Join us for an enlightening episode of BioTalk with Rich Bendis, featuring Michael J. Tarlov, Chief of the Biomolecular Measurement Division at the Material Measurement Laboratory, NIST. With a distinguished career in analytical chemistry and extensive experience in biochemical sensing and bioprocess measurements, Michael leads critical initiatives to advance biotechnology and healthcare.

In this episode, we delve into the pivotal role of NIST as a non-regulatory agency within the Department of Commerce, highlighting its profound impact on measurement science, gene therapy, gene editing, synthetic biology, and regenerative medicine. Michael shares insights into NIST's collaborations, including local companies like MedImmune/AstraZeneca and Novavax, and the importance of partnerships with academic institutions like the University of Maryland in driving local biotech advancements.

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COLUMBIA, Md. (May 30, 2024) – The Maryland Stem Cell Research Commission (“the Commission”) announces the release of Requests for Applications (RFAs) for the Maryland Stem Cell Research Fund’s (MSCRF) first funding cycle of fiscal year 2025 (FY25).

RFAs for this initial cycle are now available for five grant programs: Manufacturing Assistance, Clinical, Validation, Commercialization, and Launch. All applications are due by July 9, 2024.

Along with this announcement comes the news that the Commission is also extending grant funding to businesses outside of Maryland for the Commercialization grant program, provided the research activities are conducted within the State. The Clinical grant program is available to entities with at least one clinical site in Maryland.

Venlo, the Netherlands, and Salt Lake City, Utah, May 30, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Myriad Genetics (NASDAQ: MYGN) today announced they will develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status. This next-generation sequencing (NGS) test aims to support research into personalized medicine in multiple solid tumor types, including ovarian cancer and is expected to enhance decentralized testing capacities once a regulated product is developed with pharmaceutical partners. The project builds on the recently announced master collaboration agreement between the two companies.

BALTIMORE, MD, US, May 29, 2024 /EINPresswire.com/ -- Linshom Medical, a Maryland-based startup developing a wearable respiratory monitoring system, announced today that it has been awarded a $100,000 grant from the Maryland Industrial Partnerships (MIPS) program to support a clinical study of its respiratory monitoring device.

The study, “Advanced Prediction of Respiratory Depression Episodes with Linshom Continuous Predictive Respiratory Monitoring (CPRM),” will evaluate the Linshom Medical device's ability for early detection of patient respiratory decline in the Post Anesthesia Care Unit. Dr. Samuel M. Galvagno, Executive Vice Chair of Anesthesiology and Interim Chair of the Department of Anesthesiology, will lead this effort for UMSOM as the principal investigator.

NEW YORK – AMPEL BioSolutions is recruiting individuals with systemic lupus erythematosus (SLE) into an observational study of its blood-based prognostic gene expression assay LuGene to demonstrate a correlation between test results and standard clinical evaluations.

In addition, the company has been conducting a study to see whether different lupus subtypes as defined by its test correlate with therapeutic response.

These studies follow another one published in October in the journal Genome Medicine that showed evidence for eight transcriptionally defined SLE endotypes, or subgroups, and demonstrated LuGENE’s ability to predict patients at risk for episodes of worsening symptoms called flares with high sensitivity and specificity.

MANASSAS, Va.--(BUSINESS WIRE)--ATCC, the world’s premier biological materials management and standards organization, today announced that it has been awarded a task order with a ceiling value of $15.5 million, inclusive of base and options, by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Under this task order 75N93019D00002-75N93024F00001, ATCC will develop well-characterized challenge material (WCCM) for the In Vitro Assessment for Antimicrobial Activity (IVAAA) program. This program aims to evaluate candidate countermeasures against microbial pathogens and vectors, including those derived from clinical specimens. The assessments are conducted in vitro and focus on antiviral screening assays for biosafety level (BSL)-3/4 viruses relevant to human diseases, as well as other rapidly emerging viruses that employ similar assay methodologies.

The acquisition adds two proprietary clinical technologies to its portfolio and enhances Precision's global capabilities in clinical data management, biostatistics and programming.

BETHESDA, Maryland, May 29 – Precision for Medicine, a global leader in biomarker-driven clinical research and development supporting life sciences companies, today announced the acquisition of Algorics, one of the fastest-growing clinical technologies and biometrics service providers to the biopharma industry. The addition of Algorics brings two innovative clinical technologies and further bolsters Precision for Medicine’s reach in the Asia-Pacific region. The acquisition also enhances Precision's global capabilities in clinical data management, biostatistics, and programming.

COLUMBIA, Md., (May 29, 2024) — TEDCO, Maryland’s economic engine for technology companies, unveiled the recently completed “Cybersecurity Workforce Analysis and Study” (“Study”). The Study was commissioned by TEDCO to better understand the current status of Maryland’s cybersecurity workforce pipeline. This knowledge will be used to guide the Cyber Maryland Program (“Program”) and its 18-member board of directors as they develop a statewide cybersecurity workforce development strategic plan.

“The Study confirms what businesses and government agencies in Maryland already know: demand for skilled cybersecurity professionals—who protect our communities from criminals threatening our way of life—is incredibly nuanced. Thankfully, there is support and momentum amongst key stakeholders to bridge our talent gap,” said Roger Austin, chair of the Cyber Maryland board of directors. “My fellow board members and I are committed to address this critical need by developing innovative solutions to overcome our cyber skills talent gaps and provide good, paying jobs for our state’s residents.”

GAITHERSBURG, Md., May 29, 2024 (GLOBE NEWSWIRE) -- Today, Georgiamune Inc., a privately held, clinical-stage biotechnology company, announced the clearance of its second Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for GIM-531, a first-in-class oral treatment that selectively targets T-regulatory cells and spares other immune cells such as CD4 and CD8. The news comes just on the heels of the company’s first-in-class, dual-functioning antibody, GIM-122, progressing to clinical trial for human testing.

BioHealth Innovation Inc. (BHI) congratulates the outstanding winners of the 2024 ICON Awards announced by the Maryland Tech Council. These awards recognize the incredible contributions of individuals and companies in the fields of technology and life sciences, highlighting their impact on millions of lives.

AstraZeneca: with a member of our BHI Board of Directors, Tyrell Rivers, Ph.D., has been honored as the Life Science Company of the Year. Their continued dedication to advancing healthcare through groundbreaking research and development is truly commendable.

Nanochon: We are particularly proud of Nanochon and Benjamin Holmes, the recipients of the Chief Executive Officer of the Year—Life Sciences award. Nanochon is a previous winner of our BioHealth Capital Region Crab Trap, and it’s exciting to see their sustained excellence and innovation being recognized on a larger stage.

Solaxa: A special congratulations to Solaxa, who was awarded the Venture Mentoring Services Venture of the Year. We are pleased to note that two members of Solaxa's leadership team, Luis T. Gutierrez, Jr. and Jennifer Butler, are part of the BHI/Montgomery County Executive-In-Residence Program. This recognition underscores their remarkable leadership and commitment to advancing technology and life sciences.

ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. In VIRAGE, the ongoing multinational Phase 2b clinical study, intravenous VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with pancreatic ductal adenocarcinoma (PDAC). Previously, the FDA granted orphan drug designation to VCN-01 for treatment of PDAC.

ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced data from the planned interim analysis of the exploratory open-label Phase 2a clinical study of SPN-817 for treatment-resistant seizures. The study is examining the safety and tolerability of SPN-817 as adjunctive therapy in adult patients with treatment-resistant seizures, as well as finding effective doses in various treatment-resistant seizure types. The interim analysis is as of May 1, 2024, and is based on 41 enrolled subjects, of which 19 completed the maintenance period. Of these 19 subjects, 16 subjects had focal seizures.

RICHMOND, Va., May 23, 2024 /PRNewswire/ -- Activation Capital announces the launch of Frontier BioHealth, an educational and support program designed to provide highly specialized training, targeted mentorship, and relationship building to help scale pharmaceutical, biotech, medical device, and health-focused consumer products companies. The inaugural four-month program will be critical in bringing research-intense products and companies to market. It will broaden the continuum of regional early-stage support – additive to Virginia Commonwealth University's proof of concept fund and newly launched pre-accelerator program – and continue to coalesce the emerging private investment ecosystem in Central Virginia.

FREDERICK, Md., May 22, 2024 /PRNewswire/ -- Theradaptive, Inc., a regenerative medicine company developing targeted therapeutics, announced today it has been awarded funding from the Maryland Stem Cell Research Fund (MSCRF) to support human clinical trials for its lead product, OsteoAdapt SP.  OsteoAdapt SP is currently in Phase I/II clinical studies for transforaminal lumbar interbody spinal fusion (TLIF) to treat degenerative disc disease, spondylolisthesis, and retrolisthesis.

Theradaptive was granted an Investigational Device Exemption (IDE) in January 2024 by the U.S. Food and Drug Administration (FDA) to begin its human clinical trial. This $1 million award from the MSCRF Clinical Program will enable Theradaptive to expand its OASIS human clinical study to sites in Maryland. More details can be found at ClinicalTrials.gov: identifier NCT06154005. Theradaptive also holds three Breakthrough Medical Device designations for various spine indications including TLIF, ALIF, and PLF.

Rockville, MD, May 22, 2024. PQE Group is proud to announce that, for the third consecutive year, its US subsidiary has been Certified™ by Great Place To Work®. This prestigious award is based entirely on what current employees say about their experience working at PQE Group US. This year, 85% of employees in the US said it’s a great place to work, 28% higher than the average U.S. company.

Great Place to Work® is the global authority on workplace culture, employee experience, and the leadership behaviors proven to deliver market-leading revenue, employee retention and increased innovation. To obtain this recognition, PQE Group’s US employees completed a voluntary survey, responding to numerous questions regarding their satisfaction in a wide array of areas that encompass the framework of PQE Group’s company culture.

Legend Biotech obtains license to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to support its non-viral engineered pipeline portfolio across a variety of cell types including T cells, Gamma-Delta T cells and NK Cells.

ROCKVILLE, Md., May 22, 2024 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development, and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, today announced it has entered into a strategic platform license (SPL) agreement with Legend Biotech, a global leader in cell therapy.

GAITHERSBURG, Md., May 22, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Regenerative Medicine Advanced Therapy (“RMAT”) designation for Descartes-08 for the treatment of myasthenia gravis (“MG”).

Descartes-08, the Company’s lead product candidate, is an autologous mRNA CAR-T directed against the B cell maturation antigen (“BCMA”) initially being developed for the treatment of MG, a chronic autoimmune disorder that causes disabling muscle weakness and fatigue.

Nona Biosciences, a global biotechnology company providing a total solution from “Idea to IND” (I to ITM), ranging from target validation and antibody discovery through preclinical research, announced today that it has entered into a license agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) for preclinical monoclonal antibodies that will be used to create targeted therapies in oncology.

Under the terms of the agreement, Nona Biosciences shall receive US$19 million upon completion of the transaction. Nona is eligible to receive an additional US$10 million in potential near-term milestone payments and up to US$575 million upon achieving specified development, regulatory, and commercial milestones, as well as tiered royalty payments on net sales. In addition, Nona is eligible to receive payments for the option programs should AstraZeneca exercise these options.

COLUMBIA, Md., May 21, 2024 — Welldoc^®, a leading digital health company specializing in AI-driven cardiometabolic health, announced today that it was Certified™ by Great Place to Work® for the third consecutive year. This prestigious award recognizes companies with exceptional workplace cultures based solely on employee feedback. An impressive 90 percent of employees said Welldoc is a great place to work, exceeding the U.S. average by 31 points.

Great Place to Work is the global authority on workplace culture, known for its expertise in employee experience and leadership practices that drive business success. The Great Place to Work Certification is based on results of the Trust Index™ survey administered by the Great Place to Work Institute, which assesses employee satisfaction in key areas, including credibility, respect, fairness and camaraderie.

Looking forward to the Autumn of 2024, the BioHealth Capital Region is gearing up for three major events, September 17th, 18th, and 19^th, 2024, that promise to bring together industry leaders, investors, and innovators from across the biopharma and healthcare sectors. Whether you're a company seeking investment, an entrepreneur ready to showcase your innovations, or an industry professional looking to network and gain insights, these events are not to be missed. Mark your calendars and stay tuned as registration and application sites will be going live soon.

10th Annual BioHealth Capital Region Forum

Dates: September 17-18, 2024
Venue: US Pharmacopeia, Rockville, MD

Celebrate a decade of achievements and advancements at the 10th Annual BioHealth Capital Region Forum. This milestone event will reflect on ten years of progress within the BioHealth sector and set the stage for future innovations. Attendees will have the opportunity to engage in meaningful discussions, participate in networking sessions, and connect with hundreds of C-level executives from government, academia, and industry. If you're looking to stay on the cutting edge of biopharma developments, this is the place to be.

GAITHERSBURG, MD, May 20, 2024 (GLOBE NEWSWIRE) -- Amplexd Therapeutics, Inc. (“Amplexd” or the “Company”), a clinical stage patient-scientist-led biotech company specializing in accessible treatments for human papillomavirus (HPV)-induced Cervical Intraepithelial Neoplasia (CIN), is pleased to announce major updates in 2024 toward the finalization of product development ahead of Phase 1/2 clinical trials for its non-invasive treatments of CIN, the precursor to cervical cancer. The Company has secured US$2 Million for this initiative from an Asia-based life sciences focused family office. “The funding marks a major milestone in our R&D efforts for our two therapies after extremely promising preclinical studies were completed. The capital will enable us to finalize development and IND submissions ahead of first-in-human clinical trials, expected to commence later this year,” said Co-Founder and CEO Alia Rahman.

The strategic funding positions Amplexd Therapeutics to reshape the landscape in HPV and cervical precancer treatments with two topical, non-invasive options as potential alternatives to the “watch and wait” approach for low-grade CIN, and invasive surgery for high-grade CIN. Amplexd is poised to move the needle with the development of two low-cost therapies that favor patient comfort and increase access, and a vision to provide accessible solutions to target the often-overlooked public health crisis of HPV-induced cervical precancers.

Founded in 2022, Amplexd Therapeutics has been gaining prominence in the women’s health space as a company at the technological vanguard of the treatment of CIN, a disease which affects upwards of 178 million women globally every year. About 5% of cervical screenings in the US and Europe reveal abnormalities at any given time, with significantly higher rates in Asia, Latin America, and Africa. CIN results from certain oncogenic varieties of HPV, which can transform cervical cells into invasive cancer if left untreated. Cervical cancer is the fourth leading cause of cancer death globally in women and can largely be prevented by treatment at the CIN stage.¹

Amplexd was born from Rahman’s personal experience with persistent CIN. Following a diagnosis of carcinoma in situ (high-grade CIN) and an invasive surgery, a 13-year journey with chronic CIN ensued. Eager to avoid a subsequent surgery, Rahman set out to develop a non-invasive topical therapy using a primary active ingredient, Epigallocatechin gallate (EGCG), a polyphenol derived from green tea. Evidence for the efficacy of green tea polyphenols against CIN had been investigated in a research setting but hadn’t been adequately developed from the perspective of becoming a commercial therapeutic. Seizing upon this gap, Amplexd Therapeutics was born. “I envisioned the advent of an alternative to ‘watching and waiting’ and surgery for this incredibly common condition, having myself experienced the psychological burden of chronic CIN, the trauma of the surgery itself, and the revolving door of doctors’ appointments. Our non-invasive treatments have the potential to be a game-changer both in terms of access and comfort, as they wouldn’t require surgery or physicians to implement, and are designed to minimize discomfort. My hope is that once approved, others can have an experience better than my own, without compromising quality of care,” Rahman added.

About Amplexd Therapeutics, Inc.

Amplexd Therapeutics is developing two low-cost, novel, non-invasive therapies for the treatment of Cervical Intraepithelial Neoplasia (cervical precancer). The first is an intravaginal suppository for low-grade CIN, and the second is a photodynamic therapy (PDT) system for high-grade CIN, each designed to selectively target neoplastic cells. These treatments are designed to both modernize the paradigm for women in developed nations by sparing the need for invasive surgeries, as well as provide access to potentially lifesaving care for those in low and middle-income regions.

For more information about Amplexd Therapeutics, Inc., please visit amplexd.com.

Contact:

Media Relations
Amplexd Therapeutics, Inc.
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Forward-Looking Statement:

This press release may contain forward-looking statements that are subject to risks and uncertainties. Actual results may differ materially from those expressed or implied in such statements. Factors that could cause actual results to differ include, but are not limited to, the regulatory and commercial success of Amplexd Therapeutics, as well as the competitive landscape in the women’s health, infectious disease, and oncology markets. Amplexd Therapeutics, Inc. assumes no obligation to update any forward-looking statements.

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MCB Real Estate, the developer of Harborplace in Baltimore, announced on Thursday that it will lead the development of VIVA White Oak, a mixed use project planned for a 280-acre site in eastern Montgomery County, Maryland.

The land, near US 29 and Cherry Hill Road, is next to the U. S. Food and Drug Administration headquarters and near the Adventist HealthCare White Oak Medical Center. It’s also close to the University of Maryland’s College Park campus, the Interstate 95 corridor and BWI Thurgood Marshall International Airport. County officials have approved it for more than 12 million square feet of mixed-use development.

WASHINGTON, May 15, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the results from its second Phase III study of tradipitant in motion sickness, confirming the previously reported results of two efficacy studies demonstrating that tradipitant is effective in the prevention of vomiting associated with motion sickness. This Phase III study was conducted in real-world conditions on boats in the coastal waters of the United States (U.S.).

48 scientists receive funding from the Maryland Stem Cell Research Fund to further research

COLUMBIA, Md. (May 14, 2024)—The Maryland Stem Cell Research Commission (“Commission”) is pleased to announce the next round of awards granting a total of more than $15.4 million. These awards are aimed at fostering groundbreaking research to enhance and propel stem cell treatments and technologies across Maryland.

Several esteemed scientists from various Maryland-based research institutions and companies have been selected as recipients in this grant cycle. Among the 48 distinguished awardees are academic researchers from prestigious institutions such as Johns Hopkins University; University of Maryland, Baltimore: University of Maryland, College Park; Lieber Institute for Brain Development; and the Hugo W. Moser Research Institute at Kennedy Krieger. Commercial sector entities like Seraxis Inc., Theradaptive, Inc., HOHCells, LLC, Agnos Therapeutics, Inc., and Reprocell U.S.A., Inc. were also awarded grants.

BALTIMORE, MD – May 13, 2024 – NextStep Robotics, a University of Maryland, Baltimore (UMB) spinout company dedicated to commercializing cutting-edge stroke rehabilitation technologies, was awarded the $20,000 Grand Prize in the 2024 Pitch Dingman Competition’s All Stars Track. The signature annual competition is hosted by the Dingman Center for Entrepreneurship, part of the Robert H. Smith School of Business at the University of Maryland, College Park.
NextStep is also pleased to announce the appointment of new board members. These expert business executives bring a wealth of experience in the healthcare and technology sectors, which will be invaluable as NextStep Robotics continues to grow.

The Life Sciences Pulse strategy partners with private companies helping transform how diseases are defined, diagnosed, and treated.

Sands Capital is pleased to announce the close of our third life sciences fund, Sands Capital Life Sciences Pulse Fund III (“Pulse III”), raising $555 million. Pulse III was met with high demand from both existing and new limited partners. This close increases total Pulse strategy capital commitments to $1.3 billion, including Sands Capital Life Sciences Pulse Fund (“Pulse I”) and Sands Capital Life Sciences Pulse Fund II (“Pulse II”). The team will continue investing with the same emphasis on private therapeutics, diagnostics, medical devices, and life sciences tools businesses, in support of the strategy’s mission to help transform how diseases are defined, diagnosed, and treated.

“The life sciences sector continues to innovate at a rapid pace, leading to breakthroughs that benefit both patients and society as a whole,” said Stephen Zachary, Managing Partner. “We are grateful to both the investors joining us in Pulse III and the talented management teams we’ve partnered with since the strategy’s inception.”

GAITHERSBURG, Md., May 10, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M^™ adjuvant, has entered into a co-exclusive licensing agreement with Sanofi (Nasdaq: SNY).

The terms of the agreement include: a co-exclusive license to co-commercialize Novavax's current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing Advance Purchase Agreements and in India, Japan and South Korea where Novavax has existing partnership agreements); a sole license to Novavax's adjuvanted COVID-19 vaccine for use in combination with Sanofi's flu vaccines while Novavax retains the right to and is developing its own COVID-19-Influenza Combination vaccine candidate; a non-exclusive license to use Novavax's adjuvanted COVID-19 vaccine for use in combination with non-flu vaccines; and a non-exclusive license to use the Matrix-M adjuvant in vaccine products. In addition, Sanofi will take a minority (<5%) equity investment in Novavax.

BALTIMORE, MD, US, May 10, 2024 - Linshom Medical, a Maryland based start-up medical device company was selected as one of eight companies to represent the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant portfolio at the Angel Capital Association (ACA) annual meeting in Columbus, OH on May 13-15, 2024.

After a competitive evaluation of 190 applications, Linshom Medical was chosen by the National Heart Lung & Blood Institute (NHLBI) as 1 of 8 companies to represent an NIH portfolio of over 1,000 companies.

COLUMBIA, Md., May 9, 2024 — Welldoc^®, a leading digital health company specializing in cardiometabolic health, today announced that it has been selected as winner of the “Best Overall Digital Health Company” award for the second consecutive year in the 8th annual MedTech Breakthrough Awards. The awards program is conducted by MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies and products in the global digital health and medical technology market. This is the third year that MedTech Breakthrough has recognized Welldoc for its leadership and innovation in the digital health industry.  

The AI-powered Welldoc platform offers flexible, multi-condition digital coaching across diabetes, weight management with GLP-1 support, hypertension, heart failure, and prediabetes, with integrated mental wellbeing and sleep guidance. Through personalized, real-time and actionable insights, the platform empowers individuals to better self-manage their health and provides care teams with critical data to inform clinical decision-making. 

REDWOOD CITY, Calif. & SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (NASDAQ: GILD), and Arcellx, Inc. (NASDAQ: ACLX) today announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program. Anito-cel is the first BCMA CAR T to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact D-Domain binder.

The companies shared the design of a global, Phase 3 randomized controlled clinical trial, iMMagine-3, which Kite expects to start in the second half of this year. The trial will compare the efficacy and safety of anito-cel randomized against the standard of care (SOC) in patients with relapsed and/or refractory multiple myeloma (rrMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody.

Kite’s facility in Frederick, Maryland will manufacture anito-cel for this trial. This follows the completion of the technical transfer from a third-party contract manufacturing organization to Kite, as well as the transfer of the Investigational New Drug (IND) application for anito-cel, which has been cleared by the U.S. Food and Drug Administration.

WASHINGTON, May 9, 2024 /PRNewswire/ -- Danaher Corporation (NYSE: DHR), a global science and technology innovator ("Danaher"), today launched a collaboration with Johns Hopkins University aiming to develop new methods for diagnosing mild TBI. As part of the Danaher Beacons program, researchers at Johns Hopkins University will leverage technology from Beckman Coulter Diagnostics, a Danaher subsidiary and leader in clinical diagnostics, to potentially establish correlations between a new biomarker panel and clinical outcomes.

Julie Sawyer Montgomery, Vice President and Group Executive, Danaher Diagnostics, said: "Our latest in vitro diagnostics innovations are improving the detection of specific biomarkers found in blood when brain cells are damaged. We are thrilled to partner with Johns Hopkins with the goal of leveraging these solutions to develop tests for earlier and more precise diagnosis of mild TBI, which could ultimately lead to improved treatment outcomes and faster recovery for patients."

COLUMBIA, MD (May 8, 2024) – Maryland’s leading edge in stem cell research was on full display at the Maryland Stem Cell and Regenerative Medicine Technology Showcase (“Showcase”) on April 25, 2024. This event, hosted as a collaborative effort between Maryland Stem Cell Research Fund (MSCRF) and the Maryland Department of Commerce, served as a platform to highlight groundbreaking advancements in stem cell and regenerative medicine from MSCRF portfolio members.

“This is an exciting time in the regenerative medicine space and the Maryland Stem Cell Research Fund is honored to support the innovations in stem cell therapy taking place in Maryland,” said MSCRF executive director, Ruchika Nijhara, PhD. “Maryland is home to pivotal and innovative stem cell research, and we are pleased to partner with the Department of Commerce to bring the regenerative medicine community together to share their cutting-edge research in this growing field.” 

Agreement allows ImmunoACT to develop and commercialize a novel TriCAR-T cell therapy for leukemia and lymphoma designed to decrease lapses seen in current single CAR-T cell therapies and improve outcomes

GAITHERSBURG, Md. and MUMBAI, India, May 7, 2024 /PRNewswire/ -- Caring Cross, a 501(c)(3) non-profit dedicated to accelerating the development of advanced medicines and enabling access to cures for all patients, everywhere, and ImmunoAdoptive Cell Therapy (ImmunoACT), a Mumbai, India-based pioneering research and cell and gene therapy development company, announced an agreement to develop and commercialize a multi-targeted chimeric antigen receptor T-cell immunotherapy for leukemia and lymphoma. The TriCAR-T immunotherapy is designed to address relapse that can occur when patients with Leukemia or Lymphoma are treated with a single targeting anti-CD19 CAR T-cell product. Under the terms of the agreement, Caring Cross will provide a TriCAR-T cell immunotherapy for clinical development, manufacturing, and commercialization at ImmunoACT's facilities in India.

The NIH Entrepreneurship Bootcamp is designed to equip life science investigators and nascent companies with specialized innovation and entrepreneurship training. The course requires no prior experience and uses a life science-focused customer discovery process to assess customer and stakeholder needs, and teaches participants to develop stronger business models, market strategies, and commercialization plans in advance of their initial SBIR/STTR application.

The Bootcamp places teams on a path to take advantage of other NIH innovation programs, particularly the I-Corps and SBIR programs. Critically, this course will improve the commercialization potential of a project no matter what direction teams ultimately pursue. The program is differentiated from I-Corps@NIH as it targets teams who have not yet been awarded an SBIR or STTR for their technical innovation and who may not yet have formed a company. More information is available through NOT-OD-24-103.