On September 28, 2021 Kytopen Corp., a biotechnology company spun out of MIT offering a scalable technology for engineered cell therapies, reported it has raised $30 million in an oversubscribed Series A funding (Press release, Kytopen, SEP 28, 2021, View Source;utm_medium=rss&utm_campaign=kytopen-raises-30m-in-series-a-funding-led-by-northpond-ventures-to-transform-non-viral-delivery-via-the-flowfect-platform [SID1234590543]). The new capital will be used to commercialize Kytopen’s Flowfect Tx for cGMP-compliant cell therapy manufacturing and move towards treating the first human patient with Flowfect engineered cells. Kytopen’s mission is to enable simple and efficient non-viral manufacturing of cell therapies in days versus weeks to increase patient access to life-saving therapies.

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The Series A investor syndicate was led by the experienced life sciences investment team at Northpond Ventures, a leading science-driven venture capital firm, with participation from current investors: The Engine, Horizons Ventures, and MassVentures, as well as Aldevron Co-Founders Michael Chambers and John Ballantyne and Alexandria Venture Investments. Adam Wieschhaus, Ph.D., CFA, Director at Northpond Ventures, will join the Kytopen board of directors along with Kytopen Co-Founders Paulo Garcia and Cullen Buie and Theresa Tribble, Venture Partner at The Engine.

"We are thrilled to partner with Northpond and their innovative ecosystem to develop and commercialize our Flowfect technology. Together with Northpond’s talented and experienced team we will continue to unlock industry bottlenecks and pave the way for cost-effective engineered cell therapies," said Paulo Garcia, Ph.D., CEO and Co-Founder, Kytopen. "We are actively executing on therapeutic and academic collaborations and this funding and network will be the catalyst to accelerate our partners into the clinic and beyond. I am tremendously proud of the entire Kytopen team’s achievements and future contributions to make these potentially life-saving cell therapies more accessible to patients."

The new funding will also accelerate the commercialization of Kytopen’s high-throughput automated platform, which seamlessly links discovery to manufacturing and has the potential to unlock personalized medicines. The company’s proprietary Flowfect platform is a transformative solution that eliminates the complexity of gene editing and integrates discovery, development, and manufacturing in one flexible and scalable non-viral delivery solution.

"Cellular engineering is a vastly manual, time-consuming process. While the market demands acceleration and scale, a cell’s fragility requires that methods are also gentle from lab to clinic," said Adam Wieschhaus, Ph.D., CFA, Director at Northpond Ventures. "Kytopen is unlocking potential in genetic engineering at speeds 10,000 faster than current state-of-the-art methods while still maintaining cellular composition. Northpond is excited to collaborate with Kytopen to advance non-viral manufacturing and bring much needed cell therapies to patients."

Kytopen’s proprietary Flowfect technology speeds therapies from discovery to the clinic by enabling cell engineering without compromising functionality or viability. Flowfect reduces risk and provides maximum control and flexibility to reduce time to market by months or even years while providing safer and cost-efficient engineered cell therapies.The Flowfect technology utilizes electro-mechanical energy to gently introduce genetic material such as RNA, DNA, or CRISPR/Cas RNP, to a wide variety of hard-to-transfect primary human cells. The Flowfect technology enables cell engineering in minutes for target discovery and process development optimization. For example, 96-well plates can be processed in less than 10 minutes while direct scale up to clinical manufacturing volumes is facilitated by the processing rate of 2 billion cells per minute in a single channel.

On September 28, 2021 Admera Health, a precision-medicine company and genetics laboratory, reported that it has engaged Back Bay Life Science Advisors, a strategic advisory and investment banking firm, to explore strategic alternatives for its pharmacogenomics and clinical services business as part of a company-wide strategic review (Press release, Admera Health, SEP 28, 2021, View Source [SID1234590542]). Admera offers the most comprehensive clinical PGx test in the industry, covering 62 genes, over 270 medications, and over 20 therapeutic areas, including: psychiatry, cardiology, pain management, and oncology. Admera Health’s clinical services portfolio is built on a strong foundation of next-generation sequencing (NGS) and data analysis capabilities.

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The company’s current PGx and clinical services product portfolio consists of:

PGxOne Plus is a 62-gene pharmacogenomics test that provides insight into how patients may respond to certain medications based on DNA variants that affect pharmacokinetics and pharmacodynamics
RxVision is a secure, online digital platform that delivers PGx test results to providers and offers a complete PGx assessment with the gene-drug interactions aligning with the FDA sources and guidelines from professional organizations. The product is accessible on web-based browsers, as well as iOS and Android mobile devices, obviating the need for complicated integration with electronic medical record systems
OncoGxOneis a comprehensive 364-gene Next Generation Sequencing assay for profiling all solid tumor types. Input includes both DNA and RNA for optimal fusion detection. The product compliments Admera Health’s suite of NGS tests, spanning the continuum of cancer patient care
The company has also capitalized on its infrastructure by partnering with other domain experts to expand its product offering, notably with its Cardiovascular Test Portfolio.

"We are proud of the significant commercial value we have built in our pharmacogenomics products and are looking to select a strategic partner with additional scale and resources to realize their full potential," said Jeffrey Mitchell, interim CEO of Admera Health.

The company will continue to own and operate its biopharma services business, providing genomics and bioinformatics services in a CAP-accredited CLIA certified laboratory for researchers working on projects ranging from exploratory to clinical.

On September 28, 2021 Acceleron Pharma reported that it is in advanced talks to be acquired in a deal estimated to be worth $11 billion (Press release, Acceleron Pharma, SEP 28, 2021, View Source [SID1234590535]).

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Merck & Co.. has now emerged as the frontrunner in the race, apparently having beaten out Bristol Myers Squibb, which currently owns more than 11.5% of Acceleron in company stock. BMS picked up the shares as part of its 2019 purchase of Celgene.

The Wall Street Journal reported Monday that Merck is in advanced talks to acquire Acceleron, citing sources familiar with the matter. Merck appears to be looking to diversify a portfolio that is largely dominated by blockbuster cancer drug Keytruda.

The same people said that an announcement could come this week, providing talks do not fall apart. In its original report, WSJ said that the pricepoint for Acceleron would be about $180-a-share in cash.

Merck previously went on a buying spree that spread from late in 2020 into 2021, acquiring OncoImmune in November, and picking up autoimmune disease drug developer Pandion Therapeutics in February in a 1.85 billion deal. Other acquisitions ncluded VelosBio and Themis.

If the deal for Acceleron goes through, it would be one of Merck’s largest and signal an increasing focus on the rare disease space, particularly in the treatments for respiratory and blood diseases where Acceleron focuses.

The rumors had already been percolating as Acceleron’s stock has risen over the past 10 days from $130-a-share in mid-September to $167.65 as the market closed on Friday. The company currently has a market value of $10.2 billion. Shares of the company have climbed 60% in the past year.

The biotech, which went public in 2013, is focused on developing protein therapies to treat certain types of cancer and rare diseases. Of prime attraction value is sotatercept, an investigational reverse-remodeling agent in phase III development for the treatment of pulmonary arterial hypertension (PAH).

In May, Acceleron presented preliminary interim data from its Phase II study of sotatercept at the American Thoracic Society 2021 International Conference showing that the drug was associated with improvements in resting and exercise hemodynamics at week 24. The outcomes were obtained from the first 10 patients evaluated among a total of 21 trial participants.

On Monday, Raymond James analyst Danielle Brill wrote that she thinks most investors would prefer Acceleron wait until Phase III data is available, which is due later in 2022, rather than accept a deal at the $180-per-share pricepoint.

According to Ziad Bakri, a vice president and health care investor at T. Rowe Price, the drug has "a ton of value in it." Acceleron was recently highlighted by Barron’s as one of "5 biotech names ready for a comeback."

Acceleron has been on an upward trend the past two years. The company’s one approved drug, Reblozyl, which is part of a global collaboration with BMS, was authorized by the U.S. Food and Drug Administration (FDA) in 2019 for the treatment of anemia in adults with beta thalassemia who require regular red blood cell (RBC) transfusions. This was followed just months later in April 2020 by an approval for the drug in the treatment of anemia in adults with lower-risk myelodysplastic syndromes. Reblozyl netted Acceleron approximately $25.6 million in royalty revenue for Q2 2021 from approximately $128 million in net sales.

A third candidate, ACE-1334, is being developed to treat fibrotic disease. The drug has been granted FDA Fast Track designation in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a rare, progressive autoimmune connective tissue disorder, and Orphan Drug designation for the treatment of systemic sclerosis.

For Merck, the acquisition of Acceleron would be another part of its transition to focus on growth areas that include cancer, vaccines and animal health. The pivot was enabled by the spinoff of slower-growth assets including women’s health products and cholesterol treatments into Organon & Co.

On September 28, 2021 20/20 GeneSystems, Inc., ("20/20"), reported the launch of its Clinical Lab Innovation Axcellerator (CLIAx), believed to be the first shared CLIA laboratory facility geared to helping diagnostic test innovators worldwide substantially reduce the time and cost of launching their tests in the U.S (Press release, Minomic, SEP 28, 2021, View Source [SID1234590528]).

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"Establishing and maintaining a compliant CLIA lab can be costly and daunting for young companies, especially those seeking to enter the American market from overseas," 20/20 President and CEO, Jonathan Cohen said. "From leasing facilities to hiring qualified laboratory professionals, purchasing equipment, and running daily operations, it can be a hefty burden. These hurdles can limit or delay our nation’s access to some of the most creative and out-of-the-box testing solutions from around the world demonstrated during the pandemic to be in great demand. Our unique CLIAx accelerator removes or lowers many of the barriers in the path of these innovators."

CLIAx offers nearly 3,000 square feet of ready-to-use communal clinical laboratory space and testing equipment, including a full PCR/molecular assay suite, NextGen Sequencing (NGS), immunoassay and clinical chemistry capabilities. Importantly, 20/20’s marketing and sales teams will help promote the new test to the market segments in which 20/20 is currently active.

Earlier this month the company signed an agreement with Australian-based Minomic International Ltd, a diagnostics firm that is gearing up to introduce MiCheck Prostate, a blood test that uses proprietary algorithms and biomarkers to estimate the risk of aggressive prostate cancer.

"Our company is so excited to be working with the CLIAx team. Their clinical lab accelerator is a unique concept that allows us to tap into the expertise in laboratory testing. It is just what Minomic requires – a ‘soft landing’ site to enter the U.S. market so we can focus on the key activity of test rollout instead of the necessary minutiae of setting up and running a lab service," said Dr. Brad Walsh, CEO of Minomic International Ltd.

CLIAx was officially designated by the Maryland Department of Commerce as a "Soft Landing" program for overseas companies seeking to enter the U.S. market.

"Maryland is ‘open’ for international companies looking to expand, and the new Clinical Laboratory Innovation Axcelerator will provide the perfect soft landing for those seeking to explore the U.S. market," said Maryland Commerce Secretary Kelly M. Schulz. "We applaud 20/20 GeneSystems for taking the lead with this initiative and we hope to see similar spaces launch throughout the state."

On September 28, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported the closing of its previously announced underwritten public offering (Press release, Onconova, SEP 28, 2021, View Source [SID1234590469]). A total of 5,000,000 shares of its common stock were sold at a public offering price of $4.20 per share. The gross proceeds of the offering to the Company are $21 million, before deducting the underwriting discounts and commissions and other estimated offering expenses. In addition, Onconova granted the underwriters a thirty-day option to purchase up to an additional 750,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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Guggenheim Securities is acting as sole book-running manager. Ladenburg Thalmann & Co. Inc. and Noble Capital Markets, Inc. are acting as co-managers for the offering.

The securities described above were offered by Onconova pursuant to a shelf registration statement on Form S-3 (File No. 333-237844) which was initially filed by the Company with the Securities and Exchange Commission ("SEC") on April 24, 2020, amended on Form S-3/A that was filed with the SEC on May 15, 2020, and was declared effective by the SEC on May 18, 2020.

A preliminary prospectus supplement relating to the offering was filed with the SEC on September 23, 2021 and is available on the SEC’s website at View Source A final prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is also available on the SEC’s website at View Source Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.