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Advanced Proteome Therapeutics Announces Appointment of Dr. Benjamin Krantz to Ceo

On July 21, 2021 Advanced Proteome Therapeutics Corporation ("APC" or the "Company") (TSXV: APC) (FSE: 0E8), reported that as previously planned, Dr. Benjamin Krantz has taken over the role of CEO at its US subsidiary, Advanced Proteome Therapeutics Inc. ("APTI") (Press release, Advanced Proteome Therapeutics, JUL 21, 2021, View Source [SID1234587378]).

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Prior to this appointment, Benjamin Krantz MD, MBA was the Chief Fellow in hematology/oncology at New York University Langone Medical Center and served on the Board of Directors of APTI. His research has focused on biomarker and therapeutic development in pancreas ductal adenocarcinoma and has resulted in peer-reviewed articles on novel therapeutics for pancreas cancer and emerging biomarkers for therapeutic selection. He has also been the architect of investigational protocols for the development of new pancreas cancer biomarkers and an early phase therapeutic candidate. Dr. Krantz received a Bachelor of Arts from the University of Pennsylvania and received his Doctor of Medicine and Master of Business Administration from Tufts University. He completed his residency in internal medicine at New York-Presbyterian Hospital – Columbia University Medical Center during which time he analyzed investigator intellectual property disclosures as a Columbia Technology Ventures fellow. He subsequently worked as a hospitalist and clinical/translational researcher at Memorial Sloan Kettering Cancer Center. He is maintaining an academic affiliation at NYU as a Clinical Assistant Professor in the Division of Hematology and Medical Oncology.

Since the initial announcement of Dr. Krantz’ planned appointment on December 17, 2020, he has been working diligently in preparation for this transition. Over this period, renowned scientist, Dr. Ravi Chari, has joined the company’s Scientific Advisory Board and Dr. Rajeshkumar Manian has joined as Lead Synthetic Organic Chemist. Furthermore, existing projects with the Zeglis lab continue to advance and APTI has engaged with new potential collaborators.

Dr. Benjamin Krantz, Director and CEO stated, "I am extremely excited to be taking on the CEO of role at APTI. It is with high conviction for the potential of APTI’s technology and my ability to generate value from it that I have left a promising academic track to lead APTI. APTI is at an exciting crossroads, where we have a developed a platform that continues to demonstrate exciting results with promising novel complementary technologies in the laboratory to generate better antibody drug conjugates. As a clinical and translational focused researcher, it is my vision to rapidly move our technologies from the lab to incorporation into prospective therapeutics leading to clinical development. We have certainly received external validation for this approach with the joining of Dr. Chari to our Scientific Advisory Board and Dr. Manian as our Lead Synthetic Organic Chemist, as well as current and potential collaborator interest. Additionally, we are looking to scale up with new hires and expansion of lab capabilities to accelerate achievement of key milestones over the next 6 months. Antibody drug conjugates continue to be a hot area in biotech where multi-billion-dollar licensing deals for early-stage assets are not uncommon. With our strategy to build wholly owned clinical candidates using APTI technology, it is my goal to position APTI for that type of success."

Paul Woodward, CEO of the Company stated "I’m excited for what the next six months will bring the company. Ben has been brought on board with a singular mandate – commercialize the technology, and he is already rapidly moving down that road. Our near-term goals (within the next 12 months) are to be formally engaged with collaborators, as a precursor to licensing deals, with the longer-term goal of having those partnerships funding proprietary drug development. We believe this to be a logical pathway and the optimal program for driving valuation. In addition to commercialization opportunities, we will continue to develop IP to enhance and add to our current conjugation technologies."

Novartis Second Quarter and Half Year 2021

Kineta and Samsung Biologics Announce Development and Manufacturing Agreement for Anti-VISTA Antibody

On July 21, 2021 Samsung Biologics, one of the world’s leading contract development and manufacturing organization (CDMO), reported that signed a strategic partnership agreement with Kineta, Inc., a clinical-stage biotech company developing novel immunotherapies in oncology (Press release, Kineta, JUL 21, 2021, View Source;schBoardCtgryCcd=&schString=&schBoardYear=&boardDtm=1626706800000&page=1#new_tab&utm_source=rss&utm_medium=rss&utm_campaign=kineta-and-samsung-biologics-announce-development-and-manufacturing-agreement-for-anti-vista-antibody-immunotherapy [SID1234586786]). Samsung Biologics will provide end-to-end CDMO service from cell line development, clinical drug substance, and drug product manufacturing services to support IND filing for KVA12.1, Kineta’s novel anti-VISTA antibody in development for the treatment of solid tumors.

VISTA is a key driver of the immunosuppressive tumor microenvironment (TME) and is overexpressed on myeloid-derived suppressor cells (MDSC) and regulatory T cells (Tregs). It is a critical myeloid cell immune-checkpoint, and VISTA blockade can reprogram suppressive myeloid cells and reactivate anti-tumor immune function. Preclinical studies demonstrate single agent anti-tumor activity with KVA12.1, and also demonstrate that targeting VISTA in combination with PD-1, PD-L1 or CTLA-4 can significantly improve the anti-tumor efficacy of those checkpoint inhibitors. Kineta’s KVA12.1 aims to reprogram the TME in hard-to-treat solid tumors.

The manufacturing cell line will be developed with support from Samsung Biologics’ R&D Center in San Francisco, and its corresponding clinical trial materials will be manufactured at Samsung Biologics headquarters in Incheon, South Korea.

"We are very glad to be partnering with Kineta, to provide support in bringing this cancer immunotherapy to market," said John Rim, CEO of Samsung Biologics. "We will fully utilize our capabilities and streamlined end-to-end processes from both our headquarters and US R&D Center, to enable high-quality development of KVA12.1 with faster speed to accelerate Kineta’s success."

"Establishing this strategic partnership with Samsung is a critical step for Kineta as we advance KVA12.1 to IND and into first-in-human clinical trials next year", said Shawn Iadonato, PhD, Chief Executive Officer at Kineta. "We are excited to collaborate with Samsung to initiate and scale up drug product manufacturing of our VISTA immunotherapy".

Samsung Biologics offers seamless one-stop CDMO research and development services both at its headquarters in Incheon, South Korea and its newly built R&D Center in San Francisco. Bringing quality-driven development services at a greater speed, the company delivers cell line development to drug substance manufacturing in six months, and to drug product manufacturing in seven months, the fastest pace in the industry. Currently building its fourth and largest facility in Incheon, Korea, Samsung Biologics will have 620,000 liters of biomanufacturing capacity upon completion of the plant in 2023.

Ensysce Biosciences to Host Virtual Investor Day on July 27, 2021

On July 21, 2021 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ: ENSC, OTC: ENSCW), a clinical stage biotech company with proprietary technology platforms to reduce the economic and social burden of prescription drug abuse and overdose, reported that it will host a virtual investor day on Tuesday, July 27, 2021 from 11:00 am to 12:00 pm EDT (Press release, Ensysce Biosciences, JUL 21, 2021, View Source [SID1234585504]).

Ensysce CEO Dr. Lynn Kirkpatrick and CFO Dave Humphrey will present alongside other members of the Company’s executive management team. There will be a 30-minute question and answer session following the Company’s presentation.

Registration for the event can be found here. Interested parties may submit questions in advance of the event by emailing [email protected]. A recording of the event as well as the accompanying presentation will be provided on the Company’s website following the conclusion of the event.

Bayer’s drug that turns a cancer-protective pathway toxic eradicates breast tumors in mice

On July 21, 2021 Bayer reported that An investigational breast cancer drug Bayer recently licensed from Systems Oncology has shown strong antitumor responses in mice, offering early clues as to why the German pharma shelled out $25 million for the preclinical asset last September (Press release, Bayer, JUL 21, 2021, View Source [SID1234585129]).

The drug, dubbed ErSO, works by over-activating a normally tumor-protective pathway to make it toxic for cancer cells. It eradicated both primary and metastatic tumors in mouse models of estrogen receptor-positive breast cancers, according to results published in Science Translational Medicine.

The pathway ErSO targets is called the anticipatory Unfolded Protein Response (aUPR). Through mild and transient activation, aUPR prepares ER-positive cancer cells for growth and protects them from stress such as anticancer treatment.

But in a PNAS study in 2015, a research team from the University of Illinois at Urbana-Champaign led by biochemistry professor David Shapiro, Ph.D., showed that massive and sustained activation of aUPR with a drug could instead inhibit protein synthesis, depriving ER-positive breast cancer cells key building blocks necessary for survival.

For the new research, Shapiro and colleagues identified ErSO as a more potent aUPR hyper-activator that could selectively kill ER-positive breast cancer cells.

RELATED: ASCO (Free ASCO Whitepaper): Sanofi says early amcenestrant data could see it be ‘endocrine backbone therapy’ in breast cancer

In multiple mouse models of ER-positive breast cancer, ErSO quickly killed off tumor cells in high numbers just days after treatment. Combined data from four mouse models showed that 38 of 39 tumors regressed by over 95%, with about half of cases reduced to undetectable levels, the team reported. Even tumors that didn’t completely disappear and regrew after stopping treatment still remained fully sensitive to another cycle of ErSO, the team found.

In another mouse model bearing mutant, patient-derived breast tumors with low expression of ER, oral ErSO treatment outperformed standard-of-care therapies tamoxifen and AstraZeneca’s Faslodex (fulvestrant) at blocking tumor growth, the team found.

"Many of these breast cancers shrink by more than 99% in just three days," Shapiro said in a statement. "ErSO is fast-acting and its effects on breast cancers in mice are large and dramatic."

What’s more, the Bayer drug also significantly reduced cancer metastases at multiple locations, including the lung, bone and brain, the researchers showed.

RELATED: AstraZeneca drops breast, prostate cancer programs in Q4 pipeline cull

The success of Faslodex has prompted several biopharma companies to develop next-generation selective ER downregulators (SERDs). They include Sanofi, which is moving its drug, amcenestrant, into a phase 3 trial against tamoxifen after showing promising early results in combination with Pfizer’s CDK4/6 inhibitor Ibrance.

Roche is pairing its SERD drug, giredestrant, with Ibrance in the phase 3 persevERA trial. And Radius Health is working with Menarini on an oral SERD dubbed elacestrant. It expects phase 3 data from the EMERALD trial later this year.

The UIUC team noted that in mouse models, second-generation SERDs typically induced moderate regression of primary tumors. Those that were tested against metastases showed limited efficacy. And resistance is still a risk with CDK4/6 inhibitors.

Compared with the common inhibitory modes of action against ER, ErSO could offer "a turn-on approach to convert a tumor-selective protective pathway into a lethal, targeted anticancer response," the researchers wrote in the study. The drug’s ability to target metastatic tumors and its activity in ER-low tumors that are traditionally considered ER-negative could broaden its potential therapeutic range, the researchers said.

Bayer picked up global rights to ErSO in September for $25 million upfront, and Systems Oncology is eligible to receive milestone payments of up to $345 million.

While the current study found the drug was well tolerated in mice and dogs, further safety analyses are needed before it can be tested in humans, the UIUC team said. The researchers also plan to explore ErSO’s use against other types of ER-positive cancers.