CELL AND GENE THERAPY

Y-Biologics and Pierre Fabre Announces Strategic Partnership in the Field of Immuno-Oncology Research

Y-Biologics | November 23, 2020

The South Korean biotech organization Y-Biologics and the French pharmaceutical group Pierre Fabre have declared their arrangements to frame a key association in the field of immuno-oncology research. The choice has been recognized through a letter of aim endorsed by the two players and will be affirmed in the coming a very long time through an itemized arrangement. The joint effort is set to run for a very long time, with the chance of a two-year expansion.

Y-Biologics, which spends significant time in the revelation of monoclonal antibodies, and the Pierre Fabre gathering, France's second-biggest private drug lab, plan to join their subject matters with the point of recognizing and creating novel restorative monoclonal antibodies focusing on key immunosuppressive mechanisms activated within solid tumors.

Spotlight

Video report produced by S8 Bioengineering students at the Horizons Biotech / Medtech 2019 event. Event organized by Polytech Marseille, Grand Luminy Technopole and Centrale Marseille.


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CELL AND GENE THERAPY

Mission Bio Announces Pharma Assay Development Services for Solid Tumor Research

Mission Bio | July 18, 2022

Mission Bio, Inc., the pioneer in high-throughput single-cell DNA and multi-omics analysis, announced the launch of solid tumor assays through its Pharma Assay Development (PAD) services. The availability of this new service offering will help to accelerate the development of cancer therapeutics by reducing the time and cost associated with the characterization of solid tumor cells. Precision therapeutics for solid tumors have been historically bottlenecked due to technical challenges associated with the ability to deeply profile thousands of individual cells for a rich characterization of tumor evolution and heterogeneity. This must be done at a much higher resolution compared to bulk next-generation sequencing to enable detection of rare events, at a much earlier stage before progression. Utilizing Mission Bio's Tapestri™ platform, the company's PAD services for solid tumors partner with researchers to provide high-resolution data to unmask the underlying genetic diversity across cell populations. Insights into the clonal landscape and co-occurrence of mutations enable improved patient stratification for clinical trials and the identification of druggable targets for precision therapeutics. Researchers can also monitor treatment resistance by analyzing the acquisition of rare mutations driving tumor progression over the course of treatment. The expansion of Mission Bio's PAD services to solid tumor research comes just three months after the launch of the Solid Tumor Solution on the Tapestri™ Platform, demonstrating Mission Bio's commitment to continuously developing innovative single-cell technologies for its pharma customers. "We have seen tremendous uptake and interest from top-tier pharma companies for our blood cancer Pharma Assay Development program, and we expect the same momentum for our solid tumor services. With our solid tumor services, Mission Bio partners with pharma customers to elucidate the mechanisms of drug resistance through mutation acquisition, determine how cells transform from benign to malignant states, and reveal the genomic changes enabling cancer cells to metastasize – without having to bring single-cell technology or resources in-house. From a customer's perspective, it is as easy as shipping out samples and getting a fully analyzed report back." Todd Druley, MD, PhD, Chief Medical Officer of Mission Bio Mission Bio's PAD services deliver comprehensive support across the therapeutic development process. The company has a dedicated team that works with researchers to develop assays, identify high-impact samples, and analyze the data. As part of the service, pharma partners have access to Mission Bio's innovative technology, assay development team, R&D organization, and bioinformatics support. About Mission Bio Mission Bio is a life sciences company that accelerates discoveries and cures for a wide range of diseases by equipping researchers with the tools they need to better measure and predict our resistance and response to new therapies. Mission Bio's multi-omics approach improves time-to-market for new therapeutics, including innovative cell and gene therapies that provide new pathways to health. Founded in 2014, Mission Bio has secured investment from Novo Growth, Cota Capital, Agilent Technologies, Mayfield Fund, and others. The company's Tapestri™ platform gives researchers around the globe the power to interrogate every molecule in a cell together, providing a comprehensive understanding of activity from a single sample. Tapestri™ is the only commercialized multi-omics platform capable of analyzing DNA and protein simultaneously from the same sample at single-cell resolution. The Tapestri™ Platform is being utilized by customers at leading research centers, pharmaceutical, and diagnostics companies worldwide to develop treatments and eventually cures for cancer.

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DIAGNOSTICS

RQ Bio Launches with Goal to Transform Treatment and Prevention of Viral Infectious Diseases Through Antibody Technologies

RQ Bio | May 17, 2022

RQ Bio today emerges from stealth mode announcing its launch as a new UK-based biotechnology company following the completion of a successful licensing deal with AstraZeneca for RQ Bio's existing mAbs against SARS-CoV-2. The Company, which is headquartered in London, is dedicated to developing treatments and preventative therapies based on potent broad-spectrum mAbs to provide instant and long-lasting immunity for vulnerable people at risk of severe disease or death from existing, emerging and new viral infections. To maximise and accelerate patient impact, the company will continue to be supported by its collaborations with its scientific co-founders, the University of Oxford and leading UK medical research charity LifeArc. Professor Gavin Screaton, Head of the Medical Sciences Division at the University of Oxford, will continue to advise in his capacity as scientific and medical co-founder, as will Clare Terlouw, Head of LifeArc Ventures and UK BIA board member, as a member of the Board of Directors. Our vision is to build on our successful debut with neutralising antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral infectious diseases, By combining our expertise and innovative excellence in core areas we have created a smarter approach to antibody generation making us uniquely positioned to deliver fast patient impact." Hugo Fry, CEO of RQ Bio. LifeArc is committed to backing leading UK academics and scientists, and we were inspired to fund RQ Bio because of the exceptional group of founders who are so passionately dedicated to finding new treatments and preventative therapies in areas of high unmet patient need, LifeArc provided support from across the Charity, including the venture team, scientific labs and other in-house experts to help RQ Bio execute on its business plan, and we look forward to further supporting RQ Bio as it becomes a world-leading infectious disease company." Clare Terlouw, Head of LifeArc Ventures. About RQ Bio RQ Bio's mission has been to develop medicines based on potent broad-spectrum mAbs to provide instant and long-lasting immunity for vulnerable people at risk of severe disease or death from current and future variants of viral infections. RQ Bio has achieved this by combining innovative excellence in core areas to create a smarter approach to antibody generation. RQ Bio has multiple sources of leads and a deep collaboration with the University of Oxford. RQ Bio was founded by scientific experts previously involved with the UK BIA Antibody Taskforce, which worked to build a community of infectious disease antibody experts focussed on the development of rapid and efficient delivery of highly potent neutralising antibodies to help support the UK COVID-19 response. About AstraZeneca Licensing Deal Under the terms of the agreement, RQ Bio has granted AstraZeneca an exclusive worldwide licence to develop, manufacture and commercialise RQ Bio's exisiting early stage mAbs against SARS-CoV-2 and a right of first refusal to take an exclusive licence in respect of any additional mAbs against SARS-CoV-2. RQ Bio will receive upfront and milestone payments of up to $157 million and will be eligible to receive single digit royalties on sales. The successful licensing deal was supported by Oxford University Innovation (OUI), a wholly-owned subsidiary of the University of Oxford that manages the University's technology transfer and consulting activities, who worked efficiently and creatively with all parties on the corresponding technology licences and the filing of intellectual properties.

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MEDICAL

Bio-Manufacturing Partner BioElpida Completes Next Phase of BVX-0918 GMP Production for EU Clinical Study

BioVaxys | June 09, 2022

BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company"), announced today that its Lyon, France-based bioproduction partner, BioElpida ("BioElpida"), has completed the creation of multiple OVCAR-3 cell banks as the next step in the GMP manufacturing process development for BVX-0918, BioVaxys' vaccine for treatment of platinum-resistant ovarian cancer. The OVCAR-3 cell line is mandatory for creating the identity assays that will have to be performed on every batch of ovarian cancer vaccine. This assay is required by regulatory bodies in the EU and United States. The cell line is derived from a human ovarian adenocarcinoma, established from a patient refractory to cisplatin, a chemotherapeutic agent used in late-stage ovarian cancer. Patients whose tumors are innately cisplatin-resistant at the time of initial treatment generally have poor prognosis, which is the patient population target for BVX-0918. Completion of OVCAR-3 cell banks is another step towards our ability to produce GMP yields of BVX-0918, and brings us closer to our Phase I study in the EU planned for later this year." BioVaxys President and Chief Operating Officer Kenneth Kovan. BioVaxys recently entered collaborations with Hospices Civils de Lyon in France and Deaconess Research Institute in the United States to provide the Company with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients. Tumor samples from both hospitals are being used to validate the tumor collection protocol, cryopackaging, cryopreservation, and supply chain logistics for BVX-0918 bioproduction for prospective patients in the US and EU. Tumor samples from HCL will also be used for process testing and manufacturing "dry runs" of BVX-0918, a major step leading to the completion of Good Manufacturing Process ("GMP") production. BioVaxys' vaccine platform is based on the established immunological concept that modifying surface proteins---whether they are viral or tumor---with haptens makes them more visible to the immune system. This process of haptenization "teaches" a patient's immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response. BioVaxys' cancer vaccines are created by extracting a patient's own (autologous) cancer cells, chemically linking with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic. Haptenization is a well-known and well-studied immunotherapeutic approach to cancer immunotherapy and has been clinically evaluated in both regional and disseminated metastatic tumors. A first generation single-hapten vaccine invented by BioVaxys Co-Founder and Chief Medical Officer David Berd, MD, achieved positive immunological and clinical results in Phase I and Phase II human trials in over 600 patients with different tumor types, as well as having no observed toxicity in years of clinical study. These studies were conducted under an FDA-reviewed IND. A first generation autologous, haptenized vaccine was also tested by Dr. Berd in women with advanced ovarian cancer who had ceased to respond to conventional chemotherapy. The results were encouraging: In 24 patients, the median overall survival was 25.4 months with a range of 4.5-57.4 months; 8 patients survived for more than 2 years. BioVaxys has enhanced the first-generation approach by utilizing two haptens ("bi-haptenization"), which the Company believes will yield superior results. About BioVaxys Technology Corp. Based in Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a British Columbia-registered, clinical stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics. The Company is advancing vaccines for SARS-CoV-2, SARS-CoV-1, and a pan-sarbecovirus vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL1 checkpoint inhibitors that will initially be developed for Stage III/Stage IV ovarian cancer. Also in development is CoviDTH®, a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents, and multiple US and international patent applications related to its cancer vaccines, antiviral vaccines, and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol "BIOV" and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF).

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Cortexyme Successfully Completes Acquisition of Novosteo

Cortexyme | May 21, 2022

Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage biopharmaceutical company developing therapeutic approaches to improve the lives of patients diagnosed with degenerative diseases, today announced the completion of its acquisition of Novosteo, a privately-held biotech company focused on targeted therapeutics to treat rare skeletal diseases, bone cancer and injury. Novosteo stockholders now own approximately 15.5% of the combined company. With the completion of the acquisition, Cortexyme appointed former Novosteo executives Dr. Dirk Thye as Chief Executive Officer, and Dr. Karen Smith as Chief Medical Officer of Cortexyme. Dr. Thye and Dr. Philip Low have been appointed to the Cortexyme’s Board of Directors. Cortexyme plans to change its name to Quince Therapeutics, Inc. in the coming months to reflect the broadening pipeline of the company. Inducement Grant Under Nasdaq Listing Rule 5635(C)(4) In conjunction with the close of the Novosteo acquisition, Cortexyme reported that the Compensation Committee of the company’s Board of Directors approved grants of stock options to purchase an aggregate of 3,744,255 shares of Cortexyme’s common stock, which includes options to purchase (i) 1,979,650 shares to Dr. Dirk Thye, (ii) 1,365,449 shares to Dr. Karen Smith, (iii) 353,656 shares to Brendan Hannah, and (iv) an aggregate of 45,500 shares to six additional newly hired employees. The stock options will be issued under the Cortexyme, Inc. 2022 Inducement Plan with a grant date of May 23, 2022 and an exercise price equal to the closing price of a share of Cortexyme common stock on the grant date. The stock options are being issued as an inducement material to each new employee entering into employment with Cortexyme, in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options vest over four years, with 25% vesting on the first anniversary of the vesting commencement date for each employee and the remainder vesting in 36 installments over the following three years, subject to each employee being continuously employed by Cortexyme as of such vesting dates. About Cortexyme Cortexyme, Inc. (Nasdaq: CRTX) is a clinical stage biopharmaceutical company dedicated to improving the lives of patients diagnosed with degenerative diseases. The company’s innovative pipeline includes a precision bone growth molecule and drug-targeting platform to treat rare skeletal diseases, bone cancer and injury, in addition to small molecule therapeutics targeting the infectious pathogen P. gingivalis’ role in degenerative disease progression, including for indications such as periodontal disease, oral potentially malignant disorders, and Alzheimer’s disease, among others.

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Spotlight

Video report produced by S8 Bioengineering students at the Horizons Biotech / Medtech 2019 event. Event organized by Polytech Marseille, Grand Luminy Technopole and Centrale Marseille.

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