On June 16, 2021 Marker Therapeutics, a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that its Chief Financial Officer, Anthony H. Kim, will present at the upcoming virtual Raymond James Human Health Innovation Conference on Monday, June 21, 2021 at 9:20 a.m. ET (Press release, Marker Therapeutics, JUN 16, 2021, View Source [SID1234584079]).

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A live webcast of the presentation will be accessible from the Investors section of the company’s website at markertherapeutics.com and will be available for replay following the event.

On June 16, 2021 A1 Medical Imaging’s Chief Operating Officer, Marilyn Radakovic, applauded recent research that indicates magnetic resonance imaging (MRI) is effective in detecting interval breast cancers in women with a prior history of the disease (Press release, A1 Medical Imaging, JUN 16, 2021, View Source [SID1234584078]).

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The research that was published June 8, 2021, in the Radiology journal concluded that breast MRI has been shown to improve the early detection of recurrent breast cancers that may be missed by mammography.

The study took place between January 2008 and March 2019 and involved 2,809 women with a median age of 47 years who had undergone surgery because of breast cancer. In all, 6,603 MRI examinations were conducted.

"According to the report, the purpose of the research was to evaluate the screening of breast MRI in women with a personal history of breast cancer who might be at more risk for what’s known as interval breast cancers or IBC," Radakovic stated. "IBC is the cancer detected after a normal screening mammogram, but before the next scheduled mammogram."

Mammograms are low-dose X-rays of the breast. Regular mammograms are recommended to find breast cancer early, when treatment is most successful. However, mammograms may not be the best option for women who are at high risk.

A breast MRI is a noninvasive technology that uses strong magnets instead of radiation to make very detailed, cross-sectional pictures of the breast. It is much more sensitive than mammography and can find invasive breast cancers sooner than mammograms. It can also rule out abnormalities that appear suspicious on a mammogram.

Peter Solodko, A1 Medical Imaging’s Chief Executive Officer, commented, "This research indicates that breast MRIs can detect early stages of cancer better than mammography in women with a past history of breast cancer."

Radakovic added, "This research confirms the effectiveness of breast MRIs and provides encouraging hope for women who are at high risk of recurring cancer."

A1 Medical Imaging has open MRI centers throughout Florida and in Georgia and provides breast MRI screenings at its Aventura, Pembroke Pines, Plantation and Orange Park locations in Florida. Visit www.A1mri.com to learn more.

On June 16, 2021 The Pancreatic Cancer Action Network (PanCAN), a leading pancreatic cancer advocacy organization, reported that the latest update to its novel clinical trial platform, Precision PromiseSM, with the addition of a new treatment arm by biopharmaceutical company, FibroGen, Inc(Press release, PanCAN, JUN 16, 2021, View Source [SID1234584077]).

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Pancreatic cancer is currently the third leading cause of cancer-related death in the U.S., with an overall five-year survival rate of just 10 percent. Roughly 63 percent of patients die within the first year of a pancreatic cancer diagnosis, underscoring the urgent need for new and more effective treatment options.

The new experimental treatment arm tests FibroGen’s pamrevlumab in combination with standard of care chemotherapy treatments for pancreatic cancer, Gemcitabine and Abraxane. The combination therapy is offered to patients with metastatic pancreatic cancer as either a first- or second-line treatment option, marking the first experimental treatment arm to be offered as a first-line treatment in PanCAN’s innovative Precision Promise trial. With this addition, a newly diagnosed patient enrolling in Precision Promise has the opportunity to be randomized onto an experimental therapy as their first-line treatment, and then onto another experimental therapy as their second-line treatment if they maintain eligibility when the first treatment becomes no longer effective.

"By partnering with FibroGen to bring a first-line experimental treatment arm into Precision Promise, we are expanding options for the patients enrolling in this trial," said Anne-Marie Duliege, MD, PanCAN’s Chief Medical Officer. "It is one of PanCAN’s major objectives to continue to bring innovative, experimental drugs like FibroGen’s pamrevlumab into this study in order to accelerate drug development and hopefully bring new therapies to market faster. Pancreatic cancer patients can’t afford to wait."

FibroGen’s pamrevlumab is a first-in-class antibody that inhibits the activity of connective tissue growth factor (CTGF), which, in cancer, is characterized by promotion of tumor growth. Pamrevlumab is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC).

"We are inspired by the mission of the Pancreatic Cancer Action Network and are excited to partner with them," said Mark Eisner, M.D, M.P.H, Chief Medical Officer, FibroGen. "We share PanCAN’s goal of accelerating the development of new treatment options for pancreatic cancer patients."

PanCAN’s Precision Promise aims to revolutionize the clinical development paradigm in pancreatic cancer by enabling a faster, more efficient, and patient-centric approach to developing new treatment options and improving outcomes for pancreatic cancer patients.The novel clinical trial platform requires fewer patients to understand if a potential new therapy is working and can accelerate late stage development by up to two years. The statistical design of Precision Promise was led by renowned statistician Dr. Donald Berry (Berry Consulting), designer of the I-SPY breast cancer trials.

Precision Promise is currently open and enrolling at 15 Clinical Trial Consortium sites nationwide and PanCAN expects to add five additional sites in early 2022. In selecting the additional sites, PanCAN has set strict criteria to identify not only institutions with strong pancreatic cancer programs, but also institutions that represent new geographic areas and serve a diverse patient population in order to expand access for typically underserved communities.

To learn more about Precision Promise and PanCAN’s commitment to research, visit pancan.org. Pancreatic cancer patients and caregivers can receive personalized support and resources, and more information about Precision Promise, through PanCAN’s Patient Services or by calling 877-2-PANCAN.

On June 16, 2021 Debiopharm (www.debiopharm.com), a Swiss-based global biopharmaceutical company and Ubix Therapeutics (en.ubixtrx.com), a South Korea-based biotech company reported their co-research agreement combining two novel proprietary technologies to specifically target cancer cells(Press release, Debiopharm, JUN 16, 2021, View Source;antibody-degraducer-conjugates-301313560.html [SID1234584076]). The two companies are aiming to develop a new drug modality known as Antibody Degraducer Conjugates (ADeC), by combining one of Ubix’s Degraducer molecule, with Debiopharm’s antibody drug conjugate linker Multilink. Degraducer linked to therapeutic antibodies via Multilink will improve drug targeting and could have a synergistic effect on tumor cells, thereby resulting in improved efficacy and safety of cancer therapies.

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Cancer treatment has been revolutionized by antibody drug conjugates (ADCs) as they’ve offered patients therapy that targets mainly cancer cells while avoiding the systemic release of cancer-killing toxic payloads, like systemic chemotherapy, throughout the body. Linkers play a critical role in the function of ADCs as they help to attach the cytotoxic payload to the antibody, stabilize the molecule during circulation, and release the toxic payload specifically into the target tissue¹. Multilink is a new cleavable linker platform that allows the loading of multiple drug payloads on an antibody. Degraducer is a powerful, bifunctional, inhibitor technology that enables selective protein degradation and prolonged therapeutic effects. Combining these advanced biotechnology solutions offers the unique opportunity to produce new types of antibody conjugates with dual molecular targeting. These antibody Degraducer conjugates could extend the range of therapeutic antibody conjugates available for the treatment of various cancers.

"We hope this plan to achieve a pre-clinical, proof-of-concept for antibody Degraducer conjugates will boost the efficacy, precision and safety of antibody-based therapies and lead to clinically meaningful solutions while providing improved life quality for cancer patients," expressed Cedric Sager, CEO of Debiopharm Research & Manufacturing, "We are thrilled to collaborate with Ubix Therapeutics to understand more about the potential synergies of combining their Degraducer technology with our Multilink platform."

"We’re excited to explore Antibody Degraducer Conjugates (ADeC) with Debiopharm. In particular, we’re pleased to take the opportunity to combine our Degraducer technology, having superior efficacy and high selectivity, with Debiopharm’s Multilink technology, having lots of advantages especially excellent potency through multiple loading capability. We believe that this collaboration will open up new opportunities to develop advanced cancer therapy." said BK Seo, CEO of Ubix Therapeutics.

About Multilink
Multilink is a new cleavable linker platform suited for multidrug attachment and compatible with any conjugation technology to produce ADCs with high DAR (drug-to-antibody ratio), allowing the loading of multiple payloads on an antibody for an enhanced therapeutic effect. This highly effective and well-tolerated linker platform is available for use of other specialty biotech or pharmaceutical companies to generate a proprietary, clinical-stage ADCs.

About Degraducer
Degraducer is a technology that utilizes the ubiquitin-proteasome system (UPS), an intracellular degradation system. Degraducer is a powerful inhibitor technology that enables target protein degradation and consequent therapeutic effects by placing a disease-related target protein nearby E3 ligase, which can then initiate the protein degradation system.

On June 16, 2021 InnoCare (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its pan-FGFR inhibitor gunagratinib (ICP-192) for the treatment of cholangiocarcinoma(Press release, InnoCare Pharma, JUN 16, 2021, View Source [SID1234584075]).

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InnoCare’s ICP-192 is a highly selective pan-FGFR inhibitor targeting multiple solid tumors with FGFR gene aberrations. Currently, several clinical studies are ongoing in China and the United States.

According to the latest clinical data presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, as of February 2021, a total of 30 patients had received treatment of gunagratinib. Gunagratinib performed well in safety and tolerance, and the maximum tolerated dose (MTD) had not been reached. Among the 12 patients with FGF/FGFR gene aberrations who have completed at least one tumor assessment, the overall response rate (ORR) was 33.3%, including 1 patient (8.3%) of cholangiocarcinoma with complete response (CR), 3 patients (25%) with partial response (PR) and 7 patients having achieved stable disease (SD). The disease control rate (DCR) was 91.7%.

Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare, said, "We are very proud that our solid tumor drug has been granted ODD by the FDA following that for our blood cancer drug. Gunagratinib demonstrated anti-tumor activity for multiple tumor types, including cholangiocarcinoma, in patients with FGF/FGFR gene aberrations. We will rapidly advance the multi-center, multi-indication clinical trials in both the US and China in order to benefit patients early."

The Orphan Drug Designation by the US FDA originates from the Orphan Drug Act, which was enacted in 1983 to encourage the development of innovative drugs to treat rare diseases with a target patient population of less than 200,000 in the US. Upon marketing approval, drugs with ODD qualify for seven-year market exclusivity. In addition, US FDA also rewards ODD drugs with comprehensive incentives including tax credit for clinical trial cost, waiver of marketing registration application fee, waiver or reduced annual product fee, and other benefits, such as clinical protocol assistance and qualification for expedited development programs.

Last December, FDA granted ODD to InnoCare’s Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of mantle cell lymphoma (MCL).