On May 11, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported the financial results and corporate updates for the first quarter 2021 (Press release, Evotec, MAY 11, 2021, View Source;announcements/press-releases/p/evotec-se-reports-results-for-the-first-quarter-2021-and-provides-corporate-update-6066 [SID1234579633]).

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HIGHLIGHTS
RECORD LIKE-FOR-LIKE GROWTH OF BASE BUSINESS, STRONG BALANCE SHEET SUPPORTS ACCELERATING GROWTH
Group revenues from contracts with customers increased by 11% to € 133.1 m (Q1 2020: € 119.4 m); Base business growth of 28%, adjusted for the end of the Sanofi payment (since April 2020) and unfavourable fx effects
EVT Execute revenue growth of 16% (11% adjusted for material recharges) to € 136.9 m (Q1 2020: € 118.2 m), EVT Innovate revenues up 21% (20% adjusted for material recharges) to € 28.2 m (Q1 2020: € 23.3 m)
Just – Evotec Biologics grew by more than 60% to € 9.7 m (Q1 2020: € 5.9 m)
Like-for-like growth of adjusted Group EBITDA of 16%, despite higher R&D expenses; adjusted Group EBITDA of € 21.1 m (Q1 2020: € 30.0 m) affected by the anticipated end of the Sanofi payment (since April 2020) and unfavourable fx effects
Increased expenses for unpartnered R&D of € 14.9 m (Q1 2020: € 11.4 m) according to strategy
Strong balance sheet with comfortable net debt position of € 56 m (equivalent to 0.6x EBITDA) provides significant room for financing further growth; non-operating result benefits from fair value adjustment of the investment in Exscientia Ltd.

POSITIVE DEVELOPMENT WITH SEVERAL NEW AND EXPANDED PARTNERSHIPS; JUST – EVOTEC BIOLOGICS FURTHER GAINING MOMENTUM
Multiple new and extended partnerships and alliances (e.g. with Annexon, Chinook Therapeutics, Related Sciences, Takeda, The Mark Foundation, …)
New development collaborations and INDiGO contracts signed (e.g. Riboscience, Step Pharma, …)
New iPSC-multi-year partnership with the Medical Center Hamburg Eppendorf ("UKE")
Bristol Myers Squibb extend partnership in the field of targeted protein degradation
Just – Evotec Biologics continuing on its success course: progress of the first J.POD facility in Redmond on schedule; construction of first European "J.POD 2 EU" expected to start in H2 2021
Partnership on oncology project EVT801 with Kazia Therapeutics (after period-end)
New BRIDGEs ("beLAB2122" and "beLAB1407" (after period-end))
Projects entering into clinical phases (EVT894 (Chik-V); Immuno-oncology project A2a receptor antagonist (Exscientia))

CORPORATE HIGHLIGHTS
Implementation of next long-term strategic framework Action Plan 2025 "The data-driven R&D Autobahn to Cures"
Chairman of the Supervisory Board of Evotec to retire from office effective as of the end of the Annual General Meeting on 15 June 2021 (after period-end)

GUIDANCE FOR FULL-YEAR 2021 CONFIRMED
Business outlook for 2021 confirmed and mid-term targets given for the first time
Group revenues expected to be in a range of € 550 – 570 m (€ 565 – 585 m at constant exchange rates) (2020: € 500.9 m)
Adjusted Group EBITDA expected to be in the range of € 105 – 120 m (€ 115 – 130 m at constant exchange rates) (2020: € 106.6 m)
Unpartnered research and development expenses expected to be in a range of € 50 – 60 m (2020: € 46.4 m)

INTRODUCTION OF MID-TERM GOALS ALIGNED WITH ACTION PLAN 2025
Introduction of mid-term goals until 2025 at Capital Markets Day on 20 April 2021, targeting revenues growth to > € 1,000 m, adjusted EBITDA of ≥ € 300 m and unpartnered research and development expenses of > € 100 m

Given current global insecurities surrounding the COVID-19 pandemic, a likely negative impact – though less pronounced than in 2020 – is already estimated within the guidance for revenues and adjusted EBITDA stated above. 

More detailed information and financial tables are available in our interim statement for the first quarter published on the Evotec website under the following link: View Source;

Webcast/Conference Call
The Company is going to hold a conference call to discuss the results of the first quarter 2021 as well as to provide an update on its performance in the reporting period. The conference call will be held in English

On May 10, 2021 BWXT Medical Ltd. (BWXT Medical) reported that it has entered into a new long-term, mutually exclusive agreement to manufacture TheraSphere Y-90 Glass Microspheres for Boston Scientific, a leading global medical device company (Press release, BWXT Medical, MAY 10, 2021, View Source [SID1234579625]).

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Developed for the treatment of patients with hepatocellular carcinoma (HCC), TheraSphere treatment is comprised of millions of glass microspheres containing radioactive Yttrium-90, which are delivered directly to liver tumors via catheter and result in minimal exposure to surrounding healthy tissue.

BWXT Medical is a subsidiary of BWX Technologies, Inc. (NYSE: BWXT) and a global supplier of medical isotopes and radiopharmaceuticals.

Under the terms of the agreement, BWXT Medical will invest to automate the production process at its Ottawa, Canada facility, and thereby significantly increase capacity and dependability to support a growing global demand for TheraSphere.

"We congratulate Boston Scientific on its recent receipt of FDA PMA approval of TheraSphere, which expands patient access to this unique technology," said Martyn Coombs, president of BWXT Medical. "We share the aspiration of making a significant difference in the lives of people suffering with cancer, and we look forward to continuing to build a strong supply chain foundation for future growth."

On May 10, 2021 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that dose expansion of the ongoing Phase 1/2 study (ClinicalTrials.gov Identifier: NCT03947385) evaluating the combination of darovasertib and crizotinib in metastatic uveal melanoma (MUM) (Press release, Ideaya Biosciences, MAY 10, 2021, https://www.prnewswire.com/news-releases/ideaya-announces-dose-expansion-in-phase-12-study-of-darovasertib-and-crizotinib-combination-based-on-early-clinical-efficacy-in-first-combination-cohort-301287055.html [SID1234579624]). IDEAYA is the sponsor of this combination study, which is being conducted pursuant to a clinical trial collaboration and supply agreement with Pfizer Inc. Darovasertib is IDEAYA’s clinical stage protein kinase C, or PKC, inhibitor and crizotinib is a cMET inhibitor to which Pfizer has exclusive worldwide rights.

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"We are encouraged to see the early deep partial response in the first cohort of the darovasertib and crizotinib combination. We look forward to the dose expansion phase and to continue dose exploration to clinically validate the preclinical combination hypothesis discovered by IDEAYA," said Dr. Marlana Orloff, M.D., Assistant Professor, Thomas Jefferson University Hospitals.

IDEAYA presented translational data at AACR (Free AACR Whitepaper) 2021 retrospectively evaluating cMET expression in clinical biopsies from MUM patients in a Darovasertib Phase 1 clinical trial, as well as preclinical data evaluating synergy between darovasertib and crizotinib in relevant cell models of a liver tumor microenvironment, a site of approximately 90% of uveal melanoma metastases. "We identified inhibition of the cMET signaling pathway in combination with PKC in the metastatic setting as a potential treatment regimen, and are excited to observe our first signal of clinical activity to validate this research finding," said Mick O’Quigley, Vice President, Head of Development Operations at IDEAYA Biosciences.

Darovasertib / Crizotinib Combination Therapy

IDEAYA is continuing patient enrollment into the darovasertib / crizotinib combination arm under the clinical trial collaboration and supply agreement with Pfizer. Highlights:

6 MUM patients have enrolled in the darovasertib and crizotinib combination study and 2 of these patients were evaluable for response with at least one post-baseline scan
Observed early clinical efficacy of the darovasertib and crizotinib combination in MUM. As of data and analyses cutoff on May 5, 2021 based on preliminary data from an unlocked database, these data showed:
tumor reduction in 2 of 2 evaluable patients in a first cohort
one unconfirmed partial response in a 3rd-line patient, with a 54% tumor reduction, which is the deepest response reported in the darovasertib clinical trial to date; this patient is awaiting a confirmatory scan
Drug-related adverse events observed in the darovasertib and crizotinib combination arm in MUM as of May 5, 2021, based on preliminary data from an unlocked database, primarily include: serious adverse events of syncope and hypotension, each of which resolved with patients continuing dosing; and adverse events that occurred in at least two of the six treated patients of nausea, diarrhea, vomiting, edema, decreased appetite, and syncope
Initiated dose expansion for a cohort of the Phase 1/2 darovasertib / crizotinib combination arm, with additional dose exploration ongoing
Observed preclinical synergies between darovasertib and crizotinib in relevant cellular models under conditions simulating a tumor microenvironment in the liver, the site of approximately 90% of uveal melanoma metastases, as reported at AACR (Free AACR Whitepaper) 2021
Correlated cMET expression and activation to observed clinical response based on a retrospective analysis of human clinical biopsies from the Novartis darovasertib Phase 1 clinical trial, supporting co-targeting PKC and cMET signaling

On May 10, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that it has expanded its research collaboration with Johns Hopkins University to include studies investigating the biology of a novel myeloid target that was computationally-discovered by Compugen (Press release, Compugen, MAY 10, 2021, View Source [SID1234579623]). Initial preclinical studies demonstrate the potential of this target to serve as a novel myeloid immunomodulator, with significant tumor growth inhibition observed upon genetic deletion in in-vivo studies.

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The research program, headed by Jelani Chinelo Zarif, M.S., Ph.D., Assistant Professor of Oncology and Drew Pardoll, M.D., Ph.D., Professor of Oncology, both at Johns Hopkins University School of Medicine, will explore the biological function and mechanism of this novel target, which is expressed on myeloid cells and macrophages in various cancers. The expanded research plan is intended to further evaluate and validate the role of the target in various tumors.

"We continue to invest in our early-stage programs, which serve as our pipeline growth engine and remain a high priority for Compugen," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "Our collaboration with Johns Hopkins has played an important role in the development of our clinical stage asset, COM701, and we are thrilled to expand this collaboration to deepen our biological understanding of this novel myeloid target selected from our early-stage pipeline. We hope that these studies will provide a strong biological foundation to support the future development of a new, potentially first-in-class, therapeutic program, which may diversify our immuno-oncology pipeline programs and offer a new treatment opportunity for cancer patients."

On May 10, 2021 Irish based cell engineering company, Avectas reported the publication of ‘A novel non-viral delivery method that enables efficient engineering of primary human T cells for ex vivo cell therapy applications’ in leading international cell and gene therapy publication, Cytotherapy (Press release, Avectas, MAY 10, 2021, View Source [SID1234579622]).1

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Cytotherapy is the official journal of the International Cell & Gene Therapy Society (ISCT).

Dr Shirley O’Dea et al. examined the suitability of Avectas’ SOLUPORE non-viral delivery system for engineering primary human T cells for cell therapy applications. This publication describes how the next generation of immune cell therapy products will require complex modifications using engineering technologies that can maintain high levels of cell functionality and how non-viral engineering methods such as SOLUPORE have the potential to address limitations associated with viral vectors.

Data demonstrates efficient transfection of human primary T Cells with mRNA and CRISPR CAS9 RNP cargos while consistently maintaining high levels of cell viability. Gene expression profiling revealed minimal up or down regulation of genes, demonstrating the low level of perturbation experienced by the cells during this transfection process in contrast to electroporation which resulted in substantial changes in immune gene expression. CAR T cells engineered using the SOLUPORE system exhibited high cytotoxicity against target cancer cells in vitro and in vivo.

Avectas has previously published on the SOLUPORE Technology in PLOS ONE2 with citations in both Nature Biomedical Engineering3 and Chemical Reviews4.

Commenting on the publication, Dr Michael Maguire, CEO of Avectas, said: "It is impressive to see further published evidence showing the advantages of the SOLUPORE platform in preserving cellular functionality essential for cell therapies. Congratulations to Avectas CSO, Dr Shirley O’Dea and the Avectas R&D team on this additional publication of important work to support the efficacy and potential of SOLUPORE technology to the cell and gene therapy industry."

Using its patented SOLUPORE technology, Avectas partners with leading cell and gene therapy companies and research institutions to enable the next-generation of gene-modified cell therapies.