On May 21, 2019 EXUMA Biotechnology and affiliate Shanghai PerHum Therapeutics reported interim results of two first-in-human solid tumor CAR-T products in subjects with recurrent or refractory stage IV metastatic renal cell carcinoma (mRCC) (Press release, EXUMA Biotechnology, MAY 21, 2019, View Source [SID1234536509]). The data, presented at the Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper) 2019 Annual Meeting, continues to support the feasibility, comparative safety and pharmacokinetics of dose escalation of two CAR-T products, CCT301-38 (AXL) and CCT301-59 (ROR2), in a single patient population.

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The umbrella clinical trial design being run at SPHCC (Shanghai Public Health Clinical Center) under the direction of lead investigator Tongyu Zhu, M.D., examines the first two CAR-T products in human clinical trial to use AND logic gate control technology. The logic gate design leverages the tumor microenvironment (TME) – turning the growth inhibitory acidic TME into an activating signal – thereby minimizing the potential of on-target, off-tumor activity. One trigger of the logic gate is the TME, and the other is the target antigen (AXL or ROR2, depending on the product). Some of the key highlights presented include:

No dose-limiting toxicities have been observed to date with no indications of on-target, off-tumor toxicity attributed to either product.
CAR-T product blood exposure up to 80,000 copies/ μg observed at the 1 x 106/kg dose level.
Early radiologic evidence of antitumor activity, with stable disease as best response.
In this heavily pre-treated patient population, 6 out of 7 subjects are alive with a median follow-up of 140 days.
These interim results continue to support the potential of the company’s conditionally active biologics (CAB)-CAR-T technology to increase the safety profile of CAR-T therapeutics in mRCC and potentially other target-positive solid tumors.
"The cell processing feasibility, cell exposure and preliminary comparative safety of the two novel products support the potential of CAB-CAR-T technology for solid tumors," said Wendy Li, M.D., Chief Medical Officer of EXUMA Biotechnology. "We look forward to the complete data set from these ongoing clinical studies with collaborators and to bringing these programs forward into multicenter studies in the future."

The full abstract is now available on the annual CIMT (Free CIMT Whitepaper) meeting website (Abstract #123) and the poster will be presented on May 21, 9:00-11:30 am EST.

On May 21, 2019 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported its results from the Company’s R&D Validation study at the American Thoracic Society (ATS) 2019 International Conference, which is being held May 17 to May 22 in Dallas (Press release, BioTime, MAY 21, 2019, View Source;p=RssLanding&cat=news&id=2399321 [SID1234536544]). The poster details the compelling results from the Company’s successful R&D Validation study of DetermaVu, OncoCyte’s liquid biopsy test for the early detection of lung cancer.

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The R&D Validation study demonstrated a sensitivity of 90% (95% confidence interval from 82%-95%) and specificity of 75% (95% confidence interval from 68%-81%) of DetermaVu on a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators.

"We are very pleased to present for the first time the strong findings from our R&D Validation study of DetermaVu at this year’s ATS meeting. We believe these results are poised to redefine the paradigm in lung cancer detection," said Lyndal Hesterberg, Chief Scientific Officer of OncoCyte. "Most notably, we were able to achieve these results using gene-expression biomarkers alone and without the use of clinical parameters such as nodule size that are solely employed by the Mayo model and other algorithm models currently used to estimate the probability of cancer in patients with pulmonary nodules. Our unique Immune System Interrogation approach can potentially detect lung cancer in earlier stages of the disease when more favorable patient outcomes are feasible. We are excited about the potential of this novel test to positively impact the lives of patients globally, and are rapidly advancing through remaining development studies as we work to make DetermaVu commercially available in the second half of this year."

Summary results:

A multivariate gene expression classifier was used to identify benign from malignant nodules between 5-30mm with a high degree of accuracy in a diverse population of current and former smokers

Using only gene-expression biomarkers from whole blood, and with no clinical parameters, the DetermaVu test yielded an overall Area Under the Curve (AUC) of 0.89 with Sensitivity ~90% (95% confidence interval of 82%-95%) and Specificity ~75% (95% confidence interval of 68%-81%)

This classifier significantly outperformed the Mayo algorithm model for cancer risk that utilizes only clinical factors such as nodule size
Poster details:

Session: 110 – THE FUTURE OF LUNG CANCER BIOMARKERS: WHERE SHOULD WE LOOK?
RAPiD: Rapid Abstract Poster Discussion Session
Day and time: Tuesday, May 21, 2019 – 2:15 – 4:15 PM CDT
Location: Arena (Level 2), KBHCCD
Poster Title: Blinded Prospective Validation Study of a Whole Blood Gene-Expression Classifier
for the Diagnosis of Benign Versus Malignant Pulmonary Nodules
Poster #: 421
Viewing Time: 2:15-2:45 PM CDT
Discussion Time: 2:45-4:15 PM CDT
The poster can be viewed here.

About ATS

The American Thoracic Society improves global health by advancing research, patient care, and public health in pulmonary disease, critical illness, and sleep disorders. Founded in 1905 to combat tuberculosis (TB), the ATS has grown to tackle asthma, COPD, lung cancer, sepsis, acute respiratory distress, and sleep apnea, among other diseases.

About DetermaVu

DetermaVu is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant. OncoCyte estimates that a $2 billion to $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on the scope of physician utilization, market penetration and reimbursable pricing.

DetermaVu has the potential to dramatically reduce U.S. healthcare costs by billions of dollars each year by eliminating unnecessary biopsies, which, according to a study of Medicare data by an independent health economics firm, cost on average $14,634 each. In addition, DetermaVu can provide great benefit to patients by avoiding invasive biopsies and the complications that arise in up to 24% of those procedures, and deaths that occur in up to 1% of cases.

DetermaVu is a trademark of OncoCyte Corporation

On May 21, 2019 Bio-Techne Corporation (NASDAQ:TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the Jefferies 2019 Global Healthcare Conference on Wednesday, June 5th, 2019, at 9:30 a.m. EDT (Press release, Bio-Techne, MAY 21, 2019, View Sourcenews/detail/139/bio-techne-to-present-at-the-jefferies-2019-global-healthcare-conference" target="_blank" title="View Sourcenews/detail/139/bio-techne-to-present-at-the-jefferies-2019-global-healthcare-conference" rel="nofollow">View Source [SID1234536926]). The conference will be held at the Grand Hyatt Hotel in New York City.

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A live webcast of the presentation can be accessed via Bio-Techne’s Investor Relations website at View Source or through the following link View Source

On May 21, 2019 Insmed Incorporated (Nasdaq: INSM) reported that it priced a registered underwritten public offering of 9,615,385 shares of its common stock, at a price to the public of $26.00 per share before underwriting discounts and commissions (Press release, Insmed, MAY 21, 2019, View Source [SID1234536510]). Gross proceeds from the offering of these shares, before deducting underwriting discounts and commissions, are expected to be approximately $250.0 million. The underwriters have been granted 30-day options to purchase up to an additional 1,042,307 shares of common stock from Insmed and up to 400,000 shares of common stock from William H. Lewis, the Company’s Chairman and Chief Executive Officer.

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Insmed intends to use its net proceeds from this offering to continue to commercialize ARIKAYCE (amikacin liposome inhalation suspension); conduct further trials of ARIKAYCE, including Insmed’s required confirmatory trial to assess and describe the clinical benefit of ARIKAYCE in patients with Mycobacterium avium complex (MAC) lung disease; fund further clinical development of INS1007 and INS1009; invest in increased third-party manufacturing capacity for ARIKAYCE; fund business expansion activities in Europe and Japan; fund working capital, potential debt repayment, capital expenditures, and general research and development; and for other general corporate purposes, which may include the acquisition or in-license of additional compounds, product candidates, technology or businesses.

Morgan Stanley & Co. LLC, SVB Leerink LLC and Goldman Sachs & Co. LLC are acting as joint book-running managers for the offering. Credit Suisse Securities (USA) LLC, Stifel, Nicolaus & Company, Incorporated and H.C. Wainwright & Co. are acting as co-managers for the offering. The offering is expected to close on May 24, 2019, subject to the satisfaction of customary closing conditions.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above has been filed with the Securities and Exchange Commission (SEC), as amended by Post-Effective Amendment No. 1 thereto, and became automatically effective upon filing. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, telephone: 1-800-808-7525, ext. 6132 or email at [email protected]; and Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 1-212-902-9316 or email at [email protected].

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 jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On May 21, 2019 Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento"), reported that Dr. Henry Ji, Chairman and CEO, will be participating in the upcoming FB Riley Investor Conference and meeting with individual investors (Press release, Sorrento Therapeutics, MAY 21, 2019, View Source [SID1234536512]).

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Date/Time: May 22nd, 2019 at 10:30 AM.

Location: Beverly Hilton, Los Angeles (CA), Room 9.

A copy of the corporate presentation will be made accessible through Sorrento’s Investors Relations website at www.sorrentotherapeutics.com.