Category: MENA

AOP Health signed an agreement with Leukos Biotech for the further development of a newly discovered chemical substance. With this agreement AOP Health expands the hemato-oncology research area even further and provides additional treatment options for certain leukemia patients in the longer term.

VIENNA, Austria, Aug. 01, 2022 (GLOBE NEWSWIRE) — The AOP Health Group (AOP Health) is a European pioneer for integrated therapies for rare diseases and in critical care headquartered in Vienna, Austria. The company focuses on research, development and global sales of innovative treatment solutions and specializes in therapies for rare diseases and intensive care. In early July, AOP Health signed an agreement with Leukos Biotech, a spin-off company founded by the Barcelona-based Josep Carreras Leukaemia Research Institute. The agreement signed by AOP Health covers the option for developments of the newly discovered chemical substance within any treatable indication, not limited to oncological or rare diseases.

Luis Ruiz-Avila, Chief Executive Officer Leukos Biotech

Agreement sets basis for new areas of therapy

At first, AOP Health will focus on the development of treatment options for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS). Both are special disease types of leukemia that often start in the bone marrow. Agnes Kohl, Chief Business Officer of AOP Orphan Pharmaceuticals GmbH, Member of the AOP Health Group explains: “Based on positive data, our plan is to expand the development for further orphan indications even outside of AML and MDS at a later stage. With this agreement, we may be able to broaden the portfolio within our therapeutic areas offering even more treatment options for patients.”

Development in cooperation with Leukos

As AOP Health focuses on rare, hemato-oncological cancers and has many years of experience in the development and commercialization of hemato-oncological treatments, the company will drive the further development of the substance in cooperation with Leukos based on a new mode of action. This could potentially turn into a milestone in the treatment of many blood cancer and other cancer patients. Luis Ruiz-Avila, Chief Executive Officer of Leukos Biotech: “We focus on developing new treatments for a wide variety of tumors. We were born to transform excellent science from the Josep Carreras Leukaemia Research Institute into valuable products for cancer patients in need, and this agreement is a very significant step in that direction. We are convinced that AOP Health is the right partner to turn this promising, novel mechanism of action into a clinical reality for the benefit of patients in a wide variety of unmet medical needs”.

About AOP Health

The AOP Health Group incorporates several companies including AOP Orphan Pharmaceuticals GmbH with its seat in Vienna, Austria (“AOP Health”). The AOP Health Group is the European pioneer for integrated therapies for rare diseases and in critical care. Over the past 25 years, the Group has become an established provider of integrated therapy solutions operating from its headquarters in Vienna, its subsidiaries and representative offices throughout Europe and the Middle East, as well as through partners worldwide. This development has been made possible by a continually high level of investment in research and development on the one hand and a highly consistent and pragmatic orientation towards the needs of all its stakeholders on the other – especially the patients and their families as well as also the healthcare professionals treating them.

About Leukos

Leukos Biotech, SL (Leukos) is a spin-off company from the Josep Carreras Leukaemia Research Institute incorporated in Barcelona in 2015. The company is developing new treatments and diagnostic tools for a wide variety of tumors targeting the serotonin receptor HTR1B, which antitumoral potential was first described and patented by Leukos’ founder Dr. Ruth Risueño in her laboratory at the Josep Carreras Research Institute. Leukos’ main financial support is from private and institutional investors. The main shareholders are Inveready, CDTI Innvierte and the Josep Carreras Foundation. Besides investors’ support, Leukos has received non-dilutive grants and loans from the Catalan Government, the Spanish Government and the European Union in various programs.

About the Josep Carreras Foundation

The Josep Carreras Leukaemia Foundation was established in 1988 with the intention of contributing to finding a definitive cure for this disease. Its efforts are concentrated on four basic areas: administering the Spanish Bone Marrow Donor Registry (REDMO), scientific research, carried out by the Josep Carreras Leukaemia Research Institute, patient guidance through an online patient consultation channel, and reception apartments for patients who need to undergo treatment and have to spend a long time far from home.

About the Josep Carreras Leukaemia Research Institute

The Josep Carreras Leukaemia Research Institute, a public centre pertaining to the Generalitat de Catalunya’s CERCA network, was established in 2010 with the aim of furthering biomedical research and personalised medicine in the field of leukaemia and other onco-hematological diseases. It is the first research centre in Europe exclusively focussed on leukaemia and malignant blood diseases, and one of the very few in the world. The Josep Carreras Institutes has three coordinated but independent scientific campuses: University of Barcelona Hospital Clínic Campus, The Catalan Institute of Oncology/Germans Trias i Pujol Campus, and the Sant Pau – Autonomous University of Barcelona (UAB) Campus

About Inveready

Inveready is a leading alternative asset manager in Spain – investing in early-stage VC, growth VC, venture debt, strategic equity in listed companies, infrastructure and private equity – providing financing solutions to companies throughout their life-cycle. Founded in 2008, Inveready counts on 200 active companies, and more than €1bn of assets under management. Inveready has been investing in companies in the Life Sciences sector since 2008. Notable investments in this vertical are Atrys Health (listed on the Spanish market), EDESA Biotech (listed on Nasdaq), AVX Pharma (sold to Aerie Biotech) and PaloBiofarma (licensing agreement with Novartis). Inveready is headquartered in San Sebastian, and has other offices in Barcelona and Madrid. It has been recognized on multiple occasions by ASCRI and Preqin for the return on its funds and transactions (For more information, visit www.inveready.com).

Mag Nina Roth, MAS
nina.roth@aop-health.com

AOP Health
Needs. Science. Trust.

AOP Orphan Pharmaceuticals GmbH
Member of the AOP Health Group

Leopold-Ungar-Platz 2, 1190 Vienna, Austria
aop-health.com

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/f096650f-dbfc-4165-854b-63345d24a713

https://www.globenewswire.com/NewsRoom/AttachmentNg/9aa481fe-91da-4609-8570-2e9a1012c392

WALTHAM, Mass and SHANGHAI, China, July 31, 2022 (GLOBE NEWSWIRE) — Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients in need around the world, announced that it has received approval of its Investigational New Drug (IND) application from the National Medical Products Administration (NMPA) of China for the initiation of a Phase 1/2 clinical study of ZB001 for the treatment of Thyroid Eye Disease (TED). The main objective of the Phase 1/2 is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZB001.

TED is a debilitating vison-threatening autoimmune disease that causes inflammation and fibrosis within the orbit of the eye. With no approved therapies for TED patients in China, treatment options are limited and often involve high doses of steroids associated with serious side effects or surgical intervention. ZB001 is a differentiated humanized monoclonal antibody targeting insulin-like growth factor 1 receptor (IGF-1R) intended for the treatment of TED.

“We are proud that the IND application for ZB001 was approved by the NMPA about two months following its submission, highlighting our team’s unique ability to efficiently execute on our development programs,” said Hua Mu, MD, PhD, Chief Executive Officer at Zenas. “We are excited to work with leading clinical experts in China to accelerate the development of ZB001 to address the significant unmet clinical need in thyroid eye disease.”

Zenas BioPharma licensed the exclusive rights to develop, manufacture and commercialize ZB001 (Viridian VRDN-001) and other compounds targeting IGF-1R in non-oncology indications in the greater China area from Viridian Therapeutics, Inc. (Viridian) in October 2020. After submitting an IND for VRDN-001 to the U.S. Food and Drug Administration in October 2021, Viridian initiated a Phase 1/2 clinical trial in December 2021 to evaluate proof of concept in TED patients in North America and released encouraging interim healthy volunteer data suggesting robust activity with excellent safety and tolerability of the candidate product.

About Zenas BioPharma

Zenas BioPharma is a global biopharmaceutical company based in the USA and China committed to becoming a leader in the development and commercialization of immune-based therapies for patients in the US, China and around the world. Zenas is rapidly advancing a deep pipeline of innovative therapeutics that continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those facing autoimmune and rare diseases. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on Twitter at @ZenasBioPharma and LinkedIn.

Investor and Media Contact:
Joe Farmer
Zenas BioPharma
IR@zenasbio.com

DURHAM, N.C., July 28, 2022 (GLOBE NEWSWIRE) — Researchers from the HIV Prevention Trials Network (HPTN) presented updated results from the HPTN 084 long-acting cabotegravir (CAB) for pre-exposure prophylaxis (PrEP) study at the AIDS 2022 conference in Montreal. New findings show reductions in HIV incidence were sustained in the 12 months following trial unblinding (November 5, 2020, through November 5, 2021).

“These results are encouraging as CAB efficacy was sustained during the 12 months following unblinding, confirming a high level of protection against HIV acquisition among study participants assigned female at birth,” said Dr. Sinead Delany-Moretlwe, HPTN 084 protocol chair, director of research at Wits RHI, and research professor at the University of the Witwatersrand in Johannesburg, South Africa.

HPTN 084 is an ongoing Phase 3 randomized, controlled trial that previously demonstrated the superiority of ViiV Healthcare’s long-acting cabotegravir compared to daily oral tenofovir/emtricitabine (TDF/FTC) for HIV prevention in individuals assigned female at birth. The blinded portion of the trial was stopped at a planned interim review in November 2020 due to evidence of superior efficacy when compared to daily oral TDF/FTC. Participants were subsequently unblinded and continued their original randomized study regimen pending a protocol amendment to offer open-label CAB.

“HIV infection continues to threaten the health of women worldwide,” said Dr. Myron Cohen, HPTN co-principal investigator, and director of the Institute for Global Health at the University of North Carolina in Chapel Hill. “Empowering women with safe and effective PrEP options is critical to reducing HIV as a global health threat.”

HPTN 084 enrolled 3,223 cisgender women at research sites in Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. Twenty-three incident infections (3 CAB, 20 TDF/FTC) were detected in the 12-month unblinded period. Of these, two (1 CAB, 1 TDF/FTC) were determined to have occurred during the blinded phase. Only one of the CAB cases (blinded phase case) had ever received an injection. An additional 83 confirmed pregnancies (43 CAB, 40 TDF/FTC) occurred in the unblinded period. No congenital anomalies were reported.

“The additional pregnancy incidence data highlight the importance of establishing the safety and pharmacology of CAB among pregnant individuals,” said Dr. Wafaa El-Sadr, HPTN co-principal investigator, director of ICAP, and professor of epidemiology and medicine at Columbia University in New York.

HPTN 084 was co-funded by NIAID, the Bill & Melinda Gates Foundation, and ViiV Healthcare. Study product was provided by ViiV Healthcare and Gilead Sciences, Inc. Three other NIH institutes also collaborated on HPTN 084: the National Institute of Mental Health, the National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

About HPTN

The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community members, and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. The U.S. National Institute of Allergy and Infectious Diseases, the U.S. National Institute of Mental Health, Office of The Director, the U.S. National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, all part of the U.S. National Institutes of Health, co-fund the HPTN. The HPTN has collaborated with more than 85 clinical research sites in 19 countries to evaluate new HIV prevention interventions and strategies in populations with a disproportionate HIV burden. The HPTN research agenda – more than 50 trials ongoing or completed with over 161,000 participants enrolled and evaluated – is focused primarily on discovering new HIV prevention tools and evaluating integrated strategies, including biomedical interventions combined with behavioral risk reduction interventions and structural interventions. For more information, visit hptn.org.

Eric Miller
HIV Prevention Trials Network (HPTN)
9193846465
emiller@fhi360.org

New Product Launch Leans Heavily on Customer Retention, Monetization and Streamlining Revenue Operations

San Francisco, Calif., July 28, 2022 (GLOBE NEWSWIRE) — Chargebee, the leading subscription management platform, today announced its Summer 2022 Product Release. The slate of new products and features is focused on enabling high-performing subscription businesses to monetize their existing customers and fend off the growing threats of a tumultuous economy. These new products help businesses build their cash reserves and maintain their customer base at a time when many businesses – and their customers – are struggling with the realities of inflation and drying up of venture capital, the lingering effects of COVID-19 and a decimated global supply chain.

The centerpiece of Chargebee’s Summer 2022 Product Release is Chargebee Retention, formerly Brightback, which along with Chargebee Receivables (numberz), and RevRec (RevLock), all acquired by Chargebee over the last 18 months, represent Chargebee’s initial foray into becoming a true multi-product company.

Chargebee Retention allows businesses to focus on keeping the customers they already have at a time when both businesses and consumers are being forced to evaluate everything in their portfolios and make difficult decisions. Chargebee Retention enables businesses to customize cancellation experiences with offers geared towards continuing the customer relationship and allows businesses to test out personalized retention-magnet strategies to minimize voluntary churn and strengthen customer lifetime value with an ROI of as much as 800%.

“For subscription businesses, acquiring new customers is at least 2.5 times more expensive than upselling or expanding an existing customer. This factor can be even higher with intelligent automation that decreases customer churn while increasing the chances of expansion,” said Mark Thomason, IDC Research Director responsible for Digital Business Models and Monetization practice. “While these retention capabilities are critical during these tumultuous times, keeping happy customers is always in vogue.”

Chargebee Receivables helps businesses improve their cash flow management processes by automating accounts receivable workflows. Subscription businesses will now be able to efficiently automate their entire accounts receivables workflow and process from purchase to payment. In addition, Chargebee Receivables also lets businesses proactively engage with customers on predicted payment failure to minimize involuntary churn and increase customer retention.

“Customer retention has become an even bigger focus for us over the past year or so,” said Bob Viscount, Vice President at Silhouette U. “The economy has changed a lot, and we’ve been looking for a solution that helps mitigate some of the cancellations we’ve been seeing.  Customers have chosen to cancel due to cost and having an option to deflect some of these cancellations with a tailored offer in the moment has been a huge boost to our business. Chargebee Retention has proven to be a value-add to our business and has allowed us to provide customers with a comprehensive review of what they’d be giving up while also leveraging offers when needed. The results in a very short amount of time have convinced me that this needs to be a critical component to our business moving forward.”

The volatility of today’s market landscape has forced businesses to become adaptable and nimble in ways they hadn’t previously expected, tinkering with package and feature offerings and providing new and different services to customers at different price points.  The new Chargebee Entitlements offers businesses more control over this new path and enables them to upsell to existing customers by showing them value. Chargebee Entitlements enables businesses to “value-test” and experiment with different packaging and pricing options, better control feature launches with roll-outs to small subsets of customers, and go to market faster. Chargebee Entitlements helps go-to-market teams provide feature access to customers beyond their plan on the flip of a switch, which can be used to incentivize plan upgrades and free-to-paid conversions.

“We’ve spent months engaging with our customers, learning the ins and outs of their businesses and working with them to determine what types of tools they want and need to face their current challenges head-on,” said John Pearce, Vice President of Product Management at Chargebee. “In those conversations, the focus almost always homed in on retaining customers, building long-lasting customer relationships and understanding how Chargebee can help businesses monetize their existing customer base. Chargebee Retention, Chargebee Receivables and Chargebee Entitlements are a direct result of our findings and our desire to give our customers exactly what they need to build and scale their businesses, even in these trying times.”

The complete list of features in Chargebee’s Summer 2022 Product Release, which also includes in-app purchase management, multi-entity management, integration with PandaDoc to manage quote-based subscription workflows, a RevRec integration that helps businesses recognize revenue in local currency and avoid challenges that hinder growth, and RevRec’s ASC 606 expense recognition, can be found here: https://www.chargebee.com/summer-release-2022/

About Chargebee

Chargebee is the subscription management platform that automates revenue operations of over 4,500 subscription-based businesses from startups to enterprises. The SaaS platform helps subscription businesses across verticals, including SaaS, eCommerce, e-learning, IoT, Publications, and more, manage and grow revenue by automating subscription billing, invoicing, payments, and revenue recognition operations, provides key metrics, reports, and business insights and now offers Chargebee Retention and Chargebee Receivables. Founded in 2011, Chargebee counts businesses, like Okta, Freshworks, Calendly, and Study.com amongst its global customer base. Learn more about Chargebee at www.chargebee.com.

Jake Katz
Chargebee
jake.katz@chargebee.com