SkylineDx and Mayo Clinic Collaborate on Implementing Skin Cancer Test in Clinical Practice

On September 24, 2019 SkylineDx reported at the 32nd Biennial Dermatology Symposium: The O’Leary Meeting 2019 in Rochester (MN, US) the launch of a pilot study it will conduct with the Mayo Clinic to evaluate and optimize its diagnostic services focused on primary cutaneous melanoma (skin cancer) (Press release, SkylineDx, SEP 24, 2019, View Source [SID1234539756]). SkylineDx’ proprietary diagnostic test combines genetic information from a patient’s tumor cells (taken during a diagnostic biopsy) with tumor – and patient specific characteristics. Put together, the test can accurately predict the risk of regional metastasis at the time of melanoma diagnosis. Currently, based on tumor characteristics alone, too many patients are predicted to have metastasis at diagnosis which results in many unneeded surgical interventions, so-called sentinel lymph node biopsies. The SkylineDx diagnostic test identifies patients who can safely forgo this surgical intervention. This pilot study with Mayo Clinic is an usability evaluation and the final step before starting a national trial in the United States in 2020.

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This announcement follows the joint development agreement that SkylineDx and Mayo Clinic signed in 2018. "In the last 18 months we have been working with the research group of Alexander Meves M.D., a dermatologist of Mayo Clinic, to fully optimize and develop the test", says Dharminder Chahal, CEO SkylineDx. This extensive collaboration has been part of the Falcon Research & Development Program. As the falcon is known as an intelligent creature with unprecedented senses and skills, this R&D program is uniquely equipped to unveil new, detailed insights in the genomic, pathologic and clinical nature of melanoma. "With melanoma being the deadliest form of skin cancer, the launch of this Falcon Research & Development Program will make an important and much needed contribution to improving patient outcomes in this field," continues Dharminder Chahal.

Under the wings of the Falcon R&D Program, a series of specific studies and projects are initiated to demonstrate clinical utility, aimed at developing and introducing an array of diagnostic utilities, ready for the patient. The first focus area is called the Merlin Study Initiative, which covers clinical research and validation studies for the test that predicts if a patient can safely avoid sentinel lymph node surgery. Furthermore, under the Peregrine Study Initiative, SkylineDx is in advanced stages of research to develop a test that predicts a patient’s prognosis and identifies patients that are likely to progress faster and might benefit from early adjuvant therapy.

Dr. Meves and Mayo Clinic have financial interest in the test referenced in this release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

Preliminary results from Phase IIb Liproca® Depot dose-finding study show a strong maximum PSA decrease and sustained PSA reduction effect

On September 24, 2019 LIDDS has reported preliminary data from the LPC-004 study that aimed to determine the tolerability of Liproca Depot and the Prostate-Specific Antigen (PSA) effect at month 5 on patients in part II of the study (Press release, Lidds, SEP 24, 2019, View Source [SID1234555904]).

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The PSA reduction for part II patients was in line with the expected pattern for Liproca Depot’s sustained release and maximum PSA reduction (PSA nadir) occurred during months 2-4. The patients in part II showed a strong PSA decrease and a continued PSA reduction at month 5 as well as over the full study period of six months, confirming the NanoZolid technology’s sustained release profile.

67 % of patients receiving 16 ml dose were determined as responders. A responder is defined as a patient experiencing a PSA decrease of 15% or more. 90% of patients who received a 16 ml injection experienced a PSA decrease during their Liproca Depot treatment.

The positive preliminary results show Liproca Depot’s ability to reduce PSA levels over a period of six months, proving the NanoZolid technology´s suitability for local cancer treatment. The study also confirms the technology’s favorable toxicity and tolerability profile.

All patients in the study were under Active Surveillance with low or intermediate risk of cancer progression and these patients currently receive no treatment.

– Patients under Active Surveillance have a risk of cancer progression which places additional stress on them. Liproca Depot could provide an option for physicians to address an unmet medical need, says Anders Bjartell, Professor and Senior Consultant at the Department of Urology, Skåne University Hospital, and LIDDS Board Member.

– Liproca Depot was well tolerated without the hormonal side effects associated with anti-androgen therapies and a majority of patients in the study were positive to receiving a second injection. Administering Liproca Depot is similar to performing a prostate biopsy, says Professor Laurence Klotz, a world leading expert and one of the study investigators and Professor at the University of Toronto Division of Urology.

– These results validate the continued clinical development of Liproca Depot. LIDDS has already signed a license agreement for China with the pharmaceutical company Jiangxi Puheng which plans to conduct and finance a Phase III study. LIDDS will now continue the commercial activities in order to sign further licensing agreements in other major markets, says Monica Wallter, CEO, LIDDS.

Professor Klotz will present the Phase IIb study results in detail at the 11th European Multidisciplinary Congress on Urological Cancers (EMUC19) in Vienna, Austria, on November 16, 2019. A paper reporting the results of the Phase IIb study will be submitted to leading scientific journals for publication.

For more background information about the Phase IIb Liproca Depot clinical trial, please see enclosed file.

About prostate cancer and the market:
Of the 1.2 million men diagnosed with prostate cancer globally each year, about 420,000 are assessed as intermediate risk and placed on ‘Active Surveillance’ where they are monitored regularly. There is no standard drug treatment for these cancer patients and many treating doctors see an unmet need.

According to market research firm GlobalData, the global market for prostate cancer drugs is expected to grow to USD 8.3 billion annually by 2023. Liproca Depot’s target group is an untapped market potentially exceeding USD 3 billion per year.

Phanes and Hanmi Announce Licensing Agreement to Develop Bi- and/or Multi-specific Antibodies

On Spetember 24, 2019 Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research in immuno-oncology announced today that it has signed a licensing agreement with Hanmi Pharmaceutical Co., LTD (Hanmi), a well-known global player in the biopharmaceutical field, for the development of bi- and/or multi-specific antibodies for immuno-oncology applications (Press release, Hanmi, SEP 24, 2019, View Source;board_id=INFORMATION_ENGLISH_NEWS [SID1234573788]). Under the terms of the agreement, Hanmi will evaluate and license antibody sequences against an undisclosed target from Phanes and use them in multiple projects under the Pentambody platform, a proprietary bispecific antibody technology developed by Hanmi’s subsidiary in Beijing.

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Under the terms of the agreement, Hanmi will be responsible for the discovery, development, manufacturing and commercialization of the bi- and/or multi-specific antibodies and has exclusive worldwide commercial rights to the molecules for any cancer indications. Phanes will receive upfront and milestone payments plus royalty fees. The details of the financial terms were not disclosed.

"Phanes is an emerging leader in innovative discovery research in the immuno-oncology area and we have demonstrated significant differentiations that we believe will be clinically meaningful in multiple internal programs. We are extremely excited about partnering with Hanmi in the bi- and multi-specific antibodies area with the ultimate goal of providing cancer patients with new treatment options. We have clearly demonstrated the differentiation between our lead mAb and competitor molecules with respect to its mechanism of action. It has great potential to resolve the issues we are facing in the clinic," said Dr. Ming Wang, PhD, MBA, CEO of Phanes Therapeutics, "At Phanes, our mission is to become a source of innovation in the biopharma industry and we are fully committed to delivering robust therapeutic molecules to patients. But we can’t do it alone; we will continue to leverage partnerships with companies that have capabilities complementary to ours."

"Through the collaboration with Phanes, we are planning to expand the potential of the Pentambody platform in innovative immuno-oncology field and generate new treatment options for patients suffering from cancers." said Sechang Kwon, President and CEO of Hanmi pharmaceuticals.

BioCryst Pharmaceuticals to Present at Cantor Global Healthcare Conference

On September 24, 2019 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported that the company will present at the Cantor Global Healthcare Conference in New York on Friday, October 4, 2019 at 12:35 p.m. ET (Press release, BioCryst Pharmaceuticals, SEP 24, 2019, View Source [SID1234539741]).

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Links to a live audio webcast and replay of this presentation may be accessed in the Investors section of BioCryst’s website at http://www.biocryst.com.

Neogen reports first quarter results

On September 24, 2019 Neogen Corporation (Nasdaq: NEOG) reported that revenues for the first quarter of its 2020 fiscal year, which ended Aug. 31, were $101,424,000, compared to the previous year’s first quarter revenues of $99,626,000 (Press release, Neogen, SEP 24, 2019, View Source [SID1234539757]).

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The first quarter was the 110th of the past 115 quarters that Neogen reported revenue increases compared with the previous year — including all consecutive quarters in the last 14 years.

Net income for the first quarter of Neogen’s 2020 fiscal year was $14,652,000, or $0.28 per share, compared to $15,237,000, or $0.29 per share, in the previous year’s first quarter. In the prior year’s first quarter, Neogen benefitted from higher tax deductions relating to employee stock option exercises, which contributed to an effective tax rate of 11% for the quarter. In the first quarter of the current year, Neogen’s effective tax rate was 17%.

"Our first quarter did not meet the overall performance expectations that we have for ourselves. Even considering the difficult international business climate created by the continuing strong U.S. dollar and the U.S. trade issues with China and elsewhere, we must work to produce better results," said John Adent, Neogen’s president and chief executive officer. "We were, however, pleased with the continued strength of our genomics business, and we are continuing to build upon our core strengths to return to our historic growth rates, while also expanding our capabilities.

"In August, we announced a licensing agreement with Corvium, a leading producer of risk management software for the food safety industry, that will complement our diagnostics business by efficiently providing our customers with the information they need to make rapid data-driven decisions to protect their consumers and businesses," Adent continued. "We have also continued our genomics laboratory expansions in China, Brazil Canada and the United Kingdom, and are in the beginning stages of an expansion at our flagship operation in Lincoln, Neb., as we work to satisfy the accelerating demand for our genomics services."

Neogen’s gross margin was 47.5% of sales in the first quarter of the current fiscal year, compared to 46.9% recorded in the same period a year ago, driven by improved gross margins in the domestic genomics business, and a favorable mix shift in Food Safety towards higher margin products. Operating income for the quarter was $16,264,000, or 16.0% of sales, compared to $16,479,000, or 16.5%, a year ago, with the decline largely the result of increased spending in new product development.

"The first quarter saw a continuation of the adverse currency environment that we experienced in each of the four quarters of our previous fiscal year. In the current quarter, we would have recorded approximately $1.2 million more in revenues in a neutral currency environment," said Steve Quinlan, Neogen’s chief financial officer. "At the bottom line, we knew we faced a difficult comparison with the prior year quarter’s exceptionally low effective tax rate, which was impacted by the exercise of stock options by company employees. The timing and amount of these exercises will continue to impact the company’s effective rate going forward. But, as shown on our balance sheet, our strong cash position provides great flexibility to continue to invest in our businesses going forward."

Revenues for the company’s Food Safety segment were $51,021,000 in the current quarter, compared to $52,183,000 in the prior year’s first three months. The decrease was due primarily to lower sales internationally, caused in part by the continued strong U.S. dollar. As the majority of Neogen’s international locations report through the company’s Food Safety segment, adverse currency translations are primarily reflected in this segment’s revenue results.

Revenues at the company’s Brazilian operations decreased 16% in the current quarter compared to the prior year in U.S. dollars, as losses in sales of biosecurity products and forensic test kits were offset only partially by increases in sales of mycotoxin test kits, dairy residue test kits and culture media. The decrease in biosecurity sales was the result of a non-recurring government tender in Brazil in the prior year first quarter, while the decline in forensic test kits revenues was due to the loss of a large commercial lab customer that performs drug testing of truck and bus drivers in that country.

Mexico-based Neogen Latinoamerica’s sales increased 5% in U.S. dollars, due to strong increases in sales of mycotoxin and pathogen test kits, and dehydrated culture media; these increases were somewhat offset by lower sales of rodenticides and disinfectants. Revenues at our European operations rose 1% in local currency, as increases in cleaners and disinfectants were partially offset by lower sales in the culture media, spoilage organism and foodborne pathogen product lines, but decreased 4% when converted to U.S. dollars. In China, the African swine fever outbreak in that country resulted in lower genomic testing to the pork markets, and contributed to an 18% decline in revenues.

Global sales of Neogen’s natural toxin test kits increased 9% in the current quarter, led by a 23% increase in sales to detect aflatoxin. The quarterly increase in aflatoxin test kit sales was largely driven by increased market share gains in Brazil and Mexico during the corn harvest. Because of a relatively wet spring in the U.S., testing of domestic grain crops has largely been delayed.

Sales of Neogen’s rapid tests to detect the foodborne pathogen Listeria, including the innovative Listeria Right Now test system, increased 20% in the quarter compared to the prior year. Listeria Right Now detects the pathogen in less than an hour — without the otherwise necessary incubation time of 24 to 48 hours. Sales of Neogen’s sanitation test systems, which includes its AccuPoint Advanced ATP Sanitation Monitoring System, increased 12% in the current quarter when compared to the prior year, and the company’s test kits to detect foodborne allergens increased 8% compared to the previous year’s first quarter.

Neogen’s Animal Safety segment reported revenues of $50,403,000 for the first quarter of the 2020 fiscal year, compared to $47,443,000 in the prior year first quarter, an increase of 6%. The segment’s highlights in the quarter included strong growth in the domestic genomics testing business, a 10% increase in sales of the company’s animal care products, and a 9% increase in veterinary instruments. These increases were partially offset by lower sales of certain rodenticides.

Revenues from Neogen’s worldwide animal genomics business increased 17% in the first quarter of fiscal 2020 compared to the prior year. This growth was primarily the result of continued strength in the company’s bovine business, which includes commercial beef and dairy product lines. The increase was also the result of Neogen’s accelerating growth in companion animal genetic testing, including tests for dog and cat parentage, breed verification, and genetic health.

Neogen Corporation develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media and diagnostic test kits to detect foodborne bacteria, natural toxins, food allergens, drug residues, plant diseases and sanitation concerns. Neogen’s Animal Safety Division is a leader in worldwide biosecurity products, animal genomics testing and the manufacturing and distribution of a variety of animal healthcare products, including diagnostics, pharmaceuticals and veterinary instruments.

Certain portions of this news release that do not relate to historical financial information constitute forward-looking statements. These forward-looking statements are subject to certain risks and uncertainties. Actual future results and trends may differ materially from historical results or those expected depending on a variety of factors listed in Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Company’s most recently filed Form 10-K.