INDUSTRIAL IMPACT

AbCellera and Rallybio Announce Strategic Alliance to Discover, Develop, and Commercialize Novel Antibody-Based Therapeutics for Rare Diseases

Rallybio | December 02, 2022 | Read time : 02:00 min

AbCellera and Rallybio
AbCellera and Rallybio Corporation announced that they have entered into a strategic alliance to discover, develop, and commercialize novel antibody-based therapeutics for rare diseases. This multi-year, multi-target collaboration will combine AbCellera’s antibody discovery engine with Rallybio’s clinical and commercial expertise in rare diseases to identify optimal clinical candidates and ultimately deliver therapies to patients.

It’s clear that we need to accelerate drug development for rare diseases to address the enormous unmet medical need for these patients. Rallybio’s team has decades of experience in sourcing, identifying, and evaluating therapeutic targets. By bringing together Rallybio’s deep expertise in rare diseases with AbCellera’s integrated technology for delivering clinical leads with unmatched precision and speed, this partnership creates a unique advantage that we believe will deliver new and transformative medicines to patients.”

Carl Hansen, Ph.D., founder and CEO of AbCellera

“AbCellera’s clinically validated discovery engine will strengthen our efforts in identifying novel rare disease candidates to add to our existing pipeline,” said Martin Mackay, Ph.D., Chief Executive Officer of Rallybio. “We are excited to establish this partnership and look forward to working closely with our colleagues at AbCellera as we build novel medicines together.”

Under the terms of the agreement, AbCellera and Rallybio will co-develop up to five rare disease therapeutic targets, which will be chosen together by both companies. The collaboration will allow Rallybio to add product candidates to its existing pipeline and also provides the option for AbCellera to conduct process development and clinical manufacturing activities. The partnership’s first program will focus on addressing the significant unmet therapeutic needs of patients with rare metabolic diseases.

About AbCellera Biologics Inc.
AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development.

About Rallybio
Rallybio is a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases. Since its launch in January 2018, Rallybio has built a portfolio of promising product candidates, which are now in development to address rare diseases in the areas of hematology, immuno-inflammation, maternal fetal health, and metabolic disorders. The Company’s mission is being advanced by a team of highly experienced biopharma industry leaders with extensive research, development, and rare disease expertise. Rallybio is headquartered in New Haven, Connecticut, with an additional facility at the University of Connecticut’s Technology Incubation Program in Farmington, Connecticut.

Spotlight

Over the last five years, the global biotech and pharmaceutical landscape has witnessed continued growth. The analysis period (2017-2022) encompasses a unique timeframe including the global COVID-19 pandemic.


Other News
CELL AND GENE THERAPY, INDUSTRIAL IMPACT

GI CELL Enters Agreement with Optieum Biotechnologies

GI CELL | December 13, 2022

GI CELL, Inc. announced that it has entered into a research license and option agreement with Optieum Biotechnologies, Inc. Under the agreement, Optieum Biotechnologies will provide GI CELL with scFv antibodies directed against hematological tumor targets generated through Optieum Biotechnologies’ Eumbody System™. GI CELL will carry out feasibility studies and be responsible for further development and commercialization of the CAR-NK cell products if the company exercises an option. For each option exercised, Optieum Biotechnologies will be entitled to an option-exercise fee, development and commercial milestone payments, as well as single-digit royalties on sales. “We are pleased to enter this collaboration with Optieum Biotechnologies as we continue unlocking the full potential of our NKPURE Expander® platform. We look forward to evaluating the scFv antibodies from Optieum Biotechnologies’ discovery platform, which have the potential to accelerate the development of our novel CAR-NK cells.” Dr. Chun Pyo Hong, CEO of GI CELL “We have been dedicated to expanding the toolbox to enable immune cell-based therapies in cancer treatment, through our proprietary Eumbody System™. Optieum Biotechnologies’ strength in discovery of functional and improved scFvs in conjunction with GI CELL’s expertise in NK cell engineering and manufacturing may lead to a generation of promising cellular immunotherapy for unmet medical needs,” said Shun Nishioka, CEO of Optieum Biotechnologies. About GI CELL GI CELL is a biotechnology company that drives research and development of novel immune cell-based therapies with innovative technologies. Using its proprietary Immune CellPURE Expander® platform for highly potent NK and T cell development, GI CELL has integrated its ancillary material screening and cell expansion technologies to streamline the entire cell product development process. The Company is advancing its allogenic NK cell therapies to transform the treatment paradigm for patients with hematological malignancies and solid tumors. GI CELL has multiple NK cell product candidates in IND-enabling and preclinical development. About Optieum Biotechnologies Optieum Biotechnologies is a biotechnology company with a platform engine to elicit functional and improved scFvs for CAR-T cell and CAR-NK therapies with superior anti-tumor toxicity and persistence. Optieum Biotechnologies’ scFv generation platform, Eumbody System, enables to acquire the scFv from the CAR-T cell’s functionality perspective rather than conventional binding affinity approach. The company is advancing multiple CAR-T cell product candidates targeting hematological malignancies and solid tumors which demonstrate significantly improved anti-tumor toxicity, proliferation capacity and mitigated antigen depletion.

Read More

CELL AND GENE THERAPY

Biodesix Announces Senior Secured Financing Agreement with Perceptive Advisors for Up to $50 Million

Biodesix | November 17, 2022

Biodesix, Inc. a leading data-driven diagnostic solutions company with a focus in lung disease, announced that it has obtained a term loan facility for up to $50 million from Perceptive Advisors, a leading healthcare investment firm focused on supporting progress in the life sciences industry by identifying opportunities and directing financial resources toward the most promising technologies in modern healthcare. This debt capital, which is conditioned on the Company raising at least $30 million in gross proceeds through sale of its equity securities, is part of a strategic fundraising effort to strengthen the Company’s balance sheet, reduce near term cash use and enable the continued growth trajectory of the core lung diagnostics business. The proceeds from this debt offering will be used for repayment of existing debt facilities, working capital, and general corporate purposes, including expansion of the commercialization activities for the Company’s five Medicare reimbursed lung diagnostic tests. “This financing provides Biodesix with significant flexibility and strengthens our balance sheet thereby positioning us to continue building on the growth momentum we have seen the past few quarters. We are pleased to have the support from Perceptive, which is a recognized leader in growth capital financing.” Robin Harper Cowie, Chief Financial Officer of Biodesix “Perceptive is delighted to provide capital to support the continued growth of Biodesix’s lung diagnostics portfolio,” said Sam Chawla, Portfolio Manager of Perceptive Advisors. “With a comprehensive set of five Medicare covered tests on the market today that address the diagnostic needs of caregivers and patients across the lung continuum of care, Biodesix represents a unique opportunity to impact the lives of patients. We are excited to collaborate with Biodesix and look forward to participating in the Company’s growth.” Under the terms of the agreement, Biodesix will receive an initial $30 million funding, subject to closing conditions, including the equity issuance noted above. An additional $20 million will be available in two separate $10 million tranches under the same terms and collateral, subject to certain timelines and other defined criteria that will be subject to the lender’s approval. The credit facility is interest only for the term of the facility, which is five years from the initial funding date. The term loan bears interest at a per annum rate equal to the greater of the forward looking one-month SOFR and 3.00% per annum, plus an applicable margin of 9.00%, payable monthly in arrears. The term loan is secured by a first lien on all Company assets. In connection with the closing of the initial funding, the Company will issue to Perceptive warrants to purchase up to 5,000,000 shares of the Company’s common stock, with warrants exercisable into 3,000,000 shares of the Company’s common stock to be issued on the funding date of the initial $30 million funding (the “Initial Warrants”). The per share exercise price for the Initial Warrants will be equal to the lower of (i) the 10-day volume weighted average price (the “10-day VWAP”) ending on the business day immediately preceding the funding date of initial loan and (ii) the per share public offering price of the Company’s shares of common stock issued in connection with the required equity raise. In addition to the Initial Warrants, additional warrants will become exercisable into 1,000,000 shares of the Company’s common stock concurrently with the borrowing of each additional $10 million term loan funding. The per share exercise price for the additional warrants will be equal to the lower of (i) the Initial Warrant exercise price or (ii) the 10-day VWAP ending on the business day immediately preceding the funding date of each funding date. Each warrant will be exercisable, in whole or in part, until the 10th anniversary of the applicable date of issuance, subject to certain expiration events as set described in the warrants. Additional details of the loan agreement will be filed with the Securities and Exchange Commission on a Current Report on Form 8-K. About Perceptive Advisors Founded in 1999, Perceptive Advisors is a leading healthcare focused investment firm with approximately $9.5 billion of regulatory assets under management. Since inception, Perceptive Advisors has focused on supporting progress in the life sciences industry by identifying opportunities and directing financial resources toward the most promising technologies in modern healthcare. About Biodesix Biodesix is a leading data-driven diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® ddPCR™ test, the GeneStrat NGS™ test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of 36-72 hours, expediting time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease.

Read More

INDUSTRIAL IMPACT, MEDICAL

Can-Fite’s Partner Vetbiolix is Heading into a European Multicentric Clinical Trial with Piclidenoson for the Treatment of Pets’ Osteoarthritis

Can-Fite BioPharma | December 09, 2022

Can-Fite BioPharma Ltd. a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced progress achieved in the development of Piclidenoson for` the treatment of osteoarthritis in dogs by the Company’s veterinary commercialization partner Vetbiolix, which is covering all costs associated with veterinary clinical development. The canine osteoarthritis market is projected to reach $3 billion by 2028. Vetbiolix completed dose-ranging pharmacokinetic studies in dogs and determined the optimal efficacy and safety dosage for its upcoming European multicentric clinical study. Piclidenoson was well tolerated, with the PK data proportional to dose. Pre-clinical studies were also conducted showing Piclidenoson has a very favorable safety profile. Based on these data, Vetbiolix has designed a European Multicentric Clinical study protocol for dogs with osteoarthritis which has been approved by an ethical committee. There is clear need in the market for a safe and effective canine osteoarthritis drug. Current treatments for canine osteoarthritis include oral non-steroidal anti-inflammatory drugs (NSAIDs) which only treat symptoms and carry significant harmful side effects and an injectable disease-modifying osteoarthritis drug that targets the progression of the disease. “As Piclidenoson advances into a European Multicentric Clinical study for canine osteoarthritis in 2023, we are hopeful that our lead drug candidate, which has produced very good safety and efficacy results in human autoimmune diseases, will do the same for dogs. This veterinary indication offers Can-Fite the opportunity to get Piclidenoson onto the market faster to benefit canines, while also potentially contributing near-term revenues. We are very pleased to work productively with the team at Vetbiolix.” Can-Fite CEO Dr. Fishman In June 2021, Can-Fite entered an agreement with Vetbiolix, a France-based veterinary biotech company, for the treatment of osteoarthritis in companion animals including dogs and cats. Vetbiolix has the exclusive right to Piclidenoson in the veterinary osteoarthritis market for two years, during which time Vetbiolix is conducting studies and covering all associated costs. If the efficacy study yields positive data and Vetbiolix exercises its option to obtain the license from Can-Fite, then Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval. About Piclidenoson Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety and efficacy profile demonstrated in a Phase III clinical study in psoriasis. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity. About Can-Fite BioPharma Ltd. Can-Fite BioPharma Ltd. is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date.

Read More

CELL AND GENE THERAPY

RVAC MEDICINES AND A*STAR TO BUILD CAPABILITIES FOR mRNA PRODUCTION IN SINGAPORE

CBC Group | November 21, 2022

RVAC Medicines Pte. Ltd. a messenger RNA technology platform company incubated by CBC Group, a healthcare-dedicated asset management firm headquartered in Singapore, and the Agency for Science, Technology and Research (A*STAR) today announced the signing of a master research collaboration agreement to jointly study and develop solutions to build mRNA manufacturing and analytics capabilities in Singapore. With this collaboration, RVAC and A*STAR will set up a joint laboratory based at A*STAR's Bioprocessing Technology Institute (BTI) to develop a preclinical manufacturing platform, which will facilitate the generation of novel raw materials and potentially clinical-grade assets for the development of mRNA vaccines and therapeutics targeting infectious diseases and other conditions with unmet needs. Leveraging BTI's deep expertise in processing technologies and analytical sciences for biotherapeutics and the strong translational research in biomedical technologies across multiple research institutes in A*STAR, this collaboration seeks to enable local ecosystem innovators and global manufacturers to access the manufacturing platform to aid in preclinical asset development. The collaboration utilizes RVAC's extensive capabilities in mRNA, vaccine, and drug delivery technologies, as well as knowledge and expertise in biopharmaceutical manufacturing, research and development clinical development, and commercialization. RVAC develops mRNA-based vaccines targeting infectious diseases such as COVID-19, for which it initiated a first-in-human vaccine clinical trial in September 2022. Additional RVAC pipeline assets in development include vaccines targeting respiratory syncytial virus and Clostridioides difficile infections. Since its founding in June 2021, RVAC has recruited a team of more than 80 top-tier scientists and experienced industry veterans, and has established R&D centres in Boston, MA, USA and Shanghai, PRC. "Our collaboration with A*STAR brings together innovative research and development experience from some of the world's leading mRNA researchers. We are committed to providing the staff, equipment, and technological expertise, with support from our R&D teams around the world, to this endeavour. Combined with A*STAR's knowledge and experience, this partnership has the potential to continue the advancement of mRNA as a new class of medicines." Dr Sean Fu, Chief Executive Officer of RVAC Professor Ng Huck Hui, Assistant Chief Executive, Biomedical Research Council, A*STAR, said, "Public-private partnerships are key enablers in translating science into impact. A*STAR's multidisciplinary R&D capabilities in infectious diseases, artificial intelligence, analytics and protein engineering, coupled with RVAC's expertise, will advance the development of mRNA vaccines and therapeutics and contribute to better health outcomes for Singapore and beyond." Fu Wei, Chief Executive Officer, CBC Group added, "The collaboration between RVAC and A*STAR is a significant step in supporting the growth of innovative R&D that will ultimately drive the development of advanced vaccines and therapeutics to benefit more patients. This is aligned with CBC's mission of delivering quality and accessible medical innovation across Asia and beyond. The collaboration will also enhance the technological capability of our ecosystem, which fits well with Singapore's commitment to mission-oriented and curiosity-driven R&D." About RVAC Medicines RVAC Medicines is an mRNA platform company headquartered in Singapore with R&D centers in Boston and Shanghai. Leveraging its mRNA technology and strategic partnerships, the company is building a pipeline of novel mRNA vaccines and therapeutics to address unmet medical needs, particularly in emerging markets. The company is led by an experienced management team, supported by a world-renowned scientific advisory board. About CBC Group Headquartered in Singapore, CBC Group is Asia's largest healthcare-dedicated asset management firm, focusing on platform-building, buyout, credit/royalty, and real estate across the healthcare space, including pharmaceutical and biotech, medical technology and healthcare services. CBC is committed to creating lasting value by integrating global innovations and talents. Partnering with the world's top entrepreneurs and scientists, its unique "investor-operator" approach has empowered leading healthcare companies to widen access to affordable medical care, catalyse innovations and improve efficiency in fulfilling unmet medical needs worldwide. Founded in 2014, CBC has built a world class team of investment, industry and portfolio management professionals, headquartered in Singapore with locations in Shanghai, Beijing, Hong Kong, New York, London, and Seoul. About the Agency for Science, Technology and Research The Agency for Science, Technology and Research is Singapore's lead public sector R&D agency. Through open innovation, we collaborate with our partners in both the public and private sectors to benefit the economy and society. As a Science and Technology Organisation, A*STAR bridges the gap between academia and industry. Our research creates economic growth and jobs for Singapore, and enhances lives by improving societal outcomes in healthcare, urban living, and sustainability. A*STAR plays a key role in nurturing scientific talent and leaders for the wider research community and industry. A*STAR's R&D activities span biomedical sciences to physical sciences and engineering, with research entities primarily located in Biopolis and Fusionopolis.

Read More