On June 2, 2021 Samsung Biologics (KRX: 207940.KS), the world’s leading contract development and manufacturing organization, reported that it signed a strategic partnership with KAHR Medical Ltd., a cancer immunotherapy company developing novel multifunctional immune-recruitment proteins (Press release, Samsung BioLogics, JUN 2, 2021, View Source [SID1234583429]). Under the terms of the agreement, Samsung Biologics will provide its end-to-end cell line development and clinical drug substance and drug product manufacturing services as well as IND filling support for KAHR’s drug candidate DSP502, a TIGITxPD1 fusion protein.

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As an innovative leader in the fusion protein space, KAHR’s current technology is based on multi-functional immuno-recruitment proteins (MIRP) that bind cancer cells and T-cells to produce a synergistic effect to selectively target tumors. KAHR recently signed an exclusive license with Thomas Jefferson University in Philadelphia, PA to develop and commercialize multiple new drug candidates, including DSP502.

"We are proud to announce our partnership with KAHR Medical for the production of their novel drug candidate," said John Rim, CEO of Samsung Biologics. "We will leverage our fully integrated, scalable, and high-quality development services and experienced teams to enable a faster transition from gene to IND in order to ensure KAHR’s success in bringing cutting edge immuno-recruitment cancer drugs to patients in need."

"We are very pleased to partner with Samsung BioLogics, which is recognized as a leader in biopharmaceutical process development and manufacturing" said Yaron Pereg, Ph.D., Chief Executive Officer of KAHR. "DSP502 focuses on promising checkpoint pathways, unleashing the potential of the immune system to enhance anti-tumor immunoactivity through dual checkpoint inhibition."

Samsung Biologics offers seamless one-stop CDO research and development services both at its headquarters in Incheon, South Korea and its newly built R&D Center in San Francisco. Samsung Biologics’ CDO business brings quality-driven development services at a greater speed, delivering cell line development to DS manufacturing in six months, and to DP manufacturing in seven months at the fastest pace in the industry.

The company is currently building its fourth and largest biomanufacturing facility in Incheon, Korea. Upon completion of the said plant in 2023, Samsung Biologics will hold 620,000 liters of biomanufacturing capacity, or approximately a quarter of the entire global bio-CMO capacity.

On June 2, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of antibody therapeutics, reported that the company will participate in BIO Digital International Convention (Press release, PharmAbcine, JUN 2, 2021, View Source [SID1234583428]). The company will participate in virtual one-on-one meetings with registered pharmaceutical companies to look for business and development partnerships. The event will be held virtually from June 10-11 and 14-18, 2021.

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Details of the event are as follows:

Event: BIO Digital 2021
Date: June 10-11 & 14-18, 2021
Registration: View Source

The company’s presentation video will be available during the event. The video will feature Dr. Jin-San Yoo, Chairman and Chief Executive Officer of PharmAbcine, delivering introduction on the company’s core technology and pipelines. The company’s pipeline introduction will include olinvacimab, PMC-403, and PMC-309.

Olinvacimab, an anti-VEGFR2 (Vascular Endothelial Growth Factor Receptors-2) molecule, is the company’s lead asset. The molecule is currently undergoing multiple global clinical trials. Last April, PharmAbcine signed a clinical trial collaboration agreement with MSD for the phase II olinvacimab and pembrolizumab combo study in mTNBC (metastatic Triple Negative Breast Cancer). The company expects a multicenter trial to kick off in Australia in the second half this year.

PMC-403 is the company’s novel agonistic antibody that directly activates Tie2 receptors on endothelial cells. Once the molecule binds to the receptors, it promotes the stabilization of leaky blood vessels. In early May, the company revealed a highly encouraging non-clinical data at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting. The data showed that PMC-403 with its vessel normalizing characteristics can be a viable therapeutic option for ophthalmology indications, such as age-related macular degeneration (AMD) and diabetic retinopathy (DR). The company expects PMC-403 to enter a phase I clinical trial in 2022.

PMC-309 is one of the company’s first immuno-oncology drug candidates that targets human VISTA (V-domain Ig Suppressor of T cell Activation). VISTA is an immune checkpoint regulator, commonly found overexpressed on immunosuppressive cells including MDSCs (Myeloid-Derived Suppressor Cells) and M2 macrophages. Last April, PharmAbcine announced the non-clinical data of PMC-309 at American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting. The results show that PMC-309 induces T cell activation and the attendant tumor growth inhibition in both mono therapy and combo with a PD-1 molecule. The company expects PMC-309 to enter a phase I clinical trial in 2022.

"We are excited to participate in this convention because we have quite a bit of new data from our preclinical assets," said Dr. Jin-San Yoo, CEO of PharmAbcine. "There are definitely more interests for our assets, judging from the number of meeting requests from potential partners compared to the previous partnering events. Through this year’s Bio Digital, we hope to advance our business development initiatives."

About BIO Digital.

Bio Digital gathers global biotech industry and provides access to partners via BIO One-on-One Partnering for business opportunities. Please visit View Source/partnering for more information.

On June 2, 2021 Porton Biologics Ltd. (hereinafter referred to as Portonbio) reported a strategic cooperation with Nanjing KAEDI Biotech, Inc. (hereinafter referred to as KAEDI). Portonbio will offer CMC services for KAEDI’s CAR-T cell therapies with its end-to-end CDMO platform for gene and cell therapies to help accelerate their development process (Press release, Porton Biopharma, JUN 2, 2021, View Source [SID1234583427]).

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According to the agreement, Portonbio, as an exclusive CDMO partner, will provide KAEDI with CMC services for multiple CAR-T projects, including the process development and manufacturing of plasmids, viral vectors and CAR-T cells and IND filling (CMC part) support services. The indication of the first project of our collaboration, KD-025 CAR-T, is liver cancer and glioma. The results of its preclinical research have been published in the leading international journal of tumor immunotherapy and ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology). At present, a multi-center clinical trial of KD-025 CAR-T POC is being carried out and a number of cases of clinical infusion have been completed with no obvious toxicities and side effects being observed. At the same time, the product is being applied for IND at home and abroad.

Dr. Hongjiu Dai, Chairman and CEO of KAEDI, said: "We are very pleased to have a strategic cooperation with Portonbio. KAEDI has successfully developed a pipeline of several CAR-T new drug candidates for malignant solid tumors. We believe that Portonbio’s excellent technical team and professional CDMO platform can help KAEDI quickly and efficiently promote the drug candidates in our pipeline and accelerate the development process of our cell therapy drugs."

"We are very honored to contribute to KAEDI’s innovative research in the field of cell therapy", said Mr. Nianfeng Ju, Chairman and CEO of Portonbio, "Portonbio has established an integrated CDMO service platform for plasmids, viral vectors and cell therapy products, and has an experienced expert team and unique technical advantages. We hope to accelerate the marketing process of KAEDI CAR-T products through this cooperation, jointly promote the breakthrough of cell therapy products in the field of solid tumor, and enable the patients’ early-access to the therapies."

On June 2, 2021 BERG, a clinical-stage biotech that employs patient biology and artificial intelligence (AI) to research diseases and develop innovative treatments, reported results from a recently completed Phase 1 study of its investigational drug, BPM 31510 (novel ubidecarenone formulation) in recurrent glioblastoma multiforme (GBM) (Press release, Berg, JUN 2, 2021, View Source [SID1234583426]). The study will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) from June 4 – June 8, 2021, defining the details on identification of molecular analytes in plasma, buffy coat and urine and unveiling pathways to potentially predict clinically relevant responses to BPM 31510 in GBM patients undergoing treatment.

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"At BERG, we want to remove the stigma that brain cancer is a death sentence," said Dr. Niven R. Narain, CEO, President and Co-founder of BERG. "The limited drugs available today may not work for a patient’s unique biological footprint. The results from our study offer hope to patients, and hold promise for BERG’s BPM 31510, solving a serious unmet need in medicine today."

GBM is the most aggressive, malignant primary brain tumor, averaging 12-18 months of survival time upon diagnosis with only 25% of GBM patients surviving more than one year. Today, GBM-related tumors account for 17% of all tumors of the brain, and tend to occur between the ages of 45 and 70.

The study was conducted in collaboration with Seema Nagpal, M.D. Clinical Associate Professor of Neurology & Neurological Sciences, and Lawrence Recht, M.D., Professor of Neurology & Neurological Sciences, both of Stanford University School of Medicine, in addition to other Stanford Medicine researchers and in collaboration with BERG.

Details of the BERG presentation:

Session title

Abstract title

Presenters

Dates

Central Nervous System Tumors

2059: Comprehensive molecular pharmacodynamic assessment identifies response markers of intermediary metabolism associated with BPM 31510-IV treatment in advanced glioblastoma multiforme patients

Seema Nagpal, Rangaprasad Sarangarajan, Can Bruce, Greg M Miller, Leonardo O Rodrigues, Punit Shah, Richard Searfoss, Kennedy Ofori-Mensa, Vladimir Tolstikov, Bennett Greenwood, Valerie Bussberg, Michael A. Kiebish, Elder Granger, Niven R. Narain, Lawrence David Recht; Stanford University, Stanford, CA; Berg LLC, Framingham, MA

June 4, 2021 – June 8, 2021

Digital Program:

E-Poster

The Abstract is available online: View Source, and the Poster will be available to registered 2021 ASCO (Free ASCO Whitepaper) Virtual Scientific Program attendees starting Friday, June 4th.

In its commitment to serve patients afflicted with cancer, BERG has collaborated on other projects with leading institutions like MD Anderson Cancer Institute (clinical trials) and Harvard/BIDMC (Project Survival), among others.

On June 2, 2021 Sysmex Inostics, Inc., a global leader in the liquid biopsy revolution for oncology, reported that it is presenting the poster entitled, "Ultra-sensitive detection and quantification of human papillomavirus (HPV) DNA in the plasma of patients with oropharyngeal squamous cell carcinoma (OPSCC) enrolled in the OPTIMA 2 treatment de-escalation trial" at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting, June 4-8, 2021 (Press release, Sysmex Inostics, JUN 2, 2021, View Source;301303731.html [SID1234583425]). The featured data show that SafeSEQ cfHPV-DNA Test (HPV-SEQ) exhibits robust quantitative detection of cell-free HPV DNA (cfHPV-DNA) across a broad dynamic range, enabling high-resolution monitoring for patients with HPV+ OPSCC, a type of head and neck cancer. The ASCO (Free ASCO Whitepaper) presentation coincides with the launch of HPV-SEQ as the newest CLIA validated assay in the Sysmex Inostics portfolio of ultra-sensitive SafeSEQ NGS panels.

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HPV 16 and HPV 18 are the two most common high-risk HPV strains, and persistent infections can lead to HPV-related cancers, including cervical, anal, and head and neck cancers. HPV driven tumors are increasing in prevalence, especially in patients presenting with head and neck cancer.1 cfHPV-DNA can be measured in patients’ plasma as a non-invasive surrogate of tumor burden and can facilitate precise tracking of disease response throughout treatment.

Sysmex Inostics has introduced HPV-SEQ, an ultra-sensitive blood-based liquid biopsy solution for identifying and accurately quantifying circulating HPV 16 and HPV 18 DNA in patients with HPV-related cancers.

As patients with HPV-driven tumors often have a good prognosis, clinical investigators have recently explored new strategies for treatment de-escalation to avoid unnecessary side-effects caused by overtreatment. Important clinical data for HPV-SEQ was generated during the recent OPTIMA 2 phase II trial (NCT03107182) investigating induction chemoimmunotherapy followed by risk/response stratified de-escalated locoregional therapy for patients with HPV+ OPSCC. During the trial, HPV-SEQ was employed to evaluate levels of cfHPV-DNA alongside patients’ radiographic response to therapy in order to assess the future utility in guiding treatment de-escalation strategies. HPV-SEQ showed robust quantitative detection of HPV 16/18 across a broad dynamic range over five orders of magnitude with low quantitative variability. Importantly, a high correlation was observed between dynamic changes in patients’ cfHPV DNA levels and radiographic responses following induction therapy.

"HPV-SEQ exhibits robust quantitative detection of HPV, even when only a few copies are present, thus potentially enabling precise molecular monitoring of patients’ therapy response," said Dr. Nishant Agrawal, Professor of Surgery at the University of Chicago. Dr. Agrawal added, "We see the HPV-SEQ test becoming an important tool for refining patient treatment strategies and accelerating the development of novel de-escalation approaches for the treatment of HPV-associated OPSCC."

Poster number 6048, "Ultra-sensitive detection and quantification of HPV DNA in the plasma of patients with oropharyngeal squamous cell carcinoma (OPSCC) enrolled in the OPTIMA 2 treatment de-escalation trial," presented by Hillary Sloane, PhD, Associate Director of Medical & Scientific Affairs at Sysmex Inostics, will be available June 4 through June 8, 2021 during the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.

Currently, HPV-SEQ is being used in prospective studies to further evaluate the kinetics of cfHPV-DNA as a predictor of response to therapy in patients with HPV+ OPSCC and other HPV-related cancers. HPV-SEQ is CLIA-validated and available to support clinical trials through the Sysmex Inostics turnkey testing service in their CLIA lab located in Baltimore, Maryland.

1. Van Dyne EA, Henley SJ, Saraiya M, Thomas CC, Markowitz LE, Benard VB. Trends in Human Papillomavirus–Associated Cancers — United States, 1999–2015. MMWR Morb Mortal Wkly Rep 2018;67:918–924.