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).

On June 16, 2021 New Equilibrium Biosciences reported it has been awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) for [$$$ AMOUNT] to conduct research and development (R&D) work on drug candidates that regulate intrinsically disordered proteins implicated in cancers and neurodegenerative disorders (Press release, New Equilibrium Biosciences, JUN 16, 2021, View Source [SID1234584055]).

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New Equilibrium Biosciences is dedicated to developing new medicines through cutting edge sciences and cross-disciplinary collaborates. New Equilibrium combines big data, artificial intelligence, and biophysical experiments to accurately visualize the many different conformations that IDP’s, a class of shapeshifting proteins, may adopt. The overarching motivations for this work is to benefit the greater good by specifically targeting and drugging malfunction IDPs to restore normal cell function in those with cancer and neurodegenerative disorders.

"NSF is proud to support the technology of the future by thinking beyond incremental developments and funding the most creative, impactful ideas across all markets and areas of science and engineering," said Andrea Belz, Division Director of the Division of Industrial Innovation and Partnerships at NSF. "With the support of our research funds, any deep technology startup or small business can guide basic science into meaningful solutions that address tremendous needs."

Once a small business is awarded a Phase I SBIR/STTR grant (up to $256,000), it becomes
eligible to apply for a Phase II grant (up to $1,000,000). Small businesses with Phase II grants
are eligible to receive up to $500,000 in additional matching funds with qualifying third-party
investment or sales.

Startups or entrepreneurs who submit a three-page Project Pitch will know within three weeks if
they meet the program’s objectives to support innovative technologies that show promise of
commercial and/or societal impact and involve a level of technical risk. Small businesses with
innovative science and technology solutions, and commercial potential are encouraged to apply.
All proposals submitted to the NSF SBIR/STTR program, also known as America’s Seed Fund powered by NSF, undergo a rigorous merit-based review process. To learn more about
America’s Seed Fund powered by NSF, visit: View Source

About the National Science Foundation’s Small Business Programs: America’s Seed Fund
powered by NSF awards $200 million annually to startups and small businesses, transforming
scientific discovery into products and services with commercial and societal impact. Startups
working across almost all areas of science and technology can receive up to $1.75 million to
support research and development (R&D), helping de-risk technology for commercial success.
America’s Seed Fund is congressionally mandated through the Small Business Innovation
Research (SBIR) program. The NSF is an independent federal agency with a budget of about
$8.1 billion that supports fundamental research and education across all fields of science and
engineering.

On June 15, 2021 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, reported that the expansion of its ongoing clinical collaboration with Merck to include multiple additional phase 2 cohorts(Press release, Linnaeus Therapeutics, JUN 16, 2021, View Source [SID1234584073]). Based on promising preliminary safety, pharmacodynamic and efficacy data, this expanded agreement will allow the companies to further evaluate the combination of LNS8801 and Merck’s anti-PD-1 therapy, KEYTRUDA(pembrolizumab) in patients with selected advanced solid tumors.

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LNS8801 is a first-in-class, orally bioavailable small molecule that is a highly specific and potent agonist of the G-protein estrogen receptor (GPER). GPER is widely expressed on cancers. Stimulating GPER rapidly and durably depletes the c-Myc oncoprotein, stops cancers from proliferating, and makes them more visible to the immune system.

Linnaeus and Merck are currently evaluating the combination of LNS8801 and KEYTRUDA in patients who had previously responded to PD-1/L1 therapy but have subsequently progressed on PD-1/L1 inhibitors. Additionally, Linnaeus is currently evaluating LNS8801 as a monotherapy in patients that cannot tolerate PD-1/L1 therapy due to serious immune-related adverse events.

Under the terms of the agreement, Linnaeus will conduct six additional Phase 2 cohorts evaluating the combination of LNS8801 and KEYTRUDA in several indications including NSCLC, head and neck cancer, cutaneous and uveal melanoma, among others.

"We are very pleased to expand our collaboration with Merck, the established leader in cancer immunotherapy, as we advance LNS8801 into Phase 2 clinical trials," said Patrick Mooney, MD, Chief Executive Officer of Linnaeus. "Based on the encouraging signals we have seen so far in the advanced cancer patients treated with the combination of LNS8801 and KEYTRUDA as well as LNS8801 as monotherapy, we are optimistic that the combination of LNS8801 and KEYTRUDA will provide meaningful benefit to this patient population."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About LNS8801

LNS8801 is an orally bioavailable and highly specific, potent agonist of GPER whose activity is dependent on the expression of GPER. GPER activation by LNS8801 rapidly and durably depletes c-Myc oncoprotein levels. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. In the ongoing phase human 1/2a study, LNS8801 monotherapy has been safe and well tolerated. Additionally, LNS8801 has demonstrated target engagement, c-Myc oncoprotein depletion, and durable clinical benefit in patients with advanced cancer.