On May 19, 2021 Duality Biologics (DualityBio or Company), an innovative biotech company, reported the completion of $90 million series B financing (Press release, Duality Biologics, MAY 19, 2021, View Source [SID1234596828]). This round of financing was led by Lilly Asia Ventures (LAV) and jointly invested by YUNION Healthcare Fund, Huagai Capital, NRL Capital, Green Pine Capital Partners, and Oriza Holdings, etc. Series A investor WuXi Biologics (2269.HK) continued to increase its stake in this round to accelerate DualityBio’s R&D progress leveraging its premier-quality integrated technology platforms. DualityBio has raised more than $120 million since its establishment in January 2020. Major investors in the previous round include King Star Capital, WuXi Biologics, 6 Dimensions Capital, and other investment institutions. The funds raised in this round will be mainly used for conducting preclinical research, clinical trials, and expanding pipeline through strategic in-licensing, out-licensing and research collaborations globally.

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Develop Novel Modality Drug to Meet Unmet Medical Needs

Focusing on the field of oncology and autoimmune diseases, DualityBio has developed a novel internal pipeline of nearly 10 Best-in-Class and First-in-Class bispecific antibodies (BsAbs) and Antibody-Drug Conjugate (ADC) drugs, to fulfill the unmet medical needs for patients worldwide. The company has successfully developed the next-generation ADC platform with global intellectual property rights. The value of the platform has been fully validated with several drug candidates under preclinical development. DualityBio will continue to expand and enrich its novel modality drug platforms through internal R&D and external collaborations. The company has built up a strong and highly experienced international team with proven track record in preclinical research, clinical development, and global business development.

Dr. John Zhu, founder and CEO of DualityBio said: "I am very grateful for the recognition and strong support from the top investors in the industry, and I appreciate very much our highly productive team for their unremitting efforts. The booming of biotechnology makes it possible to develop novel modality drugs, which is not only an opportunity but also our mission. The unmet needs of patients demand new therapeutic solutions. DualityBio is committed to be the leader of novel modality drug developers, and we will continue to develop innovative and breakthrough therapies, to live up to patients’ expectations."

"We hold strong conviction of innovative therapeutics for oncology and autoimmune diseases, which offer huge market potential and fulfill the unmet medical needs worldwide. Companies with truly exceptional capabilities in innovation and globalization will stand out, and DualityBio is clearly one of such companies." Dr. Yi Shi, the Founding Managing Partner of LAV, commented, "As a veteran of more than 20 years in the industry, John has both rich industry experience and great acuity for investment. He has successfully established and incubated a number of biotech companies. Within just over one year, DualityBio has not only established a world-class team with deep industry insights and excellent execution capabilities, but also forged a globally competitive drug development platform with a very strong pipeline. LAV will offer sustained support for DualityBio to become a global leader in the industry!"

Dr. Chris Chen, CEO of WuXi Biologics, said: "ADC has emerged as an exciting therapeutic modality which attracts increasing investment from pharmaceuticals and ventures. WuXi Biologics has established the integrated technology platforms for ADC, which allows global partners to develop innovative biologics leveraging our extensive expertise and capacity. We are glad to enable DualityBio to expedite the ADC development with lower cost as they strive to build robust biologics pipeline."

Xianghong Lin, the Founding Partner of King Star Capital, remarked: "John is not only an excellent investor but also a company builder in the biotech industry. We have worked together and helped multiple biotech startups quickly attained their "0" to "1" transformations, and successfully listed as public companies on the capital market. As an investor in the early stage of DualityBio, we believe in John’s proactive, innovative entrepreneurial spirit and rich industry experience, and will continue to support the company’s future growth."

On May 19, 2021 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, reported the presentation of clinical data from the Parker Institute for Cancer Immunotherapy’s Phase 2 clinical trial evaluating sotigalimab, Apexigen’s monoclonal antibody targeting CD40, in combination therapy for patients with metastatic pancreatic cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting, being held virtually June 4-8, 2021 (Press release, Apexigen, MAY 19, 2021, View Source [SID1234590991]). Sotigalimab, Apexigen’s lead immuno-oncology therapeutic, is a potentially first-in-class and best-in-class CD40 agonist, with unique epitope specificity and Fc receptor engagement for optimal therapeutic effect and tolerability.

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"These important new data will play a critical role in our development plans for sotigalimab," said Xiaodong Yang, M.D., Ph.D., Chief Executive Officer of Apexigen. "We were thrilled to partner with the Parker Institute for Cancer Immunotherapy, Cancer Research Institute and Bristol Myers Squibb, providing our potential best-in-class CD40 therapeutic for their pancreatic cancer study to help address one of the greatest outstanding challenges in oncology. We are encouraged by the clinical benefit observed with the novel combination regimen of sotigalimab and standard of care gemcitabine/nab-paclitaxel. We believe the improvements observed in one-year overall survival, while not statistically significant as compared to the historical standard-of-care control, may provide meaningful benefit in a subset of patients with pancreatic cancer."

Dr. Yang continued, "Beyond these promising data, we are particularly encouraged by the pharmacodynamic effects of sotigalimab. These include an increase in activated myeloid dendritic cells and M1 macrophages, which demonstrates the on-mechanism and differentiated activity of sotigalimab. In addition, the identification of a unique biomarker signature that was associated with clinical benefit of treatment with sotigalimab plus chemotherapy may play a critical role in guiding our clinical strategy, as well as enabling the identification and selection of patients most likely to benefit from sotigalimab. Based on these clinical and biomarker data, we expect an additional Phase 2 trial with more patients and a biomarker-based patient selection strategy may be needed before launching a Phase 3 trial in this indication. We look forward to leveraging these important learnings in our ongoing and future studies, building upon our foundation of compelling single-agent activity in immunotherapy-naïve melanoma, durable activity in PD-1 refractory melanoma, and promising activity in our target combinations of chemotherapy and/or radiation in other solid tumors. To maximize the full therapeutic potential of sotigalimab, we have implemented a broad and comprehensive clinical development strategy and are currently conducting several Phase 2 trials across indications, lines of therapies and combination settings, from which we anticipate multiple milestones and near-term data readouts."

The poster titled, "Gemcitabine and nab-Paclitaxel ± Nivolumab ± CD40 Agonistic Monoclonal Antibody Sotigalimab (APX005M) in Participants with Untreated Metastatic Pancreatic Adenocarcinoma: Phase 2 Final Results", will be presented by Mark O’Hara, M.D., an assistant professor of Medicine, in the division of Hematology-Oncology in the Perelman School of Medicine at the University of Pennsylvania (Abstract #4019; Track: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary). The poster has been selected for presentation as part of a Poster Discussion Session from 9:00-10:00 a.m. ET on Friday, June 4, 2021. The poster will also be available on-demand through the ASCO (Free ASCO Whitepaper) conference portal, starting at 9:00 a.m. ET.

Summary of the data:
The Phase 2 study evaluated multiple novel combination regimens on top of standard of care gemcitabine/nab-paclitaxel (Gem+NP) in three cohorts: Cohort A1 (Gem+NP+Nivolumab), Cohort B2 (Gem+NP+Sotigalimab 0.3 mg/kg), and cohort C2 (Gem+NP+Nivolumbab+Sotigalimab 0.3 mg/kg). Each cohort was designed to be compared against a historical control OS.
The primary endpoint was 1-year overall survival (OS) as compared to the historical control standard of care (Gem+NP) of 35%. The one-year OS was 57.3% for A1 (P=0.007, n=34), 48.1% for B2 (P=0.062, n=36), and 41.3% for C2 (P=0.236, n=35). Improvements in OS were statistically significant for cohort A1, with moderate clinical activity observed in cohort B2
Safety profiles across all three cohorts were manageable and consistent with previously reported Phase 1b data, suggesting sotigalimab may be well tolerated when utilized in multiple combination therapy strategies
An increase of activated myeloid dendritic cells (CD86+ mDC) was found in the patients treated with sotigalimab containing regimens (Cohorts B2 and C2)
An increase of tumoral M1 macrophages was found only in patients treated with sotigalimab+chemotherapy (Cohort B2)
Lower baseline levels of effector memory CD8+ T cells, exhausted effector memory CD4+ T cells and TNF and MYC gene expression were associated with improved survival with sotigalimab+chemotherapy (Cohort B2)
Additional biomarker results from the Phase 2 study will be presented in a poster titled, "Baseline level and early on-treatment clearance of circulating mutant KRAS in metastatic pancreatic ductal adenocarcinoma treated with chemotherapy with or without immunotherapy", to be presented by Jacob Till, M.D., Ph.D., Senior Research Investigator, at Penn. (Abstract #4122; Track: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary).

About the Phase 1b/2 Clinical Trial
In the Phase 1b portion of this open-label, multicenter Phase 1b/2 clinical trial, previously untreated patients with metastatic pancreatic ductal adenocarcinoma received sotigalimab in combination with gemcitabine and nab-paclitaxel, a standard-of-care chemotherapy regimen for this patient population, and half of the patients also received Bristol Myers Squibb’s PD-1 inhibitor, nivolumab. The Phase 2 portion of the trial evaluated multiple combination regimens on top of standard of care gemcitabine/nab-paclitaxel (Gem+NP): Gem+NP plus sotigalimab, Gem+NP plus nivolumab and Gem+NP plus sotigalimab and nivolumab. The primary endpoint was 1-year overall survival (OS) rate compared with a 35% historical rate for Gem+NP. Secondary endpoint results included safety (adverse events [AEs], treatment-related adverse events [TRAEs]), objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and duration of response (DOR). Exploratory endpoints included immune pharmacodynamics, associations between tumor and immune biomarkers and clinical outcomes, and baseline and on-treatment microbiome profiles. For additional information on this trial (NCT03214250), please visit www.clinicaltrials.gov.

About Sotigalimab (APX005M)
Sotigalimab is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. Sotigalimab targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of Sotigalimab to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) initiates a multi-faceted immune response bringing multiple components of the immune system (e.g., T cells, macrophages) to work in concert against cancer. Sotigalimab is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, esophageal and gastroesophageal junction cancers, melanoma, non-small cell lung cancer, rectal cancer and sarcoma in various combinations with immunotherapy, chemotherapy, radiation therapy or a cancer vaccine. Additional information on clinical trials for Sotigalimab can be found at www.clinicaltrials.gov.

On May 19, 2021 iBio, Inc. (NYSE:IBIO) ("iBio" or the "Company"), a biotech innovator and biologics contract manufacturing organization, reported that management will present an update on the Company’s business at the UBS Global Healthcare Virtual Conference on Wednesday, May 26, 2021 at 4:00 p.m Eastern Time (Press release, iBioPharma, MAY 19, 2021, View Source [SID1234585485]).

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The presentation will be webcast live and archived on the Company’s website at www.ibioinc.com under "News and Events" in the Investors section.

On May 19, 2021 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported that Laurence Reid, Ph.D., Chief Executive Officer of Decibel, will present at the UBS Global Healthcare Virtual Conference on Wednesday, May 26, 2021 at 7:00 am ET (Press release, Decibel Therapeutics, MAY 19, 2021, View Source [SID1234585163]).

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A live webcast of the presentation may be accessed by visiting the Investors section of the Decibel Therapeutics website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the presentation.

On May 19, 2021 xCures reported their collaboration with the FibroFighters Foundation to launch a real-time learning platform for the Fibrolamellar Hepatocellular Carcinoma (FLHCC) community (Press release, xCures, MAY 19, 2021, View Source [SID1234584919]). FLHCC is a rare cancer primarily affecting adolescents and young adults. With an annual incidence of fewer than 300 cases, little is known regarding the best treatment options.

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The xCures platform is a direct-to-patient research program that brings together patients, clinicians, patient advocates, and researchers, to accelerate the understanding of cancers and find better treatments faster.

Tom Stockwell, Executive Director of FibroFighters commented "We are very excited to be working with xCures on this important project". "This platform will have an immediate impact across many of our patients’ lives." He added, "I only wish this extremely valuable tool could have been available during my son’s fight." Tom has dedicated his life to helping FLHCC patients and families.

"xCures, FibroFighters, and the entire Fibrolamellar patient community are working together to advance knowledge about FLHCC across the country and around the world," stated Mika Newton, xCures’ CEO. "This partnership will leverage access to leading therapeutics, diagnostics, and algorithms to improve patient outcomes at the point of care and provide much needed real-time data for doctors treating this rare cancer."

For FLHCC patients, xCures integrates medical records into a clear patient summary report suitable for sharing with their oncologist, including their case summary, a list of top options, the rationale supporting each recommendation, and how to access the options.

Treatment options are informed by real-world data collected on the xCures platform, learning from the experiences of all FLHCC patients, and using AI algorithms to better understand which treatments work better for different FLHCC patients and why. Novel options and therapeutic rationales are sourced from expert oncologists and key opinion leaders in treatment of FLHCC.

xCures also helps patients access treatment options through trial matching, managed access, compassionate use programs, and by supporting insurance coverage of treatments with data. At the patient’s request, xCures may also convene a Virtual Tumor Board (VTB) where nationally recognized cancer experts further refine the xCures options summary based on a discussion of the patient’s personal medical history and preferences.

xCures and FibroFighters are actively assembling this expert panel for the Fibrolamellar community.