Phio and Glycostem to Collaborate on Use of its sd-rxRNA® platform and Glycostem’s oNKord® Cell Therapy Products for the Next Generation of Natural Killer Cell-based Immunotherapy for Cancer Treatment

On March 28, 2019 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) reported that it has entered into a research collaboration with Glycostem Therapeutics BV to explore the potential synergies of using Phio’s self-delivering RNAi technology (sd-rxRNA) in combination with Glycostem’s proprietary Natural Killer-cell (NK-cell) generation technology (oNKord) to develop cellular immunotherapies for cancer treatment with enhanced efficacy and/or safety (Press release, Phio Pharmaceuticals, MAR 28, 2019, View Source [SID1234534695]).

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 companies’ research teams will collaborate and examine the applicability of Phio’s sd-rxRNA technology to be integrated into Glycostem’s processes to produce NK-cells with the ultimate goal to further improve Glycostem’s cellular immunotherapies for the treatment of cancer patients.

Dr. Jan Spanholtz, CSO of Glycostem commented, "One of the research focuses of Glycostem is novel oNKord products with improved functions. Towards that goal we have already established several collaborations, and we are glad to expand our efforts in this field in collaboration with Phio Pharmaceuticals. We believe their proprietary self-delivering RNAi technology can provide new and more effective ways for expanding and differentiating NK-cells. In addition, their technology can help overcome immune checkpoints or other immunosuppressive roadblocks that NK-cells may encounter, which may further enhance the efficacy and safety of our cellular therapies."

Dr. Gerrit Dispersyn, President and CEO of Phio Pharmaceuticals, added, "We are excited to partner with Glycostem, a leading cellular immunotherapy company. Their focus on safe and cost-effective allogeneic approaches with the promise of providing ‘off-the-shelf’ cellular products very much aligns with our vision on the use of innovative technology to create a next generation of very powerful adoptive cell therapies against various cancers."

OBI Pharma Announces Poster Presentations at AACR 2019 for Novel Globo H Immuno-Oncology Therapeutics: OBI-888 and OBI-999

On March 28, 2019 OBI Pharma, Inc. (TPEx: 4174), a leader in Glycosphingolipid Immuno-Oncology therapeutics targeting the Globo Series antigens (Globo H, SSEA-3 and SSEA-4), reported that data highlighting OBI-888 (Globo H mAb) and OBI-999 (Globo H ADC) mechanism of action, anti-tumor efficacy and pharmacokinetics profile in multiple cancer types, will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from March 29–April 3, 2019 in Atlanta, Georgia (Press release, OBI Pharma, MAR 28, 2019, View Source [SID1234534694]).

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!

Title: Anti-tumor efficacy and potential mechanism of action of a novel therapeutic humanized anti-Globo H antibody, OBI-888
Session: PO.IM02.16 – Therapeutic Antibodies 1
Date/Time: March 31, 2019 from 1:00 PM – 5:00 PM EST
Location: Section 23
View Source!/6812/presentation/2395

Title: Specificity, biodistribution, tumor targeting, and pharmacokinetics of a novel humanized anti-Globo H antibody, OBI-888, for cancer immunotherapy
Session: PO.ET07.01 – Targeted Therapies
Date/Time: April 3, 2019 from 8:00 AM – 12:00 PM EST
Location: Section 14
View Source!/6812/presentation/3113

Title: Novel Globo H targeting antibody-drug conjugate with binding specificity and anti-tumor efficacy in multiple cancer types
Session: PO.ET07.01 – Targeted Therapies
Date/Time: April 3, 2019 from 8:00 AM – 12:00 PM EST
Location: Section 14
View Source!/6812/presentation/3114

Preclinical studies showed that OBI-888’s mechanism of action involves antibody-induced tumor lysis which may have substantial therapeutic potential. OBI-888 is currently in a Phase 1 clinical study in solid tumor patients at the MD Anderson Cancer Center in Houston, Texas (USA). For OBI-999, preliminary pharmacological studies in established animal tumor models showed potent and long lasting anti-tumor activity in multiple cancer types, including breast, pancreatic, lung and gastric cancer. A US FDA IND submission is planned for 2019. OBI Pharma owns global rights to OBI-888 and OBI-999.

About OBI-888

OBI-888 is a novel first-in-class monoclonal antibody, which selectively targets Globo H, an antigen expressed in up to 15 types of epithelial cancer. This Globo H targeting antibody has been shown to induce tumor-killing via antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cell-mediated phagocytosis (ADCP) and complement-dependent cytotoxicity (CDC).

OBI-888 is also anti-immunosuppressive and anti-angiogenic. In pre-clinical xenograft animal models in multiple tumor types (pancreatic, colon, lung, and breast), OBI-888 has demonstrated tumor shrinkage at various doses. In pre-clinical single and repeated dose toxicology studies, OBI-888 was well-tolerated with no adverse effects observed in all the doses tested.

About OBI-999

OBI-999 is an antibody-drug conjugate (ADC) treatment for cancer. OBI-999 uses a Globo H antibody to target cancer cells of high Globo H expression. By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells. Preliminary pharmacological studies and animal verification have already been completed and showed impressive and long lasting anti-tumor efficacy in multiple cancer types, including breast, pancreatic, lung and gastric cancer. It is currently undergoing Chemistry Manufacturing Control (CMC) planning and toxicology study design.

Heat Biologics Reports 2018 Results and Provides Corporate Update

On March 28, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing therapies designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the fourth quarter and year ended December 31, 2018 (Press release, Heat Biologics, MAR 28, 2019, View Source [SID1234534693]).

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!

Jeff Wolf, Heat’s CEO, commented, "We are making excellent progress advancing HS-110 and recently reported interim Phase 2 non-small cell lung cancer (NSCLC) data on HS-110 plus nivolumab at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium. Importantly, we observed a survival benefit in patients with low CD8+ "cold" tumors at baseline compared to high CD8+ patients. This Cohort B data was especially encouraging, as all of the enrolled patients had previously experienced disease progression while receiving an immune checkpoint inhibitor. Preliminary data suggest the addition of HS-110 to Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, Opdivo (nivolumab), may restore responsiveness to treatment after tumor progression on prior checkpoint inhibitor therapy. We believe we are the first company to present clinical data in advanced NSCLC with patients whose prior checkpoint inhibitor treatment has failed. The results have generated significant interest within the industry and oncology community."

"We also expanded our Phase 2 trial to dose patients with HS-110 in combination with Merck’s anti-PD1 checkpoint inhibitor, KEYTRUDA (pembrolizumab) with or without ALIMTA (pemetrexed), in patients receiving front-line maintenance therapy for advanced NSCLC."

"We look forward to filing our Phase 1 Investigational New Drug (IND) for our next-generation therapy (HS-130) in the first half of 2019. HS-130 in combination with HS-110 combines T-cell activation and co-stimulation, potentially providing superior immune activation at reduced treatment costs. Further, we also plan to submit an IND for a CPRIT-funded 70 patient Phase 1 clinical program of PTX-35 in the first half of 2019. PTX-35 is our novel co-stimulatory antibody designed to harness the body’s natural antigen-specific T cell immune activation mechanisms. We remain encouraged by the preliminary pre-clinical efficacy and safety data, which show a lack of adverse effects across a wide range of doses."

"We ended 2018 with approximately $28 million of cash, cash equivalents and short-term investments. We also are on track to receive an additional $6.9 million in Cancer Prevention Research Institute of Texas (CPRIT) grant funds for PTX-35 in the coming months. As a result, we believe we are well funded beyond completion of our Phase 2 HS-110 trial. As previously disclosed, we have been efficient in our use of funds, which has allowed us to operate under budget, further extending our runway on primarily clinical development programs."

Full Year 2018 Financial Results

Recognized $5.8 million of grant revenue for qualified expenditures under the CPRIT grant.

Research and development expenses were $16.2 million for the year ended December 31, 2018 compared to $8.3 million for the year ended December 31, 2017. The increase was primarily due to the increase enrollment in the Phase 2 portion of our multi-arm NSCLC clinical trial as well as the PTX expense as we continue pre-clinical development of the PTX-35 program.

General and administrative expenses were $7.0 million for the year ended December 31, 2018 compared to $6.4 million for the year ended December 31, 2017.

Net loss attributable to Heat Biologics was $15.7 million, or ($0.90) per basic and diluted share for the year ended December 31, 2018 compared to a net loss of $11.8 million, or ($3.08) per basic and diluted share for the year ended December 31, 2017.

As of December 31, 2018, the Company had approximately $28 million in cash, cash equivalents and short term investments.

ISA Pharmaceuticals to Present Phase 2 Cervical Cancer Data at AACR Annual Meeting 2019

On March 28, 2019 ISA Pharmaceuticals B.V., a clinical-stage immuno-oncology company, reported that its Chief Scientific Officer Prof. Dr. Cornelis Melief will give an oral presentation at the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, GA, USA, on March 31, 2019 (Press release, ISA Pharmaceuticals, MAR 28, 2019, View Source [SID1234534689]).

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 presentation titled "A strong HPV-specific T-cell response after chemo-immunotherapy for advanced cervical cancer is associated with prolonged survival"is scheduled for Sunday, March 31, 2019, as part of the session "Predictive Biomarkers for Immunotherapy" (12:45-2:45pm, Marcus Auditorium- Bldg A-GWCC).

The data will outline the effects of vaccination with ISA Pharmaceuticals´ therapeutic vaccine ISA101 during chemotherapy in 77 patients with advanced, recurrent or metastatic cervical cancer in a dose assessment study.

ISA101 is directed against the HPV16 oncoproteins E6/E7 and is the Company´s clinical-stage lead compound. It is being developed to treat HPV16-induced cancers such as cervical cancer and head-and-neck cancer. Clinical efficacy of ISA101 in combination with Regeneron’s PD-1 inhibitor cemiplimab is currently being tested in a randomized controlled Phase 2 trial in platinum refractory, HPV16-positive oropharyngeal cancer patients (NCT03669718). The results to be presented at AACR (Free AACR Whitepaper) form the basis for a planned Phase 3 trial, in which the clinical benefit of the combination of ISA101 plus cemiplimab on top of standard-of-care chemotherapy will be studied in patients with advanced HPV16-positive cervical cancer.

Evotec AG Fiscal Year 2018 results: Accelerated growth and strong long-term outlook

On March 28, 2019 Evotec AG (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the fiscal year ended 31 December 2018 (Press release, Evotec, MAR 28, 2019, View Source;announcements/press-releases/p/evotec-ag-fiscal-year-2018-results-accelerated-growth-and-strong-long-term-outlook-5795 [SID1234534685]).

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!

STRONG FINANCIAL PERFORMANCE
Group revenues up 42% to € 375.4 m (2017: € 263.8 m); € 364.0 m Revenues from customer contracts, excluding revenues from recharges according to IFRS 15
Adjusted Group EBITDA up 67% to € 95.5 m (2017: € 57.2 m); € 92.0 m excluding one-off effects from tax credits and receivables
Total R&D expenses of € 35.6 m (2017: € 17.6 m) including € 12.7 m of infectious diseases-related expenses fully reimbursed by Sanofi ("partnered R&D")
Strong strategic liquidity position of € 149.4 m
OPERATIONAL AND SCIENTIFIC EXCELLENCE – "EXCELLENCE SQUARED"
Multiple new and extended drug discovery and development alliances
INDiGO roll-out and integration of high-end CMC offering
Leading application of Artificial Intelligence ("AI") in drug discovery projects
Continued strong performance of high-throughput ADME-tox testing (Cyprotex)
Significant progress in partnered co-owned pipeline; Clinical Phase I & Phase II starts
Multiple important milestone achievements, also in iPSC-based alliances
Continued expansion of iPSC leadership and focus on patient-centric approaches
Initiation of world-leading protein degradation platform
Global roll-out and expansion of Academic BRIDGE model
CORPORATE
Creating important footprint in infectious disease through acquisition of Evotec ID (Lyon)
Conversion into European Company (SE) expected to become effective by end of March 2019
FINANCIAL GUIDANCE 2019 – CONTINUED STRONG LONG-TERM GROWTH
Group revenues expected to increase by approx. 10% (2018: € 364.0 m excluding revenues from recharges according to IFRS 15)
Adjusted Group EBITDA expected to improve by approx. 10% (2018: € 92.0 m excluding one-off effects from tax credits and receivables)
Unpartnered research and development expenses expected to be approximately € 30-40 m (2018: € 22.9 m)

1. STRONG FINANCIAL PERFORMANCE
In 2018, Evotec’s Group revenues increased by 42% to € 375.4 m (2017: € 263.8 m). This increase was driven primarily by the strong performance in the base business, increased milestone payments and a positive first full-year contribution from the acquired business of Aptuit (€ 117.7 m) while contributing only € 46.0 m in 2017 (mid-August to December 2017). Revenues from milestones, upfronts and licences amounted to € 29.5 m, an increase of 6% in comparison to the previous year (€ 27.8 m). Milestones in 2018 resulted mainly from the collaborations with Bayer in endometriosis/chronic cough and kidney diseases, and from Evotec’s iPSC-based collaborations with Celgene in neurodegeneration as well as Sanofi in diabetes.

In 2018, Evotec focused its R&D expenses of € 35.6 m primarily on its iPSC research, projects in metabolic diseases, oncology and R&D platforms (2017: € 17.6 m). Furthermore, Evotec increased its R&D expenses significantly in infectious disease (ID)-related research following the acquisition of Evotec ID (Lyon) from Sanofi. These additional ID-related R&D expenses (€ 12.7 m) are fully reimbursed by Sanofi in context of the five-year agreement and are recognised under other operating income. Thus, they are not detrimental to the operating result and the adjusted EBITDA.

In 2018, the Group’s selling, general and administrative ("SG&A") expenses increased as expected by 35% to € 57.0 m (2017: € 42.4 m). This increase resulted primarily from first full-year SG&A expenses of Aptuit, additional Evotec ID (Lyon) costs as well as M&A-related and increased business development and administrative expenses in response to overall Company growth. However, this increase remained sub-proportional to revenue and adjusted EBITDA growth rates.

Evotec recorded a significant step-up in the adjusted Group EBITDA for 2018 to € 95.5 m (2017: € 57.2 m), yielding an adjusted EBITDA margin of 25.4% (2017: 21.7%). This adjusted EBITDA contains positive one-off effects from receivables and tax credits relating to prior periods in the amount of € 3.5 m. Without this effect, the adjusted EBITDA would amount to € 92.0 m.

Evotec’s operating result amounted to € 77.5 m in 2018 (2017: operating result of € 36.7 m) being positively impacted by the income from bargain purchase and higher R&D tax credits as well as positive one-off effects from receivables and tax credits. In 2018, an income from bargain purchase of € 15.4 m was recorded for the acquisition of Evotec ID (Lyon) as the purchase price was below the net assets acquired. The Company’s net result in 2018 amounted to € 84.1 m (2017: net result of € 23.2 m), being impacted by most recent acquisitions and the strong performance of the base business.

Evotec ended 2018 with a liquidity of € 149.4 m (2017: € 91.2 m), which was composed of cash and cash equivalents (€ 109.0 m) and investments (€ 40.4 m). The strong increase in liquidity in 2018 resulted mainly from the prepayments received from Celgene and the upfront received from Sanofi for Evotec ID (Lyon) (€ 61 m), off-set by net loan repayments (€ 78.2 m).

2. OPERATIONAL AND SCIENTIFIC EXCELLENCE – "EXCELLENCE SQUARED" IN EVT EXECUTE & EVT INNOVATE
The EVT Execute segment demonstrated strong progress in 2018 with new and extended alliances (e.g. CHDI, C4X, Dermira, Ferring, Forge, LEO Pharma, Novo Nordisk). In 2018, Evotec was involved in more than 700 customer alliances and recorded a repeat business of 92%. Following the launch of its INDiGO services in early 2018, Evotec was able to sign multiple new INDiGO agreements with e.g. Ankar, Astex, Carna Biosciences, Inflazome, and Yumanity. The high-throughput ADME-tox testing business of Cyprotex continued its excellent performance.

In EVT Innovate, 2018 was characterised by important progress in its strategic partnerships (iPSC neurodegeneration alliance with Celgene; iPSC diabetes alliance with Sanofi; kidney disease alliance with Bayer) as well as the signing of new partnerships, e.g. two new partnerships with Celgene in oncology as well as a new partnership with Almirall in dermatological diseases. Furthermore, the Company is blending artificial intelligence ("AI") and machine-learning tools into many of its biology- and chemistry-driven platforms to further accelerate and increase effectiveness in the process and continues to place great emphasis on patient-centric approaches to drug discovery. The partnered clinical projects are progressing to plan.

In 2018, Evotec’s academic BRIDGE model continued to attract significant interest from academia and industry partners.

3. CORPORATE
ACQUISITION OF EVOTEC ID (LYON)

Effective 01 July 2018, Evotec acquired 100% of the shares of Evotec ID (Lyon), the former Sanofi infectious disease unit in Lyon. The collaboration resulted in an upfront payment of € 61 m (€ 43 m in cash plus € 18 m cash of the acquired company) to Evotec. Evotec is eligible for significant further long-term funding from Sanofi in order to ensure the support and progression of a world-leading portfolio in this field.

4. FINANCIAL GUIDANCE 2019 – CONTINUED STRONG LONG-TERM GROWTH
Revenues, research and development expenses and adjusted EBITDA remain the financial key performance indicators of the Evotec Group.

For the financial year 2019, the Management Board expects Evotec to show Group revenue growth from contracts with customers without revenues from recharges of approx. 10%. This revenue growth is based on visibility of the current order book, expected new contracts, contract extensions and milestone opportunities. Projections are based on constant 2018 exchange rates.

Evotec’s adjusted Group EBITDA from 2018 includes one-off effects associated to the business years 2016 and 2017 in the amount of € 3.5 m. Without these one-off effects, the adjusted Group EBITDA in 2018 would amount to € 92.0 m. Against this number, Evotec’s adjusted Group EBITDA is expected to improve by approx. 10% in 2019 compared to 2018.

Evotec will continue to significantly invest in its own "unpartnered" research and development (R&D) efforts to create a long-term pipeline of first-in class assets and platforms. In addition, the Company will also continue to invest in its infectious disease-related efforts. ID-related R&D expenses of approx. € 35 m will be completely cost-covered by its partner Sanofi ("partnered R&D"). For better comparison against previous years, Evotec will focus its guidance and reporting during the course of 2019 on the "unpartnered R&D" part, estimated at approx. € 30-40 m.

WEBCAST/CONFERENCE CALL
The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. Furthermore, the Management Board will present an outlook for fiscal year 2019. The conference call will be held in English.

Conference call details

Date: Thursday, 28 March 2019

Time: 02.00 pm CET (09.00 am EDT, 01.00 pm GMT)

From Germany: +49 69 201 744 220

From France: +33 170 709 502

From Italy: +39 02 3600 6663

From the UK: +44 20 3009 2470

From the USA: +1 877 423 0830

Access Code: 75185877#

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our home page www.evotec.com shortly before the event.

A replay of the conference call will be available for 24 hours and can be accessed in Europe by dialling +49 69 20 17 44 222 (Germany) or +44 20 3364 5150 (UK) and in the USA by dialling +1 844 307 9362. The access code is 315534320#. The on-demand version of the webcast will be available on our website: View Source