DOCSLIB.ORG

Syneos Health® Consulting Biopharma BD Newsletter

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Syneos Health® Consulting Biopharma BD Newsletter Syneos Health® Consulting BioPharma BD Newsletter February 19, 2021 2020 | H2 Overview Newsletter Despite a slowing in deal making due to economic uncertainty and deal friction caused by Content the global pandemic in H1, the biopharmaceutical industry has rebounded nicely in H2 with large increases in both deal volume and deal value. Not surprisingly, growth was driven by a focus on COVID-19 assets as well as mergers and acquisitions within the usual . H2 Deal Summary drivers of oncology and immunology therapeutic areas. We expect oncology, immunology, . H2 US IPOs and cell therapy to remain as in-demand areas for deal-makers in 2021. Additionally, the . 2020 Deal Spotlight influx of funding into the biopharma industry continues to drive an upward trend of US IPOs with 42 companies going public in H2 2020. 2020 Overview H2 Deal Summary1 HIGHLIGHTS . AstraZeneca announced that it w ould acquire Alexion for $39B, a strategic move to build a greater presence in immunology 2 . Strengthening their position in Oncology, Gilead laid out $21B to acquire Immunomedics and their lead product Trodelvy, a fir st-in- class antibody drug conjugate approved to treat triple-negative breast cancer w ith promise for additional solid tumors 3 . AstraZeneca and Daiichi Sankyo have entered a global development and commercialization collaboration agreement for oncology candidate, trastuzumab deruxtecan (DS-8201); the partnership deepens each company’s oncology portfolios 4 H2 2020 # of Deals Tot. Deal Avg. Deal No. of Deals Avg. Upfront YoY Growth Summary disclosed Value (M) Value (M) With upfront Payments % H2 2020 v. finances of payments (M) H2 2019 total Tot. Deal Value Mergers & 25 (of 41) $93,304 $2,323 17 $2,389 255% Acquisitions Partnerships 47 (of 256) $39,180 $834 36 $132 88% Asset 11 (of 70) $9,994 $909 6 $616 49% Purchases Deals by Geography WW -- | 32 | 4 NA EU 22 | 1 | 7 2 | 1 | -- APAC 1 | 13 | -- 1 Legend: Note: M&As deals used the sellers HQ country. Partnerships deals listed through the licensing territory. Asset M&A Partnerships Asset Purchases Purchases deals used either the HQ country or the licensing territory. YoY Growth only includes deals with disclosed value syneoshealth.com © 2021 All rights reserved | Confidential | For Syneos Health® use only Syneos Health® Consulting BioPharma BD Newsletter February 19, 2021 H2 2020 Deal Summary1 Value & No. of Deals by Quarter Value of Deals (M) No. of Deals 100,000 61 Deals 70 $80,026M 60 80,000 22 Deals $62,451M 50 60,000 29 Deals 40 31 Deals $37,086M 40,000 43 Deals 30 Deals 30 $29,758M $26,521M $23,591M 20 20,000 10 0 0 Q3 ‘19 Q4 ‘19 Q1 ‘20 Q2 ’20 Q3 ’20 Q4’ 20 Deal volume saw a sharp increase for Q3 YoY and a slight drop off for Q4 YoY; however, overall deal value increased mainly due to mega mergers such as the AstraZeneca acquisition of Alexion ($39B) Value & No. of Deals by Therapeutic Area H2 2020 Value of Deals (M) No. of Deals 60,000 30 Deals 30 $48,661M 50,000 3 Deals 25 $40,705M 40,000 20 30,000 15 14 Deals 3 Deals 20,000 $15,611M $14,940M 12 Deals 10 $8,967M 3 Deals 10,000 $5,950M 3 Deals 4 Deals 4 Deals 4 Deals 1 Deal 1 Deal 1 Deal 5 $2,367M $2,283M $1,530M $1,192M $211M $46M $15M 0 0 Onc Hem Neuro Auto Inf ec Inf lam Endo/Meta Hepatic Muscu Cardio Genito Ophth Gastro Driven primarily by M&As, oncology and hematology continue to see growth for both deal value and deal volume in 2020 Value & No. of Deals by Development Phase H2 2020 Value of Deals (M) No. of Deals 70,000 12 Deals 25 60,000 $56,315 20 50,000 15 40,000 9 Deals 22 Deals $27,777M $28,824M 30,000 10 18 Deals 20,000 8 Deals $11,250M $8,283M 6 Deals 4 Deals 5 10,000 1 Deal 3 Deals $1,360M $1,626M $3,748M $3,305M 0 0 Marketed Approv ed Registration Phase III Phase II Phase I Preclinical Research Undisclosed Preclinical and Phase II stages of development saw the highest volume of deals while deal value was highest for marketed products 2 Legend: Note: Therapeutic count was determined by the largest drug in the pipeline or the focus drug M&A Partnerships Asset Purchases Deal Count of the deal. The graph only includes deals with disclosed financing. syneoshealth.com © 2021 All rights reserved | Confidential | For Syneos Health® use only Syneos Health® Consulting BioPharma BD Newsletter February 19, 2021 H2 Deal Summary – Top Deals by Total Deal Value1 Top 3 Mergers & Acquisitions Tot. Deal Upfront Buyer Company Summary Value (M) Payment (M) AZ acquires Alexion to expand its immunology presence, $39,000 $39,000 ASTRAZENECA ALEXION and accelerate the companies strategic development IMMUNO- Gilead Sciences acquires Immunomedics to strengthen GILEAD $21,000 $21,000 MEDICS their oncology portfolio CBPO CHINA China Biologic merges w ith parent company CBPO $4,760 -- HOLDINGS BIOLOGICS Holdings to go private Top 3 Partnerships Tot. Deal Upfront Licenser Licensee Partnership TA Phase Value (M) Payment (M) DAIICHI Development and ASTRAZENECA $6,000 $1,000 Oncology Phase II SANKYO Commercialization License SEATTLE Development and MERCK & CO $4,475 $600 Oncology Phase II GENETICS Commercialization License DENALI Development and BIOGEN $2,150 $560 Neurology Phase I THERAPEUTIC Commercialization License Top 3 Asset Purchases Tot. Deal Upfront Buyer Seller Phase Asset Value (M) Payment (M) US GSK & Supply the US w ith 100 million doses of $2,100 $2,100 Preclinical GOVERNMENT SANOFI COVID-19 vaccine – Warp Speed US PFIZER & Pfizer & BioNTech enter supply agreement $1,950 -- Phase II GOVERNMENT BIONTECH w ith US to supply COVID-19 vaccine US Novavax receives funding to manufacture NOVAVAX $1,600 -- Phase II and supply the US w ith COVID-19 vaccine – GOVERNMENT Warp Speed 3 Legend: M&A Partnerships Asset Purchases syneoshealth.com © 2021 All rights reserved | Confidential | For Syneos Health® use only Syneos Health® Consulting BioPharma BD Newsletter February 19, 2021 H2 US IPOs – Top 20 IPOs by Amount Raised1 Ticker Amount Lead Product Date Company Therapeutic Area (NASDAQ) Raised (M) Status Complete Relay Therapeutics RLAY $460 Oncology Phase I Jul 15 Atea Pharmaceuticals AVIR $345 Infectious Disease Phase II Oct 29 AlloVir Inc. ALVR $318 Infectious Disease Phase III Jul 30 Nkarta Inc. NKTX $290 Oncology Preclinical Jul 10 Kronos Bio Inc. KRON $288 Oncology Phase II Oct 08 Kinnate Biopharma Inc. KNTE $276 Oncology Preclinical Dec 02 Dyne Therapeutics Inc. DYN $268 Musculoskeletal Preclinical Sep 16 Annexon Inc. ANNX $251 Neurology Phase I Jul 23 PMV Pharmaceuticals Inc. PMVP $244 Oncology Preclinical Sep 24 Olema Pharmaceuticals Inc. OLMA $240 Oncology Preclinical Nov 18 Shattuck Labs Inc. STTK $232 Oncology Phase I Oct 08 Poseida Therapeutics Inc. PSTX $224 Gene/Cell Therapy Phase II Jul 09 4D Molecular Therapeutics Inc. FDMT $222 Gene/Cell Therapy IND Dec 10 C4 Therapeutics Inc. CCCC $210 Oncology Preclinical Oct 01 Nurix Therapeutics Inc. NRIX $209 Oncology Preclinical Jul 23 Athira Pharma Inc. ATHA $204 Neurology Phase II Sep 17 Kymera Therapeutics Inc. KYMR $200 Inflammation Preclinical Aug 20 Praxis Precision Medicines PRAX $190 Neurology Phase II Oct 15 BioAtla Inc. BCAB $189 Oncology Phase II Dec 15 Prelude Therapeutics Inc. PRLD $182 Oncology Phase I Sep 24 Value & No. of IPOs by Quarter Value of IPOs (M) 20 IPOs No. of IPOs 4,000 19 IPOs $3,835M 25 $3,576M 22 IPOs 3,500 $3,167M 20 3,000 2,500 15 2,000 8 IPOs 1,500 12 IPOs $1,258M 10 5 IPOs $1,033M 1,000 $625M 5 500 0 0 Q3 ’19 Q4 ’19 Q1 ’20 Q2 ’20 Q3 ’20 Q4 ’20 4 Legend: Amount Raised No. Financing Data syneoshealth.com © 2021 All rights reserved | Confidential | For Syneos Health® use only Syneos Health® Consulting BioPharma BD Newsletter February 19, 2021 2020 Deal Summary – Spotlight on COVID-191 Value & No. of Deals for COVID-19 COVID-19 Deal Summary Value of Deals ($M) 2020 Summary # of Deals Tot. Deal Avg. Deal Value 37 Deals 11,500 $11,319M 40 with Value (M) (M) Disclosed 11,000 35 No. of Deals No. of Finances 30 3,000 Mergers & 1 $15 -- 2,500 25 Acquisitions 2,000 20 1,500 15 Partnerships 28 $2,624 $94 1,000 10 Asset 500 5 8 $8,680 $1,085 Purchases 0 0 COVID-19 Top 10 COVID-19 Deals Tot. Deal Value Upfront Deal Type Summary (M) Payment (M) Sanofi & GSK partner w ith US Gov. to supply US w ith 100M doses of $2,100 $2,100 Asset Purchase COVID-19 vaccines Pfizer & BioNTech enter supply agreement w ith US Gov. for COVID-19 $1,950 -- Asset Purchase vaccine candidate Novavax receives $1.6B funding from US Gov. to develop & manufacture $1,600 -- Asset Purchase COVID-19 vaccine candidate NVX-CoV2373 Moderna partners w ith US Gov. to supply 100M doses of mRNA-1273 $1,525 -- Asset Purchase vaccine to prevent COVID-19 $1,000 -- Asset Purchase J&J enters supply agreement w ith US Gov. for COVID-19 vaccine candidate BARDA partners w ith Moderna to develop mRNA-1273 vaccine against $955 -- Partnership COVID-19 Pfizer partners w ith BioNTech to co-develop and distribute BNT162, a $748 $72 Partnership mRNA-based COVID-19 vaccine Vir Biotechnology partners w ith Samsung Biologics to manufacture SARS- $362 -- Asset Purchase COV-2 antibody treatments for COVID-19 $250 -- Partnership GSK and Vir Biotechnology partner to find coronavirus solutions Novartis partners w ith Molecular Partners to develop and commercialize $231 -- Partnership MP0420 and MP0423 to treat COVID-19 infection 5 Legend: M&A Partnerships Asset Purchases syneoshealth.com © 2021 All rights reserved | Confidential | For Syneos Health® use only Syneos Health® Consulting BioPharma BD Newsletter February 19, 2021 2020 Summary1 Top Dealmakers of 2020 No.
Load more

Recommended publications
  • Darpinstm the Next Generation of Protein Drugs MP0112 – the Best
    Developing DARPin® therapies to improve health and advance modern medicine Corporate Presentation June 2015 Disclaimer NEITHER THIS DOCUMENT NOR ANY PART OR COPY OF IT NOR THE INFORMATION CONTAINED IN IT AND ANY RELATED MATERIALS MAY BE TAKEN OR TRANSMITTED INTO THE UNITED STATES OR DISTRIBUTED OR REDISTRIBUTED, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES. This presentation is not an offer to sell or a solicitation of offers to purchase or subscribe for shares of Molecular Partners AG, nor shall it or any part of it nor the fact of its distribution form the basis of, or be relied on in connection with, any contract or investment decision. This presentation is not an offering circular within the meaning of Article 652a of the Swiss Code of Obligations, nor is it a listing prospectus as defined in the listing rules of the SIX Swiss Exchange AG or a prospectus under any other applicable laws. Copies of this presentation may not be sent to countries, or distributed in or sent from countries, in which this is barred or prohibited by law. This document is not a prospectus or a prospectus equivalent document and investors should not subscribe for or purchase any securities referred to in this document. This document does not constitute a recommendation regarding the shares. This presentation contains specific forward-looking statements, beliefs or opinions, including statements with respect to the product pipelines, potential benefits of product candidates and objectives, estimated market sizes and opportunities as well as the milestone potential under existing collaboration agreements, which are based on current beliefs, expectations and projections about future events, e.g.
    [Show full text]
  • Investor Presentation
    Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Q1 2021 Results Investor presentation 1 Investor Relations │ Q1 2021 Results Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding the impact of the COVID-19 pandemic on certain therapeutic areas including dermatology, ophthalmology, our breast cancer portfolio, some newly launched brands and the Sandoz retail and anti-infectives business, and on drug development operations; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings of the Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions; or regarding the Group’s liquidity or cash flow positions and its ability to meet its ongoing financial obligations and operational needs; or regarding our collaboration with Molecular Partners to develop, manufacture and commercialize potential medicines for the prevention and treatment of COVID- 19 and our joining of the industry-wide efforts to meet global demand for COVID-19 vaccines and therapeutics by leveraging our manufacturing capacity and capabilities to support the production of the Pfizer-BioNTech vaccine and to manufacture the mRNA and bulk drug product for the vaccine candidate CVnCoV from CureVac.
    [Show full text]
  • Swiss Biotech Report – "Agility, Leadership and Innovation in the Time of COVID-19” – Is Indeed Appropriate
    SwissSwiss BiotechBiotech ReportReport 2021 2019Agility, leadership and innovation in the time of COVID-19 Schweizerische Eidgenossenschaft Confédération suisse Confederazione Svizzera Confederaziun svizra Swiss Confederation Innosuisse – Swiss Innovation Agency “The biopharma industry’s response to COVID-19 has truly been a global one – with Swiss companies and academic institutions at the forefront. Swiss-based biopharma players are contributing across the spectrum of patient needs.” George Scangos | Vir Biotechnology, Inc. “2020 was the best year ever for Swiss biotech in relation to financing activities, with a total of approximately CHF 3.4B raised” Jürg Zürcher | GSA Biotechnology Leader, EY “Compared to 2019, trading volumes rose sharply by 177% and the total free float market capitalization of all SIX-listed biotech companies was up 30% on 2020.” Fabian Gerber | SIX Agility, leadership and innovation in the time of COVID-19 “Technologies developed by scientists in Switzerland have been crucial in the fight against COVID-19, including cloning the virus, cryo electron microscopy to visualize the spike proteins, and the use of radioactive molecules that bind to receptor proteins to investigate how the virus enters the host.” Florian Fisch | Swiss National Science Foundation “On May 1 2020, Moderna and Lonza announced a strategic collaboration to enable manufacturing of up to 1 billion doses of the vaccine per year. Lonza acquired equipment and built the production lines in just 8 months.” Jan Lucht | scienceindustries “Industrial
    [Show full text]
  • Molecular Partners Reports Key Financials for H1 19 and Corporate Highlights: EMA Has Validated the Marketing Authorization Appl
    Molecular Partners reports key financials for H1 19 and corporate highlights: EMA has validated the marketing authorization application for abicipar; Focus of MP0250 on multiple myeloma with expected initiation of ph2 IMiD trial in Q4 19; MP0310 ph1 start on track for H2 19 August 27, 2019 Research & Development: MP0250 (VEGF x HGF) in MM: PI Trial (in combination with Velcade®) – Encouraging responses observed in first patient cohorts triggered decision for further investment; IMiD Trial (in combination with Pomalyst®) – Start of phase 2 trial expected in Q4 19, having received FDA approval MP0250 in EGFR-mutated Non-Small Cell Lung Cancer (EGFR-mut NSCLC) in combination with Tagrisso®: Following lift of partial clinical hold by FDA, strategic decision to discontinue phase 2 trial and focus resources on MM trials MP0274 (Her2): Phase 1 dose escalation trial in Her2-positive cancer patients progessing; first patients dosed at level of 4mg/kg MP0310 (FAP x 4-1BB): Novel Therapeutic Design for tumor-localized immune-modulator on track to dose the first patient in the phase 1 trial in H2 19 (co-development with Amgen) Research portfolio is focused on DARPin® candidates with innovative therapeutic designs, including tumor-localized FAP x CD40, peptide-MHC DARPin® binders and DARPin® T cell-engager candidates, and continues to progress according to plan Abicipar (VEGF): EMA has validated marketing authorization application for abicipar; EMA decision may be received in H2 20; US launch, following FDA filing and review, expected mid-2020; abicipar
    [Show full text]
  • UNITED STATES SECURITIES and EXCHANGE COMMISSION Washington, D.C
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of August 2021 Commission File Number: 001-40488 Molecular Partners AG (Translation of registrant's name into English) Wagistrasse 14 8952 Zurich-Schlieren Switzerland (Address of principal executive office) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [ X ] Form 40-F [ ] Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): EXHIBIT INDEX Exhibit No. Description 99.1 Press Release dated August 26, 2021 99.2 Half-Year Report SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Molecular Partners AG (Registrant) Date: August 26, 2021 /s/ PATRICK AMSTUTZ Patrick Amstutz Chief Executive Officer EXHIBIT 99.1 Molecular Partners Reports Corporate Highlights and Key Financials for H1 2021 -- Significant progress in COVID-19 trials, including positive results from healthy subjects and COVID-19 patients, supporting the launch of ongoing late-stage trials EMPATHY and ACTIV-3 Research & Development: Initiated two global Phase 2 and
    [Show full text]
  • Molecular Partners Reports Key Financials for FY 2019 and Corporate Highlights from Q4 2019
    Molecular Partners reports key financials for FY 2019 and corporate highlights from Q4 2019 January 6, 2020 Research & Development: Abicipar in Neovascular Wet Age-Related Macular Degeneration: Two-year results from CEDAR and SEQUOIA presented at AAO in October 2019 demonstrate that vision gains observed after one year with both, every 8-week and every 12-week dosing were maintained in second year FDA and EMA filings accepted and under review MP0250 (VEGF x HGF) in Multiple Myeloma: Updated data presented at ASH in December show long-lasting and deepening responses in patients with relapsed/refractory disease U.S. FDA Orphan Drug Designation received in December 2019 Previously planned clinical trial investigating MP0250 in combination with an IMiD will not be initiated, in alignment with company’s corporate strategy to pursue combination data in collaboration with a partner MP0310 / AMG 506 (FAP x 4-1BB): Dose escalation ongoing; current clinical timelines on track with additional clinical updates expected in H2 2020 MP0317 (FAP x CD40): Tumor-localized immune agonist nominated as second DARPin® protein in company’s immuno-oncology pipeline Research: Progress continues on novel therapeutic designs including tumor-localized immune-cell agonists, peptide-MHC complex DARPin® binders, and next-generation immune cell engagers Financial Highlights: Strong financial position with CHF 95.1 million in cash (incl. short-term deposits) as of December 31, 2019 Net cash used in operating activities of CHF 1.2 million in 2019 – Upfront free from Amgen (USD 50 million) reflected the majority of our investments into the pipeline Operating loss of CHF 37.2 million and net loss of CHF 36.8 million in 2019 Company funded into H2 2021, one year beyond expected FDA decision regarding Abicipar Talent base of 135 full-time employees at year-end 2019 (+15% year-on-year), reflective of growth of the company and its pipeline Zurich-Schlieren, Switzerland, February 6, 2020.
    [Show full text]
  • Switzerland's Biotech
    Switzerland’s biotech hub - a powerful source of innovation AFSSI Connexions, Convention 2019, July 2nd, Lyon Michael Altorfer CEO, Swiss Biotech Association The Swiss biotech industry is a key asset Switzerland is one of the best Local companies hold and most innovative locations leading positions throughout many for biotechnology in Europe and sectors and thus attract capital and the world researchers from all over the world The basis for this success is a In addition to being an attractive close-knit network between place to live for international research and development, driven specialists, Switzerland also offers a by renowned universities, highly modern infrastructure, a specialized SMEs and strong beneficial funding environment multinational corporations and access to a highly-qualified workforce 2 swissbiotech.org A tight cross-functional network Veterinary R&D CMO Bio-IT Analytical Therapeutics Engineering SBA member company activities Cell culture Food & industrial Medtech Biotech consulting Diagnostics Agriculture Chemicals reagents Labware Bio-equipment Non-biotech consulting 3 swissbiotech.org Swiss Biotech: Structural changes offer new investment and partnering opportunities CRO share research risk Biotech companies stay independent: CMOs take over production sites • build their commercial Clinical trials are outsourced organizations and even financed by partners • partner with distributors team up with partners Service providers start that have access to SBA member sharing risks and benefit patients company activities • combine drug and Business models not relying medical device or on product development service provider Investors go it alone, build Some Biotech companies are virtual project teams rather fully financed, eliminating the than companies need for small incremental financing rounds 4 swissbiotech.org Capital investment in Swiss biotech companies 5 Swiss Biotech Day 2019 From 2007 - 2018 Venture Kick invested CHF 3.16 million in 48 Swiss biotech startups.
    [Show full text]
  • Annual Report 2019
    ANNUAL REPORT 2019 Making the DARPin® Difference Reality for Patients At a Glance: Key Milestones, Company Profile & Contents • Advancement of balanced portfolio of differentiated DARPin® product candidates offering patients a new dimension of protein therapeutics for the treatment of serious diseases • Ongoing successful transition from a DARPin® platform company to a clinical oncology product company 2019 R&D Milestones Abicipar in Neovascular Wet Age-Related Macular Degeneration • Two-year results from CEDAR and SEQUOIA presented at AAO in October 2019 demonstrate that vision gains observed after one year with both,every 8-week and every 12-week dosing were maintained in second year • MAPLE trial with improved manufacturing process demonstrated decreased intraocular inflammation; • FDA and EMA filings accepted and under review MP0250 (VEGF x HGF) in Multiple Myeloma • Updated data presented at ASH in December show long-lasting and deepening responses in patients with relapsed/refractory disease • U.S. FDA Orphan Drug Designation received in December 2019 • Previously planned clinical trial investigating MP0250 in combination with an IMiD will not be initiated, in alignment with Group’s corporate strategy to pursue combination data in collaboration with a partner MP0274 • Phase 1 dose escalation trial in Her2-positive cancer patients progressing; first patients dosed at level of 8mg/kg MP0310 / AMG 506 (FAP x 4-1BB) • First patient cohorts dosed in phase 1 trial for this tumor-localized immune-modulator, representing a key milestone
    [Show full text]
  • Molecular Partners Announces New Clinical Data, Immunomodulation Platform Advances, and Virology Portfolio Strategy
    Molecular Partners Announces New Clinical Data, Immunomodulation Platform Advances, and Virology Portfolio Strategy December 17, 2020 First-in-human data from ongoing phase 1 study of MP0310 (AMG 506) demonstrate encouraging biological activity, including successful localized tumor engagement and saturation Data from ongoing phase 1 COVID-19 study show that MP0420 (ensovibep) is well tolerated in first dose cohort Unique immunomodulation platforms advanced to readiness for candidate generation using CD-3 T cell engagers and pMHC binders Virology portfolio launched with focus on major global viral threats where unique DARPin® therapeutic profile could make major impact Zurich-Schlieren, Switzerland, December 17, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced multiple advances across clinical and preclinical programs, as well as an expansion of its corporate strategy to develop a portfolio of therapies targeting global viral threats. These advances will be detailed during a virtual R&D Day for investors and analysts starting at 9:00 a.m. ET on Thursday, December 17. (Registration link here) “In 2020, we delivered several advances across our pipeline, including first clinical proof of a unique DARPin-mediated cancer-localized immune mechanism, de novo development and clinical entry for our COVID-19 program, and important platform advances for the design of new immunomodulatory multi-domain DARPin® molecules,” said Patrick Amstutz, Ph.D., chief executive officer of Molecular Partners. “We have dramatically expanded the capabilities of the DARPin® drug class and unlocked multiple new opportunities in immuno-oncology and virology, the latter of which we are pursuing given the momentum of our first antiviral candidates and the clear fit between the DARPin® therapeutic profile and the unmet need across multiple globally significant viral infections.” In addition to senior management, Virtual R&D Day speakers will also feature Dr.
    [Show full text]
  • Allergan and Molecular Partners Announce Topline Safety Results from MAPLE Study of Abicipar Pegol
    Allergan and Molecular Partners Announce Topline Safety Results from MAPLE study of Abicipar pegol April 2, 2019 The MAPLE study used a modified manufacturing process and demonstrated decreased intraocular inflammation Previously reported positive Phase 3 results demonstrated the potential for abicipar to be the first anti-VEGF therapy to maintain initial vision gains in all patients on a true fixed 12-week dosing interval Abicipar BLA submission to the FDA planned for first half of 2019 DUBLIN, IRELAND – April 2, 2019 – Allergan plc, (NYSE: AGN), a leading global pharmaceutical company and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of drugs known as DARPin® therapies, today announced topline safety results from MAPLE, a 28 week open-label study which enrolled 123 age-related Neovascular Macular Degeneration (nAMD) patients and evaluated the safety of abicipar produced via a modified manufacturing process. In this single arm study, treatment naïve or prior anti-VEGF treated patients received three monthly 2mg abicipar injections followed by 2mg injections every 8 weeks for up to a total of five injections through week 28. As a result of the improvements in the manufacturing process, the incidence of intraocular inflammation (IOI) was 8.9 percent in the MAPLE study, which was lower than the rate observed in prior Phase 3 studies. Most IOI events were assessed as mild to moderate in severity. The incidence of severe IOI was 1.6 percent with one reported case of iritis and one reported case of uveitis. There were no reported cases of endophthalmitis or retinal vasculitis in this study.
    [Show full text]
  • Making the Darpin® Difference Reality for Patients
    192 – 0 – 0 3 – 6 – 87 253 – 80 – 3 40 – 40 – 122 254 – 142 – 92 61 – 61 – 185 254 – 181 – 148 183 – 183 – 231 114 – 154 – 0 127 – 127 – 127 Making the 167 – 226 – 0 166 – 166 – 166 205 – 255 – 63 191 – 191 – 191 ® 229 – 255 – 155 217 – 217 – 217 DARPin Difference MP0230 PD-1/VEGF Reality for Patients MP0310 MP0274 MP0250 Patrick Amstutz, CEO Abicipar Andreas Emmenegger, CFO Presentation of the FY 2017 Financial Results February 8, 2018 – Molecular Partners AG (SIX: MOLN) © 2018 Molecular Partners AG – Slide 1 192 – 0 – 0 3 – 6 – 87 253 – 80 – 3 40 – 40 – 122 Disclaimer 254 – 142 – 92 61 – 61 – 185 254 – 181 – 148 183 – 183 – 231 This presentation is not an offer to sell or a solicitation of offers to purchase or subscribe for shares of Molecular Partners AG, nor shall it or any part of it nor the fact of its 114 – 154 – 0 127 – 127 – 127 distribution form the basis of, or be relied on in connection with, any contract or investment decision. This presentation is not an offering circular within the meaning of Article 652a 167 – 226 – 0 166 – 166 – 166 of the Swiss Code of Obligations, nor is it a listing prospectus as defined in the listing rules of the SIX Swiss Exchange AG or a prospectus under any other applicable laws. Copies of this presentation may not be sent to countries, or distributed in or sent from countries, in which this is barred or prohibited by law. This document is not a prospectus or a 205 – 255 – 63 191 – 191 – 191 prospectus equivalent document and investors should not subscribe for or purchase any securities referred to in this document.
    [Show full text]
  • Molecular Partners and Novartis Report Positive Initial Results from Phase 1 Study of Its COVID-19 Antiviral Therapy, Ensovibep, in Healthy Volunteers
    Molecular Partners and Novartis Report Positive Initial Results from Phase 1 Study of its COVID-19 Antiviral Therapy, Ensovibep, in Healthy Volunteers March 9, 2021 Initial findings show ensovibep to be safe and well tolerated with no significant adverse events Predictable exposure seen post administration, confirming the expected half-life of 2‑3 weeks Global phase 2/3 registrational study planned to initiate in Q2 2021 Zurich-Schlieren, Switzerland, March 09, 2021. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, and its collaborator Novartis, today announced initial results from its ongoing phase 1 study of its first tri-specific COVID-19 antiviral treatment, ensovibep (MP0420), in healthy volunteers. In the placebo-controlled phase 1 study, healthy volunteers were randomized 3:1 to receive an infusion of ensovibep, or placebo, respectively. Two dosing cohorts have been fully enrolled and received a single infusion of 3mg or 9mg per kilogram body weight, with 8 patients per dose cohort (16 total: 12 active, 4 placebo). In each of these cohorts, ensovibep was seen to be safe and well tolerated, with no significant adverse events reported. Preliminary results showed extended exposure of the DARPin® candidate in serum, with a half-life of 2-3 weeks, as was expected from preclinical experiments. These data confirm the systemic administration of a multi-specific DARPin® antiviral therapy to be safe and well tolerated, and support advanced plans for additional clinical work in positively diagnosed patients. “We are excited to see the predictable exposure of ensovibep in this study.
    [Show full text]