On May 10, 2021 Hamlet Pharma reported the successful outcome of the dose-escalation study, which is an extension of the Phase I/II trial. Patients with bladder cancer were treated with increasing doses of Alpha1H, following a dose-escalation protocol (Press release, HAMLET Pharma, MAY 10, 2021, View Source;utm_medium=rss&utm_campaign=marked-increase-in-tumor-response-with-higher-doses-of-alpha1h [SID1234579587]). The initial data analysis has revealed a dramatic increase in the tumor response to Alpha1H, measured both as shedding of tumor fragments into the urine and as changes in remaining tumor tissue.
Hamlet Pharma has previously reported the successful completion of the Phase I/II bladder cancer study using a 1.7 mM dose of Alpha1H. We have now performed a dose-escalation study, using 8.5 or 17 mM, i.e. five or ten times higher doses in patients with superficial bladder cancer.

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Alpha1H triggered massive shedding of tumor cells and tumor fragments into patient urine. A dose-dependent increase was demonstrated, resulting in significantly higher shedding than in the first study (P<0.0001). As shown earlier, significant cell shedding did not occur in the placebo group, supporting a treatment effect.

Major effects on tumor tissue were detected by histopathology of tumor biopsies, obtained at surgery after the end of treatment. Tumor fragmentation and shedding of tumor fragments was visible and the remaining tumor showed a loss of viability, with large areas of cells undergoing apoptosis or necrosis.

Apoptosis is a beneficial, non-toxic form of cell death, and a desirable outcome to limit the side effects of cancer therapy. In addition to the apoptotic changes in the tumors, a pronounced apoptotic response was detected in cells and tumor fragments shed by the treated patients, confirming that Alpha1H accelerates cell death in the tumor.

Furthermore, the tumor fragments in urine were shown to contain large amounts of Alpha1H, confirming the efficiency with which the higher doses of Alpha1H reach tumor tissue. The results suggest that uptake of Alpha1H by the tumor triggers apotosis, tumor fragmentation and release of the affected tumor fragments by shedding into the urine.

"The dose-dependent increase in tumor response is dramatic and provides further motivation to develop Alpha1H for therapeutic use in bladder cancer," says Catharina Svanborg, founder and chairman of the board of Hamlet Pharma Ltd.

"The results support our strategy to develop Alpha1H for Phase III trials" says Mats Persson, CEO of Hamlet Pharma Ltd.

On May 10, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that the Company intends to release its first quarter 2021 financial results on Monday, May 17, 2021 (Press release, Onconova, MAY 10, 2021, View Source [SID1234579605]). Management plans to host a conference call and live webcast at 4:30 p.m. ET on that day to discuss these results and provide an update on its pipeline programs.

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Conference Call and Webcast Information
Interested parties who wish to participate in the conference call may do so by dialing (855) 428-5741 for domestic and (210) 229-8823 for international callers and using conference ID 4895447.

Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.

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 Flow Eighteen38 and FairJourney Biologics S.A. (FJB), leaders in the discovery and optimization of antibodies, have reported an agreement with the Hubrecht Institute to harness the potential of FJB’s proprietary llama naïve libraries to develop antibodies to be used as research tools for the group of Hans Clevers (Press release, FairJourney Biologics, MAY 10, 2021, View Source [SID1234580202]).

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The Clevers group dedicates its activity to the study of the molecular mechanisms of tissue development and cancer of various organs using organoids made from adult Lgr5 stem cells. Under the agreement, Flow Eighteen38/FJB will provide the Clevers group at the Hubrecht Institute with research tools, arising from an accelerated antibody research campaign, that will support the group’s future scientific developments.

The reagent antibodies generated by Flow Eighteen38/FJB for the Hubrecht Institute comply with the recent EU recommendations on Non-Animal-derived antibodies and will be derived from FJB’s proprietary llama naïve libraries through its phage display technology platform. The Clevers group will benefit from the combination of this technology and the increased speed of delivery from this innovative approach, thought and optimized by the experienced scientists at Flow Eighteen38/FJB.

António Parada, CEO of FairJourney Biologics commented: "Our experience in antibody development has been continuously reinforced throughout the years and our reagent antibodies platform is proving to be essential for the swift generation of unparalleled research tools. We look forward to supply the Clevers group at the Hubrecht Institute with robust reagents that can contribute to further scientific developments in their cancer organoids studies."

Hans Clevers, Principal Investigator at the Hubrecht Institute commented: "The development of novel and more suitable antibodies presents itself as an advantageous approach for the next generation of research tools. FairJourney Biologics’ experience in antibody discovery, combined with the speed of Flow Eighteen38’s reagent antibodies program, makes them ideal partners as we focus on finding novel research tools that can leverage our stem cell-based organoids platform."

On May 10, 2021 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, reported financial results for the first quarter ended March 31, 2021 and provided a business update (Press release, Allakos, MAY 10, 2021, View Source [SID1234579543]).

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Recent Accomplishments

Announced the acceptance of two oral and five poster presentations at the Digestive Disease Week (DDW) Annual Meeting taking place May 21 to 23, 2021. ePosters and ePapers will be available from the DDW ePosters and ePapers website. Abstracts can now be found here.
Initiated a randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with eosinophilic duodenitis.
Upcoming 2021 Milestones

Topline data from a randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) expected in the fourth quarter of 2021.
Topline data from a randomized, double-blind, placebo-controlled Phase 2/3 study of lirentelimab in patients with eosinophilic esophagitis (EoE) expected in the fourth quarter of 2021.
Initiation of a randomized, double-blind, placebo-controlled Phase 2/3 study of subcutaneous lirentelimab in patients with EG and/or EoD expected in the second half of 2021.
Initiation of a Phase 2 study in a non eosinophilic gastrointestinal disease in the second half of 2021.
First Quarter 2021 Financial Results

Research and development expenses were $38.9 million in the first quarter of 2021 as compared to $18.3 million in the same period in 2020, an increase of $20.6 million.

General and administrative expenses were $16.7 million in the first quarter of 2021 as compared to $11.6 million in the same period in 2020, an increase of $5.1 million.

Allakos reported a net loss of $55.6 million in the first quarter of 2021 as compared to $27.8 million in the same period in 2020, an increase of $27.8 million. Net loss per basic and diluted share was $1.04 for the first quarter of 2021 compared to $0.57 in the same period in 2020.

Allakos ended the first quarter of 2021 with $615.9 million in cash, cash equivalents and marketable securities.