On April 21, 2021 Synthesia, the AI video company, that has built and operates the world’s first and largest AI video platform, reported a $12.5M Series A financing round led by Matt Turck from FirstMark Capital with participation from all existing investors (Press release, UCLB, APR 21, 2021, View Source [SID1234578291]). The round is the largest investment to date in the synthetic AI video space.

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Founded in 2017 by technology entrepreneurs Victor Riparbelli, Steffen Tjerrild and world-renowned professors of computer vision Matthias Niessner and Lourdes Agapito, Synthesia is focused on reducing the friction of video creation and making it possible for anyone to create professional-looking videos in minutes, directly from their browser.

The funding will be used to fuel both Synthesia’s rapid enterprise user growth and product development of their AI video generation platform.

On April 21, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company, reported the publication of "A phase 1 trial of intratumoral PVSRIPO in patients with unresectable, treatment-refractory melanoma" in the BMJ’s Journal for ImmunoTherapy of Cancer (Press release, Istari Oncology, APR 21, 2021, View Source [SID1234578290]). The results of this study suggest that PVSRIPO holds promise for patients with advanced melanoma refractory to both PD-1 inhibitors and BRAF-targeted therapy.1

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Twelve patients received 1, 2, or 3 intratumoral injections of PVSRIPO at 21-day intervals. Four of six patients (67%) who received 3 injections had an objective response, 3 of whom received anti-PD-1 therapy within 30 days prior, suggesting that PVSRIPO was able to initiate or rekindle immune responses in patients who have failed anti–PD-1 therapy. Responses were observed in both injected and noninjected tumors, suggestive of an abscopal response. These results are consistent with the findings from mechanistic studies that PVSRIPO generates a functional antitumor CD8+ T cell response capable of mediating effective, systemic antitumor immunity.2,3

Following study completion, 11/12 patients (92%) re-initiated immune checkpoint inhibitor-based therapy, and 6/12 patients (50%) remained without progression at a median follow-up duration of 18 months. The antitumor responses observed suggest that PVSRIPO, either alone or in combination with anti–PD-1, may be an effective treatment in anti–PD-1 refractory melanoma.1

"The responses observed in patients with advanced disease, including in noninjected tumors in patients with significant in transit metastases, is potentially good news for the growing population of patients with unresectable melanoma who are refractory to anti–PD-1 and BRAF-targeted therapies," said Georgia Beasley, MD, Principal Investigator of the phase 1 study at Duke University. "These responses were observed without serious or dose-limiting toxicities."

"The responses seen in both injected and noninjected in-transit tumors with PVSRIPO are an important finding," noted Yana Najjar, MD, Assistant Professor of Medicine at the UPMC Hillman Cancer Center and Principal Investigator of the LUMINOS-102 phase 2 multicenter study (NCT04577807), which is investigating PVSRIPO alone and in combination with anti–PD-1 therapy and is now open to enrollment across the United States. "LUMINOS-102 will build on these data and further evaluate the ability of PVSRIPO to generate a systemic immune response that fights cancer in both injected and noninjected tumors and suppresses cancer growth over time in patients with unresectable anti–PD-1 refractory melanoma."

"The findings of this study are important further evidence of the therapeutic potential of PVSRIPO," said W. Garrett Nichols, MD, MS, Chief Medical Officer at Istari Oncology. "PVSRIPO appears uniquely capable of engaging both innate and adaptive immune responses to generate antitumor immunity."

For more information about Istari Oncology and their ongoing clinical trials and research on PVSRIPO, visit istarioncology.com.

About PVSRIPO
PVSRIPO is an investigational immunotherapy based on the live attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO has a distinct point of entry (the poliovirus receptor, CD155), which is expressed on virtually all solid tumors and antigen-presenting cells. Upon entry into the cell, PVSRIPO targets tumors via two primary mechanisms: 1) direct damage to and killing of cancerous cells; and 2) generating innate and adaptive antitumor immune responses via nonlethal infection of antigen presenting cells in the tumor, which stimulates a specific signaling pathway resulting in a sustained, robust type-I/III interferon-dominant response, with minimal release of unwanted cytokines. Its effects are potentiated by prior vaccination against poliovirus. PVSRIPO has been granted Breakthrough Therapy Designation and Orphan Status by the FDA in recurrent glioblastoma. PVSRIPO has also been granted Orphan Status by the FDA for advanced melanoma.

On April 21, 2021 Recursion Pharmaceuticals, Inc. ("Recursion" or "we") reported the closing on April 20, 2021 of its initial public offering of 27,878,787 shares of its Class A common stock, which includes the exercise in full of the underwriters’ option to purchase 3,636,363 additional shares of its Class A common stock, at a price to the public of $18.00 per share (Press release, Recursion Pharmaceuticals, APR 21, 2021, View Source [SID1234578289]). Including the option exercise, the gross proceeds from the offering were $501.8 million, before deducting underwriting discounts and commissions and other offering expenses payable by Recursion. All of the shares were offered by Recursion. The shares began trading on the Nasdaq Global Select Market on April 16, 2021 under the symbol "RXRX."

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Goldman Sachs & Co. LLC and J.P. Morgan acted as lead book-running managers for the offering. BofA Securities, SVB Leerink and Allen & Company LLC also acted as active book-running managers. KeyBanc Capital Markets acted as book running manager for the offering.

Registration statements relating to this offering have been filed with the Securities and Exchange Commission and became effective on April 15, 2021. This offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; or J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at (866) 803-9204 or by email at [email protected]. Copies of the final prospectus related to the offering are also available at www.sec.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will 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.

On April 21, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported a preliminary estimated revenue range for the fiscal second quarter ended March 31, 2021 and a business update (Press release, Applied DNA Sciences, APR 21, 2021, View Source [SID1234578286]). The Company expects revenues for its fiscal second quarter to be in the range of $2.5 million to $2.7 million. This compares to revenues of $1.6 million in the fiscal first quarter of 2021 and $552 thousand in the fiscal second quarter of 2020. The sequential growth in quarterly revenues was driven principally by demand for safeCircle, the Company’s pooled COVID-19 surveillance testing program, and from sales of its Linea COVID-19 Assay Kit (the "Assay Kit").

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Concurrently, the Company announced that it had received notification during the fiscal quarter that a loan of approximately $847 thousand received in May 2020 under the Paycheck Protection Program of the Coronavirus Aid, Relief, and Economic Security Act was fully forgiven. As a result of the full forgiveness of the loan, the Company is debt-free.

These preliminary unaudited results are based on management’s initial analysis of operations for the second fiscal quarter of 2021 ended March 31, 2021 and are subject to review and revision. The Company expects to issue full financial results for the second fiscal quarter of 2021 in mid-May 2021.

Dr. James A. Hayward, president and CEO, stated, "We are pleased to preliminarily report a second consecutive quarter of revenue growth that was driven primarily by the continued adoption of safeCircle as the surveillance testing component of clients’ COVID-19 ‘normalization’ strategies. The high sensitivity of our Assay Kit that powers safeCircle and its resultant ability to detect asymptomatic infections, coupled with the favorable economics of pooled testing, offers compelling value to communities that continue to see significant transmission alongside expanding vaccine eligibility. As such, under-vaccinated populations and organizations implementing reopening compliance strategies are target market segments for us and we are evolving our sales strategy to match.

"Our diagnostics business model has been made more resilient through product diversification and service improvements to develop adjacent revenue streams. In particular, the launch of our Selective Genomic Surveillance (SGS) Mutation Panel (SGS Panel) is coincident with the rising need for tools to supplement and strengthen the nation’s genomic sequencing capacity. Our SGS Panel can quickly and cost-effectively identify COVID-19 mutations and potentially influence vaccine/booster or therapeutics design. We also continued to demonstrate the potential for our LinearDNA platform as an alternative to plasmids to produce nucleic acid-based therapies, notably reporting compelling positive preliminary Phase I results for our LinearDNA COVID-19 vaccine candidate in felines," concluded Dr. Hayward.

Business Update

Applied DNA Clinical Labs, LLC (ADCL)

Resubmitted for and completed a re-inspection of its facility by the New York State Department of Health (DoH) Clinical Laboratory Evaluation Program (CLEP) as a requisite for Clinical Laboratory Improvement Amendments (CLIA) certification. If granted, CLIA certification would enable ADCL to serve as a diagnostic laboratory that would allow for it to conduct diagnostic COVID-19 testing utilizing its Assay Kit. The Company offers no timeline to a CLIA determination by the DoH. CLIA certification would also potentially allow ADCL to develop an additional revenue stream through the development and commercialization of a broad-array of diagnostic tests, including laboratory-developed tests (LDTs), that once approved by the applicable regulatory authority, could be offered by ADCL;
Secured an LSL (Limited Service Laboratory) registration from DoH to conduct COVID-19 diagnostic testing using third-party EUA-authorized, CLIA-waived COVID-19 testing platforms. The LSL enables ADCL to offer faster turnaround times on confirmatory diagnostic tests to safeCircle clients and capture testing revenues for diagnostic tests currently being conducted by third-party clinical labs.
Nearing completion of an upgrade of space and equipment within the Company’s Stony Brook, NY facility intended for diagnostic testing and cGMP (current Good Manufacturing Practice standards and procedures) capacity for LinearDNA production and processing.
LineaRx

Continued execution on a phased approach towards higher standards of cGMP, including upgrades in space and equipment noted above to support human therapeutic trials, veterinary therapeutics, and the subsidiary’s biotherapeutic CRO customers seeking to move into human clinical trials using LinearDNA.
About safeCircle
ADCL’s pooled surveillance testing program, known as safeCircle, utilizes frequent, high-sensitivity pooled testing to help prevent virus spread by quickly identifying infections within a community, school, or workplace. safeCircle provides 24-hour results using real-time PCR (RT-PCR) testing.

Click through to learn more about how safeCircle can help your community, school, and workplace: safeCircle

About the LineaCOVID-19 Assay Kit and Pooled Surveillance Testing
The LineaCOVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider. The scope of the LineaCOVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

The Company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of saliva and pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company’s EUA authorization for the LineaCOVID-19 Assay Kit. The Selective Genomic Surveillance (SGS) Mutation Panel (the "SGS Panel") is for Research Use Only (RUO) and shall not be used for clinical diagnostic purposes. The SGS Panel has not been approved or authorized to diagnose, ameliorate and/or detect any disease by any U.S. or international regulatory authority.

On April 21, 2021 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported that Swissmedic and Swissethics approval has been received to initiate a Phase 1b clinical trial with the Swiss Group for Clinical Cancer Research (SAKK) of Oasmia’s Docetaxel micellar in patients with advanced prostate cancer (Press release, Oasmia, APR 21, 2021, View Source [SID1234578283]). Trial initiation is expected to commence in the first half of 2021.

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Bone metastases in advanced prostate cancer are common and cause bone fragility. During the long course of the disease, corticosteroids are used, and corticosteroid premedication is mandatory with solvent-based docetaxel. High-dose steroid use is known to change the bone metabolism and further increase the fragility risk in these patients. Bone fractures impact patients’ quality of life and may also reduce survival time.

Oasmia’s Docetaxel micellar is a solvent-free formulation of docetaxel to avoid the need for solubility enhancers and mandatory high-dose steroid premedication while providing an effective treatment option. Docetaxel is approved for a wide range of solid malignancies and is a standard of care for advanced prostate cancer.

The SAKK 67/20 trial (NCT04629781) is an open-label, multicenter, single-stage Phase 1b trial at major hospitals in Switzerland, recruiting 18 chemotherapy-naïve patients with metastatic castration resistant prostate cancer (mCRPC) with adequate bone marrow, liver and renal function. Using a standard Phase I trial design, the primary objective of this study is to determine the maximum tolerated dose of Docetaxel micellar in patients with mCRPC. The secondary objectives are to evaluate the safety of Docetaxel micellar, to assess the preliminary anti-tumor activity, and to characterize the pharmacokinetics of Docetaxel micellar in this population. The treatment will be a 21-day cycle of one of three dose levels of Docetaxel micellar until progression or occurrence of unacceptable toxicity or withdrawal, for a maximum of 10 cycles.

Prostate cancer is a significant and increasingly prevalent health problem worldwide and is the leading cause of male cancer deaths.

SAKK is a non-profit organization, which has been conducting clinical trials in oncology since 1965. Its primary objective is to research new cancer therapies, to develop existing treatments further and to improve the chances of a cure for patients with cancer.

Professor Markus Jörger, President Project Group Developmental Therapeutics, at
SAKK commented: "We approached Oasmia about collaborating on a clinical trial in advanced prostate cancer using Docetaxel micellar as we saw the potential to remove pre-treatment with corticosteroids, thereby greatly reducing the incidence of adverse events such as bone fractures and other skeletal related events. We are optimistic that Docetaxel micellar could provide a much-needed treatment option for patients with advanced prostate cancer."

Commenting on the clinical trial approval, Heidi B. Ramstad, M.D., Chief Medical Officer of Oasmia, said: "SAKK approached us to collaborate on this clinical trial and we are delighted to be partnering with such a prestigious organization in oncology with a distinguished history in clinical trials. We believe that Docetaxel micellar could provide a new treatment option for patients with advanced prostate cancer, without the mandatory steroid use that is necessary with existing, solvent-based docetaxel formulations."