CELL AND GENE THERAPY

Cimeio Therapeutics Announces Issuance of Key Patent Covering Cell Therapy Platform

Cimeio | November 29, 2022 | Read time : 01:00 min

Cimeio Therapeutics
Cimeio Therapeutics, a biotechnology company developing a novel approach to cell therapies, today announced the U.S. Patent Office has issued a key patent covering the company’s Shielded-Cell & Immunotherapy Pairs platform.

U.S. Patent No. 11,499,168 covers a method for in vivo selective depletion of edited primary hematopoietic cells or non-edited primary hematopoietic cells. This method was first discovered and developed in the lab of company founder Lukas Jeker, M.D., Ph.D., at the University of Basel, and is exclusively licensed to Cimeio.

This comprehensive intellectual property provides broad protection for our platform. We believe this patent, along with those we’ve filed for our target antigen and immunotherapy portfolio, cements us as a leader in the emerging field of cell shielding and will enable the broad development of our SCIP platform.”

Cimeio CEO Thomas Fuchs

Cimeio uses genome editing to insert novel protein variants into hematopoietic stem cells or other types of cells, allowing the cells to maintain their function while making them resistant to paired immunotherapy depletion. Cimeio’s platform has effectively shielded cells from depletion mediated by antibodies, T-cell engagers, ADCs, and CAR-T cells in preclinical studies.

The company is advancing its first programs towards clinical development for genetic and malignant hematologic diseases. As previously disclosed, two posters for the company’s pipeline programs will be presented at the American Society of Hematology meeting in December 2022 in New Orleans.

About Cimeio
Cimeio is an applied gene editing and immunotherapy company developing a portfolio of Shielded-Cell & Immunotherapy Pairs® which has the potential to transform hematopoietic stem cell transplant. Cimeio’s technology platform is based on the design and expression of modified variants of naturally occurring cell surface proteins in HSCs. These novel variants maintain their function but are resistant to depletion when targeted by a paired immunotherapy which has high affinity for the wild-type version of these proteins. This technology has significant therapeutic potential, which Cimeio is using to develop curative treatments for patients with genetic diseases, hematologic malignancies, and severe autoimmune disorders.

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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.


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INDUSTRIAL IMPACT, MEDICAL

Solve Therapeutics Announces Mission to Advance Novel Antibody-Based Therapies Against Cancer-Specific Targets

Solve Therapeutics, Inc. | December 15, 2022

Solve Therapeutics, Inc. an oncology-focused biopharmaceutical company, announced its mission to develop novel antibody-based therapies targeting tumor-specific antigens. The company's formation reunites the former VelosBio Inc. team, a highly experienced group with a proven ability to rapidly advance innovative therapeutics that address unmet medical needs in the treatment of cancer. SolveTx is supported by an accomplished board of directors and a top-tier investor syndicate. The company is fully operational with 25+ employees and is actively pursuing discovery and development efforts at its 10,000-square-foot, state-of-the-art laboratory in San Diego. SolveTx's management team is headed by Chief Executive Officer Dave Johnson. In previous roles as CEO, Mr. Johnson oversaw the development of a best-in-class Bruton's tyrosine kinase inhibitor, acalabrutinib, at Acerta Pharma and a first-in-class, anti-ROR1 ADC, zilovertamab vedotin, at VelosBio. The founding members of SolveTx from VelosBio who have worked with Mr. Johnson to establish the new company include Langdon Miller, MD, Executive Vice President of Development and Chief Medical Officer; Brian Lannutti, PhD, Executive Vice President of Research; Jeff Watkins, PhD, Senior Vice President, Protein Technology; and Katti Jessen, PhD, Senior Vice President, Translational Sciences. Collectively, SolveTx management possesses extensive expertise in drug discovery, development candidate selection, investigational new drug application (IND)-enabling evaluation, clinical trial conduct, and business development. SolveTx's initial $126 million Series A financing was completed with a syndicate of top-tier venture capital firms including Matrix Capital Management, Decheng Capital, General Atlantic, and Surveyor Capital/Citadel, each represented on the company's board of directors. "I am delighted to reassemble this highly collaborative and successful team of drug developers. Together with this incredible group of investors, we are empowered to apply our expertise and resources toward the ultimate goal of prolonging and improving the lives of patients with cancer." Dave Johnson, CEO of SolveTx SolveTx will use the proceeds for production of antibody-based therapeutics for nonclinical POC characterization, producer cell line generation, good manufacturing practices drug production, IND-enabling pharmacology and toxicology studies, and Phase 1 clinical program initiation. The foundation of SolveTx's approach to oncology therapeutics development is the identification of novel cancer-specific targets and the generation of mAbs with ideal characteristics to serve as the backbones for antibody-based therapeutics. The company has signed a licensing agreement with the University of California San Diego for a series of antibodies that show high reactivity with tumors and no or low reactivity with normal tissues, which may enable the selective killing of tumor cells and a broad therapeutic index. SolveTx is reviewing other potential in-licensing opportunities as well as performing in-house antibody discovery research. The company's focus is on the development of novel mAbs, ADCs incorporating next-generation linker and payload constructs, and bispecific antibodies.

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MEDTECH

SpectrumX Confirms Next Step in Clinical Development of Respiratory Drug Candidate SPX-001 After MHRA Meeting

SpectrumX | November 25, 2022

SpectrumX, a UK-based healthcare and pharmaceutical company announces that following a constructive scientific advice meeting with the Medicines and Healthcare products Regulatory Agency on Monday, 14th November, the Company is prepared to move forward with the next stage in clinical development of its respiratory drug candidate SPX-001. Per regulatory guidelines, SpectrumX will submit a combined Clinical Trial and Ethics Committee application for a placebo-controlled phase Ib influenza viral challenge study of SPX-001 in healthy volunteers to the MHRA in December 2022. SPX-001 is SpectrumX’s nebulised respiratory infection drug candidate, based on the Company’s licensed hypochlorous acid based SPC-069 drug substance, which is believed to have broad-spectrum antipathogenic properties. “We believe SPX-001 could be a significant new weapon in the fight against viral respiratory infections, and this is a critical milestone in progressing our drug candidate toward targeted market authorisation approval. We would like to thank the MHRA for their helpful guidance and responses to our initial proposal to begin human clinical trials, and we hope this brings us another step closer to trialling what we believe is a revolutionary treatment for respiratory infections.” Commenting, Damien Hancox, CEO of SpectrumX Dr Donna Lockhart, Consulting Head of Medicines at SpectrumX, said: “After productive discussions at a scientific advice meeting with the MHRA, during which we presented our lab-driven data, supporting evidence from existing literature, and key features of our novel solution, SPX-001, supporting its potential effects in combating respiratory infections, as well as our proposed clinical study protocol, I am pleased that we are one step closer to starting our clinical trial programme and the subsequent processes that are essential to market authorisation.” If approved, this will the first in-human trial to deliver SPX-001 via a nebulizer to test its efficacy and safety versus a placebo treatment in healthy subjects infected with influenza. Following successful completion of the planned trial, SpectrumX will move forward with further trials in patients with respiratory infections to gather the additional necessary data for a market authorisation approval. As previously announced, SpectrumX has already begun the production process for SPX-001, working with a GMP-certified partner, which will accelerate trial-readiness once requisite approvals have been received. About SpectrumX SpectrumX is a UK-based healthcare and pharmaceuticals company focused on bringing to market an innovative respiratory infection therapy and the roll-out of the most powerful hand sanitiser in the world to the NHS and other healthcare clients. Both products utilise unique, patent-pending HOCl formulations. HOCl is naturally occurring in human white blood cells and is a key contributor in the immune response to infection. HOCl also has direct killing activity against bacteria, viruses and fungi. It is well-tolerated in humans while also being the most effective known disinfectant when used on surfaces.

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INDUSTRIAL IMPACT, MEDICAL

WILLOW FURTHER OPTIMIZES ITS BUSINESS TO FOCUS ON NEAR-TERM REVENUE GENERATION AND REDUCE CASH BURN

Willow Biosciences Inc. | December 08, 2022

Willow Biosciences Inc. a leading biotechnology company focused on revolutionizing industrial manufacturing of pure, consistent and sustainable functional ingredients announced today that it has taken additional steps to focus on near-term revenue generation, protect its balance sheet and reduce its cash burn. Since the early part of the year, the Company has reviewed its market opportunities and its portfolio, using a rigorous evaluation process that has taken into consideration the challenges in the current operating environment. As a result of this review, the Company has taken the following proactive actions The Company's business development focus has shifted to near-term revenue generating programs. On May 31, 2022, the Company announced its first partnered program for a pharmaceutical project that has already generated revenue for the Company. A second program was announced in November with Kalsec, a leading global producer of natural taste and sensory, food protection, colors and advanced hops ingredients for the food and beverage industry. The terms for both programs include near-term research and development revenue and milestone payments with the potential for further upside after commercialization. Furthermore, the Company is optimistic that it will be able to announce at least one new additional program in 2023. The Company consolidated its R&D operations into one lab, located in Mountain View, California and is pleased to report that key personnel have relocated to the Mountain View site and the transfer of operations was completed with minimal downtime for operations. In addition, Willow was able to ship and repurpose a significant portion of the existing equipment from its prior Burnaby, British Columbia lab location to the Mountain View facility, thereby reducing the overall costs by centralizing lab activities. The lower overhead cost associated with operating a single lab versus two labs is expected to reduce the Company's burn rate. The Company remains optimistic on the future opportunity for CBG and other cannabinoids and will be well-positioned to capture that value as the markets develop, but with its new focus on other ingredients will not invest in developing new products without partner funding. Willow outsourced its internal Quality Control analytical testing and release requirements, eliminating a number of full-time employee positions in Burnaby. The above-mentioned actions combined with an extensive review of the Company's workflows resulted in a total reduction of non-research and development workforce of eight persons, including four management positions, resulting in a current total headcount of 31 of which 77% are in R&D and operations. Willow continues its focus on operating in a lean fashion while maintaining sufficient R&D and operational resources to execute on its partnered programs and continuing to develop its own product portfolio. With no debt and a significant cash balance of $18.4 million as of September 30, 2022, the Company intends to approve a fully funded budget which covers the entirety of 2023. "By optimizing our business and reducing our cash burn we are in a strong position to pursue a strategic focus on development programs that leverage our precision fermentation technology platform for near-term revenue generation and market success," said Dr. Peter Seufer-Wasserthal, Willow's President and CEO. "Looking forward to 2023, we are excited about a number of new options we see to utilize the platform more broadly within the health and wellness, food and beverage and personal care markets, while working hard to realize shareholder value from our existing and future research and development programs and sale of functional ingredients to our customers." About Willow Biosciences Inc. Willow develops and produces precision fermented functional ingredients for the health and wellness, food and beverage and personal care markets. Willow's FutureGrownTM biotechnology platform allows large-scale production with sustainability at its core. Willow's R&D team has a proven track record of developing and commercializing bio-based manufacturing processes and products to benefit our B2B partners and their customers.

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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.

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