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Revolutionizing Cancer Treatment: OncoBay Clinical Joins The Leukemia & Lymphoma Society’s Beat AML® Master Clinical Trial

Raleigh, NC – April 14, 2023 | OncoBay Clinical, a leading oncology-focused full-service CRO, is pleased to announce its collaboration with The Leukemia & Lymphoma Society (LLS) on its groundbreaking Beat AML® Master Clinical Trial, the first collaborative precision medicine clinical trial for a blood cancer. Launched in 2016, it is now revolutionizing treatment for acute myeloid leukemia (AML), one of the deadliest blood cancers.

The LLS-led Beat AML® Master Clinical Trial, among the first cancer clinical trials to be sponsored by a nonprofit, brings together a broad global collaboration of the best and brightest clinicians, cancer centers, pharmaceutical companies, and operational and technology partners, all unified to fundamentally change the treatment approach to AML. The trial has generated impressive results, showing superior survival rates and better quality of life when patients receive targeted treatment matched to the genetic mutations of their cancer in place of standard chemotherapy treatment.

LLS has selected OncoBay Clinical as the clinical CRO because of its excellent track record for successfully managing complex oncology trials, utilizing the extensive know-how of its expert staff and its access to cutting-edge technology. This enables OncoBay to provide superior data-driven trial management services that ensure high-quality results for the Beat AML® Master Clinical Trial. All these factors combined make OncoBay Clinical an optimal choice for providing the services needed for the Beat AML® Master Clinical Trial.

“We are honored to have been chosen as the CRO for this groundbreaking clinical trial. OncoBay is committed to embracing new and innovative approaches to research, and we are proud that The Leukemia & Lymphoma Society, the global leader in creating a world without blood cancer, has recognized our expertise,” said Dannelle Palmer, COO of OncoBay.

“Our partners are critical to the success of the Beat AML Master Clinical Trial, and we are pleased that OncoBay Clinical is joining this unprecedented global collaboration in our quest to change the treatment paradigm for patients with acute myeloid leukemia,” said Len Rosenberg, PhD, RPh, Head of Clinical Operations at The Leukemia & Lymphoma Society. “As we continue to innovate and build on the success of this trial, we are confident that the patients enrolled will benefit from the expertise and experience of OncoBay’s team of oncology professionals and cutting-edge technology.”

This study is yet another example of OncoBay’s commitment to advancing medicine and delivering results that improve the lives of patients around the world. By partnering with The Leukemia & Lymphoma Society on this critical endeavor, OncoBay looks forward to supporting researchers, clinicians, and patients as they develop new solutions to fight cancer.

For more information on the Beat AML® Master Clinical Trial, visit www.lls.org/beataml.

About OncoBay
OncoBay Clinical is a global boutique contract research organization (CRO) specializing in immuno-oncology/cell therapy and other complex oncology programs. OncoBay offers strategic and full- service custom-curated solutions for global pharmaceutical and biotech companies looking to advance their product or device. Originated from Moffitt Cancer Center, OncoBay embeds scientific expertise, operational excellence and integration of technology including AI analytics to drive quality and data integrity. Built on years of oncology expertise, an advanced technology framework, a highly aligned site network, and a skilled team of experienced professionals, OncoBay is committed to operational excellence from start to finish. For more information, visit OncoBay.com and follow us on Facebook, Twitter and LinkedIn.

About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society® (LLS) is a global leader in the fight against blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.

Founded in 1949 and headquartered in Rye Brook, NY, LLS has regions throughout the United States and Canada. To learn more, visit LLS.org. Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.

For additional information visit lls.org/lls-newsnetwork. Follow us on Facebook, Twitter, Instagram, and LinkedIn.

LLS is one of Fast Company’s “2022 Brands That Matter.“ As the only cancer organization on the list, LLS stands out among brands around the world for its relevancy, cultural impact, ingenuity, and mission impact.

About the Beat AML® Master Clinical Trial (more…)

Hillstream BioPharma Selects OncoBay Clinical to Advance Clinical and Regulatory Development for its Lead Drug Candidate, HSB-1216, an Anti-Cancer Mechanism

OncoBay Clinical is a boutique clinical research organization (CRO) that is a subsidiary of the Moffitt Cancer Center and has extensive experience in oncology drug development

BRIDGEWATER, N.J., April 13, 2023 (GLOBE NEWSWIRE) — Hillstream BioPharma, Inc. (Nasdaq: HILS) (“Hillstream” or the “Company”), a biotechnology company developing therapeutic candidates targeting drug resistant and devastating cancers using ferroptosis, an emerging new anti-cancer mechanism resulting in iron-mediated cell death, and immuno-oncology targeted novel biologics, has selected immune-oncology clinical research organization (CRO), OncoBay Clinical, to provide comprehensive clinical and regulatory support for the clinical development program for its lead drug candidate HSB-1216.

HSB-1216, Hillstream’s most advanced candidate, utilizes ferroptosis, an emerging new anti-cancer mechanism resulting in iron-mediated cell death (IMCD) of drug-resistant cancers. As part of the agreement, OncoBay Clinical’s engagement will provide comprehensive clinical expertise across data management, statistical programming, scientific writing, regulatory affairs and clinical operations services for clinical, and observational studies. Additionally, OncoBay will leverage the support of a multitude of top scientific advisors and highly experienced teams to support Hillstream.

“OncoBay is a natural partner for us, complementing the oncological expertise of our team,” said Randy Milby, CEO of Hillstream BioPharma. “With their experience managing the complexity of oncological research programs and scientific support from the Moffitt Cancer Center, we believe that the team at OncoBay is uniquely positioned to support the advancement of the HSB-1216 development program.”

“We are excited to be partnering with Hillstream BioPharma on the development of HSB-1216,” said Krystyna Kowalczyk, President and CEO of OncoBay Clinical. “We are confident that our proven ability to succeed in managing the complexities of oncological research will enable the accelerated development of Hillstream’s HSB-1216 program and ultimately make an impact on patients.”

About OncoBay Clinical
OncoBay Clinical is a global boutique contract research organization (CRO) specializing in immuno- oncology/cell therapy and other complex oncology programs. OncoBay offers strategic and full- service custom-curated solutions for global pharmaceutical and biotech companies looking to advance their product or device. Originated from Moffitt Cancer Center, OncoBay embeds scientific expertise, operational excellence and integration of technology including AI analytics to drive quality and data integrity. Built on years of oncology expertise, an advanced technology framework, a highly aligned site network, and a skilled team of experienced professionals, OncoBay is committed to operational excellence from start to finish. For more information, visit Oncobay.com and follow us on Facebook, Twitter, and LinkedIn.

About Hillstream BioPharma, Inc.
Hillstream BioPharma, Inc. is a biotechnology company developing a focused portfolio of therapeutic candidates targeting drug resistant and devastating cancers. The Company anticipates submitting an investigational new drug application and plans to initiate a clinical study in the second half of 2023 with HSB-1216, which targets ferroptosis, an emerging new anti-cancer mechanism, resulting in iron mediated cell death (IMCD) of drug resistant cancers. The Company’s emerging immuno-oncology pipeline is led by HSB-3215, a novel anti-HER2 monoclonal antibody targeting unique epitopes with a novel mechanism of action. The erbB/HER family of cell surface proteins include well-known and validated drug targets including HER2 and HER3 found in multiple solid tumors, including breast, lung, GYN, endocrinological and CNS. For more information, please visit: www.hillstreambio.com.

Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Hillstream’s expectations, strategy, plans or intentions. These forward-looking statements are based on Hillstream’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Investors should read the risk factors set forth in our Form 10-K for the year ended December 31, 2022 and our periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Hillstream does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

OncoBay Clinical and Clinscience Partner to Expand Immuno-oncology Research Globally

OncoBay Clinical and Clinscience Partner to Expand Immuno-oncology Research Globally

TAMPA, FL – January 9, 2023

OncoBay Clinical, an oncology-focused boutique clinical research organization (CRO) initially funded by Moffitt Cancer Center, has partnered with Clinscience, a global CRO based in Warsaw, Poland. The investment gives NEUCA Group, Clinscience’s parent company, a majority stake in OncoBay. The partnership immediately unites OncoBay’s unrivaled scientific expertise and deep US clinical network with NEUCA Group’s revolutionary technology services and extensive European presence. The partnership provides a significant global footprint with physical offices in United States, Poland, Germany, Spain, Italy, and India. The new global partnership will work to advance immuno-oncology research for a global portfolio of clients.

OncoBay was formed by Moffitt in 2019 to offer streamlined, custom-curated services for biopharmaceutical and biotechnology companies conducting research in the immuno-oncology space. Since its inception, OncoBay has grown to provide services for over 60 clients, with many clinical trials being conducted in partnership with Clinscience; this new partnership builds upon a 2 year relationship between the companies.

Clinscience is a global CRO with a focus on patient centricity and data centralization that has provided its service to over 150 biotechnology clients worldwide. As part of the listed parent company, NEUCA Group, since 2015, Clinscience is known industry-wide for its data-driven procedures and approach, and for their ability to improve patient experience and retention by use of its digital-health technologies.

“This innovation collaboration gives us an exciting opportunity to build upon our clinical expertise, innovative analytics, and data-assessment tools to impact immuno-oncology research globally. The goal is to transform and accelerate discoveries to reach patients more quickly,” said Krystyna Kowalczyk, OncoBay CEO and co-founder.

“The unbound dedication to immuno-oncology, tailored solutions, and use of technology and data consistency are elements that tied our organizations right from the beginning. Our combined powers, supercharged by complementing competencies, proprietary technologies, and streamlined organizational structure, set the stage for a full-scale global alternative in the clinical research market,” said Tomek Dabrowski, Executive Chairman of Clinscience. “It allows us to further expand our abilities in cancer research providing our clients with comprehensive support in their pursuit to develop innovative cancer treatments.”

“Moffitt made an investment 3 years ago when it launched OncoBay, and in that short period of time we have taken this concept to a global entity with an international research footprint,” said James Mulé, iPhD, associate center director of Translational Science at Moffitt and OncoBay advisor. “This new partnership with Clinscience will allow us to continue to provide tailored immuno-oncology on a much larger scale.”

Kowalczyk will remain CEO of the combined OncoBay and Clinscience operation. She and Dannelle Palmer, OncoBay’s Chief Operating Officer, will also join NEUCA Group’s leadership team.

About OncoBay Clinical
OncoBay Clinical is a boutique CRO specializing in immuno-oncology (IO)/cell therapy, offering full-service custom-curated CRO solutions for global pharmaceutical and biotechnology companies looking to advance their immuno-oncology product or device. Built on years of IO and cell-therapy expertise, a streamlined technology framework, a highly trained site network, and a dedicated team of experienced professionals, OncoBay embeds scientific expertise and operational excellence into all of its projects.

About Clinscience
Clinscience is a global CRO company offering intelligent (end-to-end) CRO services, ie, from protocol creation to final study report development. More than 150 clients of Biotechnology companies in Europe and USA trust the Clinscience brand. The company has offices in Poland, Spain, Italy, Germany, and USA and provides its services in 6 European countries.

About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 53 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. With more than 7,800 team members, Moffitt has an economic impact in the state of $2.4 billion. For more information, call 1-888-MOFFITT (1-888-663-3488) or visit MOFFITT.org.

About NEUCA GROUP
The NEUCA Group has been operating in the area of healthcare for 30 years, synergistically combining the needs of pharmacists, manufacturers, and patients. It is the market leader in the wholesale distribution of pharmaceuticals in Poland. The key partners for the NEUCA Group are independent pharmacists, whom the Group supports in their daily operation of pharmacies, providing tools to build competitiveness and profitability. The NEUCA Group cares for the health of its patients by developing a network of medical clinics. It is an expert in the clinical research segment, executes ambitious telemedicine projects, and successfully operates in e commerce. It is also an experienced producer of medicines and pharmacy preparations. Since 2004, NEUCA has been a publicly company listed on the Warsaw Stock Exchange, regularly improving its financial results.

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OncoBay is now Kapadi

 

Once three entities – OncoBay Clinical, Clinscience, and Exom Group s.r.l – now we stand as one, bringing forth a symphony of expertise and seamless operations. To celebrate our unity, we re-brand under the banner of Kapadi, and embark on a new chapter of exceptional service in oncology clinical research.

Kapadi is not just a name; it's a testament to our fusion. It signifies the our standing as a global CRO powerhouse committed to accelerating groundbreaking cancer therapies that uplift patients worldwide. From conceptualizing studies, navigating regulations, and analyzing data, we provide a comprehensive array of services designed to empower your oncology clinical trials.

 

Visit Kapadi.com

 

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