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BHR Week Coming Soon

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

By News, News Archive

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, News Archive

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, News Archive

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, News Archive

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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Sands Capital’s Pulse Fund III Secures $555M Close

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Sands Capital LogoThe 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.”

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Maryland Stem Cell Research Commission Announces $15.4 Million in Awards to Accelerate Cures

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MSCRF logo48 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.

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NextStepRobotics

NextStep Robotics Wins Pitch Dingman Competition Grand Prize, Announces New Board Members

By News, News Archive

NextStepRoboticsBALTIMORE, 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.

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Linshom

Linshom Medical Chosen by the NIH to Attend the Angel Capital Association Annual Meeting

By News, News Archive

LinshomBALTIMORE, 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.

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NovavaxSanofi

Novavax and Sanofi Announce Co-exclusive Licensing Agreement to Co-commercialize COVID-19 Vaccine and Develop Novel COVID-19-Influenza Combination Vaccines

By News, News Archive

NovavaxSanofiGAITHERSBURG, 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 IndiaJapan 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.

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KiteArcellex

Kite and Arcellx Continue Momentum with Advances in Anito-Cel Multiple Myeloma Program

By News, News Archive

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.

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