iBio Establishes Oncology Drug Discovery Pipeline with Three New Antibody Programs

On July 8, 2021 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a biotech innovator and biologics contract manufacturing organization, has taken another major step towards leveraging the speed and throughput of its proprietary, plant-based FastPharming Protein Expression System by reported it is adding three anti-cancer targets to its pipeline of therapeutic candidates (Press release, iBioPharma, JUL 8, 2021, View Source [SID1234585486]). This development establishes the Company’s new drug discovery capabilities announced just a few weeks ago.

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As part of iBio’s efforts to change the drug development paradigm with the FastPharming System by reducing the time and cost to move from initial concept to the clinic, the Company intends to partner with best-in-class technology partners to help achieve that vision. Accordingly, iBio has entered into a research services agreement with FairJourney Biologics S.A. ("FairJourney"), leaders in antibody optimization. Pursuant to the agreement, iBio will gain access to novel display technologies and proprietary antibody libraries.

"We believe combining our ‘speed-to-clinic’ advantages and Glycaneering TechnologiesTM with the antibody optimization technologies provided by FairJourney may enable us to quickly develop differentiated cancer therapeutic antibodies with improved antibody-dependent cell-mediated cytotoxicity, or ADCC," said Martin B. Brenner, DVM, Ph.D., iBio’s Chief Scientific Officer.

António Parada, CEO at FairJourney commented, "Our experience in antibody discovery for use in oncology has grown in recent years, with a number of undisclosed collaborations rapidly moving towards the clinic. We are excited to work with an innovator like iBio, which we believe has the ability to change the bioprocess paradigm, using its proprietary glycosylation technologies to enhance human anti-cancer antibody development."

Updated results from phase 3 OCEAN study shows melflufen met primary endpoint of superior PFS – Overall Survival data lead to partial clinical hold

On July 8, 2021 Oncopeptides, a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported updated results and safety measures based on the head-to-head phase 3 OCEAN study evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) plus dexamethasone versus pomalidomide plus dexamethasone in patients with relapsed refractory multiple myeloma who have received 2 – 4 prior lines of therapy (Press release, Oncopeptides, JUL 8, 2021, View Source [SID1234646792]). The randomized study was initiated in 2017 and includes 495 patients from more than 100 hospitals in 21 countries around the world. The topline results were announced on May 25[th].
The updated OCEAN results follow a blinded reassessment by the Independent Review Committee (IRC). During the preparations of the clinical study report and regulatory documents it became apparent that the IRC was not provided with all the information available in the clinical database during the time of their initial assessment. This led to a thorough investigation of all 495 patients where a comparison was made between the data provided to the IRC and what data was available in the clinical database. Consequently, data from 29 patients had to be reassessed. In the final analysis melflufen met the primary endpoint of superior Progression Free Survival (PFS) compared to pomalidomide with a Hazard Ratio (HR) of 0.792 (95% CI 0.640-0.979, p-value 0.0311) as determined by the IRC.

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Overall Survival (OS) was a key secondary endpoint in the OCEAN study. The OS HR was 1.104 (0.846-1.441) in favor of pomalidomide for the Intention to Treat population. Oncopeptides has performed analyses of the OS data and the Company believes that the OS results are primarily explained by substantial HR differences between pre-specified subgroups in both directions.

Based on the observed large differences in overall survival in pre-specified subgroups, the FDA has requested a partial clinical hold of all clinical studies with melflufen, pending further investigation. Oncopeptides will co-operate closely with the FDA to expeditiously perform necessary analysis to fully understand the benefit/risk profile of melflufen and to identify what patients do benefit from treatment with melflufen in earlier lines of therapy in relapsed refractory multiple myeloma.

This update and measures will be presented at a webcast on July 8, 2021, at 11:00 (CET), log in details is available below.

For more information, please contact:

Rolf Gulliksen, Global Head of Corporate Communications, Oncopeptides AB (publ)
E-mail: [email protected]
Cell phone: + 46 70 262 96 28

Linda Holmström, Director of Investor Relations, Oncopeptides AB (publ)
E-mail: [email protected]
Cell phone: +46 70 873 40 95

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 persons above, on July 8, 2021, at 07:30 (CET).

Exact Sciences schedules second quarter 2021 earnings call

On July 8, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company plans to release its second quarter 2021 financial results after the close of the U.S. financial markets on July 28, 2021 (Press release, Exact Sciences, JUL 8, 2021, View Source [SID1234584698]). Following the release, company management will host a webcast and conference call at 5 p.m. EDT to discuss financial results and business progress.

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An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 3969691. The webcast, conference call and replay are open to all interested parties.

Alex Huybens appointed as Chief Executive Officer (CEO) of HAL Allergy Holding B.V. and HALIX B.V.

On July 8, 2021 The Supervisory Board of the HAL Allergy Group reported that it has appointed Alex Huybens as Chief Executive Officer (CEO) and Member of the Board of HAL Allergy Holding B.V., as well as CEO of HALIX B.V (Press release, HALIX, JUL 8, 2021, View Source [SID1234584699]).

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Alex Huyebsn appointed as CEO of HALIXAlex Huybens, Master of Business Administration (MBA) and with a degree in Engineering, started his career at HAL Allergy in 2003. In the following years, he took responsibility in several positions in Production, Supply Chain Management, Technical Services, Biochemistry, Microbiology and R&D functions.

"Alex Huybens is the right business leader for HAL Allergy and HALIX", says Harry Flore, Chairman of the Supervisory Board of the Group and former CEO of the Company. "Alex Huybens has a proven track record of translating business opportunities into value-creating growth."

Alex Huybens took over the role as Chief Operations Officer in the newly established HALIX B.V. creating a Contract Development and Manufacturing Organization (CDMO) for GMP-manufacturing of biologics for small- and midsized biotech companies as well as for big pharma (on BSL2 and BSL3-level). Today, HALIX is one of the leading European CDMOs producing drug substance/API for clinical trials as well as for commercial use, including the COVID-19 vaccine for AstraZeneca.

"In my role as CEO of HAL Allergy and HALIX, my focus will be on realizing the opportunities the markets are offering for us. While the further development of HALIX including the expansion
towards cell & gene therapy is on top of my list, HAL Allergy through its existing immunotherapies as well as its pipeline portfolio holds vast opportunities for us. By forming a bridge between both
companies, I want to be the number one contact for clients, partners as well as our employees."

HAL Allergy specializes in the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. With a highly competitive product portfolio, including subcutaneous and sublingual products, and a future-oriented pipeline portfolio, HAL Allergy works intensively in collaboration with the world’s allergy specialists. Through its pipeline portfolio (including AIT candidates for food, especially peanut, in clinical and preclinical stage), HAL Allergy is well-positioned to meet its growth ambitions and enhance the quality of life for millions of people.

Alex Huybens, will head the Board of Directors of the HAL Allergy Group with the co-members Florian Rösch (CCFO), Dr. Hans van Schijndel (CRDO) and Gareth West (COO).

32,884 Orion Corporation A shares converted into B shares

On July 8, 2021 Orion Corporation reported that 32,884 A shares have been converted into 32,884 B shares (Press release, Orion , JUL 8, 2021, View Source [SID1234584715]). The conversion has been entered into the Trade Register on 8 July 2021.

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The total number of shares in Orion Corporation is 141,134,278 which, after the conversion, consists of 35,006,523 A shares and 106,127,755 B shares. The number of votes of the company’s shares is after the conversion 806,258,215.