On September 21, 2022 Abpro, a biotech company with the mission of improving the lives of mankind facing severe and life-threatening diseases with next-generation antibody therapies, reported a strategic partnership with Celltrion, a biopharmaceutical company headquartered in Incheon, South Korea, today, for its cancer molecule ABP 102, an antibody therapy for patients suffering from HER2+ cancer, including breast, gastric, and pancreatic cancer (Press release, Abpro Therapeutics, SEP 21, 2022, View Source [SID1234621315]). Through this global partnership, Abpro will receive payments from Celltrion of up to $1.75 Billion, including an equity investment, development and commercial milestone payments and worldwide profit sharing. Celltrion will be in charge of the development of ABP 102 following the completion of in vitro studies by Abpro and will have world-wide commercialization rights. HER2+ type cancer is implicated in up to 30% of all cases in breast, gastric, pancreatic, and other forms of cancer.

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"We are thrilled to be able to enter this collaboration with Celltrion and are excited to work with such an excellent partner on bringing this treatment to market. Through our commitment to patients, we strive to enable them to live life to the fullest, and this collaboration with Celltrion, a world class pharmaceutical company, will help us meet that goal," said Ian Chan, co-founder and CEO of Abpro. "This is a significant validation of our technology platform and also our pipeline of t-cell engagers. We aim to deliver therapies to help patients facing severe disease that leads to a better quality of life."

"Abpro’s ABP 102 molecule has shown preliminary data of better efficacy and less toxicity compared to other therapies treating the same indication," said Dr. Sooyoung Lee, VP and head of the new drug research division of Celltrion. "We are confident this partnership will allow us to deliver the best possible care to patients suffering from HER2+ cancer. Abpro’s platform looks highly promising and potentially best-in-class. Together, we will go great lengths to ensure people live longer, healthier lives."

On September 21, 2022 BostonGene reported that it will participate in the 81st Annual Meeting of the Japanese Cancer Association (Press release, BostonGene, SEP 21, 2022, View Source [SID1234621314]). The event, to be held at Pacific Convention Plaza Yokohama from September 29 – October 1, will bring together leading oncologists and basic and clinical researchers in academia or industry to discuss cutting-edge findings in cancer research and recent progress in cancer, such as genomic medicine and immune therapy. BostonGene will also exhibit in Hall B, booth 87.

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BostonGene will showcase how its innovative computational platform performs AI-based molecular and immune profiling to discover correlations between tumor genomics, a patient’s immune system and the effectiveness of all available approved and investigational treatments can advance how physicians treat their patients and dramatically improve clinical outcomes.

"I look forward to participating at the Annual Meeting of the Japanese Cancer Association and to presenting the clinical utility of the BostonGene Tumor PortraitTM Tests," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "We firmly believe BostonGene’s deep molecular and immune profiling, computational power, and analytics will positively impact the standard of care for cancer patients worldwide."

Details about the abstracts selected for presentation can be found below:

Abstract Number: E-1044
Title: Analytical Validation of the BostonGene Tumor Portrait Assay
Date and Time: Thursday, September 29 at 3:15 PM JST
Location: Room 7
English Oral Session Title: E7-2 Elucidating the significance of mutations through informatics and novel technologies

With the increasing use of molecular profiling to guide personalized decision-making, the analytical capabilities of next-generation sequencing (NGS) assays are critical. This presentation describes the analytical performance of the BostonGene Tumor PortraitTM Test, which integrates whole-exome sequencing (WES) and RNA sequencing (RNA-seq).

Abstract Number: E-2073
Title: Combinatory Technology for Single Sample Gene Expression Projection onto a Cohort Sequenced with a Different Technology
Date and Time: Friday, September 30 at 1:00 PM JST
Location: Room 13
English Oral Session Title: E14-7 Gastric cancer (1)

This presentation highlights the importance of BostonGene Batch Correction technique that enables the analysis of single tumor gene expressions by comparison with datasets collected from cohorts of patients with a similar diagnosis to support personalized treatment decisions.

Abstract Number: E-3075
Title: Urothelial carcinoma (UC) subtypes defined by genomic and tumor microenvironment (TME) features predict therapy response properties for precision oncology
Date and Time: Saturday, October 1 at 1:30 PM JST
Location: Room 10
English Oral Session Title: E14-10 Basic and clinical research for urologic cancer (1)

This presentation demonstrates the ability of BostonGene’s novel transcriptome-based classification platform to identify tumor microenvironment (TME) subtypes for a specific cancer type, urothelial carcinoma, that are predictive of response to immunotherapy.

Abstract Number: P-3081
Title: Astraea: A biomarker database integrating genomic, transcriptomic, and TME properties for precision oncology
Date and Time: Saturday, October 1 at 5:15 PM
Location: Room P
Poster Session Title: P25-1 Towards Understandings of Cancer Biology from Viewpoints of Mathematical Modelings and Computational Biology

This presentation underscores the application of BostonGene’s cutting-edge analytical tools to improve treatment for cancer patients by identifying biomarkers for diverse therapies and ultimately helping guide decision-making for personalized medicine.

On September 21, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, and Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported a collaboration to develop FoundationOneCDx as a companion diagnostic for Day One’s lead investigational therapy, tovorafenib (DAY101) (Press release, Foundation Medicine, SEP 21, 2022, View Source [SID1234621313]).

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Tovorafenib is an investigational, oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor, which is currently being evaluated in an ongoing pivotal Phase 2 clinical trial (FIREFLY-1) for the treatment of pediatric, adolescent and young adult patients with relapsed pediatric low-grade glioma (pLGG). In June 2022, Day One reported positive initial data from the FIREFLY-1 study and topline results for the full pivotal study population are expected in the first quarter of 2023. Day One has also initiated a pivotal Phase 3 study (FIREFLY-2/LOGGIC) with tovorafenib in newly-diagnosed patients with pLGG and tovorafenib is additionally being evaluated alone and as a combination therapy for other recurrent or progressive solid tumors with MAPK pathway aberrations.

"New advancements in pediatric cancer research, including novel targeted therapies and companion diagnostics, have the ability to provide a more precise perspective into a patient’s disease helping to inform a tailored therapeutic strategy that may increase the odds of long-term success for children with these diseases," said Samuel Blackman, M.D., Ph.D., co-founder and chief medical officer of Day One. "Combining our purposeful approach to drug development with Foundation Medicine’s genomic profiling expertise and global reach, will enable greater patient access to tovorafenib once approved, and ultimately help more children living with this debilitating form of cancer."

Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offer physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. Currently, Foundation Medicine’s tissue and blood-based tests have more than 60 companion diagnostic indications collectively in the United States and Japan and are available in more than 100 countries globally.

"Foundation Medicine and Day One Biopharmaceuticals have a shared commitment to deepening our understanding of cancer biology so we can deliver more treatment options to patients of all ages, faster," said Sanket Agrawal, Chief Biopharma Business Officer at Foundation Medicine. "We’re proud to partner with Day One to provide access to tovorafenib through companion diagnostic development once approved and look forward to our ongoing collaboration to address significant unmet needs in pediatric oncology."

If tovorafenib, and this companion diagnostic indication are approved, this would be the first companion diagnostic indication for FoundationOne CDx in pediatric oncology.

On September 21, 2022 Merck KGaA, Darmstadt, Germany, a leading science and technology company, reported a collaboration agreement with licensing option with Nerviano Medical Sciences S.r.l. (NMS) for the next-generation highly selective and brain-penetrant PARP1 (poly (ADP-ribose) polymerase) inhibitor, NMS-293 (Press release, Merck KGaA, SEP 21, 2022, View Source [SID1234621312]). NMS-293 has strong potential in combination with a wide variety of DNA-damaging agents, including systemic or targeted chemotherapy (Antibody-Drug Conjugates) or with DNA damage response inhibitors, in numerous tumor types. NMS-293 is in early clinical development for the treatment of patients with BRCA-mutated tumors as a single agent and in combination with temozolomide in recurrent glioblastoma.

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"Building on the therapeutic impact that PARP inhibitors have had over the last several years, we believe this new PARP1 program, if successful, could fill a significant unmet need for patients unresponsive to existing PARP inhibitors with an improved hematological adverse event profile," said Victoria Zazulina, M.D., Head of Development Unit, Oncology, for the Healthcare business of Merck KGaA, Darmstadt, Germany. "The work of NMS to discover and advance this next generation PARP1 selective inhibitor coupled with our deep expertise in developing therapies which modify DNA damage response mechanisms, creates a strong foundation to further develop this investigational therapy for patients."

PARP is key in the repair of DNA damage, and PARP inhibitors have been shown to be highly efficacious in the treatment of patients with tumors deficient in homologous recombination repair, such as breast, ovarian, prostate and pancreatic cancers with BRCA-mutations.

Under the current agreement, Merck KGaA, Darmstadt, Germany will make early payments (up-front and option exercise fees) of up to $65 million to NMS. Furthermore, NMS will receive payments for the achievement of certain development, regulatory and commercial milestones and tiered royalties on net sales by Merck KGaA, Darmstadt, Germany. Upon exercise of the option, NMS will grant to Merck KGaA, Darmstadt, Germany the exclusive rights to research, develop, manufacture, and commercialize NMS-293.

During the option period, NMS and Merck KGaA, Darmstadt, Germany will collaborate on the clinical development of NMS-293, with NMS designing, sponsoring, conducting, and funding global clinical trials.

All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group website. In case you are a resident of the USA or Canada, please go to www.emdgroup.com/subscribe to register online, change your selection or discontinue this service.

About NMS-293
NMS-293 is an orally available small molecule inhibitor of PARP1 and is currently in early clinical development for the treatment of patients with BRCA mutated tumors as single agent and with recurrent Glioblastoma (GBM), a brain tumor with very high medical need, in combination with temozolomide (TMZ).

On September 21, 2022 Provectus (OTCQB: PVCT) reported that the Company has entered into an option agreement with the University of Miami (UM) for an exclusive worldwide license of intellectual property developed by the Ophthalmic Biophysics Center (OBC) of Bascom Palmer Eye Institute (BPEI), which is part of the UM Health System, for the use of OBC’s photodynamic antimicrobial therapy (PDAT) medical device in combination with Provectus’ proprietary pharmaceutical-grade rose bengal for the treatment of bacterial, fungal, and viral infections of the eye (Press release, Provectus Biopharmaceuticals, SEP 21, 2022, View Source [SID1234621311]). The Company also initiated a sponsored research program with OBC to investigate Provectus’ rose bengal for the treatment of infectious keratitis.

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Established in 1970 by BPEI founding director Edward W.D. Norton, MD and Jean-Marie Parel, IngETS-G, PhD, FARVO, OBC performs translational eye care research in all areas of ophthalmology, from the retina and vitreous to the cornea, glaucoma, cataracts, neuro-ophthalmology, and ocular oncology. OBC has developed more than 350 surgical instruments and clinical devices to date.

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors said, "Provectus is pleased to advance its collaboration with OBC director Dr. Parel, Dr. Guillermo Amescua, MD, a board-certified ophthalmologist and director of Bascom Palmer’s Ocular Surface Center, and the entire OBC team to now include this important option-to-license step. OBC’s innovative and comprehensive work on rose bengal PDAT has, among other things, shown in vitro activity against multiple etiologies of microbial keratitis1,2,3,4,5, including drug-resistant strains3,6, established in vivo safety7, demonstrated in vitro superiority over riboflavin PDAT8,9, and achieved clinical proof-of-concept for the treatment of infectious keratitis10,11."

Mr. Rodrigues added, "OBC’s clinical work in ophthalmology, Provectus’ clinical trials in oncology and dermatology, and the Company’s wide-ranging preclinical work in hematology, infectious diseases, animal health, tissue regeneration and repair, and other disease areas support a key component of Provectus’ business strategy, which is to demonstrate the broad spectrum therapeutic platform potential of the Company’s proprietary pharmaceutical-grade halogenated xanthene small molecule rose bengal."

About Bascom Palmer Eye Institute

BPEI serves as the Department of Ophthalmology for the UM Miller School of Medicine in Miami, Florida. Its mission is to enhance the quality of life by improving sight, preventing blindness, and advancing ophthalmic knowledge through compassionate patient care and innovative research. For 2022-2023, U.S. News & World Report (U.S. News) ranked BPEI as the nation’s best in ophthalmology, marking the 21st time and 19th consecutive year that BPEI has received the No. 1 ranking since U.S. News began surveying American physicians for its annual "Best Hospitals" rankings 33 years ago.