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Thursday, September 2, 2021

Scopus BioPharma Launches Duet Therapeutics

 Duet Therapeutics Integrates Immunotherapy Assets of Scopus and Olimmune, Acquired by Scopus in June 2021

Integration Creates Comprehensive, Industry-Leading Portfolio of Bi-Functional Cancer-Targeting Oligonucleotides

Scopus BioPharma Inc. (Nasdaq: “SCPS”), a clinical-stage biopharmaceutical company developing transformational therapeutics for serious diseases with significant unmet medical need, today announced the launch of Duet Therapeutics.

Duet Therapeutics integrates the management and clinical development of the immunotherapy assets of Scopus and Olimmune, acquired by Scopus in June 2021. Duet is a wholly-owned subsidiary of Scopus.

Joshua R. Lamstein, Chairman of Scopus, stated, “We are extremely excited to announce the launch of Duet Therapeutics. The integration of the immuno-oncology assets of Scopus and Olimmune creates a comprehensive, industry-leading portfolio of bi-functional cancer-targeting oligonucleotides. Our highly complementary IP-protected technologies all target STAT3 inhibition. We believe our oligonucleotide technologies are unique, highly differentiated and superior to other STAT3 inhibitors currently under development.”

Alan Horsager, Ph.D., President and Chief Executive Officer of Duet and President — Immuno-Oncology for Scopus, stated, “Overseeing the integration and clinical development of Duet’s immuno-oncology platform is an extraordinary opportunity. It is a privilege to play a key role in integrating and developing Duet’s drug candidates. Based on the large body of scientific data, we firmly believe our oligonucleotide platform has enormous potential to address one of society’s most significant unmet medical needs — unprecedented treatments, and potentially cures, for many different types of cancer. I can think of no greater professional mission than creating new standards of care, improving patient outcomes and saving lives.”

The Duet Platform is comprised of three complementary, underpinning technologies:

RNA silencing

CpG-STAT3siRNA

(“DUET-01”)

Antisense

CpG-STAT3ASO

(“DUET-02”)

Protein degradation

CpG-STAT3decoy

(“DUET-03”)


https://finance.yahoo.com/news/scopus-biopharma-launches-duet-therapeutics-131500733.html

Precision BioSciences, Tiziana Agree to Evaluate Monoclonal Antibody as CAR T Candidates for Cancer

 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS® genome editing platform, and Tiziana Life Sciences plc (Nasdaq: TLSA / LSE: TILS), a clinical stage biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced an exclusive license agreement to explore Tiziana’s foralumab, a fully human anti-CD3 monoclonal antibody (mAb), as an agent to induce tolerance of allogeneic CAR T cells to potentially improve the clinical outcome of CAR T cell therapy.

The Cluster of Differentiation (CD) 3 is a receptor on effector T cells and an anti-CD3 antibody, such as foralumab, has the potential to eliminate or tolerize patient effector T cells. Precision’s manufacturing process, which uses ARCUS to knock out the TRAC gene and implements a CD3-depletion step, produces allogeneic CAR T candidates that are >99.9% CD3-negative. Thus, an anti-CD3 antibody, such as foralumab, might be used to enable the CAR T cells to expand, proliferate, and persist to maximize long term clinical benefits.

Under the terms of the agreement, Precision gains an exclusive license to use foralumab as a lymphodepletion agent in conjunction with its allogeneic CAR T therapeutics for the treatment of cancers. Precision will be responsible for the development, commercialization, and costs for use of foralumab, and Tiziana will receive upfront payment, certain milestone payments, and royalties for foralumab.

https://finance.yahoo.com/news/precision-biosciences-tiziana-life-sciences-060000680.html

Bristol Myers greenlights neurodegenerative medicine from Evotec pact for $20M

 Evotec is headed to the bank with a cool $20 million after Bristol Myers Squibb opted in on a neurodegenerative medicine called EVT8683.

The licensing opt-in could also trigger $250 million in milestone payments down the line plus royalties on future sales.

EVT8683 is the first treatment to emerge from a collaboration Evotec signed back in 2016 with Celgene, the company that was gobbled up by Bristol Myers soon after. The $45 million upfront deal includes programs for other neurodegenerative diseases as well, with $250 million in milestones up for grabs if successful. Bristol Myers expanded the deal in 2020 to include additional cell lines for a $6 million payment to Evotec.

Evotec said that the small-molecule therapy EVT8683 is ready for clinical development after the FDA cleared a request for human testing. The biotech developed the therapy from its induced pluripotent stem cell drug discovery platform, which screens human models to find new therapies quickly.

The companies did not name the specific indications that will be targeted with the new therapy. Bristol Myers will lead development and commercialization from this point.

Bristol Myers’ opt-in with Evotec is the latest sign that the new parent company is getting what it paid for through the $74 billion deal to buy Celgene.

New York-based Bristol Myers also opted in on an immune system modulator from artificial-intelligence-powered drug miner Exscientia for $20 million in August. The therapy is the first to emerge from a $1.2 billion partnership Celgene signed with Exscientia in 2019.

Cancer and inflammatory disease-focused Celgene seems to have brought in plenty of open-ended discovery deals to stock Bristol Myers’ pipeline.

https://www.fiercebiotech.com/biotech/bristol-myers-green-lights-neurodegenerative-medicine-from-evotec-pact-for-20m

Plus Therapeutics in Commercial Manufacturing Supply Agreement for Lead Investigational Drug

 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced that it has entered into an agreement with RadioMedix, Inc. (RadioMedix) for the commercial production of the Company’s radiopharmaceuticals.

“RadioMedix is a global leader in the development and production of GMP radiopharmaceutical products,” said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. “This strategic partnership substantially supports our efforts to have fully compliant 186RNL available by mid-2022 for a potential Phase 2/3 clinical study in adults with recurrent glioblastoma (GBM).”

“We are very excited to be the GMP manufacturing arm of Plus Therapeutics and participate in the development of 186RNL, a promising radiotherapeutic for central nervous system tumors. Our investment in state-of-the-art facilities for radiopharmaceutical manufacturing and highly trained experts emphasizes our commitment to delivering positive customer experiences across all phases of radiopharmaceutical development and commercial manufacturing,” said Ebrahim S. Delpassand, M.D., Chairman and Chief Executive Officer of RadioMedix.

Under the agreement, RadioMedix will produce cGMP drug product meeting all applicable requirements of the U.S. Food and Drug Administration (FDA) and similar global regulatory entities. This strategic partnership further secures the commercial supply chain for 186RNL and extends to future products under the RNL platform.

186RNL is being developed to treat recurrent GBM, leptomeningeal metastases, and pediatric brain cancer. It has been designed to safely, effectively and conveniently deliver high doses of radiation to rare and central nervous system tumors. Plus Therapeutics is currently enrolling patients with recurrent GBM in the U.S. NIH-supported multi-center ReSPECT™-GBM Phase 1 dose-finding clinical trial.


Baxter to Acquire Hillrom, Expanding Connected Care and Medical Innovation

 Transaction valued at $156.00 per Hillrom Share for an All-Cash Purchase Price of $10.5 Billion

  • Brings together two leading medical technology companies to broaden access to care in the hospital, home and alternate site settings

  • Accelerates digitally-enabled connected care solutions across the continuum of care

  • Builds on Baxter’s global footprint to expand Hillrom’s penetration of international markets

  • Creates significant opportunities to position Baxter for faster top- and bottom-line growth

  • Expected to generate high single-digit ROIC by year five

Regencell Biosciences Establishes Joint Venture to Offer COVID Treatment

 Regencell Bioscience Holdings Limited (NASDAQ: RGC) ("Regencell" or the "Company"), today announced that Regencell Bioscience Limited ("Regencell HK"), the Company’s wholly-owned subsidiary in Hong Kong, has entered into a joint venture agreement with Honor Epic Enterprises Limited ("Honor Epic"). The joint venture ("JV") is expected to offer COVID-19 ("COVID") related treatments to patients in ASEAN countries, India, Japan, Australia and New Zealand.

As COVID vaccination rates in the Asian region are low and COVID infections and deaths rates are rising rapidly, there is a pressing need for a COVID treatment that can be widely available and easily accessible. Since March 2020, Mr. Sik-Kee Au, Regencell’s strategic partner TCM practitioner, started to develop a Traditional Chinese Medicine treatment formula targeting COVID patients. So far, 12 patients (suspected or confirmed COVID cases) have been treated, and their health records showed improvements after an average treatment period of 5 days.

Regencell HK and Honor Epic plan to work together to make this treatment available in the ASEAN countries, India, Japan, Australia and New Zealand. Regencell will own 60% of the JV with customary drag-along option. The principal business of the JV shall be to trade, manufacture, market and distribute TCM formulae products, procure, enable, provide or support the treatment of COVID using TCM in the ASEAN countries, India, Japan, Australia and New Zealand.

Yat-Gai Au, Regencell’s Chairman & CEO noted, "While the research is still ongoing, we strongly believe that our formula can make a difference in the fight against COVID. With Mr. Ji Yang Lee’s strong business relationships and extensive network in over 60 countries, we believe that together we will be able to have a positive impact in the fight against COVID."

Why INmune Bio Is Trading Higher

 INmune Bio, Inc. (NASDAQ: INMB) shares traded higher since Wednesday afternoon following data out of a trial for the company's Alzheimer's drug candidate.

The company said its selective dominant-negative tumor necrosis factor inhibitor candidate for the treatment of Alzheimer's disease, XPro (pegipanermin), was found to decrease multiple species of Phospho Tau and improve neuroimaging biomarkers of myelination in patients with Alzheimer's.

These biomarker data are from the analysis of the company's recently concluded Phase 1 study of XPro™ in Alzheimer's patients. AD patients treated with 1.0 mg/kg of XPro™ once a week for three months had a 46% reduction is CSF pT217 (p<0.0001) and a lesser reduction in pT181 (p<0.01). While pT181 is recognized as the standard CSF biomarker of AD, recent studies suggest that pT217 has higher discriminative accuracy for AD and a stronger correlation with amyloidosis and cognitive decline.

"CSF pT217 appears to be the more sensitive tau biomarker of neurodegeneration in patients with AD, and our data show that controlling neuroinflammation decreases pT217," said CJ Barnum, PhD, Head of Neurosciences for INmune Bio. "Tau pathology has been associated with decreased white matter integrity in AD and we believe these data are consistent with our biomarkers for the measurement of white matter pathology in patients with AD. White matter pathology starts early, the changes are measurable, and appear to be reversed following treatment with XProTM."

The company will host a webinar on Tuesday, September 7 at 4:30 p.m. EDT to discuss the findings.

https://finance.yahoo.com/news/why-shares-inmune-bio-trading-204505418.html