Global Roundup: Prota's Immunotherapy Shows Success Against Peanut Allergy
Australia-based biotech company Prota Therapeutics hit the mark in a Phase IIb study of an oral immunotherapy aimed at peanut allergies. The company said it validated significant Health-Related Quality of Life improvements in the study assessing PRT120. Data showed that 51% of children ages 1 to 10 achieved clinical remission of their allergy compared to placebo.
The company also noted that treatment with PRT120 led to a significant and substantial improvement in the quality of life for children and their families. Children and families affected by food allergies suffer severely reduced quality of life due to lifestyle restrictions imposed by the need for allergen avoidance and the unpredictability of potentially life-threatening reactions.
In its announcement, the company noted that children who achieved remission were able to stop treatment and introduce peanuts into their diet. The group of children who achieved desensitization only did not have such quality-of-life improvement.
"Improving quality of life is the most meaningful outcome for peanut allergy patients. We are very pleased to have shown such meaningful improvement in quality of life compared with standard care, exceeding minimum clinically important quality of life differences," Lead Investigator Mimi Tang, head of the Allergy Immunology Group at Murdoch Children's Research Institute said in a statement. "As well, this is the first treatment that offers a solution for every child with peanut allergy, whether they react to tiny or large amounts of peanut. This is important because all children with peanut allergy live with lifestyle restrictions, fear and anxiety caused by current management, and can benefit from treatment."
Elsewhere around the Globe:
Proteros biostructures GmbH: Based in Germany, Proteros expanded its epigenetic drug development collaboration with AstraZeneca. The new multi-year agreement builds on an ongoing collaboration with AstraZeneca announced last year and will include the development of small molecule inhibitors targeting a second cancer-associated epigenetic protein. The collaboration combines Proteros' expertise in identifying and characterizing inhibitors with novel binding mechanisms for technically challenging drug targets with AstraZeneca's leadership in the discovery and development of oncology medicines.
Under the terms of this new agreement, Proteros will receive research funding and will be eligible for success-based research, development, and commercial milestone payments of up to $75 million plus tiered royalties on annual net sales.
Affimed NV: Another Germany-based company, Affimed, announced the presentation of new data on AFM24 in a poster presentation at the Society for Natural Immunity meeting. The AFM24 presentation showed correlative science data of the exposure and pharmacodynamic effects of the compound in patients with epidermal growth factor receptor (EGFR)-expressing solid tumors from the ongoing Phase I/IIa study. The poster presentation included an analysis of the longitudinal effects of AFM24, a CD16A/EGFR‑targeting bispecific innate cell engager, in patients treated in the AFM24-101 clinical study. The data confirmed the mechanism of action of AFM24 on the innate immune system.
BioMed X: Also based in Germany, BioMed X announced the start of its Ukraine Refugees Funding Program, which supports doctoral students and master-level researchers in the life sciences who cannot continue their work at institutions in Ukraine. In collaboration with some of its partners, BioMed X aims to allow these scientists to continue their work in a research group at the BioMed X Institute in Heidelberg, Germany, for up to four years.
Inventiva: France-based Inventiva secured a €50 million bullet credit agreement with the European Investment Bank that will be used to support the development of the company's preclinical and clinical pipeline. That includes funding the company's Phase III clinical trial of lanifibranor in patients with NASH.
Osivax: Also based in France, Osivax entered into a research collaboration with the National Institute of Allergy and Infectious Diseases to conduct a preclinical evaluation combining Osivax's T-cell based influenza candidate OVX836, with a range of the NIAID Vaccine Research Center (VRC) 's influenza vaccine candidates. OVX836 is a nucleoprotein-targeting influenza vaccine developed using the company's proprietary oligoDOM technology. The company noted that immune responses produced by OVX836 involve T-cells against the nucleoprotein, a highly conserved internal antigen across flu strains, and those made by the NIAID VRC vaccine candidates involve B-cells against hemagglutinin surface antigens. As both approaches are directed to potential pandemic influenza strains, Osivax and NIAID will evaluate potential synergies between these respective immune responses and possible additive effects in animal challenge models in an effort to create improved, broad-spectrum influenza vaccines.
Avacta Group: London-based Avacta Group announced that AffyXell, its joint venture with South Korean drugmaker Daewoong Pharmaceutical, expanded its strategic partnership with GenScript ProBio. The partnership extension covers AffyXell's first drug development program and additional future programs. The collaboration covers the process development and production of viral vectors required for the production of AffyXell's future cell therapy products. In addition, as part of this strategic alliance, GenScript has now committed to taking an equity position in AffyXell at future funding rounds, and the two companies will collaborate in business development, including potential out licensing.
OKYO Pharma: Also based in London, OKYO, which is developing novel molecules to treat inflammatory dry eye diseases and ocular pain, secured $2.5 million from the pricing of an underwritten public offering of 625,000 American Depositary Shares. The company will use the funds to advance the development of its preclinical asset OK-101, a potential treatment for dry eye disease.
Vivasure Medical: Across the Irish Sea from England, Galway-based Vivasure closed the first €22 million tranches, about $23 million, as part of its Series D financing round. The round could increase to €52 million, about $54 million. The funding will support the U.S. and European clinical development and regulatory approval of the company's portfolio of fully absorbable, patch-based large-bore percutaneous vessel closure devices for transcatheter endovascular and cardiovascular procedures. The Series D was supported by Fountain Healthcare Partners, Orchestra BioMed, LSP Health Economics Fund managed by the EQT Life Sciences team, Panakès Partners and Evonik Venture Capital.
Havn Life Sciences: Based in Vancouver, Havn announced a partnership with TheraPsil, a non-profit organization dedicated to helping Canadians in medical need access legal psilocybin-assisted psychotherapy and GMP-quality psilocybin. TheraPsil will support prescribing healthcare professionals in requesting psilocybin from HAVN Life, and other licensed dealers enrolled in TheraPsil's "Project Solace," through Canada's Special Access Program. Under SAP, prescribing healthcare professionals can request psilocybin manufactured by Health Canada-approved licensed dealers for seriously-ill patients requiring emergency access to this medicine.
Revive Therapeutics – Based in Toronto, Revive has submitted a request to the U.S. Food and Drug Administration to determine an agreement on the endpoints for the Phase III study of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. The company expects to obtain an FDA agreement on the potential new primary efficacy endpoints in June. Revive Therapeutics believes that with the Omicron variant, including the BA.2 variant, being the dominant strain over the Delta variant and with COVID-19 hospitalizations in the U.S. in decline, there is an urgent unmet need to treat symptom resolutions in addition to preventing hospitalizations.
Kamada Ltd.: Israel's Kamada, which is developing specialty plasma-derived therapeutics, provided an update on the Phase III InnovAATe trial assessing the company's proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD). With the moderation of COVID-19 infections across the globe, the company is expanding its study to sites in Europe.
Quotient Limited: Based in the Channel Islands, Quotient announced the opening of its new office in Dubai. Coinciding with the office's opening, Quotient launched its subsidiary Quotient Middle-East and Africa FZ LLC to better support customers in the region.
Immunovia AB: Sweden's Immunovia announced that its U.S. subsidiary, Immunovia, Inc., received a license for its clinical laboratory from the Rhode Island Department of Health. The license will allow physicians in Rhode Island to order the IMMray PanCan-d test for patients.
Gedea Biotech: Also based in Sweden, Gedea received regulatory approval from the Ethics Committee and the Swedish Medical Products Agency and will start the EpHect clinical study of its lead product, pHyph, a vaginal tablet for topical treatment. The study is designed to assess the safety and efficacy of pHyph in adult women with confirmed Vulvo Vaginal Candidiasis and to restore a beneficial vaginal microbiome to prevent the recurrence of the infection.
Biotage: Another Swedish company, Biotage, launched Biotage Extrahera HV-5000, an automated workstation dedicated to column-based sample preparation that can aspirate and dispense high volume samples.
EpiEndo Pharmaceuticals: Iceland-based EpiEndo completed the Phase I study of EP395, a non-antibiotic macrolide being developed for the treatment of chronic obstructive pulmonary disease (COPD). EP395 was well tolerated, and with pharmacokinetics consistent with once daily dosing.