On May 18, 2020 MaxCyte, the global clinical-stage cell-based therapies and life sciences company, reported that clinical data from the first three cohorts of the ongoing Phase I dose-escalation trial demonstrating safety of MCY-M11 and feasibility of one-day manufacturing will be shared at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) upcoming annual meeting (Press release, MaxCyte, MAY 18, 2020, View Source [SID1234558261]). The ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program will be held May 29-31, 2020.

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The Poster Discussion presentation, entitled Feasibility and preliminary safety and efficacy of first-in-human intraperitoneal delivery of MCY-M11, anti-human-mesothelin CAR mRNA transfected into peripheral blood mononuclear cells, for ovarian cancer and malignant peritoneal mesothelioma, will be available in the Developmental Therapeutics: Immunotherapy session, which can be accessed on demand beginning at 8 a.m. ET on Friday, May 29, 2020.

MCY-M11 is a wholly-owned, non-viral, mRNA-based cell therapy candidate manufactured using un-manipulated peripheral blood mononuclear cells. It is under development for the treatment of ovarian cancer and peritoneal mesothelioma. The ongoing study so far demonstrates both the safety and of MCY-M11 as well as the feasibility of one-day manufacturing and intraperitoneal delivery of our cell product.

"This is a presentation of the preliminary results of our ongoing first-in-human study with the novel mRNA-based CARMA platform designed to treat malignancies expressing mesothelin," said Christina M. Annunziata, MD, PhD, Investigator at the Women’s Malignancies Branch and Head of the Translational Genomics Section at the National Cancer Institute Center for Cancer Research. "We have so far demonstrated the feasibility to deliver MCY-M11 CARMA cells intraperitoneally to treat patients, the acceptable overall safety of using a transient CAR expression approach and early evidence that supports moving forward with and further building on this strategy."

As previously announced, dosing began in October 2019 in the third cohort in MaxCyte’s Phase I dose-escalation trial with MCY-M11 and there have been no dose-limiting toxicities or related serious adverse events observed in the three completed cohorts. A fourth dosing cohort commenced in March 2020 as expected. Preliminary clinical results for the trial are expected to be announced in H2 2020. Clinical development of MCY-M11 continues now under the auspices of MaxCyte’s subsidiary CARMA Cell Therapies.

For more information about the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program and a link to the abstract, please visit: View Source

About CARMA Cell Therapies
Through its wholly owned subsidiary, CARMA Cell Therapies, MaxCyte is facilitating advancement of novel mRNA-based cell therapies for cancer and other diseases with serious unmet needs. MaxCyte has developed CARMA, a novel and proprietary platform for the development of non-viral, human messenger RNA (mRNA)-based, chimeric antigen receptor (CAR) or T-cell receptor (TCR) redirected immune cell therapies. CARMA [derived from CAR mRNA] utilizes MaxCyte’s Flow Electroporation technology for highly efficient, non-viral, delivery of one or more mRNA(s) into un-manipulated peripheral blood mononuclear cells (PBMCs) or isolated immune cells such as T- or NK-cells. CARMA offers the potential for a safer cell therapy, as a result of transient expression of receptor(s) and a non-viral delivery approach. Together, CARMA and MaxCyte’s EXPERT family of instruments also offer the potential for a significantly streamlined, scalable, and cost-effective GMP manufacturing process without the complexity of virus-based products. At the start of 2020, MaxCyte established CARMA Cell Therapies as a wholly owned subsidiary to facilitate independent investment and new partnerships to advance the CARMA platform. MaxCyte has retained Locust Walk, a global life science strategic advisory and transaction firm. The Company expects CARMA to be self-funded by end of 2020. For more information, visit View Source

On May 18, 2020 Arcadia Biosciences, Inc. (Nasdaq: RKDA), a leader in science-based approaches to enhancing the quality and nutritional value of crops and food ingredients, reported the closing of a transaction resulting in gross cash proceeds to the company of approximately $6.8 million, through the exercise of certain existing warrants by several holders to purchase an aggregate of 1,392,345 shares of common stock shares at a reduced exercise price of $4.90 per share (Press release, Arcadia Biosciences, MAY 18, 2020, View Source [SID1234558260]).

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In consideration for the immediate exercise of the existing warrants for cash, the exercising holders received new unregistered warrants to purchase up to an aggregate of 1,392,345 shares of common stock at an exercise price of $4.775 per share with an exercise period of five years from the date of issuance. The common shares issued upon exercise of the existing warrants are registered for resale pursuant to a registration statement on Form S-1 (File No. 333-229047).

The net proceeds of the offering are estimated to be approximately $6.3 million after deducting placement agent fees and other estimated offering expenses. Arcadia expects to use the net proceeds from this offering to pursue a range of near-term inorganic growth opportunities within the company’s hemp business unit.

"We saw this warrant exercise as an opportunity with our current investors to strengthen our balance sheet and to provide additional cash resources as we persevere through the headwinds of the COVID-19 pandemic," said Matt Plavan, president and CEO. "The proceeds of this financing will also help advance our strategy for growth and transform our business through the potential acquisition of assets aiming to add value and speed to our hemp and hemp products business."

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act and, along with the shares of common stock issuable upon the exercise thereof, have not been registered under the Securities Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy 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 the registration or qualification under the securities laws of any such state or jurisdiction.

On May 18, 2020 LIPAC Oncology LLC reported the presentation of positive interim data from the TD-001 trial evaluating the safety and efficacy of investigational agent LiPax (paclitaxel) for intravesical instillation in patients with low-grade highly recurrent Non-Muscle Invasive Bladder Cancer (NMIBC) (Press release, Lipac Oncology, MAY 18, 2020, View Source [SID1234558259]). The study was accepted for presentation at the 2020 American Urological Association (AUA) Annual Meeting, published as a supplement to the April 2020 issue of The Journal of Urology and presented as part of the AUA Virtual Experience. The presentation can be accessed via the AUA website here.

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Trial results showed 100% (6/6) of patients treated with Transurethral Resection of Bladder Tumor (TURBT) and LiPax achieved a complete response three, six and nine months after the start of therapy. The 12-month recurrence free survival rate was 85% (5/6) and 100% (3/3) for all patients that reached the 18-month mark. Follow-up will continue until all patients have reached the 24-month mark.

"By pairing a simple outpatient procedure (TURBT) with LiPax, we have an opportunity to substantially improve both clinical outcomes and quality of life for people living with highly recurrent NMIBC," said Michael Oefelein, M.D., Chief Medical Officer of LIPAC Oncology. "This positive data validates that our proliposomal technology platform increases penetration and persistence of treatment and significantly improves the effectiveness of intravesical therapy."

Based on the biopsy results obtained from TURBT, NMIBC is stratified into three risk categories: low, intermediate, and high risk. To reduce recurrence and prevent progression, The AUA NMIBC guidelines recommend various durations of intravesical therapy after TURBT. The low to intermediate risk category is estimated to comprise 90,000 Americans, yet no intravesical agent is approved by the U.S. Food and Drug Administration for this disease.

In the study, LiPax was well tolerated with no change in patient reported urinary health related quality of life, no dose limiting toxicity (grade 3 or greater severity adverse events), and no evidence of systemic exposure to the active product ingredient (paclitaxel).

About The Phase 1/2a TD-001 Trial
TD-001 is an open-label, single-arm, multi-center Phase 1/2a clinical trial of TSD-001 (paclitaxel) for intravesical instillation to evaluate its safety and efficacy in patients with low to intermediate risk NMIBC.

About LiPax
LiPax (paclitaxel) for intravesical instillation is an investigational drug formulation of paclitaxel in Phase 2 development for the treatment of NMIBC. Utilizing the proliposomal technology platform, LIPAC Oncology’s proprietary formulation to enhance persistence and penetration of bladder tissue to paclitaxel, is designed to enhance the standard of care of outpatient endoscopic tumor removal, histological risk assessment followed by intravesical instillation using a standard urinary catheter. LIPAC Oncology completed enrollment in TD-001 in May 2020 and intends to advance the program to a pivotal study to further investigate LiPax in the treatment of this condition.

On May 18, 2020 PANTHERx Rare Pharmacy reported that it has been selected by Deciphera Pharmaceuticals as a limited distribution partner for new drug QINLOCK (ripretinib) (Press release, Deciphera Pharmaceuticals, MAY 18, 2020, View Source [SID1234558258]). QINLOCK is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib . Deciphera is focused on developing and commercializing innovative drugs that address the unmet medical needs of cancer patients by addressing key mechanisms of drug resistance.

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"PANTHERx is thrilled to be chosen by Deciphera Pharmaceuticals to deliver hope, this new oncology therapy with a novel mechanism of action, and our award winning white-glove services to patients living with advanced gastrointestinal stromal tumors," said Dr. Gordon Vanscoy, Chairman & CEO of PANTHERx. "As a partner, PANTHERx is proud to do our part in advancing oncology care and we are excited to offer more treatment options for people living with rare cancers."

QINLOCK (ripretinib) targets the broad spectrum of KIT and PDGFRα mutations known to drive GIST, including KIT mutations known to cause resistance to currently approved agents. Metastatic GIST is a disease characterized by many mutations, with over 90% of GIST patients harboring multiple mutations that drive progression of their disease. The complex heterogeneity of mutations within individual tumors and individual patients is a major cause of resistance to existing therapies.

While approved kinase inhibitors control certain initiating and drug resistance-causing mutations in KIT and PDGFRα, the kinases that drive disease progression in most GIST patients, these approved drugs fail to inhibit all known mutations. QINLOCK (ripretinib) was specifically designed to improve the treatment of GIST patients by inhibiting the full spectrum of known mutations in KIT and PDGFRα.

Learn more about the symptoms, diagnosis, and treatment of Gastrointestinal Stromal Tumors.

On May 18, 2020 Citius Pharmaceuticals Inc. (Nasdaq: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, reported the closing of the previously announced registered direct offering priced at-the-market under Nasdaq rules (Press release, Citius Pharmaceuticals, MAY 18, 2020, View Source [SID1234558257]). In the offering, Citius sold 7,058,824 shares of its common stock, at a purchase price per share of $1.0625. Additionally, Citius issued to the investors unregistered warrants to purchase up to 3,529,412 shares of its common stock.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds of the offering were approximately $7.5 million and the net proceeds from the offering were approximately $6.8 million, after deducting placement agent fees and other offering expenses. Citius intends to use the net proceeds from the offering for general corporate purposes, including clinical trial expenses, research and development expenses, manufacturing expenses and general and administrative expenses.

The warrants are exercisable immediately at an exercise price of $1.00 per share and will expire five and one-half years from the issue date.

The shares of common stock described above (but not the warrants or the shares of common stock underlying the warrants) were offered pursuant to a "shelf" registration statement (File No. 333-221492) filed with the Securities and Exchange Commission (SEC) and declared effective on December 15, 2017. The offering of such shares was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement and the accompanying prospectus relating to the offering of the shares of common stock was filed with the SEC. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the offering of the shares of common stock may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by emailing [email protected] or by calling 646-975-6996.

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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.