Monthly Archives

June 2020

Jun 30
0

Protaryx Medical Announces $8.3M in Funding for First-in-Class Technology for Left Atrial Access in Transcatheter Cardiac Procedures

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$5.1M Series A Funding Led by Ajax Health Will Be Used to Develop First-in-Class Product Designed with Three-Dimensional, Independent Steerability to Deliver Reliable Access

BALTIMORE–(BUSINESS WIRE)–Protaryx™ Medical, a company committed to reimagining access to the left atrium for transcatheter cardiac procedures, today announced that it has raised $8.3 million in funding to develop the company’s first-in-class device for precision transseptal access to the left atrium during structural heart and catheter ablation procedures. The company’s funding includes non-dilutive grants and a seed round totaling $3.2 million and the recently closed $5.1M Series A financing led by Ajax Health, with participation from University of Maryland (UM) Ventures, a returning investor.

Designed for use in catheter-based procedures such as mitral valve repair and replacement, left atrial appendage closure and catheter ablation to treat cardiac arrhythmias, the Protaryx device is intended to provide physicians with confidence in accuracy and safety through independent steerability and three-dimensional control to streamline rapid crossing to the left heart.

“There is currently an opportunity for technologies that can optimize access to the left atrium during beating-heart cardiology procedures, a market that continues to see worldwide growth,” said Terri Burke, chief executive officer and co-founder of Protaryx. “We’re pleased to partner with the experienced team at Ajax Health to leverage its proven expertise and reputation for supporting successful emerging medical device companies.”

“Transseptal access performed with today’s existing technology can be challenging, time-consuming and difficult to learn, which creates a clear pain point for physicians,” said Protaryx co-founder James S. Gammie, M.D., professor and chief of Cardiac Surgery at the University of Maryland School of Medicine as well as the co-founder and inventor for Harpoon Medical, which was acquired by Edwards Lifesciences in 2017. “The innovative Protaryx device is designed with the goal of simplifying transseptal access for physicians, which may lead to fewer complications and improved outcomes for patients.”

In addition to the investment, Ajax Health leaders Doug Koo, chief financial officer and managing director, and Aftab Kherani, chief medical officer and managing director, will join the Protaryx Board of Directors.

“We are pleased to include Protaryx in the Ajax portfolio, and I’m personally excited to join the board to move this innovative company forward,” said Koo. “We have been impressed with the team and the potential of this unique technology to fill a growing clinical need in cardiovascular care.”

The Protaryx device is not available for sale anywhere in the world.

About Protaryx Medical

Protaryx Medical is a medical device company committed to reimagining access to the left atrium for transcatheter cardiac procedures. Taking an innovative approach, Protaryx aims to deliver meaningful improvements for physicians and patients. The company is headquartered in Baltimore, Maryland, with engineering operations in Minneapolis, Minnesota. Learn more at www.protaryx.com.

About Ajax Health

Ajax Health seeks to identify, support and scale disruptive technologies in the healthcare space. Taking an active operating role, the Ajax team has a proven track record of helping companies of all sizes, stages and structures achieve their value-creation goals. Ajax is headquartered in Menlo Park, California and backed by an investor group led by HealthQuest Capital. www.ajaxhealth.com

About UM Ventures

UM Ventures commercializes the University of Maryland, Baltimore’s (UMB) breakthrough therapies, diagnostics, and devices. Through early-stage investment in innovative technologies with promising commercial potential and strong management teams, UM Ventures fuels the creation of UMB start-up companies. Since the program began in 2014, UM Ventures has made 12 investments in nine companies, four of which—Harpoon Medical, Living Pharma, SurgiGyn, and Breethe—have been acquired. Learn more about the UM Ventures investment portfolio at www.umventures.org/investments.

Contacts

For Protaryx:
Health+Commerce
Hannah Boxerman
hannah@healthandcommerce.com
(707) 326-0870

Jun 30
0

Smiths Detection Enters Into Agreement to Acquire PathSensors to Expand Its Biological-Detection Capability

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Smiths Detection, a global leader in detection and screening technologies, today announces that it has entered into an agreement to acquire PathSensors, a leading bio-technology solutions and environmental-testing company based in Baltimore, MD. The acquisition expands Smiths Detection’s sensing capabilities across the CBRNE (chemical, biological, radiological, nuclear and explosive) spectrum to respond quickly to emerging threats.

PathSensors provides high-speed, highly sensitive pathogen-detection and biothreat solutions and has developed a robust fieldable method of identifying biological threats in minutes. The company shares a similar customer base to that which Smiths Detection serves for chemical-threat detection, while also allowing for expansion into adjacencies such as food and agricultural safety.

PathSensors offers multiple assays that are already available, at an independently verified speed and sensitivity data, which offer an opportunity to develop their future potential. The transaction will enable Smiths Detection to accelerate its position in biological-detection capabilities which are important both within our current markets and beyond.

“The acquisition of PathSensors will allow us to broaden our detection capabilities within the biological spectrum, which is becoming more relevant in the current environment,” said Roland Carter, President of Smiths Detection. “This is consistent with our approach to increase our focus on investing selectively in technology and innovation for the purpose of getting closer to our customers and expanding into new adjacencies.”

The contract is subject to customary closing conditions and is expected to conclude within the next four weeks.

—

About Smiths Detection

Smiths Detection, part of Smiths Group, is a global leader in threat detection and screening technologies for aviation, ports and borders, defence and urban security markets. Our experience and history across more than 40 years at the frontline, enables us to deliver the solutions needed to protect society from the threat and illegal passage of explosives, prohibited weapons, contraband, toxic chemicals and narcotics. For more information visit www.smithsdetection.com or follow us at LinkedIn at www.linkedin.com/company/smiths-detection

About PathSensors

PathSensors is a leading biotechnology solutions and environmental testing company providing high-speed, high-sensitivity pathogen detection and threat prevention solutions. PathSensors’ solutions can detect a wide range of threats, including anthrax, ricin, Ebola, salmonella, Phytophthora, Ralstonia, and many more. Visit PathSensors at www.PathSensors.com

Media contacts:

Natasha Perfect, Smiths Detection Natasha.perfect@smithsdetection.com

Jun 29
0

Alex Philippidis, Genetic Engineering and Biotechnology News Senior News Editor, Guests on BioTalk

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Alex Philippidis joins Rich Bendis on BioTalk to discuss the BioHealth Capital Region from a National viewpoint, other Hubs, and how the industry has adapted in the age of COVID-19.

Alex specializes in biopharma business news and industry issues for GEN. He joined GEN in 2011 after four years at GenomeWeb, where he covered research institutes and spent three years following biotech economic development as editor of the weekly newsletter BioRegion News. Alex reports a variety of news stories for GEN and Clinical OMICs and compiles the popular A-Lists series.

Alex previously worked for more than 20 years for various newspapers covering business, science, the Navy, and general-interest news. He has been interviewed and quoted by news outlets, including the New York Times and the BBC. He enjoys solving crossword puzzles, watching classic TV game shows, and traveling with his family.

Listen now on Google https://bit.ly/2Zj6Jd8, Apple https://apple.co/3eMbNNu, Spotify https://spoti.fi/389Jk1C, https://bit.ly/38d32K3, and YouTube (audio) https://bit.ly/31tr16m.

Click here to view the transcript.

Jun 29
0

Altimmune Announces Dosing of First Patient in Phase 1B Clinical Trial of NasoShield™, a Single Dose Intranasal Anthrax Vaccine Candidate

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GAITHERSBURG, Md., June 30, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced dosing of the first patient in the Company’s Phase 1b clinical trial of NasoShield, a single dose intranasal anthrax vaccine candidate. The NasoShield program is being developed under a contract with the Biomedical Advanced Research and Development Authority (BARDA), with a total potential value of $133.7 million if all options in the contract (HHSO100201600008C) are exercised.

“NasoShield is the only single dose anthrax vaccine in development that is supported by BARDA, and has the potential to provide a significant improvement over the available two- and three-dose injectable anthrax vaccine regimens”, said Vipin K. Garg, Ph.D., President and CEO of Altimmune. “We are excited to begin enrollment in this important clinical trial as this is an opportunity to further validate our vaccine platform and its broadly-applicable intranasal approach, and we look forward to reviewing the results later this year.”

The clinical trial is expected to enroll 42 healthy subjects who will receive intranasally administered NasoShield or placebo and be followed for 6 months. The primary immunogenicity readouts are the serum titers of antibody to protective antigen and toxin-neutralizing antibody 28 and 56 days after dosing. As with Altimmune’s other vaccine programs, stimulation of a mucosal IgA immune response in the nasal cavity will also be assessed as a potential additional benefit to serum antibody responses. Nasal mucosal immunity is not stimulated by the vast majority of vaccines but is likely to play an important role in the body’s defense against respiratory diseases.

Because NasoShield is intended to protect against anthrax after a single intranasal dose, it has the potential to be a convenient and simple alternative to the only approved vaccine, which must be given as a series of three injections over 1 month. The simplified immunization route and schedule, together with the reliable stability at ambient temperature may allow NasoShield to be deployed in an anthrax event more easily and faster than the currently approved vaccine. At the conclusion of the Phase 1b NasoShield trial, BARDA will have the option of exercising the remaining contract options valued at approximately $105 million to enable Phase 2 development.

Yesterday, Altimmune also announced it was awarded funding by the U.S. Army Medical Research & Development Command (USAMRDC) to fully support its T-COVID Phase 1/2 clinical trial in outpatients with early COVID-19 disease, making the COVID-19 therapeutic candidate the second Company program to be funded by the US government.

About Altimmune
Altimmune is a clinical stage biopharmaceutical company focused on developing treatments for liver disease, immune modulating therapies and intranasal vaccines. Our diverse pipeline includes next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™), an intranasal immune modulating treatment for COVID-19 (T-COVID™) and intranasal vaccines (AdCOVID™, NasoShield™ and NasoVAX™). For more information on Altimmune, please visit www.altimmune.com.

Forward-Looking Statement

Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the initiation and timing of the NasoShield clinical trial and receipt of data from the clinical trial in 2020, the potential for additional funding from BARDA, the potential immunization effects of NasoShield, and the prospects for regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: potential impacts due to the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; funding delays, reductions in or elimination of U.S. government funding and/or non-renewal of expiring funding under the Company’s agreement with BARDA; the Company’s ability to satisfy certain technical milestones under the Company’s contracts with BARDA that would entitle the Company to receive additional funding over the period of the agreement; the Company’s ability to obtain potential regulatory approvals on the timelines anticipated, or at all; and the Company’s ability to expand its pipeline of products and the success of future product advancements, including the success of future clinical trials, and the Company’s ability to commercialize its products. Further information on the factors and risks that could affect the Company’s business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2019 and quarterly report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC, which are available at www.sec.gov.

Contacts
Will Brown Ashley R. Robinson
Chief Financial Officer Managing Director LifeSci Advisors
Phone: 240-654-1450 Phone: 617-430-7577
Email: wbrown@altimmune.com Email: arr@lifesciadvisors.com
Jun 25
0

MaxCyte® Initiates Launch of New ExPERT™ Range of Expanded Research and GMP Grade Disposables for Complex Cellular Engineering

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R-1000, a cuvette that can process up to 1 mL (or up to 200 million) cells, is first new product offering Enhanced range of volumes and design features will support expanded use in both cell therapy drug development and early drug discovery
Gaithersburg, MD – June 25, 2020: MaxCyte, the global clinical-stage cell-based medicines and life sciences company, announced today the launch of the first product in the new and expanded range of ExPERT™ disposables. The new R-1000 cuvette can process a volume of up to 1 mL, or up to 200 million cells, and provides increased versatility for companies developing cell therapy drugs as well as those advancing early drug discovery. This expands the company’s range of disposables and provides additional growth opportunities by addressing one of the processing volumes frequently requested by customers. Based on extensive customer feedback, this new design can be used across the complete range of MaxCyte’s electroporation instrumentation, including the recently launched ExPERT ATx™, STx™ and GTx™, and represents the first product in a new industrial design that provides improved usability and handling.

 

“The ExPERT R-1000 represents the first product in our next-generation disposable design and further expands the range of products requested by customers to address the rapidly growing fields of cellular therapy and gene editing,” said Brad Calvin, Executive Vice President of Global Commercial Operations for MaxCyte. “We are continually focused on improving and expanding our disposable product range to provide scalable, high performance solutions that address the variety of cell processing volumes encountered by customers for a wide range of therapeutic indications.”

 

As part of creating a unifying technology from concept to clinic, MaxCyte is focused on innovative solutions to provide a range of disposables that will enable customers to use a single high-performance transfection technology across all stages of development. Creating cellular editing platforms standardized on a single, scalable, high performance technology can assist the industry in accelerating timelines, reducing costs and achieving milestones critical to the translation of this promising new generation of cellular therapies.

 

The new instrument family can be viewed online at //myexpertplatform.com/r-1000.

 

About MaxCyte

MaxCyte, the clinical-stage global cell-based therapies and life sciences company, uses its proprietary next-generation cell and gene therapies to revolutionize medical treatments and ultimately save lives. The Company’s premier cell engineering enabling technology is currently being deployed by leading drug developers worldwide, including all of the top ten global biopharmaceutical companies. MaxCyte licenses have been granted to more than 100 cell therapy programs, with more than 70 licensed for clinical use, and the Company has now entered into ten clinical/commercial license partnerships with leading cell therapy and gene editing developers. MaxCyte was founded in 1998 and is headquartered in Gaithersburg, Maryland, US. For more information, visit www.maxcyte.com

 

For further information, please contact:

MaxCyte Inc. 

Doug Doerfler, Chief Executive Officer

Ron Holtz, Chief Financial Officer

 

 +1 301-944-1660
US Media Relations

Jamie Lacey-Moreira

PressComm PR, LLC

+1 410-299-3310

jamielacey@presscommpr.com
Jun 24
0

Replicate Bioscience and Immunomic Therapeutics Form Collaboration to Combat Infectious Diseases and Cancers

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ROCKVILLE, Md. & SAN DIEGO–(BUSINESS WIRE)–Replicate Bioscience, Inc. (“Replicate”), a privately-held biopharmaceutical company creating novel treatments to prevent drug resistance in cancers, and Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that the companies have entered into a research and licensing option agreement to combine their platform technologies to combat infectious diseases and cancers.

ITI and Replicate will develop candidates combining ITI’s UNITE technology with Replicate’s scalable self-replicating RNA (SynRGY technology) for COVID-19, HPV, and EBV. Through the collaboration, ITI will be responsible for all development costs and ITI will also invest in Replicate Bioscience. As part of the investment, ITI’s Co-founder and Chief Scientific Officer, Dr. Teri Heiland, will be appointed to Replicate’s Scientific Advisory Board.

“We are excited to partner with Replicate and invest in their seed round as the first strategic shareholder of the company. They have an impressive team with a wealth of expertise in RNA therapeutics and immuno-oncology and we believe that their SynRGY technology is a next-generation solution for combatting drug resistance in cancer,” said Dr. William Hearl, CEO of Immunomic Therapeutics. “Through this collaboration, we look forward to combining SynRGY with our UNITE platform in infectious disease development programs, including those useful in cancers.”

“Ninety-percent of cancer related deaths are a direct result of drug resistance caused by the evolution of the tumor over time. Developing treatments for drug resistance that are deployable at earlier stages of care is a critical unmet need. Alongside their investment, the Immunomic Therapeutics team brings immense value in supporting the development of our internal wholly-owned immuno-oncology candidates. In addition, their team is ideally suited to clinically advancing our joint candidates,” said Dr. Nathaniel Wang, CEO of Replicate Bioscience. “Through this partnership, we are excited to rapidly advance candidates into the clinic for COVID-19 and infectious diseases that lead to the development and progression of various cancers.”

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

About Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical stage biotechnology company pioneering the development of vaccines through its proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE), which is designed to utilize the body’s natural biochemistry to develop vaccines that generate broad immune responses. UNITE has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy and autoimmune diseases. ITI is primarily focused on applying the UNITE platform to oncology, where it could potentially have broad applications, including viral antigens, cancer antigens, neoantigens and antigen-derived antibodies as biologics. The Company has built a large pipeline from UNITE with six oncology programs and two allergy programs. ITI has entered into a significant allergy partnership with Astellas Pharma and has formed several academic collaborations with leading Immuno-oncology researchers at Fred Hutchinson Cancer Research Institute, Johns Hopkins University of Medicine, and Duke University. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit www.immunomix.com.

About Replicate Bioscience

Replicate Bioscience, Inc. (Replicate) is a privately-held clinical stage biopharmaceutical company focused on creating novel oncology treatments to prevent drug resistance. By deploying its SynRGY technology, Replicate aims to create solutions that enhance the effectiveness of many immuno-oncology regimens in early stages of care. Replicate is a Duke University spinout of tumor resistance-targeting technology from faculty members H. Kim Lyerly and Zachary Hartman and is developing its own pipeline of immuno-oncology products in breast, lung, and prostate cancers. Replicate aims to maximize the potential of its SynRGY platform through partnerships in infectious diseases. Replicate has entered into strategic collaborations with Immunomic Therapeutics and Duke University. Replicate maintains its headquarters in San Diego, CA as part of the BioLab community of companies. For more information, please visit www.replicatebioscience.com.

Jun 24
0

HemoShear Therapeutics Receives FDA Clearance of IND for Phase 2 Study of its Investigational Drug HST5040 for the Treatment of Methylmalonic Acidemia and Propionic Acidemia

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Charlottesville, Va., June 24, 2020 –  HemoShear Therapeutics, a clinical stage company developing treatments for rare metabolic disorders, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to conduct a phase 2 clinical trial of HST5040, an oral small molecule drug for the treatment of patients with methylmalonic acidemia (MMA) and propionic acidemia (PA).  MMA and PA are rare genetic disorders caused by the deficiency of certain enzymes required to metabolize amino acids. The diseases result in the rapid buildup of life-threatening metabolites that can lead to severe organ damage, seizures, developmental deficits, and premature death.

“There are currently no targeted pharmacologic treatments for MMA or PA that can improve quality of life or extend lifespan, and there is a lot of enthusiasm in the community for the potential of a daily oral treatment approach,” said Marshall Summar, MD, Division Chief, Genetics and Metabolism and Director of the Rare Disease Institute at Children’s National.  “This is a very exciting time for patients with MMA or PA and their families.”

HemoShear’s phase 2 clinical study, HERO (HElp Reduce Organic Acids), is designed to enroll at least 12 patients with MMA and PA. The study, which will start with patients age 12 and over and then expand to age 2 and older, will be conducted at select leading children’s hospitals in the United States. The HERO Study will include three stages:  open-label dose escalation; followed by a randomized, double-blind, placebo-controlled crossover; and then an open-label long-term extension.

“The FDA clearance to move HST5040 forward into a Phase 2 clinical trial is an important milestone in developing treatments for these devastating diseases as well as evidence of the potential of our innovative human disease modeling platform,” said Jim Powers, Chairman and CEO of HemoShear. “I am very proud of the accomplishments of our team. We will be working closely with the MMA and PA communities to enroll patients into our clinical trial of this novel and convenient oral therapy.”

 

About HST5040

HST5040 is an investigational oral small molecule therapy developed by HemoShear to correct metabolic abnormalities associated with MMA and PA. Because HST5040 is a small molecule, it has the ability to distribute to multiple affected tissues and thus has the potential to be active throughout the body, including the brain, heart and muscles. HST5040 is designed for convenient daily administration at home as a liquid formulation taken either orally or through a gastric feeding tube.

 

About HemoShear Therapeutics

HemoShear Therapeutics is a privately held clinical stage company developing treatments for rare metabolic disorders with significant unmet patient need. HemoShear’s drug discovery platform, REVEAL-Tx™, enables the Company’s scientists to create best-in-class, biologically relevant human disease models to uncover the underlying mechanisms of disease, translate those discoveries into drug targets, and select candidates that may treat patients successfully. In addition to the Company’s proprietary rare disease programs, HemoShear has exclusive partnerships to identify novel therapeutic approaches in nonalcoholic steatohepatitis (NASH) with Takeda and in gout with Horizon Therapeutics.  For more information visit www.HemoShear.com.

Jun 23
0

Kemp Proteins Affirms Commitment to Quality with ISO 9001:2015 Certification

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FREDERICK, MD. (PRWEB) JUNE 23, 2020

Kemp Proteins, a leading provider of gene-to-protein and monoclonal antibody development services, today announced that the company has received ISO9001:2015 certification for the development and manufacturing of protein-based products and services to the pharmaceutical, diagnostics, and research industries. The decision to pursue ISO9001 accreditation demonstrates Kemp’s commitment to a culture of continuous improvement focused on providing clients with world-class protein development services.

The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide products and services through quality systems for planning, resources, manufacture and delivery that meet client requirements.

“Since Six.02 Bioservices purchased Kemp in 2019, it has been our goal to promote a Quality ethos within the company. Achieving ISO certification affirms that we have successfully implemented a quality management system that conforms to the ISO world-wide standards,” said David Hicks, COO and Head of Quality for Kemp Proteins. “The ISO 9001 certification represents an important milestone for our company and reflects our commitment to providing our clients with a high-quality service.”

Michael Keefe, CEO of Kemp Proteins commented, “In the last 18 months, we have increased facility space from 3,000 to 12,000 square feet, personnel from 5 to 22, obtained AAALAC accreditation for our vivarium and now achieved ISO9001 certification. We are positioning ourselves as a world-class bioservices company, one that attracts high achieving and driven personnel. All of these advancements are a testament to the hard work of the team and the high level of quality we expect throughout the development, manufacturing and support of our clients. These milestones provide a solid quality base for our company – one that we will build upon. We are committed to becoming ISO13485 within the near future.”

About Kemp Proteins (http://www.kempproteins.com)
Kemp Proteins (formerly Kempbio) is a leading provider of gene-to-protein, hybridoma and cell line development services. For more than 20 years, Kemp’s team of protein problem-solvers has delivered best-in-class services that optimize productivity and mitigate risk for life sciences innovators developing protein-based products, including human and veterinary diagnostics, biopharmaceuticals, and vaccines. Kemp Proteins is a Six.02 Bioservices member company.

About Six.02 Bioservices (http://www.six02bio.com)
Six.02 Bioservices is a holding company focused on acquiring and managing a family of companies that will provide a continuum of best-in-class research services and products to protein-based innovators across the life sciences. The Six.02 Bioservices name reflects Avogadro’s number (6.023 x 1023), defined as the number of atoms or molecules per mole of any substance. The mole is a bridge between our world and the microscopic world—for example, a protein is 3×10-9 moles. Six.02 Bioservices was incorporated in 2018 on Mole Day (October 23), a date celebrated between 6:02 a.m. and 6:02 p.m. by scientists around the world.

Source: www.prweb.com

Jun 22
0

Preclinical Data for PRGN-3005 UltraCAR-T® Demonstrate Superior Expansion and Persistence of UltraCAR-T Compared to Traditional CAR-T

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– UltraCAR-T cells eliminated tumor burden in mice following tumor rechallenge three months after prior treatment demonstrating superior expansion, persistence and improved efficacy in ovarian cancer model –
– UltraCAR-T cells were selectively and effectively eliminated by kill switch activator –

GERMANTOWN, Md., June 22, 2020 /PRNewswire/ — Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced preclinical data for its innovative investigational PRGN-3005 UltraCAR-T® in patients with advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer has been published as an e-poster and accompanying audio presentation at the American Association for Cancer Research (AACR) Virtual Annual Meeting II. The e-poster presentation titled PRGN-3005 UltraCAR-T: Multigenic CAR-T Cells Generated Using Non-viral Gene Delivery and Rapid Manufacturing Process for the Treatment of Ovarian Cancer (Abstract 6593) is part of the Immunology/Adoptive Cell Therapy session and is accessible on the AACR e-poster website.

Precigen Logo (PRNewsfoto/Precigen, Inc.)
Precigen Logo (PRNewsfoto/Precigen, Inc.)

Traditional methods for CAR-T cell manufacturing involve the use of viral vectors and ex vivo cell expansion at centralized manufacturing facilities, contributing to potentially high costs and extended waiting periods. Precigen’s UltraCAR-T platform, in contrast, is based upon a non-viral multigene delivery system combined with a rapid, decentralized manufacturing process without ex vivo expansion. Following isolation of the patient’s own T cells after blood draw, non-viral gene transfer occurs overnight at the medical center’s cGMP facility. The next day, UltraCAR-T cells are infused into the patient.

PRGN-3005 is an autologous CAR-T treatment simultaneously expressing three gene products, which results in a uniform, homogenous CAR-T cell therapy: 1) CAR to specifically target the unshed portion of Mucin 16 (MUC16), which is overexpressed on over 80% of ovarian tumors with limited expression found in healthy tissues; 2) membrane-bound IL-15 (mbIL15) to provide improved UltraCAR-T persistence and maintenance of preferred stem cell like memory phenotype; and 3) a kill switch to eliminate the CAR-T cells, if needed.

Preclinical data demonstrate the specificity and efficacy of using the rapidly manufactured PRGN-3005 UltraCAR-T cells for the treatment of ovarian tumors. Specifically, a single administration of PRGN-3005 showed significantly superior expansion and preferred memory phenotype of UltraCAR-T in vivo and significantly superior efficacy compared to traditional CAR-T resulting in all PRGN-3005 treated mice becoming tumor-free. Furthermore, rechallenging these tumor-free mice three months later with ovarian tumors for a second time (to simulate tumor relapse) led to the elimination of tumor burden without additional PRGN-3005 UltraCAR-T treatment. These data demonstrate the potential of UltraCAR-T cells to persist long-term in vivo, prevent CAR-T cell exhaustion, and mount a durable anti-tumor response with the ability to continue to respond upon tumor rechallenge.

“We are pleased to be able to share the preclinical data for PRGN-3005 that led to the IND clearance and initiation of the Phase I study,” said Helen Sabzevari, PhD, President and CEO of Precigen. “Our preclinical results demonstrate that PRGN-3005 UltraCAR-T administered one day after non-viral gene transfer has superior anti-tumor efficacy and persistence compared to traditional CAR-T cells and represents a promising opportunity for ovarian cancer treatment. We look forward to sharing the first clinical data for PRGN-3005 in the second half of 2020.”

Based on these preclinical results, the FDA approved the IND application, and the first-in-human PRGN-3005 Phase I clinical trial for advanced ovarian cancer is currently under way (clinical trial identifier: NCT03907527). The PRGN-3005 UltraCAR-T Phase I clinical study is an open-label, dose escalation study to evaluate the safety and maximal tolerated dose of PRGN-3005 UltraCAR-T delivered by intraperitoneal infusion (IP) or intravenous infusion (IV). The study population includes patients with advanced stage (III/IV) recurrent ovarian, fallopian tube, and primary peritoneal cancer who are platinum-resistant and have progressed after receiving standard-of-care therapies or are not eligible to receive available therapies with known clinical benefit.

About Ovarian Cancer
Worldwide, nearly 300,000 women are diagnosed with ovarian cancer every year1 with approximately 22,000 of them in the US2. Since early ovarian cancer is often without obvious symptoms, the disease is frequently diagnosed at an advanced stage where cancer has spread to distant parts of the body, such as the liver or lungs2,3. Five-year survival rates depend on stage and type of ovarian cancer with rates decreasing for advanced stage cancers that have spread to distant parts of the body3.

Precigen: Advancing Medicine with Precision™
Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit www.precigen.com or follow us on Twitter @Precigen and LinkedIn.

Precigen’s UltraCAR-T® Therapeutic Platform
Precigen’s UltraCAR-T platform has the potential to disrupt the CAR-T treatment landscape by increasing patient access through shortening manufacturing time, decreasing manufacturing-related costs, and improving outcomes using advanced approaches for precise tumor targeting and control of the immune system. The platform brings several key advancements: 1) Non-viral gene transfer using multigenic vectors for expression of multiple effector genes leads to better precision and control of tumor targeting and eliminates the need for virus; 2) Sustained persistence and desired phenotype of infused UltraCAR-T helps address T-cell exhaustion, a common issue with current CAR-T therapies; 3) T-cell control by incorporation of kill switch technology to potentially improve the safety profile; and 4) Rapid manufacturing of UltraCAR-T cells using our proprietary non-viral gene transfer process, which eliminates the need for ex vivo propagation, thus dramatically reducing wait times for patients from weeks to one day after gene transfer.

Trademarks
Precigen, UltraCAR-T, and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.

Cautionary Statement Regarding Forward-Looking Statements
Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company’s business, including the timing and progress of preclinical and clinical trials and discovery programs, the promise of the Company’s portfolio of therapies, the Company’s refocus to a healthcare-oriented business, and its continuing evaluation of options for the Company’s non-healthcare businesses. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties, including the possibility that the timeline for the Company’s clinical trials might be impacted by the COVID-19 pandemic, and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission.

For more information, contact:

1 World Health Organization, International Agency for Research on Cancer, Global Cancer Observatory. Cancer Today, Estimated number of new cases in 2018. WHO IARC GCO website.
2 American Cancer Society Ovarian Cancer Special Section. ACS website.
3 American Cancer Society. Survival Rates for Ovarian Cancer. ACS website.

View original content to download multimedia:http://www.prnewswire.com/news-releases/preclinical-data-for-prgn-3005-ultracar-t-demonstrate-superior-expansion-and-persistence-of-ultracar-t-compared-to-traditional-car-t-301080945.html

SOURCE Precigen, Inc.

Source: investors.precigen.com

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Jun 22
0

Altimmune Announces IND Clearance for a Phase 2 Trial of HepTcell™ Immunotherapeutic for the Treatment of Chronic Hepatitis B

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GAITHERSBURG, Md., June 22, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 2 trial of HepTcell, a peptide-based immunotherapeutic for the treatment of chronic hepatitis B. The Company is also filing clinical trial applications in Canada, Spain, Germany and the United Kingdom. Altimmune plans to initiate a multinational trial in Q4 of this year, subject to an ongoing assessment of the impact of COVID-19 on study conduct.

“We are pleased to have obtained IND clearance for the evaluation of HepTcell in a Phase 2 trial. HepTcell is the only investigational immunotherapeutic designed specifically to restore antiviral T cell responses against the most conserved antigenic domains of the Hepatitis B virus (HBV),” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “We believe that HepTcell could also be the key immunotherapy component of a future anti-HBV combination regimen to help break immune tolerance and achieve a functional cure.”

According to World Health Organization estimates, chronic HBV affects 292 million worldwide, and nearly 900,000 people die annually of complications of the disease. There is no cure for chronic HBV, and currently available antiviral medications only control the disease and require life-long treatment. These treatments represent a significant burden for chronic hepatitis B patients, considering life-long commitment to medication and monitoring costs. If left untreated, chronic HBV infection can lead to serious health issues including cirrhosis, liver failure and liver cancer.

HepTcell is an immunotherapeutic product candidate composed of nine synthetic HBV-derived peptides formulated with IC31®, a TLR9-based adjuvant from Valneva SE. The HBV peptides were designed to drive T cell responses against all HBV genotypes in patients of diverse genetic background. In the Phase 1 clinical study conducted in the United Kingdom and South Korea, three monthly injections at two dose levels of HepTcell peptides were given with and without IC31® adjuvant as add-on therapy to entecavir or tenofovir in patients with Hepatitis B e-antigen (HBeAg)-negative chronic infections. All arms were generally well-tolerated and both high and low doses of HepTcell given in combination with IC31® resulted in potent T cell responses against HBV antigens – representing a break in immune tolerance with no evidence of immune-mediated adverse events.

Acute HBV infections are cleared through a T cell-dependent immune response. However, in chronically infected patients, high viral antigen load can induce a state of immune tolerance that prevents T cells from clearing the infection. Breaking immune tolerance is considered essential to achieving a functional cure, defined as the loss of hepatitis B surface antigen (HBsAg) in the blood. Ultimately, the goal of all HBV therapeutics in current development is to achieve a functional cure by reactivating the T cell immune response and overcoming immune tolerance, either indirectly by further lowering HBV antigen load or directly, as is the goal of HepTcell.

The double-blind, randomized, placebo-controlled Phase 2 study of HepTcell plans to recruit 80 adult subjects with HBeAg-negative chronic HBV infection and low HBsAg levels. This patient population was selected as it is envisioned to mimic the HBV status of the patient population when HepTcell is combined with a novel direct-acting antiviral in subsequent trials. HepTcell will be administered intramuscularly at intervals of 4 weeks for 6 doses. The primary endpoint will be the virological response, defined as a 1-log reduction in HBsAg levels; secondary endpoints will incorporate safety, immunologic criteria, and other assessments of virologic response.

“HepTcell is a novel immunotherapeutic in development that holds potential for the treatment of patients with chronic hepatitis B,” said Dr. Mark Thursz, Professor of Hepatology and Head, Department of Metabolism, Digestion and Reproduction, Imperial College London and Lead Investigator of the multinational trial. “Immune tolerance is a considerable problem in chronic HBV patients, and I see the potential for HepTcell to be combined with the newer direct acting agents in development. HepTcell, if approved, could offer an additional agent in our efforts to achieve functional cure”.

About Altimmune
Altimmune is a clinical stage biopharmaceutical company focused on developing treatments for liver disease, immune modulating therapies and intranasal vaccines. Our diverse pipeline includes next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™), an intranasal immune modulating treatment for COVID-19 (T-COVID™) and intranasal vaccines (AdCOVID™, NasoShield™ and NasoVAX™). For more information on Altimmune, please visit www.altimmune.com.

Forward-Looking Statement
Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, our expectations for the potential of HepTcell as a therapy for HBV, the further development of HepTcell, the initiation and timing of clinical trials for HepTcell, and the prospects for regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: potential impacts due to the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to obtain potential regulatory approvals on the timelines anticipated, or at all; and the Company’s ability to expand its pipeline of products and the success of future product advancements, including the success of future clinical trials, and the Company’s ability to commercialize its products. Further information on the factors and risks that could affect the Company’s business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2019 and quarterly report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC, which are available at www.sec.gov.

Phone: 240-654-1450 Phone: 617-430-7577

Source: Altimmune, Inc.

Source: ir.altimmune.com

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