Evotec reports first quarter 2018 results and provides corporate update

On May 9, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported financial results and provided corporate updates for the first quarter of 2018 (Press release, Evotec, MAY 9, 2018, View Source;announcements/press-releases/p/evotec-reports-first-quarter-2018-results-and-provides-corporate-update-5682 [SID1234526299]).

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GOOD FINANCIAL PERFORMANCE WITH NEW BUSINESS MIX
Group revenues: 55% increase to € 79.0 m (Q1 2017: € 50.9 m);
EVT Execute revenues of € 78.5 m (Q1 2017: € 48.6 m);
EVT Innovate revenues of € 10.4 m (Q1 2017: € 12.5 m)
Adjusted Group EBITDA up 4% to € 14.0 m (Q1 2017: € 13.4 m);
Adjusted EBITDA for EVT Execute of € 17.2 m (Q1 2017: € 12.4 m);
Adjusted EBITDA for EVT Innovate of € (3.2) m (Q1 2017: € 1.0 m)
Group R&D expenses at € 4.6 m (Q1 2017: € 4.7 m)
Solid liquidity position of € 78.5 m

EVT EXECUTE – HIGH QUALITY AND EFFICIENCY IN R&D
Significant progress within ongoing alliances (e.g. start of third clinical Phase I study in endometriosis with Bayer (after period-end))
Aptuit integration according to plan
Launch of INDiGO solution to accelerate drug candidate delivery; first alliances established (e.g. Petra Pharma, Japanese company Carna Biosciences (after period-end))
New and extended integrated drug discovery and development agreements
Expansion of CRISPR-based technology offering with licence from ERS Genomics (after period-end)

EVT INNOVATE – FOCUS ON ACCELERATING INNOVATION
In Q1 2018, as expected, no noteworthy milestones, but all key projects on track
Continued focus on expansion of iPSC platform and patient-centric approaches
Academic BRIDGE model gaining momentum: First project identified in LAB150 with MaRS Innovation, further three projects identified in LAB282 with Oxford University
Alliance with Sanofi to accelerate infectious disease R&D (close of transaction expected in H1 2018)

CORPORATE
Preparation to convert into European Company (SE)

FINANCIAL GUIDANCE 2018 CONFIRMED
1. GOOD FINANCIAL PERFORMANCE WITH NEW BUSINESS MIX
In the first quarter of 2018, Evotec’s Group revenues grew to € 79.0 m, an increase of 55% compared to the same period of the previous year (Q1 2017: € 50.9 m). This increase resulted primarily from the strong performance in the base business and the Aptuit contribution (€ 25.3 m). Due to the timing of milestones, revenues from milestones, upfronts and licences in Q1 2018 decreased to € 2.7 m (Q1 2017: € 6.2 m). Q1 2017 revenues were driven by significant milestone achievements. The gross margin amounted to 23.4% in the first three months of 2018 (Q1 2017: 37.3%). This margin decrease compared to the prior-year period primarily reflects a new business mix following the most recent acquisition of Aptuit, amortisation, adverse FX effects and the timing of milestones. Gross margin excluding amortisation from M&A would be at 27.3%.

In the first quarter of 2018, Evotec’s R&D expenses amounted to € 4.6 m (Q1 2017: € 4.7 m) and were focused on first-in-class innovation mainly in CNS, metabolic disease, oncology and academic BRIDGE initiatives. Selling, general and administrative (SG&A) expenses increased as expected by 82% in the first quarter of 2018 to € 13.3 m (Q1 2017: € 7.3 m) and are on a similar level as in Q4 2017. This increase mainly results from expenses of Aptuit for three months as well as an increase in headcount in response to Company growth.

Adjusted Group EBITDA in the first quarter of 2018 increased to € 14.0 m (Q1 2017: € 13.4 m). Evotec’s operating result in the first quarter of 2018 amounted to € 6.5 m (Q1 2017: € 9.9 m). The Company’s net result in Q1 2018 amounted to € 3.5 m (Q1 2017: € 7.1 m) and decreased compared to the prior year mainly due to increased amortisation resulting from the purchase price allocations of recent acquisitions, adverse foreign currency effects, milestone timing and the higher share of the loss of associates accounted for using the equity method.

Liquidity, which includes cash and cash equivalents (€ 57.3 m) and investments (€ 21.2 m) amounted to € 78.5 m as of 31 March 2018 (31 December 2017: € 91.2 m). This decrease reflects the repayment of loans, increased capital expenditure, equity investments and bonus payments.

Revenues from the EVT Execute segment were € 78.5 m in Q1 2018 and significantly increased compared to the prior-year period (Q1 2017: € 48.6 m). This increase is primarily attributable to growth in the base business and a full three months Aptuit contribution. Also included in this amount are € 9.9 m of intersegment revenues (Q1 2017: € 10.3 m). The gross margin for EVT Execute was 20.8% and was affected, against the prior-year period, by amortisation, the new business mix with a different margin expectation in the Aptuit business, adverse FX effects and the timing of milestones. In Q1 2018, the adjusted EBITDA of the EVT Execute segment was very strong at € 17.2 m and significantly improved compared to the prior year (Q1 2017: € 12.4 m).

Revenues from the EVT Innovate segment amounted to € 10.4 m (Q1 2017: € 12.5 m) and consist entirely of third-party revenues. EVT Innovate revenues in Q1 2018 include lower milestone revenues than revenues in the prior-year period. EVT Innovate generated a gross margin of 31.1%, which was affected by adverse FX effects and the timing of milestones. R&D expenses for the EVT Innovate segment were € 5.6 m in Q1 2018 (Q1 2017: € 5.8 m). The EVT Innovate segment reported an adjusted EBITDA of € (3.2) m (Q1 2017: € 1.0 m). Adjusted EBITDA of EVT Innovate in Q1 2017 was driven by significant milestone achievements of € 4.5 m, which were not expected in Q1 2018. All key projects to achieve significant milestones in 2018 are on track.

2. EVT EXECUTE & EVT INNOVATE
EVT EXECUTE – HIGH QUALITY AND EFFICIENCY IN R&D
The first quarter of 2018 saw a strong operational performance by the EVT Execute segment. The Aptuit integration into the Evotec Group is proceeding according to plan. In March 2018, Evotec launched the INDiGO offering, which was part of the strategic rationale behind the Aptuit acquisition. INDiGO is the market-leading integrated drug development solution that accelerates drug candidate delivery from candidate selection through to IND submission. Shortly afterwards, Evotec entered into new INDiGO alliances, e.g. with Petra Pharma and Carna Biosciences (Japan) (after period-end).

Furthermore, Evotec made significant progress within its ongoing alliances. Another promising small molecule was advanced into Phase I for the treatment of endometriosis in Evotec’s strategic Bayer endometriosis alliance (after period-end). Since the beginning of this collaboration, six first-in-class/best-in-class non-hormonal pre-clinical candidates have been generated, three of which have now advanced into Phase I clinical trials.

In addition and amongst other highlights, Evotec entered into new and extended integrated drug discovery and development agreements in the first quarter of 2018 and extended its CRISPR-based technology offering with a licence from ERS Genomics after period-end.

EVT INNOVATE – FOCUS ON ACCELERATING INNOVATION

EVT Innovate also had a very good start into 2018. Evotec continues to place a strong focus on its iPSC platform and the development of patient-centric approaches. The academic BRIDGE model is also gaining momentum. A first project was selected in LAB150 with MaRS Innovation, which was only initiated in September 2017, and three additional projects were selected in LAB282 with Oxford University (initiated in November 2016).

Furthermore, on 08 March 2018, Evotec announced that Evotec and Sanofi entered into exclusive negotiations to accelerate infectious disease research and development through a new open innovation platform led by Evotec. This transaction is expected to close in the first half of 2018, subject to finalisation of definitive agreements and completion of the appropriate social process.

3. CORPORATE
PREPARATION TO CONVERT INTO EUROPEAN COMPANY (SE)
At the end of the first quarter 2018, Evotec announced its preparations for legal conversion of the Company into a European Company (Societas Europaea, SE). The proposal, which has already been approved by the Supervisory Board, will be put to a vote at this year’s Annual General Meeting on 20 June 2018. The conversion reflects the continuing European and international focus of the Evotec Group, which has grown considerably in recent years with subsidiaries in France, Germany, Italy, Switzerland, the United Kingdom and the USA.

4. FINANCIAL GUIDANCE 2018 CONFIRMED

Guidance 2018 Actual 2017
Group revenues More than 30% growth € 257.6 m
Adjusted Group EBITDA1) Improve by approx. 30% compared to 2017 € 58.0 m
R&D expenses Approx. € 20-30 m € 17.6 m
1) EBITDA is defined as earnings before interest, taxes, depreciation, and amortisation of intangibles. Adjusted EBITDA excludes contingent considerations, income from bargain purchase and impairments on goodwill, other intangible and tangible assets as well as the total non-operating result

Webcast/Conference Call

The Company will 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 the fiscal year 2018. The cnference call will be in English.

Conference call details

Date: Wednesday, 09 May 2018

Time: 02.00 pm CEST (01.00 pm BST/08.00 am EDT)

From Germany: +49 69 22 22 29 043
From France: +33 170 750 705
From Italy: +39 023 601 3806
From UK: +44 20 3009 2452
From USA: +1 855 402 7766
Access Code: 37969784#

A simultaneous slide presentation for participants dialling in via phone is available at http://www.audio-webcast.com/, password: evotec0518.

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 22 22 33 985 (Germany) or +44 20 3426 2807 (UK) and in the USA by dialling +1 866 535 8030. The access code is 654573#. The on-demand version of the webcast will be available on our website: View Source

Epigenomics AG announces 2018 First Quarter Financial Results

On May 9, 2018 Epigenomics AG (FSE: ECX, OTCQX: EPGNY), or the "Company", reported its financial results for the first quarter 2018 ended March 31 (Press release, Epigenomics, MAY 9, 2018, View Source [SID1234526298]).

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Q1/2018 Financial results

-Total revenue slightly increased to EUR 309 thousand (Q1 2017: EUR 281 thousand) due to higher product sales (+38%).

-Operating costs increased to EUR 3.6 million (Q1 2017: EUR 3.1 million), mainly due to higher R&D expenses for the FDA required Epi proColon post approval study.

-Operating loss (EBIT) increased to EUR 3.3 million (Q1 2017: EUR 2.7 million). EBITDA (loss) before expenses for share-based compensation increased to EUR 3.2 million (Q1 2017: EUR 2.4 million).

-Net loss increased to EUR 3.2 million (Q1 2017: EUR 2.4 million). Loss per share increased to EUR 0.13 (Q1 2017: EUR 0.10).

-Cash consumption increased to EUR 2.4 million (Q1 2017: EUR 1.6 million).

-The Company’s liquidity (cash, cash equivalents and marketable securities) at the reporting date was EUR 11.2 million (Dec 31, 2017: EUR 13.7 million).

Operational highlights

-Senators Capito and Heinrich Introduce Bi-Partisan Colorectal Cancer Detection Bill: Senators Shelley Moore Capito (R -WV) and Martin Heinrich (D – NM), introduced the "Colorectal Cancer Detection Act of 2018" to the United States Senate in Washington D.C. This Senate Bill (S. 2523) is parallel to House Bill (H.R. 1578) "Donald Payne Sr. Colorectal Cancer Detection Act" introduced by Congressman Donald M. Payne, Jr. (D – NJ). These bipartisan initiatives aim to provide payment and coverage under the Medicare program for FDA-approved qualifying colorectal cancer screening blood-based tests.

-Blood test shows promise in the detection of liver cancer: Results from two clinical studies published in EBioMedicine supported by Cell Press and The Lancet, demonstrated high accuracy of Epigenomics’ proprietary epigenetic circulating biomarker mSEPT9 in detecting liver cancer among patients with cirrhosis. In the studies, the mSEPT9 test exhibited higher diagnostic accuracy than the currently established diagnostic marker. A further independent, prospective clinical study with 440 patients was initiated.

Outlook 2018 confirmed

-The Company confirms the outlook for the financial year 2018 as provided in the Annual Report 2017 published on March 23, 2018.

-Overall, we expect that revenue will increase but will remain on low levels, ranging between EUR 2.0 million and EUR 4.0 million.

-We anticipate that EBITDA before share-based payment expenses will be in a range EUR -11.5 million and EUR -14.0 million in 2018.

Further Information

The report on the first quarter 2018 can be downloaded from Epigenomics’ website at:
View Source

Conference call for analysts and investors

The Company will host a conference call and webcast at 3.30 pm CET / 9.30 am EDT, today. The presentation can be followed on the Company’s website.

The dial-in numbers for the conference call are:

Germany: +49 30 232531428
UK: +44 1635 598062
USA: +1 516-269-8980

The webcast will be made available on: View Source;lang=en

An audio replay of the conference call will be provided on Epigenomics’ website subsequently.

argenx reports first quarter 2018 financial results and provides business update

On May 9, 2018 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported financial results and provided a business update for the first quarter ended March 31, 2018 (Press release, argenx, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2347969 [SID1234526297]).

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"We made excellent progress this quarter in executing on our pipeline strategy and are well-prepared for another milestone-rich year ahead in 2018. To start with our lead program efgartigimod (ARGX-113), we presented the full data set from the Phase 2 clinical trial in myasthenia gravis at the American Academy of Neurology (AAN) Annual Meeting showing a reduction in disease scores that correlated with our understanding of the drug candidate’s mechanism. We also made headway in Europe, having received an orphan drug designation in this first indication. We remain on track to report data from two additional indications for efgartigimod, including immune thrombocytopenia and pemphigus vulgaris, in the second half of the year," commented Tim Van Hauwermeiren, CEO of argenx. "The rest of our pipeline is also progressing, including ARGX-110, where we transitioned into the Phase 2 portion of the clinical trial in newly diagnosed AML patients unfit for chemotherapy and expect to report new response data by the end of the year. We continue to look for exciting targets across our research institution partners, and showcased this in the first quarter with the addition of ARGX-117 to our pipeline, offering a new target pathway for argenx and potentially a way to add synergistic value to our efgartigimod pipeline-in-a-product approach."

FIRST QUARTER 2018 AND RECENT HIGHLIGHTS

Presented complete data from Phase 2 clinical trial of efgartigimod (ARGX-113) in generalized myasthenia gravis (MG) at the AAN Annual Meeting.
Announced orphan drug designation for efgartigimod for treatment of MG in Europe.
Initiated Phase 2 part of Phase 1/2 proof-of-concept trial of ARGX-110 (10mg/kg) in combination with azacytidine in newly diagnosed acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) patients who are unfit for chemotherapy.
Expanded pipeline with the addition of complement-targeted ARGX-117 for the treatment of severe autoimmune diseases. ARGX-117 has potential synergistic effects with our lead autoimmune compound, efgartigimod.
Received third preclinical milestone payment from collaboration with LEO Pharma following approval of a clinical trial application (CTA) filing for ARGX-112.
Announced €2.5 million grant from Flanders Innovation and Entrepreneurship (VLAIO), which will be used to examine the role and therapeutic potential of proteins involved in regulating the localized release of transforming growth factor-beta (TGF-beta).
Appointed R. Keith Woods as Chief Operating Officer.
FINANCIAL HIGHLIGHTS (as of March 31, 2018) (compared to financial highlights as of March 31, 2017)

Operating income of €6.9 million (March 31, 2017: €7.2 million).
Total comprehensive loss of €17.7 million (March 31, 2017: €8.4 million).
Cash position of €346.6 million (cash, cash-equivalents and current financial assets) (March 31, 2017: €85.0 million), allowing us to pursue development of our product candidate portfolio in line with our communicated business plan.
DETAILS OF OPERATIONAL RESULTS

Products in Clinical Development:

Efgartigimod (ARGX-113)

Presented full efficacy data from Phase 2 clinical trial of efgartigimod in generalized MG at the AAN Annual Meeting (April 24, 2018; Los Angeles). The eight-week follow-up phase shows that the administration of efgartigimod resulted in clinical improvement over placebo through the entire duration of the trial (11 weeks). Clinical benefit in the efgartigimod treatment group maximized as of one week after administration of the last dose, achieving statistical significance over the placebo group (p = 0.0356) on the Myasthenia Gravis Activity-of-Daily-Living (MG-ADL) score.
All patients in the treatment arm showed a reduction of total IgG levels. Clinically meaningful disease improvement was found to correlate with a reduction in pathogenic IgG levels.
Total IgG reduction in patients was consistent with the Phase 1 healthy volunteer trial.
Reduction of IgG levels was consistent across IgG subtypes, including AChR autoantibodies (IgG1 and IgG3).
Updated results show mean maximum IgG reduction of up to 70.7% among treated patients.
Completed enrollment in the Phase 2 clinical trial of efgartigimod in immune thrombocytopenia (ITP). Topline data are expected in the second half of 2018.
Received orphan drug designation for the use of efgartigimod for the treatment of MG, from the European Commission (EC), based on the positive opinion of the European Medicines Agency (EMA) adding to the orphan drug designation already granted in the United States.

ARGX-110

Initiated the Phase 2 part of the Phase 1/2 proof-of-concept trial of ARGX-110 in combination with standard of care azacytidine in newly diagnosed, elderly acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) patients who are unfit for chemotherapy. The Phase 2 part expects to enroll an initial 21 patients and use the selected ARGX-110 dose of 10 m/kg as determined from the dose-escalation part of the study.
Given the potential of ARGX-110 in newly diagnosed AML patients based on early data from the Phase 1/2 proof-of-concept trial, we intend to prioritize the development of ARGX-110 in AML and MDS. We will complete the ongoing Phase 2 trial of ARGX-110 in cutaneous T-cell lymphoma (CTCL), but do not expect to devote resources to its further development in this indication.
Products in Preclinical Development:

ARGX-117

Launched new pipeline candidate, ARGX-117, targeting complement cascade with therapeutic potential in autoantibody-mediated indications. ARGX-117 is a highly differentiated therapeutic antibody product candidate, equipped with the proprietary Fc engineering technology NHance, that addresses a novel target in the complement cascade. With a potentially differentiated mechanism of action, ARGX-117 represents a broad pipeline opportunity across several autoantibody-mediated indications and may have a synergistic effect with lead autoimmune compound, efgartigimod.

Collaborations

Achieved third preclinical milestone from collaboration with LEO Pharma, following approval of clinical trial application (CTA) filing for ARGX-112.
Corporate

Appointed R. Keith Woods as Chief Operating Officer. In this role, Mr. Woods will be responsible for all aspects of early commercial planning for efgartigimod, if approved, including marketing, market access, program management and supply chain operations.
UPCOMING EXPECTED MILESTONES

Report the full data of the Phase 1 healthy volunteer trial with the subcutaneous formulation of ARGX-113 during the second quarter of the year.
Report interim data of the Phase 2 proof-of-concept trial in pemphigus vulgaris and topline data of the Phase 2 proof-of-concept trial for ARGX-113 in ITP in the second half of 2018.
Report the full data of the Phase 2 proof-of-concept trial for ARGX-113 in ITP at the American Society of Haematology (ASH) (Free ASH Whitepaper) Annual Meeting.
Progress ARGX-113 into Phase 3 clinical development in generalized MG before the end of the year.
Report the full data of the AML Phase 1/2 and CTCL Phase 2 clinical trials of ARGX-110 at the ASH (Free ASH Whitepaper) Annual Meeting. (Press release, argenx, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2347969 [SID1234526297])

The Company has adopted IFRS 15 on January 1, 2018 using a modified retrospective approach. The impact of adopting IFRS 15 amounts to €0.9 million for the three months ended March 31, 2018.

DETAILS OF THE FINANCIAL RESULTS

Operating income reached €6.9 million for the three months ended March 31, 2018, compared to €7.2 million for the three months ended March 31, 2017. The decrease of €1.1 million in revenue resulted primarily from a decrease in revenue recognition linked to the forthcoming completion of the preclinical activities under our ongoing collaboration with LEO Pharma. Other operating income increased by €0.8 million, resulting mainly from (i) an increase in payroll tax rebates for employing certain research and development personnel and (ii) an increase in government grant income following the approval in March 2018 of a €2.5 million VLAIO grant to identify novel therapeutic antibodies.
For the three months ended March 31, 2018, research and development expenses totaled €15.1 million, compared to €12.2 million for the three months ended March 31, 2017. The increase of €2.9 million in research and development expenses in 2018 was principally related to (i) costs associated with a planned increase in research and development headcount and (ii) increased share-based compensation expense linked to the grant of stock options to our research and development employees (including an increase of €1.1 million of social security costs on stock options granted to certain Belgian and non-Belgian resident employees).

Selling, general and administrative expenses amounted to €5.9 million for the three months ended March 31, 2018, compared to €3.4 million for the three months ended March 31, 2017 (which included €1.3 million of expenses related to our U.S. initial public offering in May 2017). The increase in selling, general and administrative expenses in 2018 was principally due to an increase of €3.7 million of personnel expenses resulting from (i) an increase of €3.3 million in share-based compensation expense linked to the grant of stock options to our selling, general and administrative employees (including an increase of €1.5 million of social security costs on stock options granted to certain Belgian and non-Belgian resident employees) and (ii) an increase of €0.4 million for additional employees recruited to strengthen our selling, general and administrative activities.
For the three months ended March 31, 2018, financial income amounted to €0.5 million and related primarily to interest received on our cash, cash equivalents and current financial assets.
Exchange losses totaled €4.0 million on March 31, 2018, compared to €0.01 million on March 31, 2017. This increase is mainly attributable to unrealized exchange rate losses on our cash, cash equivalents and current financial assets position in U.S. dollars due to the unfavorable fluctuation of the EUR/USD exchange rate during the three months ended March 31, 2018.
For the three months ended March 31, 2018, we generated a total comprehensive loss of €17.7 million, compared to a total comprehensive loss of €8.4 million for the three months ended March 31, 2017.
On March 31, 2018, our cash, cash equivalents and current financial assets amounted to €346.6 million, compared to €359.8 million on December 31, 2017 and €85.0 million on March 31, 2017.

EXPECTED 2018 FINANCIAL CALENDAR:

August 2, 2018: Half-year 2018 business update and financial results
October 25, 2018: Q3 2017 business update and financial results

ERYTECH to Host First Quarter 2018 Conference Call and Business Update

On May 9, 2018 ERYTECH Pharma (Euronext Paris: ERYP – Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that it will host its 2018 first quarter conference call and webcast on Tuesday, May 15, 2018, at 2:30 PM CEST/8:30 AM EST to discuss operational highlights (Press release, ERYtech Pharma, MAY 9, 2018, View Source [SID1234526278]).

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The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 3498017#:

USA/Canada: +1 409 350 3501

United-Kingdom: +44 2031070289

Switzerland: +41 445802606

Germany: +49 6922224728

France: +33 176748988

Belgium: +32 24003547

Sweden: +46 856619361

Finland: +358 972519310

Netherlands: +31 207075547

Spain: +34 914142503

The webcast can be followed live online via the link: View Source

An archived replay of the call will be available for 7 days by dialing + 1 800 585 8367, Conference ID: 3498017#. An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at View Source

New Preclinical Data for Novel Immunotherapy Bispecific Candidate ALG.APV-527 presented by Alligator Bioscience and Aptevo Therapeutics

On May 8, 2018 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, and Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company focused on developing novel immuno-oncology and hematology therapeutics, reported the presentation of new preclinical data supporting ALG.APV-527 as a promising new immunotherapeutic candidate for the treatment of a variety of 5T4-expressing solid tumors (Press release, Alligator Bioscience, MAY 8, 2018, View Source [SID1234538677]).

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ALG.APV-527 is designed to simultaneously target 5T4 and the co-stimulatory receptor 4-1BB (CD137) to promote potent, tumor-directed immune T-cell activation. 5T4 is a well-defined tumor antigen expressed on many different types of malignancies including, non-small cell lung, renal, pancreas, prostate, breast, colorectal, gastric, ovarian and cervical cancers. Conversely, 5T4 has limited expression on normal tissues, making it an attractive target for cancer immunotherapy.

New ALG.APV-527 preclinical data show that ALG.APV-527 has the potential to selectively activate and enhance tumor specific T cell responses at the tumor site without triggering systemic immune activation. Notably, the preclinical in vitro and in vivo data show that ALG.APV-527:

Stimulates increased T cell activation in the presence of 5T4-expressing cells
Localizes to the site of 5T4 positive tumors in an in vivo melanoma tumor model
Inhibits tumor growth in a 5T4 expressing in vivo human colon carcinoma model
Has an extended, antibody-like serum half-life of 9 days in an experimental model
The data were recently presented at the PEGS Summit 2018 and American Association of Immunologists (AAI) annual meeting and will be presented next week at the Annual Meeting of Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper).

"Taken together, the accumulating preclinical data package for ALG.APV-527 support its potential to provide effective tumor-directed immune activation with reduced systemic side effects. We are continuing to advance this candidate and look forward to commencing clinical development in 2019," said Christina Furebring, Senior Vice President Research at Alligator.

"Our collaboration with Alligator Bioscience continues to yield encouraging data supporting the advantages of this novel pathway for targeted immunotherapy of cancer," said Jane Gross, Ph.D., Chief Scientific Officer for Aptevo. "As a first-in-class molecule, ALG.APV-527 showcases the versatility of our ADAPTIR platform in generating bispecific antibodies with unique mechanisms of action and a therapeutic profile that is more consistent with traditional antibodies, including an extended half-life, desirable antibody-like manufacturing characteristics and increased potency and stability."

Aptevo and Alligator believe that the precise targeting of 4-1BB within the tumor microenvironment can overcome some of the limitations seen with other 4-1BB therapies. ALG.APV-527 employs a novel mechanism of action, 4-1BB x 5T4 binding, to direct the therapeutic immune response towards the tumor, thereby potentially reducing the harmful side effects of systemic immune stimulation while providing a strong tumor directed immune activation.

About ALG.APV-527
ALG.APV-527 is a bispecific antibody (4-1BB x 5T4) intended for tumor-directed treatment of solid cancers. ALG.APV-527 was built using Aptevo’s ADAPTIR bispecific platform and combines binding domains sourced from the ALLIGATOR-GOLD human scFV library. The ALG.APV-527 bispecific antibody consists of two parts, one part activating tumor-specific T cells through the co-stimulatory receptor 4-1BB, the other part binding to the 5T4 protein expressed on the surface of tumor cells. This enables the immune-activating effect of ALG.APV-527 to be directed specifically to the tumor and not against normal tissue.