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NonaAZ

Nona Biosciences Announces Global License and Option Agreement with AstraZeneca for Monoclonal Antibody to be Developed into Novel Tumor Targeted Therapies

By News

NonaAZNona 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.

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Theradaptive

Frederick’s Theradaptive Secures $1M in Funding from Maryland Stem Cell Research Fund for Human Clinical Trials

By News

TheradaptiveFREDERICK, 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.

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PQE Group

PQE Group US Earns Great Place to Work Certification™

By News

PQE GroupRockville, 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.

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Maxcyte Legend

MaxCyte Signs Strategic Platform License Agreement with Legend Biotech to Accelerate Cell Therapy Discovery and Development

By News

Maxcyte LegendLegend 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.

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cartesiantherapeutics logo

Cartesian Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Descartes-08 for the Treatment of Myasthenia Gravis

By News

cartesiantherapeutics logoGAITHERSBURG, 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.

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Welldoc

Welldoc Certified as a Great Place to Work® for Third Year in a Row

By News

WelldocCOLUMBIA, 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.

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BHR Week Coming Soon

Save the Dates: 2024 BioHealth Capital Region Week Registration Coming Soon

By News

BHR Week Coming SoonLooking forward to the Autumn of 2024, the BioHealth Capital Region is gearing up for three major events, September 17th, 18th, and 19th, 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.

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amplexd logo text 250

Gaithersburg’s Amplexd Therapeutics, Innovating to Revolutionize the Future of Non-Invasive HPV-induced Cervical Intraepithelial Neoplasia (CIN) Treatments for the Prevention of Cervical Cancer: Developed by Women for Women

By News

amplexd logo text 250GAITHERSBURG, 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: press@amplexd.com

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.

Fishbowl

Baltimore Fishbowl: MCB Real Estate announces plans for a mixed-use development in Montgomery County that will have a focus on the life sciences and biohealth

By News

FishbowlMCB 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.

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Vanda

Vanda Pharmaceuticals Reports Positive Results from a Second Phase III Study of Tradipitant in Motion Sickness

By News

VandaWASHINGTONMay 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.).

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