SEP 17, 2018, View Sourcenews-releases/news-release-details/unum-therapeutics-announces-abstract-accepted-presentation" target="_blank" title="View Sourcenews-releases/news-release-details/unum-therapeutics-announces-abstract-accepted-presentation" rel="nofollow">View Source [SID1234529485]). Three of the six patients treated at the first dose level achieved a complete response, two of which remained ongoing at the time of the most recent data cut off. No dose-limiting toxicities (DLTs) were observed in any of the four DLT-evaluable patients, and no serious or severe adverse events of cytokine release syndrome or neurotoxicity were observed in any patients. These data will be presented at the Fourth Annual CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) on September 30 in New York, New York.

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"These preliminary clinical data suggest that complete responses may be achieved without cytokine release syndrome, further validating the potential of our proprietary ACTR technology platform," said Chuck Wilson, Chief Executive Officer of Unum. "The ATTCK-20-03 trial is a key element of our strategy to develop novel therapeutics for patients with no available treatment options."

"Complete responses observed in this heavily pre-treated patient population at the first dose level of the ATTCK-20-03 trial support the potential potency of ACTR T cells for these patients," said Michael Vasconcelles, Chief Medical Officer of Unum. "Based upon this encouraging preliminary profile, we look forward to continuing the dose escalation phase of this study. We expect these and future data to support selection of an ACTR product candidate to progress into potential registration trials in patients with r/r NHL."

Enrollment and ACTR707 dosing in the second dose cohort (60×106 ACTR+ T cells) of the ATTCK-20-03 trial has been completed and dose escalation is proceeding. The Company expects to present additional data from this study later this year.

Safety and Preliminary Efficacy of ACTR707, Autologous T Lymphocytes Expressing an Antibody-Coupled T Cell Receptor, in Combination with Rituximab in Subjects with Relapsed or Refractory CD20-Positive B-cell Lymphoma (Abstract #A003)

Presenter: Dr. Veronika Bachanova, University of Minnesota

Date: Sunday, September 30, 2018, 11:45am – 2:15pm

Location: New York Marriott Marquis, Westside Ballroom

ATTCK-20-03 is a Phase I, multi-center, open label, single arm clinical trial evaluating ACTR707 in combination with rituximab in patients with r/r NHL. Eligible patients for enrollment must have, among other criteria, received adequate prior anti-lymphoma therapy, including rituximab and chemotherapy, for their CD20-positive r/r NHL. Key eligibility criteria include: pre-specified eligible NHL subtypes, including DLBCL, disease progression following immediate prior therapy, adequate organ function and performance status, and measurable disease. The trial design includes a dose escalation phase using an adaptive design, followed by a cohort expansion phase. Primary study objectives are to characterize the safety of ACTR707 in combination with rituximab and to determine the maximum tolerated dose and proposed recommended Phase 2 dose. Secondary study objectives include: assessment of the anti-lymphoma activity of the combination, ACTR707 persistence, rituximab pharmacokinetics, and inflammatory markers and cytokine levels. Following leukapheresis, each patient receives lymphodepletion followed by the first infusion of rituximab and then a single infusion of ACTR707. Rituximab infusions continue on a regular, pre-specified schedule.

Data in the first cohort of the trial demonstrate complete responses at the first response assessment in 3/6 patients treated with ACTR707 in combination with rituximab, two of which remained ongoing at the time of the most recent data cut off. There were no serious or severe adverse events of cytokine release syndrome, neurotoxicity, or autoimmune events. Grade 3 or higher adverse events were mostly hematologic including neutropenia (n=2), febrile neutropenia (n=2), and thrombocytopenia (n=1). ACTR+ T cells were detectable in all subjects and ACTR+ T cells persisted in the presence of continued rituximab administration. These results support the continued dose escalation of ACTR707 in combination with rituximab.

Conference Call and Webcast
Unum will host a conference call and webcast at 8:30 a.m. EDT today to discuss the data. To participate in the conference call, please dial (866) 300-3411 (domestic) or (636) 812-6658 (international) and enter the conference code: 2958105. To join the live webcast, please visit the investor relations section of the Unum Therapeutics website at View Source at least 10 minutes before the event begins. A webcast replay will be available at the same location on the Unum Therapeutics website beginning approximately two hours after the event and will be archived for 90 days.

About ACTR707

ACTR707 is an investigational drug that may represent an important construct not only for adult patients with CD20+ r/r NHL, when used in combination with rituximab, but also for patients with other cancer types when used in combination with other antibodies. ACTR707 was identified through a comprehensive high-throughput screening effort aimed at identifying receptors with improved functional characteristics across several dimensions. In preclinical testing, ACTR707 demonstrated potent activity against a wide range of hematologic and solid tumor cancers. Given the challenges of the immunosuppressive solid tumor microenvironment, Unum believes that ACTR707’s increased activity may be particularly important in addressing solid tumor cancers. ACTR707 is currently being tested in combination with rituximab in patients with r/r NHL in a Phase I multi-center open label clinical trial, ATTCK-20-03. Testing is expected to be initiated later in 2018 in ATTCK-34-01, a Phase I multi-center open label clinical trial exploring the combination of ACTR707 with trastuzumab in patients with HER2+ advanced cancers.

On September 17, 2018 Inspyr Therapeutics reported that it has entered into an agreement with Ridgeway Therapeutics Inc. in which Ridgeway will license and assume control of certain assets relating to Inspyr’s oncology development programs, including intellectual property rights relating to adenosine antagonists owned by Inspyr (Press release, Inspyr Therapeutics, SEP 17, 2018, View Source [SID1234568253]).

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Adenosine receptors have a variety of functions in the body that are expressed through four subtypes (A1, A2A, A2B, and A3). The adenosine A2 receptor subtypes (A2R) are of particular interest as potential targets for the treatment of cancer. Extremely high levels of adenosine are found locally in the tumor microenvironment. These have a direct immunosuppressive effect on T-cells and other cell types that would otherwise attack and kill cancer cells. Inhibition of the A2R has the potential to reverse these immunosuppressive effects.

Inspyr and Ridgeway will collaborate on certain aspects of development which will include a minimum level of purchased services by Ridgeway within 18 months of this transaction. In addition, Inspyr is eligible for approximately $12 million in success-based milestones from the Transaction. Inspyr is also entitled to receive royalties on all commercial sales. In the event Ridgeway sub-licenses these assets, Inspyr is entitled to share in the proceeds of any future transaction.

On September 17, 2018 Cytori Therapeutics (NASDAQ: CYTX) ("Cytori" or the "Company") reported that it received FDA orphan drug designation for its ATI-1123 chemotherapy drug product candidate, an albumin-stabilized pegylated liposomal docetaxel, for the treatment of small cell lung cancer (Press release, Cytori Therapeutics, SEP 17, 2018, View Source [SID1234529464]).

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The FDA’s Orphan Drug Designation Program provides orphan status to drugs, such as ATI-1123, which are intended for the safe and effective treatment of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Sponsors of a drug receiving orphan designation qualify for various incentives including tax credits for clinical testing, 7 years of marketing exclusivity following FDA approval, and a waiver of prescription drug user fees.

Small cell lung cancer (SCLC), which accounts for approximately 15% of bronchogenic carcinomas with 33,375 new cases and 23,380 deaths estimated for 2017, has been identified by Cytori as a compelling target for ATI-1123. While SCLC is responsive to chemotherapy and radiation therapy, cure occurs only in ~20% of patients, generally restricted to those with limited stage disease. The remaining 80% of patients, including all patients with extensive disease, relapse within months of completing their initial therapy. Availability of 2nd line therapy options are limited, toxic, and provide little benefit in terms of extending survival. Topotecan is the only FDA-approved agent for 2nd line treatment of SCLC and is associated with an overall response rate of 24%, median response duration or time to progression of 14 weeks, and median overall survival of 25 weeks. Treatment usually involves a consecutive 5 day regimen of either IV or oral administration of drug, both which have black box warnings for severe myelosuppression as their use is associated with substantial morbidity including bone marrow suppression leading to neutropenia, thrombocytopenia and anemia requiring interventions of transfusion and growth factor support.

No major treatment advances for SCLC have occurred over the past 30 years. Hence, there remains a significant unmet need for novel agents with better safety profiles both for patients who cannot tolerate the adverse effects of 1st line chemo-radiotherapy and for relapsed/refractory patients who receive Topotecan. Cytori’s ATI-1123 has been designed to fill this need. ATI-1123’s combination of improved liposome stability, reduced toxicity, and superior delivery are expected to provide a therapeutic for SCLC that offers comparable or better efficacy to currently-available standards while having a less intensive administration routine and improved side effect profile.

Cytori is also exploring the development of ATI-1123 to address the shortcomings of docetaxel, a workhorse chemotherapy drug which generated $2.7B in worldwide sales at its peak. Compared to docetaxel, ATI-1123 may have potential to improve safety by removing the need for unwanted solvents, reduce morbidity by eliminating the requirement for standard pretreatment medications, provide better patient convenience and comfort via less time spent in the treatment center, decrease the cost of therapy, and enhance systemic docetaxel exposure.

A U.S. Phase 1 clinical study of ATI-1123 has been completed and published. Of the 29 patients in the study with cervical, gastric, melanoma, non-small cell lung, ovarian, pancreatic, prostate, thyroid, urachal and uterine cancers, 82% demonstrated a clinical benefit with ATI-1123. ATI-1123 exhibited an improved safety profile versus the Taxotere label with a 31% reduction in neutropenia and anemia. Further, ATI-1123 showed a 20% increase in maximum tolerated dose versus standard docetaxel and signs of efficacy with 1 partial responder.

On September 16, 2018 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 four oral clinical data presentations on two of its late-stage investigational therapies, tislelizumab and zanubrutinib, at the 21st Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) (Press release, BeiGene, SEP 16, 2018, View Source [SID1234529451]). The meeting will take place September 19 – 23 in Xiamen, China. Tislelizumab is an investigational anti-PD-1 antibody, and zanubrutinib is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK).

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Oral Presentations:

Title: Clinical Profile of Tislelizumab in Chinese Patients with Microsatellite Instability High (MSI-H) or Mismatch Repair-Deficient (MMRd) Solid Tumors: Preliminary Results from an Indication-Expansion Cohort
Abstract ID: 449
Location: Second Floor, Straits Hall
Date: Thursday, September 20, 2018
Time: 16:45 – 16:55 (CST)
Presenter: Lin Shen, M.D.


Title: Tislelizumab Combined with Chemotherapy as First-Line Treatment in Chinese Patients (Pts) with Advanced Lung Cancer
Abstract ID: 450
Location: First Floor, Concert Hall
Date: Friday, September 21, 2018
Time: 11:30 – 11:38 (CST)
Presenter: Jie Wang, M.D., Ph.D.


Title: Preliminary Results with Tislelizumab in Chinese Patients with Non-Small Cell Lung Cancer (NSCLC)
Abstract ID: 448
Location: First Floor, Concert Hall
Date: Friday, September 21, 2018
Time: 11:38 – 11:45 (CST)
Presenter: Qing Zhou, M.D.


Title: A Phase 1 Clinical Study to Investigate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of BTK Inhibitor BGB-3111 in Chinese Patients with B-Cell Lymphoma
Abstract ID: N/A
Location: First Floor, G Hall
Date: Saturday, September 22, 2018
Time: 08:30 – 08:45 (CST)
Presenter: Jun Zhu, M.D.

About Tislelizumab
Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. Discovered by BeiGene scientists in Beijing, tislelizumab is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is potentially differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells, based on preclinical data. Tislelizumab 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. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan). Tislelizumab’s new drug submission for the treatment of patients with relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL) has been accepted and is under review by the National Medical Products Administration of China (NMPA, formerly known as CFDA or CDA).

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that was discovered in BeiGene’s research facilities in Beijing, China. It is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Zanubrutinib is under review as a Category 1 new drug submission for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL) by the NMPA of China.

On September 14, 2018 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH), reported its consolidated financial results for the first six months of 2018 (Press release, Innate Pharma, SEP 14, 2018, View Source [SID1234529426]). The financial statements are attached to this press release.

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"In the first half of 2018 we have continued to advance our innovative portfolio, both with our partnered and proprietary immuno-oncology programs. We are encouraged by the emerging clinical data from our lead antibody, monalizumab, and look forward to presenting the updated data set from the Phase I/II study of monalizumab in combination with cetuximab in patients with recurrent or metastatic head and neck cancer at the upcoming ESMO (Free ESMO Whitepaper) 2018 congress," commented Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "Our commitment to continue the clinical development momentum remains a priority. Together with our partner AstraZeneca/MedImmune, we recently decided to recruit additional patients into the monalizumab plus cetuximab study to gain more experience in patients with advanced SCCHN** previously treated with anti-PD-1/L1. The Phase I trial evaluating IPH5401 in combination with durvalumab has been initiated and we look forward to share new data on IPH4102."

A conference call will be held today at 2:00pm (CEST)

Dial in numbers:

France and International: +33 (0)1 72 72 74 03 US only: +1 646 722 4916

PIN code: 53841185#

The presentation is available at the bottom of this page.

A replay is available on Innate Pharma’s website.

Financial highlights of the first half of 2018

The key elements of Innate Pharma’s financial results for the first half of 2018 are as follows:

Cash, cash equivalents and financial assets (current and non-current) amounting to €141.6m (million euros) as of June 30, 2018 (€176.6m as of December 31, 2017).
Financial liabilities amounting to €5.2m, including €3.9m of non-current liabilities (€5.9m as of December 31, 2017, including €4.5m of non-current liabilities).
Revenue and other income amounting to €23.7m (€21.2m for the first half of 2017). This amount mainly results from revenue from licensing and collaboration agreements (€16.9m) and from research tax credit (€6.2m).
Revenue related to the licensing and collaboration agreements mainly results from phasing of initial payment received by Innate Pharma in the context of the agreement signed in April 2015 relating to monalizumab with AstraZeneca/MedImmune (€16.7m).
Operating expenses amounting to €39.4m (€37.1m for the first half of 2017), of which 86% are related to research and development.
R&D expenses were up €4.6m during the periods under review, in line with the broadening and progress of Innate’s pipeline.Share-based payments were down €4.0m, including €1.9m in R&D and €2.1m in G&A, making up the most of G&A expenses decrease.
A net loss for the first half of 2018 amounting to €16.2m (€16.6m for the first half of 2017).