Oncopeptides announces 26% Overall Response Rate of melflufen in triple-class refractory multiple myeloma patients from the pivotal HORIZON study

On March 26, 2020 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported the final topline results from the pivotal phase 2 HORIZON study evaluating melflufen in relapsed refractory multiple myeloma (RRMM) patients (Press release, Oncopeptides, MAR 26, 2020, View Source [SID1234555844]). These results will form the basis for the upcoming NDA for accelerated approval in the US. The application is on track for a submission to the FDA at the end of Q2 2020. Oncopeptides will host a webcast today to provide an update on the final study results at 14.00 (CET).

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The final HORIZON results represent an Overall Response Rate (ORR) improvement for triple-class refractory RRMM patients compared to the interim data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December 2019. The HORIZON results show a good efficacy and safety profile for melflufen in difficult to treat RRMM patients. The final HORIZON data reinforce Oncopeptides’ view that melflufen could play an important role in the treatment of patients with RRMM.

Primary end-point results

Primary End-Point Investigator Assessed
January 14th IRC January 14th Incl. unconfirmed responses at time of data-cut*
ORR in the ITT population (n=157) 29% 30% 31% (inv. and IRC)
ORR in triple-class refractory patients (n=119) 26% 26% 27% (inv. and IRC)
ORR in patients with Extramedullary Disease (EMD, n=55) 24% 27% NA
*Two unconfirmed responders on January 14th have later been confirmed

Data has also been reviewed by the independent review committee (IRC)
The safety profile was consistent with previous reports from the HORIZON study with primarily hematologic Adverse Events (AE) and a low incidence of non-hematologic AEs
Full results will be disclosed in a future peer-reviewed publication

Jakob Lindberg, CEO comments:
"The presentation of final data from our pivotal HORIZON study, with competitive results in triple-class refractory myeloma patients, represents the most important milestone for Oncopeptides to date. These data confirm that melflufen has a good efficacy and safety profile in triple-class refractory myeloma patients – a fast-growing patient population with significant unmet medical need and lack of approved treatments. The safety profile was consistent with previous melflufen studies with good tolerability and a low rate of non-haematological adverse events. We firmly believe that melflufen has the potential to become an important treatment option for patients with relapsed refractory multiple myeloma. Study physicians and clinical sites have been immensely supportive and with their help we are on schedule to submit the NDA for accelerated approval end of Q2 2020."

"Furthermore, with the strong final results from HORIZON our Peptide-Drug Conjugate (PDC) platform has been validated. In today’s webcast we will describe the PDC pipeline development to date and the possibilities this gives us", concludes Jakob Lindberg.

Oncopeptides will host a webcast today to present the data and provide a general clinical update at 14.00 (CET) that can be followed via the link:
View Source

Participants who would like to ask questions can use the telephone numbers below:

Sweden: + 46 8 50558358

Europe: + 44 3333009269

USA: + 1 8446251570

The presentation can be found at:
www.oncopeptides.com / Investor Relations / Presentations / Presentation webcast HORIZON Topline results /

For more information, please contact:
Jakob Lindberg, CEO of Oncopeptides
E-mail: [email protected]
Telephone: +46 8 615 20 40

Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 70 853 72 92

The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person above, on March 26, 2020 at 09.30 (CET).

About the OP-106 HORIZON study
In the pivotal phase 2 HORIZON study 157 multiple myeloma patients have been enrolled and evaluated. The study was fully recruited in October 2019 and the final data cut was made on January 14th. The patients in the study are refractory to pomalidomide and/or daratumumab after failing on immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). The HORIZON study population includes subgroups of patients who were triple-class refractory and/or had EMD and/or had cytogenetic high-risk features.

About melflufen
Melflufen (INN melphalan flufenamide) is a first-in-class anti-cancer peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

Evotec SE fiscal year 2019 results: Excellent 2019 performance; very good outlook for continued growth 2020

On March 26, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the fiscal year ended 31 December 2019 (Press release, Evotec, MAR 26, 2020, View Source;announcements/press-releases/p/evotec-se-fiscal-year-2019-results-excellent-2019-performance-very-good-outlook-for-continued-growth-2020-5917 [SID1234555843]).

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FINANCIALS REFLECT STRONG GROWTH
Group revenues up 19% to € 446.4 m (2018: € 375.4 m)
Adjusted Group EBITDA up 29% to € 123.1 m (2018: € 95.5 m)
Unpartnered R&D expenses of € 37.5 m (2018: € 22.8 m)
Liquidity position more than doubled to € 320.0 m (31 December 2018: € 149.4 m)

"ACTION PLAN 2022" ON TRACK, DESPITE MASSIVE GLOBAL INSECURITIES
Multiple new and extended strategic drug discovery and development alliances, e.g. expansion of agreement with Sanofi to create a centralised global sample management hub in Toulouse; multiyear agreement with Takeda; new precision medicine initiatives in women’s health and oncology
Continued strong performance and growth in all EVT Execute service offerings at all sites
Successful start of Just – Evotec Biologics integration; Construction and ramp-up of first J.POD in Seattle initiated; first J.POD partner MSD signed up (in January 2020)
Significant expansion and progress in partnered pipeline; e.g. positive clinical Phase II POC results in chronic cough with Bayer and several clinical Phase I & Phase II starts
Multiple important milestone achievements, e.g. in iPSC-based drug discovery alliances
Focus on "omics", machine-learning and artificial intelligence platforms in all modalities
Formation of spin-off Breakpoint Therapeutics on DNA damage response; joint venture NephThera created with Vifor Pharma focused on novel nephrology therapeutics
Academic BRIDGE model continuous to mature and gain momentum
Building a leading position in anti-infectives drug discovery and development (e.g. alliances with GARDP, GNA Now, Helmholtz, and the Bill & Melinda Gates Foundation)

FINANCIAL GUIDANCE 2020 – CONTINUED STRONG ORGANIC GROWTH
Given current global insecurities surrounding the COVID-19 pandemic, a likely negative impact is already estimated within the guidance for revenues and adjusted EBITDA stated below. It is not possible to precisely predict or quantify the potential impact on revenue and financial performance at this early stage. This uncertainty also explains the broader than usual ranges. Evotec will continue to very closely monitor the further development of this exceptional situation and update on guidance in case the situation changes materially.

Group revenues expected to be in a range of € 440 – 480 m (2019: € 446.4 m including revenues from material recharges according to IFRS 15)
Adjusted Group EBITDA expected to be on the similar level as in 2019, € 100 – 120 m (2019: € 123.1 m)
Unpartnered research and development expenses expected to be approx. € 40 m (2019: € 37.5 m)

FINANCIALS REFLECT STRONG GROWTH
In 2019, Evotec’s Group revenues increased by 19% to € 446.4 m (€ 431.9 m excl. IFRS 15) (2018: € 375.4 m / 2018 excl. IFRS 15: € 364.0 m). This increase resulted primarily from the growth performance in the base business, increased milestone payments and a positive contribution from the acquired business of Just – Evotec Biologics (€ 16.1 m) in the 2nd half of the year. Full year impact from IFRS 15 amounts to € 14.5 m (2018: € 11.4 m). In total, revenues from milestones, upfront payments and licences increased by 32% to € 39.0 m in 2019 (2018: € 29.5 m), mainly due to milestone payments from existing long-term alliances as with Bayer in endometriosis/chronic cough and kidney diseases, from Evotec’s iPSC-based collaborations with Bristol-Myers Squibb/Celgene in neurodegeneration as well as from Sanofi in diabetes.

In 2019, Evotec focused its unpartnered R&D expenses of € 37.5 m (2018: € 22.8 m) primarily on initiatives in the fields of metabolic diseases, oncology, and platform projects. Platform investments focused in particular on the continued expansion of Evotec’s industry-leading iPSC platform as well as industrialisation and integration of "omics", artificial intelligence ("AI") and machine learning, as well as data analytics platforms. Its partnered R&D expenses of € 20.9 m (2018: € 12.7 m) related to its infectious disease portfolio were predominantly reported as R&D expenses while the costs fully reimbursed by its partner Sanofi were recognised under other operating income and thus do not negatively affect the operating result or adjusted EBITDA. This split into unpartnered and partnered R&D expenses has only been applied since July 2018 when the Lyon site was acquired from Sanofi.

In 2019, the Group’s selling, general and administrative ("SG&A") expenses increased by 17% to € 66.5 m (2018: € 57.0 m). This increase resulted primarily from first full year SG&A expenses of Evotec ID Lyon, first half year contribution of Just – Evotec Biologics, higher personnel expenses due to growth and temporary staff costs due to a strengthening of the support functions, higher consultancy fees as well as M&A and financing related expenses.

In 2019, Evotec recorded impairments of intangible assets of € 11.9 m (2018: € 4.2 m) for the full impairment of SGM-1019 and related goodwill. This one-off impairment was mainly due to the termination of the SGM-1019 agreement by Evotec’s partner Second Genome.

Adjusted Group EBITDA for 2019 increased by 29% to € 123.1 m (2018: € 95.5 m), yielding an adjusted EBITDA margin of 27.6% (2018: 25.4%), mainly due to very strong performance in the base business, milestones and licence contributions, a positive EBITDA contribution by Just – Evotec Biologics and effects from the first-time application of the new accounting standard IFRS 16.

Evotec’s operating result amounted to € 62.6 m in 2019 (2018: € 77.5 m). A year-on-year comparison is not meaningful, as the 2018 result was significantly positively affected by a one-off impact from the bargain purchase ID Lyon (€ 15.4 m). The higher gross profit in 2019 was off-set by the significantly increased investments in R&D and the impairment of the intangible asset SGM-1019 and the related goodwill. The Company’s net result for the year 2019 amounted to € 37.2 m (2018: € 84.1 m) and also cannot be compared like for like as it was affected by the one-off effect of the bargain purchase in 2018 and deferred tax income.

Evotec ended the year 2019 with a liquidity of € 320.0 m (2018: € 149.4 m), which was composed of cash and cash equivalents (€ 277.0 m) and investments (€ 42.3 m). Cash and cash equivalents as well as current investments can be accessed within a period of less than three months. The increase in liquidity in 2019 resulted mainly from the issuance of the promissory note ("Schuldscheindarlehen") in the amount of € 249.1 m net and a positive operating cash flow of € 42.2 m (2018: € 156.2 m).

MID-TERM STRATEGY ON TRACK TO ACHIEVE SERVICE INCOME, MILESTONES, AND ROYALTIES
The EVT Execute segment continued to demonstrate strong progress in 2019 with new and extended alliances (e.g. Sanofi, Takeda). In 2019, Evotec was involved in 769 alliances and recorded a repeat business of 92%. Following the acquisition of Just Biotherapeutics, now Just – Evotec Biologics, in July 2019, Evotec was able to sign agreements with Teva, Biocon and, after period-end, with MSD and OncoResponse. The step into biologics is already showing significant scientific synergies and cross selling potential across the Evotec alliances.

In EVT Innovate, 2019 was characterised by important progress and strong milestone income in its strategic partnerships (iPSC neurodegeneration alliance with Bristol-Myers Squibb/Celgene; iPSC diabetes alliance with Sanofi; kidney disease and endometriosis/chronic cough alliances with Bayer) as well as the signing of new partnerships, amongst others with Galapagos in fibrosis, with the Mark Foundation in immuno-oncology, with Indivumed in oncology as well as with Bayer and Celmatix in women’s health. In July 2019, Evotec was able to report significant clinical progress within its multi-target alliance with Bayer by achieving phase II POC in chronic cough with the P2X3 antagonist BAY1817080. Evotec expects further clinical evaluation of this promising programme by Bayer in 2020. Other partnered clinical projects are progressing according to plan.

Evotec and Vifor Pharma launched NephThera, a joint venture focused on the discovery and development of novel nephrology therapeutics. Both companies will hold a 50% share (transaction closed early 2020). Furthermore, Evotec and a venture capital consortium formed the Company’s second spin-off, Breakpoint Therapeutics. The Company made further new investments in promising Biotech companies as Aeovian Pharmaceuticals, Celmatix and Immunitas Therapeutics and continued to financially support already existing holdings. Additionally, Evotec made significant progress with its leading iPSC platform as well as the industrialisation and integration of "omics", AI and machine learning, and as data analytics platforms.

In the field of anti-infectives, Evotec closed additional collaborations, e.g. kicking off "GNA Now", a new initiative for the development of novel antibacterial agents. The increasing recognition of antibiotic resistance as a growing threat to public healthcare systems enabled Evotec to receive grants for projects to further accelerate drug discovery efforts in this area of high medical need. Evotec initiated multiple partnerships with the Bill and Melinda Gates Foundation (especially in Tuberculosis).

In 2019, Evotec’s academic BRIDGE model continued to attract significant interest from academia and industry partners, leading to the building of LAB10x and LAB555.

FINANCIAL GUIDANCE 2020 – CONTINUED STRONG GROWTH
Given current global insecurities surrounding the COVID-19 pandemic, and possible future disruption of business within Evotec and our partners, guidance for 2020 has been critically assessed. However, due to the drastic and very dynamic developments in the overall economic environment since the end of February 2020 and the unforeseeable special situation triggered by the COVID-19 pandemic and its associated unknown time lines, it is not possible to precisely predict or quantify the potential impact on revenue and financial performance at this early stage. This uncertainty also explains the broader than usual ranges. Evotec will continue to very closely monitor the further development of this exceptional situation and update on guidance in case the situation changes materially.

Revenues, research and development expenses, and adjusted EBITDA remain the financial key performance indicators of the Evotec Group.

For the financial year 2020, the Management Board expects Evotec’s total Group revenues in a range of € 440 – 480 m. This anticipated revenue growth is based on visibility of the current order book, expected new contracts, contract extensions and milestone opportunities. Projections are based on constant 2019 exchange rates.

Evotec’s adjusted Group EBITDA is expected to be in the range of € 100 – 120 m despite increased R&D investments, expected loss of the Sanofi subsidy for the Toulouse site after Q1 2020 and significantly ramping up the Just – Evotec Biologics business by investing in and building highly innovative J.POD capacities in the USA.

Evotec will continue to significantly invest in its own "unpartnered" research and development (R&D) to create a long-term pipeline of first-in class assets and platforms. Evotec expects these expenses to be at approx. € 40 m. These expenses are independent of the "partnered" R&D spending in infectious diseases, which is fully covered under the Sanofi partnership.

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 2020. The conference call will be held in English.

Conference call details

Date: Thursday, 26 March 2020

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: 97681453#

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 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 201744221 (Germany) or +44 20 3364 5150 (UK) and in the USA by dialling +1 (844) 307-9362. The access code is 315578854#. The on-demand version of the webcast will be available on our website: www.evotec.com/financial-reports

Vivoryon Therapeutics AG Reports Full Year 2019 Financial Results  

On March 26, 2020 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY; ISIN: DE007921835), reported its financial results for the twelve month period ending December 31, 2019, prepared in accordance with German GAAP ("HGB") and on a voluntary basis, in accordance with IFRS as endorsed by the European Union (Press release, Vivoryon Therapeutics, MAR 26, 2020, View Source [SID1234555842]). The Financial Statements are available on the company website (www.vivoryon.com/investors-news/financial-information/).

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KEY HIGHLIGHTS – January – December 2019

USD 15 million grant from National Institutes for Health (NIH) for a US-based Phase 2b trial received, together with the Alzheimer’s Disease Cooperative Study (ADCS)
EUR 8.2 million raised from investors in successful private placement of new shares in April 2019
Probiodrug AG became Vivoryon Therapeutics AG
Vivoryon entered into a collaboration with University of Kiel to select candidates from its QPCTL inhibitor portfolio
MorphoSys and Vivoryon entered an agreement on small molecule inhibitors of CD47-SIRP alpha signaling in immuno-oncology
Vivoryon successfully completed a EUR 43 million capital raise in October 2019
Vivoryon included in AScX index

POST PERIOD HIGHLIGHTS – January – March 2020

Vivoryon and Nordic Bioscience entered research and development collaboration
Vivoryon announced update on Phase 2b Alzheimer’s clinical trial, VIVIAD

Comment from, Dr. Ulrich Dauer, Chief Executive Officer of Vivoryon Therapeutics:

"2019 proved to be a pivotal year for Vivoryon during which the Company established itself with a new name and a re-energized corporate vision unified by the same goal: to discover and develop small molecule therapeutics to meet complex medical needs. During the past 12 months, Vivoryon has undergone a corporate transformation designed to build value for shareholders, patients and collaborators and that will ultimately steer the Company toward success. Equipped with a secure financial position, strong strategic partnerships and growing clinical knowledge, Vivoryon has entered 2020 with the momentum required to reach future milestones.

First, from a financial perspective, 2019 was an important year for the Company in which securing adequate funding was particularly critical for the advancement of PQ912 in Alzheimer’s Disease. At the start of the year, we received a USD 15 million grant from the NIH. After that, the Company raised EUR 8.2 million from investors in a successful private placement of new shares in April, followed by a EUR 43 million capital raise in October. These monetary developments fortify our fiscal well-being and place us in an optimal position to continue to advance our pipeline.

Based on our clinical development efforts in 2019, we are now reaching the final stages of preparation for the European Phase 2b clinical trial, VIVIAD, testing PQ912 in patients with early-stage Alzheimer’s Disease. In parallel, the funding from the NIH will be allocated to our US Phase 2b trial in Alzheimer’s which we aim to initiate as soon as the required financial resources have been secured. Our lead candidate, PQ912 is a first-in-class inhibitor of the QPCT enzyme that addresses a very distinct disease pathway and provides a mode of action affecting multiple pathology hallmarks in contrast to many other Alzheimer’s Disease drug candidates in development. Building on positive Phase 2a data, we aim to continue to validate our approach in this complex neurodegenerative disease and look forward to initiating VIVAD in Europe within the second quarter of 2020. We expect to announce the topline results of this important trial towards the end of 2022.

The preparation for the VIVIAD trial also involved two strategic relationships that add significant value to the trial design. We kicked-off the new year by announcing our research and development collaboration with Nordic Bioscience for the clinical development of PQ912 for Alzheimer’s Disease as well as for the development of blood-based biomarkers for the identification of specific patients that may benefit most from treatment with PQ912. We also entered into a collaboration with Winterlight Labs, a company that has developed a proprietary, tablet-based technology that assesses cognitive health (including memory, thinking, and reasoning) by analyzing hundreds of language markers from short snippets of speech. This collaboration will enable Vivoryon to perform an additional non-invasive, cognitive test on patients that will further enhance the full data package from the Phase 2b European VIVIAD clinical trial. Prof. Dr. Scheltens, VU Amsterdam will act as coordinating investigator for VIVIAD.

During last year, we also made rapid progress in the immuno-oncology space as illustrated by both the collaboration with the University of Kiel as well as our option-agreement with MorphoSys. The MorphoSys relationship combines our portfolio of proprietary small molecule QPCTL inhibitors with their leading antibody technology. Both collaborations underscore the potential of our therapeutic agents as well as our ability to forge meaningful and strategic partnerships to advance our pipeline.

In closing, 2019 was a defining year for Vivoryon. I therefore want to extend our thanks to our shareholders for all the support throughout our transformation as well as to the team at Vivoryon. 2020 will bring both new opportunities and challenges and together, we have the resources and the clear objective to positively change the lives of patients battling difficult-to-treat diseases."

Details of the Financial Results (according to IFRS)

Net loss

The operating loss slightly rose in 2019 to EUR 7,715 (2018: EUR 7,698k). Research and development expenses slightly decreased to EUR 4,751k (2018: EUR 4,836). General and administrative expenses increased to EUR 3,023k (2018: EUR 2,891k). The net loss is slightly higher than last year at EUR 7,823k (2018: EUR 7,737k).

All expenditures are in line with the projections of Vivoryon Therapeutics.

Equity

The equity as of December 31, 2019 amounts to EUR 42,665k (December 31, 2018: EUR 1,230k), corresponding to an equity ratio of 93,0 %. In 2019, the share capital increased at EUR 19,975k.

Cash

The cash flow used in investing activities amounted to EUR -47k (2018: EUR 460k) consisting of costs in intangible assets and equipment. Cash and cash equivalents at year end 2018 were EUR 41,524k (2018: EUR 3,783k).

Noncurrent/ current liabilities

As of December 31, 2019, non-current liabilities amounted to EUR 2,266k (December 31, 2018: EUR 1,854k) and consist of pension obligations of EUR 1,951k (2018: EUR 1,854k ) and long-term lease liabilities in accordance with IFRS 16, which was applicable for the first time in 2019 of EUR 315k. Short-term liabilities as of December 31, 2019 of EUR 930k remained almost the same as in the previous year (December 31, 2018 EUR 964k). Trade payables of EUR 539k (2018: EUR 772k) result from the normal course of business. They have a remaining term of up to one year. The short-term lease liabilities of EUR 91k reported for the first time on December 31 also result from the first-time application of the new IFRS 16.

OUTLOOK

The mid-term focus of Vivoryon’s business activities can be summarized as follows:

Initiate Phase 2b clinical study program for PQ912 in Europe
Continue the development of PQ912 in oncology
Conclude one or more industrial partnerships
Further scientific analysis of potential indications for the use of QC inhibitors

ANNUAL FINANCIAL REPORT 2019

Vivoryon Therapeutics has finalized its financial statements for the year ended December 31, 2019 according to German GAAP ("HGB") and IFRS. The auditor KPMG has issued an unqualified auditors report for both statements. The reports are available on the company website (View Source).

FINANCIAL CALENDAR

May 14, 2020 Interim Management Statement Q1 2020
June 24, 2020 Annual General Meeting 2020
August 27, 2020 Interim Report, Half Year Results 2020
November 26, 2020 Interim Management Statement Q3 2020

CONFERENCE CALL AND WEBCAST

Vivoryon Therapeutics will host a conference call and webcast open to the public today, March 26, 2020, at 3:00 pm CET (10:00 am EDT); the presentation will also be available on the company website. The conference will be held in English. A Question & Answer session will follow the presentation of results.

To participate in the conference call, please call one of the following numbers listed below 10 minutes prior to the commencement of the webcast.

A live webcast and slides will be made available at: View Source

Approximately a day after the call, a slide-synchronized audio replay of the webcast will be available on: View Source

Innovent Biologics Enters into a Collaboration with Alector to Develop and Commercialize Anti-SIRP-alpha Antibody in China

On March 26, 2020 Innovent Biologics, Inc. ("Innovent" or the "Company") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, and Alector, Inc. ("Alector", Nasdaq ticker symbol: ALEC), a clinical stage biotechnology company and leader in the discovery and development of immune system focused therapeutics, jointly reported that they have entered into a licensing agreement to develop and commercialize an anti-SIRP-alpha antibody (Alector’s project code: AL008) for the treatment of oncology indications in China (Press release, Innovent Biologics, MAR 26, 2020, View Source [SID1234555834]).

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AL008 is Alector’s novel antibody targeting the CD47-SIRP-alpha pathway, a potent survival pathway co-opted by tumors to evade the innate immune system. AL008 is a first-in-class SIRP-alpha inhibitor with a unique dual mechanism of action that non-competitively antagonizes the CD47-SIRP-alpha pathway by inducing the internalization and degradation of the inhibitory receptor on macrophages to relieve immune suppression (a "don’t eat me signal") while also engaging Fc gamma to promote immuno-stimulatory pathways that drive anti-tumor immunity.

"Alector has been a pioneer in discovering and developing first-in-class therapeutics modulating the innate immune system since their founding and AL008 represents another successful program from their pipeline," said Dr. Michael Yu, Founder, Chairman and CEO of Innovent Biologics. "Currently, we have a successfully commercialized PD-1 inhibiting antibody, Tyvyt (sintilimab injection), targeting the adaptive immune system and we believe in the importance of modulating innate immune system in oncology as well, especially the SIRP-alpha-CD47 pathway. We believe that AL008 will complement perfectly with our current pipeline, further solidifying our position in this promising space while providing more options to patients in need."

"We are excited to enter into a collaboration with Innovent, one of the premier Chinese biologics companies, which has a fully-integrated multi-functional platform. We have been impressed with the diligence and speed that the Innovent team brings to bear to advance their development programs through clinical trials and beyond. We believe AL008 has great potential and look forward to demonstrating this in the clinic," said Dr. Arnon Rosenthal, Co-Founder and CEO of Alector. "We will be collaborating closely with Innovent to rapidly advance AL008 through clinical trials in order to get this program to benefit more patients both in China and globally."

Under the agreement, Innovent will lead the development and commercialization of the molecule in China, including the manufacturing of the product. Alector will lead development of AL008 outside of China. Financial terms are not disclosed.

About AL008

AL008 is an anti-SIRP-alpha antibody that non-competitively antagonizes the CD47-SIRP-alpha pathway by inducing the internalization and degradation of the inhibitory receptor on macrophages to relieve immune suppression (a "don’t eat me signal) while also engaging Fc gamma to promote immuno-stimulatory pathways that drive anti-tumor immunity. Tumor associated macrophages are associated with poor prognosis in many cancer types and are believed to inhibit the anti-tumor immune response. Targeting the CD47-SIRP-alpha pathway has shown activity in myeloid and lymphoid cancers, but additional agents targeting this pathway are needed to enhance activity and improve safety in solid tumors. AL008 monotherapy reduces tumor growth and enhances M1 macrophage activation in a humanized pre-clinical model. In comparison with other SIRP-alpha targeting antibodies, AL008 binds to all common alleles of SIRP-alpha and has best-in-class potency in tumor cell phagocytosis. AL008 promotes T cell function and in preclinical studies is not associated with depletion of red blood cells or platelets. These data highlight the potential potency of this differentiated mechanism of simultaneously providing immune-activating signals while removing immune-checkpoint signals and demonstrate the potential activity for AL008.

Sumitomo Dainippon Pharma Announces the Approval of RETHIO for an Additional Indication of Conditioning Treatment Prior to Autologous Hematopoietic Stem Cell Transplantation for Malignant Lymphoma

On March 25, 2020 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura hereinafter called "Sumitomo Dainippon Pharma") reported that, on March 25, 2020, it obtained approval for a partial change in the marketing approval previously acquired in Japan for RETHIO 100 mg for I.V. infusion (generic name: thiotepa; hereinafter, "RETHIO") (Press release, Sumitomo Dainippon Pharma, 25 25, 2020, View Source [SID1234605562]). The change approved at this time involves an additional indication of RETHIO for conditioning treatment prior to autologous hematopoietic stem cell transplantation (auto-HSCT) for malignant lymphoma.

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RETHIO is a drug that Sumitomo Dainippon Pharma launched on May 28, 2019, for an indication of conditioning treatment prior to auto-HSCT for pediatric malignant solid tumors. Malignant lymphoma, which is related to this additional indication, is a type of hemocytes-derived cancer in which lymphocytes, a subpopulation of leukocytes (white blood cells) become cancerous, and typically occurs in lymphoid tissues, such as lymph nodes, spleens, and tonsils, but it often develops in other sites as well. It has been reported that 34,240 persons affected with this disease in FY2016*, making it the most common hematological malignancy in Japanese adults. As with conditioning treatment prior to auto-HSCT for pediatric malignant solid tumors, for which approval was received in 2019, the Evaluation Committee on Unapproved or Off-labeled Drugs with High Medical Needs of the Ministry of Health, Labour and Welfare (MHLW) determined similarly high medical need for thiotepa in conditioning treatment prior to auto-HSCT for malignant lymphoma. Accordingly, Sumitomo Dainippon Pharma conducted Phase 1 trials in Japan and subsequently applied for approval of the additional indication.

Sumitomo Dainippon Pharma believes that this approval will allow it to offer a new treatment option for malignant lymphoma patients who need conditioning treatment prior to auto-HSCT, a therapeutic area with a high unmet medical need, thus contributing to improved healthcare.

*Cancer Incidence of Japan 2016, Cancer and Disease Control Division, Health Service Bureau, MHLW

About autologous hematopoietic stem cell transplantation (auto-HSCT)
Autologous hematopoietic stem cell transplantation is a therapy that aims to reconstruct hematopoietic capacity via intravenous transfusion of normal hematopoietic stem cells of the patient himself/herself after eradicating intractable cancers by conditioning myeloablative treatment prior to transplantation using maximum levels of anti-cancer drugs or radiation.

About the Evaluation Committee on Unapproved or Off-labeled Drugs with High Medical Needs
The Evaluation Committee on Unapproved or Off-label Drugs with High Medical Needs is a committee established to promote the development of unapproved or off-label drugs by pharmaceutical companies that are approved for use in Europe and the United States, etc., but not approved in Japan. It is organized under the MHLW of Japan and consists of academic experts in medical and pharmaceutical fields.