On August 13, 2019 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, reported that it has been awarded three distinct patents in the U.S., Canada, and Europe: U.S. Patent No. 10,369,568 entitled CELL SEPARATION USING MICROCHANNEL HAVING PATTERNED POSTS; Canadian Patent No. 2,756,493 entitled DEVICES AND METHODS OF CELL CAPTURE AND ANALYSIS; and European Patent No. 2,619,588 entitled METHODS AND REAGENTS FOR SIGNAL AMPLIFICATION (Press release, Biocept, AUG 13, 2019, View Source [SID1234538705]).

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The U.S. issued patent broadly covers methods and apparatus used for the capture of target biomolecules, including cells of interest, using microchannels that disrupt flow to aid capture. The Canadian patent covers the capture of target cells, including CTCs, using a combination of binding partners and methods for capture on any surface. The European patent encompasses methods for enhancing the detection of cells using fluorescent complexes. The combination of these patents significantly expands the breadth of intellectual property protection for Biocept’s technologies in terms of their applications and global reach. These three new patents expand Biocept’s intellectual property estate to 36 issued patents globally.

"Collectively, the granting of these additional patents further broadens Biocept’s U.S. and international footprint for capturing and analyzing any biological target of interest," said Lyle Arnold, Ph.D., Chief Scientific Officer at Biocept. "For Biocept’s core business, this includes CTCs from any sample type, however these patents also expand the use of Biocept’s technologies well beyond its current core business and may provide opportunities to out-license our technologies for a variety of uses."

"Increasing shareholder value by broadening U.S. and international patent protection used in our Target Selector liquid biopsy platform is a key strategic initiative, as we seek to develop our business globally, with the potential to license our technologies for uses outside the scope of our core business," said Michael Nall, Biocept President and CEO. "We now have been granted 36 issued patents covering our tests and technologies, and plan to continue to strengthen our intellectual property position with additional patent issuances to come."

On August 13, 2019 NKMax America, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, reported that it has dosed the first subject in study SNK01-US01, a phase I clinical trial evaluating SNK, an ex vivo expanded autologous natural killer cell therapeutic, in patients with pathologically confirmed cancer refractory to conventional therapy (Press release, NKMax America, AUG 13, 2019, View Source [SID1234538704]).

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"We are pleased to initiate the first clinical study for SNK in the U.S. We are looking forward to establishing clinical data to support SNK’s potential as a safe and effective treatment for patients with refractory cancers," said Paul Song, MD, CMO and COO of NKMax America.

Stephen Chen, MBA, CTO of NKMax America commented, "Our ability to manufacture and deliver multiple doses of an NK cellular immunotherapy advances us towards our goal of providing a transformative cancer treatment to patients."

The company’s SNK product is an autologous therapy manufactured by harvesting a small number of a patient’s immune cells. After harvesting, NK cells are separated from the blood, purified, activated, and expanded in a cGMP facility. The activated NK cells, known as "SNK" are reinfused in the patient to fight against cancer.

The single arm, dose escalation study evaluates SNK administered intravenously once a week for five weeks at three different dosing levels. Nine subjects will be enrolled in the trial to investigate the safety and tolerability of SNK in adults with pathologically confirmed cancer refractory to conventional therapy.

The SNK study for refractory cancer is currently recruiting participants; for more information about the study, please visit View Source

On August 13, 2019 Potentially curative cancer treatments, like chimeric antigen receptor (CAR) T-cell therapies, have revolutionized care for illnesses once thought to be a death sentence after relapse, such as pediatric acute lymphoblastic leukemia (pALL) and diffuse large B-cell lymphoma (DLBCL). While 2 approved treatments are available (tisagenlecleucel and axicabtagene ciloleucel), therapy initiation is often delayed due to payment processes—in fact, it was only this month that the Centers for Medicare and Medicaid Services released a long-awaited payment decision for Medicare beneficiaries with cancer in need of treatment with CAR T-cell therapy as well as a boost in hospital payment rates (Press release, The American Journal of Managed Care, AUG 13, 2019, View Source [SID1234538661]). In a new study in the current issue of The American Journal of Managed Care (AJMC), researchers defined the concept of the social value that these potentially curative therapies provide, but they caution that treatment delays caused by a lack of payment mechanisms and policies are limiting the potential impact of these treatments.

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The issue stems from the fact that one-time CAR T-cell therapies, and even more costly upcoming gene therapies, are a challenge to existing US payment structures; their costs accrue up front, in contrast with other cancer drugs that are given—and paid for—over an extended time period.

Using an economic framework, researchers measured the social value of CAR T-cell therapy for relapsed or refractory pALL and DLBCL. Social value analyses were used to quantify a therapy’s economic value from a societal perspective and determine the share of that value accruing to the manufacturer and patients. Expanded patient access and greater health benefits increase social value, while higher production costs to develop the therapy reduce it.

Manufacturers have stronger incentives for innovation with a rising share of social value, but when treatment is delayed, social value is lost for both patients and manufacturers: Patients lose access to health improvements and manufacturer profit is reduced.

The study found that CAR T-cell therapy generated up to $6.5 billion and $34.8 billion of social value for patients with pALL and DLBCL, respectively. However, with one, two and six months of treatment delay, patients with pALL lost 9.8 percent, 36.2 percent and 67.3 percent of social value, respectively; patients with DLBCL lost 4.2 percent, 11.5 percent and 46 percent of social value, respectively.

The degree of CAR T-cell therapy’s value depends on timely patient access, but the authors note that it is not unusual for CAR T-cell therapy reimbursement approval to take up to 90 days, which may be longer than a waiting patient may live. Given other high-cost therapies in the pipeline, lessons learned from CAR T-cell therapies can help payers, policy makers and manufacturers, the authors say.

"Our research shows that CAR T offers potentially large value for patients and society, but only if patients can access it promptly," said lead study author Julia Thornton Snider, PhD. "It will be essential for all stakeholders to work together to ensure appropriate policies are in place to secure timely access for patients."

The study was funded by Novartis, maker of tisagenlecleucel.

On August 13, 2019 Quanterix Corporation (Nasdaq: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported the closing of its previously announced underwritten public offering of 2,732,673 shares of its common stock at a public offering price of $25.25 per share, including 356,435 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares (Press release, Quanterix, AUG 13, 2019, View Source [SID1234538660]). Gross proceeds from the sale of the shares, before deducting underwriting discounts and commissions and offering expenses, were approximately $69.0 million.

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J.P. Morgan Securities LLC and SVB Leerink LLC acted as joint book-running managers for the offering. Canaccord Genuity LLC acted as co-manager for the offering. Perella Weinberg Partners acted as independent capital markets advisor to Quanterix for the offering.

The public offering was made pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the Securities and Exchange Commission ("SEC"). The final prospectus supplement and the accompanying prospectus relating to this offering has been filed with the SEC and is available on the SEC’s website located at www.sec.gov, copies of which can be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at (800) 808-7525, ext. 6132 or by e-mail at [email protected].

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

On August 13, 2019 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported that it will present at the following investor conference in September (Press release, Medpace, AUG 13, 2019, View Source [SID1234538659]):

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Baird Global Healthcare Conference
Location: New York, NY
Date: Wednesday, September 4, 2019
Presentation: 9:05 a.m. ET
Speakers: Dr. August Troendle, President & Chief Executive Officer, and Jesse Geiger, Chief Financial Officer & Chief Operating Officer, Laboratory Operations

A live webcast of each presentation will be accessible through the "Investors" section of the Company’s website at www.medpace.com and will be available for replay following each event.