Manhattan BioSolutions, Inc.

NORTH PALM BEACH, FL and NEW YORK, NY / ACCESSWIRE / February 6, 2024 / Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent"), a clinical-stage biotechnology company pioneering the development of monoclonal antibodies for the treatment of various cancers and viral infections, announced today it has entered into a research collaboration agreement with Manhattan BioSolutions, Inc. (Manhattan Bio), an emerging biotech company focused on precision biologics, to explore antibody-drug conjugates (ADCs) using Nascent's lead clinical candidate pritumumab (PTB) as the tumor-targeting antibody element. Pritumumab (PTB) is a natural human antibody. This monoclonal antibody targets extracellular form of vimentin, a protein that has been linked to cancer growth and metastasis and is overexpressed in both brain and pancreatic cancers as well as other hard tumor cancers. PTB is a targeted immunotherapy that binds to vimentin in tumors and recruits the immune system to eliminate cancer cells. PTB has demonstrated a promising safety pro preliminary efficacy in completed Phase I study in glioblastoma patients. Nascent has been recently cleared by the FDA to begin Phase II clinical trials for brain cancer. In preclinical experiments, PTB antibody has shown the capacity to cross the blood-brain barrier with the additional potential to transport conjugated drugs into brain tissues, and Nascent holds a patent covering this specialized delivery mechanism. Under the terms of the agreement, Manhattan Bio will perform PTB conjugations to industry standard linker-payloads and will evaluate the resulting ADCs in the in vitro cell assays. The most promising candidates will be prioritized for further development for the treatment of vimentin-positive and potential secondary targets in advanced or metastatic tumors. Nascent CEO, Sean Carrick, commented: "We are thrilled to unlock the full disruptive potential of pritumumab against cancer by collaborating with Manhattan Bio's world-leading scientists. This collaboration serves as an exciting first step in uncovering the possibilities of better targeted cancer therapies." "Pritumumab offers unexplored potential as an ADC vector, and we are excited to test that promise leveraging our expertise in ADC discovery and development. This could pave the way for applying our newest linker-payload innovations to pritumumab in the future" said Dr. Borys Shor, CEO of Manhattan Bio. About Nascent Biotech Nascent Biotech, Inc. (OTCQB:NBIO) is a clinical-stage biotech company pioneering the development of human monoclonal antibodies to be used in the treatment of various cancers, helping people worldwide. Its products are not yet commercially available. The Company's lead candidate, Pritumumab (PTB), is a human monoclonal Antibody (Mab) that has progressed to Phase 2 clinical trials for the treatment of Brain Cancer. For further information please visit our website . Forward Looking Safe Harbor Statement Statements in this press release about our future expectations constitute 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time and our actual results could differ materially from expected results. These risks and uncertainties include, without limitation, Nascent Biotech Inc's ability to target the medical professionals; Nascent Biotech Inc's ability to raise capital; as well as other risks. Additional information about these and other factors may be described in the Nascent Biotech Inc's Form 10, filed on May 2, 2015, and future subsequent filings with the Securities and Exchange Commission. The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law. Corporate Contact: Sean Carrick sean.carrick@nascentbiotech.com About Manhattan BioSolutions Manhattan BioSolutions, Inc is a privately held biotechnology company focused on the development of biologic immunotherapies targeting host defense pathways for the treatment of advanced cancers. The company advances two technology platforms for drug discovery: RNA-degrader proteins, and antibody-drug conjugates (ADCs) - through collaborations with leading academic institutions. Manhattan Bio has established partnerships with the National Cancer Institute (NCI), Stony Brook University, The University at Buffalo, Binghamton University, INSERM, Nascent Biotech, EVQLV, and has been awarded grants by the National Institutes of Health (NIH), the National Science Foundation (NSF), the New Jersey Commission on Science, Innovation and Technology (CSIT), the New York State Center For Biotechnology and the University at Buffalo Center for Advanced Technology in Big Data and Health Sciences (UBCAT). Learn more at manhattanbiosolutions.com and follow Manhattan BioSolutions on LinkedIn or Twitter. Contact for investor inquiries: Borys Shor, Ph.D. ir@manhattanbiosolutions.com SOURCE: Nascent Biotech Inc. View the original press release on accesswire.com

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 12, 2020. News information is not all-inclusive. Please check back for updates. FDA Actions New Actions to Accelerate Prevention and Treatment Options for COVID-19 : The FDA provided new guidance for innovators and researchers conducting work on COVID-19. The guidance was issued with the goal to make the process for submitting applications more efficient and outlines ways to design clinical trials to evaluate safety and efficacy. EUA : The FDA issued a EUA for Fresenius Propoven 2% Emulsion to sedation via continuous infusion for patients older than 16 who require mechanical ventilation during the pandemic. Warning Letters: The FDA and FTC issued warning letters to Seanjari Preeti Womb Healing, L.L.C. and Plum Dragon Herbs, Inc. for selling fraudulent COVID-19 products. To date, there have been 46 COVID-19 related warning letters. Conduct of Clinical Trials of Medical Products During COVID-19 : The FDA added content to the Q&A appendix in its guidance. The updated content includes information on considerations for using alternative labs or imaging centers, holding trial participant visits via video conference, conducting required post-marketing clinical trials and more. Abbreviated New Drug Applications: The FDA approved ANDAs for cisatracurium besylate injection USP 20 mg/10 mL and azithromycin tablets USP, 600 mg . Both ANDAs are relevant to COVID-19 as both medicines are listed in the FDA Drug Shortage Database. Policy for Coronavirus Disease-2019 Tests : The FDA updated this policy and includes EUA submission templates for molecular, antigen and serology tests. Surveillance Inspections : The FDA released a statement indicating it will continue to utilize and implement alternative inspection tools and approaches as they postpone domestic and foreign routine surveillance inspections. This will continue as needed. Diagnostics Update : The FDA has worked with more than 385 test developers who plan to submit EUA requests to detect COVID-19. Also, 92 individual EUAs have been issued, which includes 12 antibody tests and 1 antigen test. The FDA has been notified that more than 245 laboratories have begun testing under the policies set forth in its COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. Diagnostics ProMIS Neurosciences identified 18 potential antibody targets unique to the spike protein halo of SARS CoV-2, which will be synthesized over the coming weeks as a high-throughput antibody test. The synthesis will occur in the serology lab of Hans Frykman at the University of British Columbia . Testing Therapies, Antivirals and Vaccines CEPI awarded an additional $384 million in grant money to Maryland-based Novavax to advance the development and manufacturing of that company’s COVID-19 vaccine candidate. A Phase I study is expected to begin this month in Australia and a global Phase II trial is planned for July. The Food and Drug Administration (FDA) granted Moderna, Inc . ‘s mRNA vaccine candidate against COVID-19 Fast Track Designation. The designation will expedite regulatory review of the vaccine that recently entered Phase II development. Moderna is finalizing the protocol for a Phase III study, expected to begin in early summer of 2020. Switzerland-based Neovii Pharmaceuticals AG and Tel Aviv University’s technology transfer company RAMOT, will work in collaboration to develop a COVID-19 vaccine. The collaboration focuses on the development of a first-in-class COVID-19 vaccine that targets the Achilles’ heel of the virus by reconstructing the coronavirus’s Receptor Binding Motif (RBM), a critical structure of its spike protein. Company Actions Nascent Biotech entered into a research collaboration agreement with Manhattan BioSolutions to initiate a COVID-19 vaccine program. The program will augment Nascent’s current development plans to investigate pritumumab for COVID-19. Manhattan’s platform is based on the recombinant Mycobacterium Bovis Bacillus Calmette-Guerin (rBCG), a genetically engineered vaccine to express selected SARS-CoV-2 proteins. BCG is a live non-pathogenic bacterium that has been used as a tuberculosis vaccine. Other Industry News As reported by CNBC , Dr. Scott Gottlieb said Alabama, South Dakota and Texas have already begun to see an increase in confirmed COVID-19 cases since they’ve eased coronavirus restrictions. Mylan CEO Heather Bresch said the pharmaceutical company’s global medical supply chain has experienced minimal disruption during the COVID-19 pandemic, according to CNBC .

After waiting with bated breath, Johnson & Johnson Innovation finally opened its New York City JLABS facility with 26 resident companies, including the four winners of the JLABS @ NYC QuickFire Challenge. After waiting with bated breath, Johnson & Johnson Innovation finally opened its New York City JLABS facility with 26 resident companies, including the four winners of the JLABS @ NYC QuickFire Challenge. The 30,000 square-foot biotech incubator opened in in the heart of SoHo at the nonprofit New York Genome Center. The facility is a collaboration between J&J Innovation, the state of New York and the New York Genome Center. With 26 resident companies in place, JLABS @ NYC is near capacity. The facility has space to accommodate 30 startup companies. The four winners of winners of the JLABS @ NYC QuickFire Challenge are Lab11 Therapeutics LLC, Lab11 Therapeutics LLC, a startup biotech company developing host-targeting, small molecule, broad spectrum, anti-viral drugs. The company’s first target indication is influenza A virus; Manhattan Biosolutions. That company’s lead platform is based on the safe, attenuated BCG bacteria targeting mutated cancer driver genes to induce innate and adaptive cancer-specific immune responses; Sapience Therapeutics, Inc., a biotechnology company focused on discovering and developing peptide-based therapeutics that inhibit oncogenic and immune-modulatory protein-protein interactions; and Mobile Sense Technologies, Inc., a digital health technology company providing foundational technology enabling off-the-chest medical wearables for long-term management of cardiac arrhythmias. Each of the winners received one year of residence in JLABS @ NYC, which provides each company with access to a bench, workstation and the global JLABS community. Paul Stoffels, chief scientific officer at Johnson & Johnson, said opening a JLABS site in New York City will “link entrepreneurs around the region with Johnson & Johnson Innovation experts.” That, he said, will allow for a collaborative working environment that will benefit healthcare. Cheryl Moore, president and chief operations officer of the New York Genome Center, said the addition of the JLABS facility will strengthen the city’s life science sector. She said the genome center’s work to translate genomic research into new diagnostic tools and treatments for diseases is in “perfect harmony with JLABS’ vision of providing a platform to support emerging companies.” Melinda Richter, Global Head of JLABS at Johnson & Johnson Innovation, said New York City is home to “some of the greatest minds in scientific innovation” who have the skills and spirit to make an impact in healthcare. “JLABS provides those innovators the environment they need to deliver life-enhancing, life-saving solutions to the people who need them. By opening up vital industry connections, entrepreneurial programs and a capital-efficient, flexible platform to help alleviate the cost burden that typically slows or kills innovation, we know NYC will light up our world,” Richter said in a statement. Johnson & Johnson has opened a number of its JLABS sites across North America, as well as Europe and Asia. Sites in North America include San Diego, San Francisco, South San Francisco, Boston, Lowell, Mass., Houston and Toronto. There is also a JLABS in Beerse, Belgium and Shanghai. To date, the JLABS facilities have incubated more than 370 companies. The JLABS @ NYC marks the third biotech incubator to have opened in New York City within the last year. Last year Alexandria LaunchLabs , located at the Alexandria Center for Life Science, became the first biotech incubator to launch in New York City. In December another incubator, BioLabs@NYULangone opened in the Big Apple. There are additional plans for more life science space in New York. Last summer The New York Life Sciences and Biotechnology Center announced plans to construct a building that will provide 1.35 million square feet of “state of the art” space for life science companies. The building is expected to include flexible wet and dry laboratory space as well as build to suit Class A offices. Construction has been planned to begin this year.