On January 8, 2019 Biond Biologics Ltd. ("Biond" or the "Company"), a privately-held Israeli biotechnology company, developing novel immunotherapies for cancer and autoimmune diseases, reported the closing of a $17 million Series B financing (Press release, Biond Biologics, JAN 8, 2019, View Source [SID1234532582]).

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Biond was founded in 2016 by the former scientific team of cCam Biotherapeutics, an immuno-oncology company which was fully acquired by Merck in July 2015. The former cCAM Biotherapeutics team was joined by additional veterans of the Israeli biotech industry, with the aim to build a strong, sustainable and innovative science-driven biotechnology company. The company’s vision and strategy are to bring innovative drugs to patients based on synergistic long-term collaborations with leading global companies in the immunotherapy field.

Biond intends to use the proceeds to move its lead drug candidate, BION-202, into clinical trials and to advance the preclinical development of BION-206 and its proprietary antibody cell-internalization technology.

The financing and due diligence were led by Israel Biotech Fund and Harel Insurance & Finance Group, with participation of Celgene Corporation, (NASDAQ: CELG), the Japanese-Israeli fund, SBI JI Innovation Fund and existing investors.

"We are excited to have such prominent investors as shareholders who are aligned with the company’s vision of delivering breakthrough immune-based solutions to patients with serious diseases," said Dr. Tehila Ben Moshe, Co-Founder and Chief Executive Officer of Biond Biologics. "After two years of intense and creative discovery work, we are ready to advance our first innovative drug candidate into clinical trials."

"We were very impressed by the innovative science discovered at Biond and by the quality and experience of its managerial and scientific team," said Dr. David Sidransky, M.D., Co-Founder and General Partner at Israel Biotech Fund and Biond board member. "Biond’s novel pipeline candidates have the potential of becoming paradigm shifting therapies in immuno-oncology."

"We are happy to support the outstanding management team at Biond and its cutting-edge pipeline and technology," stated at Harel Insurance & Finance. "This investment aligns with the group’s ongoing effort of investing in breakthrough and innovative technologies developed by companies with great growth potential."

On January 8, 2019 Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director, Gyo Sagara; "ONO") reported that it received a manufacturing and marketing approval of Demser (metyrosine) Capsule 250 mg ("Demser"), a tyrosine hydroxylase inhibitor, in Japan for the improvement of status of catecholamine excess secretion in patients with pheochromocytoma (Press release, Ono, JAN 8, 2019, View Source [SID1234605553]). Pheochromocytoma (PC) is a neuroendocrine tumor deriving from the adrenal medulla or the extraadrenal gland ganglion with 2,920 patients estimated in Japan*. Catecholamine excessively secreted from PC causes various symptoms, such as tachycardia, headache, palpitation, sweating, constipation, including hypertension. Sympatholytic drugs, α-blocker and β-blocker, for control of blood pressure and heart rate have been usually used to improve these symptoms. As there are many cases where surgical removal of tumors is not applicable in patients with locally invasive or metastatic malignant PC, a long-term therapy, such as radiotherapy and chemotherapy is required. The chronic continuation of catecholamine excess secretion may increase a risk of causing cardiovascular-related adverse events such as heart failure or fatal arrhythmia. Demser inhibits tyrosine hydroxylase related to the production of catecholamine, reduces catecholamine extremely secreted from PC, and alleviates symptoms due to catecholamine excess secretion. Demser is a promising drug with an efficacy in the improvement of the symptoms in patients who are not able to sufficiently control the symptoms with sympatholytic drugs. Demser is a product for which development companies were recruited in Japan at the "Review Committee on Unapproved or Off-label Drugs with High Medical Needs", established by the Ministry of Health, Labour and Welfare (MHLW), and ONO has been developing this product. In May 2015, the product was designated for the orphan drug by the MHLW. ONO obtained exclusive rights to develop and commercialize metyrosine in Japan for the treatment of PC (and conditions and symptoms related thereto), in accordance with the license agreement concluded in October 2013 with Valeant Pharmaceuticals North America LLC, an affiliate of Valeant Pharmaceuticals International, Inc. (In July 2018, the company name was changed to Bausch Health Companies Inc., "Bausch Health"). In the US, Bausch Health markets the product under the tradename of "Demser" in the indication of PC. *: "Actual condition survey and preparation of medical guideline of pheochromocytoma" Research Report 2009, Research Project on Overcoming Intractable Diseases Project being conducted by the Ministry of Health, Labour and Welfare Overview of Demser Capsule 250 mg Product Name Demser Capsule 250 mg Generic name (JAN) Metyrosine Indication Improvement of status of catecholamine excess secretion in patients with pheochromocytoma Dosage and administration Usually, for adults and children 12 years of age and older, start to administer 500 mg of metyrosine orally daily. When the effect is insufficient, titrate the dose by 250 mg or 500 mg daily at intervals of 3 days or more by monitoring the clinical course closely, and dosage should be adjusted under adequate observation of urinary catecholamine amount and symptoms of the patient. However, the maximum daily dose is 4,000 mg with the highest dose of 1,000 mg per dose at intervals of 4 hours or longer. The daily dose of 500 mg is divided twice a day, 750 mg three times a day and 1,000 mg four times a day. Manufacturer/distributor Ono Pharmaceutical Co., Ltd. Approval date January 8, 2019 Conditions for approval 1. Risk Management Plan should be designed appropriately implemented. 2. Because of the very limited number of patients treated with the product in Japanese clinical trials, a post-marketing use-results survey covering all cases should be performed until data on a certain minimum number of patients have been accumulated. Through these activities, actions necessary to ensure the proper use of the product should be taken by identifying the characteristics of patients to be treated with the product and collecting safety and efficacy data as soon as possible.

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On January 8, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, reported topline results from the ongoing pivotal Phase 3 OLYMPUS clinical trial of UGN-101 (mitomycin gel) for instillation, an investigational mitomycin formulation for the non-surgical treatment of low-grade upper tract urothelial cancer (UTUC) (Press release, UroGen Pharma, JAN 8, 2019, View Source [SID1234532583]). This analysis showed that on an intent-to-treat basis, 57 percent of patients achieved a complete response (CR) rate at their primary disease evaluation (PDE, or the primary endpoint) which was conducted four to six weeks after completion of UGN-101 treatment. Importantly, all evaluated patients in CR remain disease free at six months.

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This international, multi-center trial completed enrollment with 71 patients in December 2018. Of the 71 patients enrolled in the trial, 61 patients have been evaluated for the primary endpoint which was a CR as defined as a negative ureteroscopic evaluation and a negative wash cytology. The remaining 10 patients are awaiting PDE evaluation.

"We are pleased to report that the CR and durability data remain consistent with the Interim Analysis presented in May 2018. These results continue to validate the potential of UGN-101 to shift the surgical treatment paradigm and benefit patients whose only alternative would be repetitive endoscopic surgical intervention or complete loss of a kidney," said Mark P. Schoenberg, M.D., Chief Medical Officer of UroGen. "The durability observed in the OLYMPUS study provides further evidence that the non-surgical treatment of LG UTUC with UGN-101 may result in clinically-meaningful, recurrence free survival. We are grateful to the patients, their families, and clinical investigators who have made this important study possible."

Approximately 45 percent of tumors treated were categorized as unresectable by surgery at baseline. Of the patients who achieved CR, UroGen now has six-month durability on half of these patients. Durability is a key secondary endpoint for the trial.

The safety profile of UGN-101 continues to be acceptable with most treatment-emergent adverse events characterized as mild or moderate and transient and in line with ureteral procedures. These included ureteral narrowing and hydronephrosis, urinary tract infection, flank pain and creatinine elevation.

UroGen intends to seek regulatory approval of UGN-101 in LG UTUC based on data from all 71 patients and initiated its rolling submission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in December 2018. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.

Seth Paul Lerner, M.D., FACS, Professor of Urology at Baylor College of Medicine in Houston, Texas served as Principal Investigator of the OLYMPUS trial.

About UGN-101

UGN-101 (mitomycin gel) for instillation is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade upper tract urothelial cancer (LG UTUC). Utilizing the RTGel technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-101 is designed to enable longer exposure of mitomycin to urinary tract tissue, thereby enabling the treatment of tumors by non-surgical means. UGN-101 is delivered to patients using standard ureteral catheters.

On January 8, 2019 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported certain unaudited preliminary fourth quarter 2018 financial results (Press release, Integra LifeSciences, JAN 8, 2019, View Source [SID1234532568]).

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The company expects reported revenue for the fourth quarter of 2018 to be at the higher end of its previous guidance range of $378 million to $383 million. Organic revenue growth in the fourth quarter 2018 is expected to be slightly above 4%.

The company is scheduled to present at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2019 at 2:30pm PT (5:30pm ET). A live audio webcast of the presentation will be available on the Investor section of the company’s website at www.integralife.com.

The company will report its final, audited fourth quarter and full year 2018 financial results during a conference call in February 2019. A press release with the date, time and webcast information will be provided closer to the reporting date.

On January 8, 2019 Adimab, LLC, the global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, reported that in 2018 it entered into agreements with 10 new companies (Press release, Adimab, JAN 8, 2019, View Source [SID1234532584]). In addition, Adimab announced the expansion of seven of its current partnerships and the achievement of 70 technical and development milestones across numerous collaborations.

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In the past ten years, Adimab has partnered with over 60 companies for the discovery of therapeutic IgGs and bispecific antibodies, resulting in more than 260 therapeutic programs derived from the Adimab Platform. In 2018, Adimab and its partners added 56 new therapeutic programs. New alliances for 2018 include collaborations with Biotheus, Boehringer Ingelheim, Cullinan Oncology, Cygnal Therapeutics, Pliant Therapeutics, REGiMMUNE, and Werewolf Therapeutics, among others. In addition, Adimab expanded its collaborations with Boehringer Ingelheim, Innovent Biologics, Mapp Biopharmaceutical, Sanofi, Surface Oncology, and Takeda.

"In 2018, we saw fantastic growth in the number of therapeutic programs coming from our platform," said Guy Van Meter, Senior Vice President of Business Development. "In addition to being the leader for antibody discovery, Adimab has become the go-to provider for bispecifics and protein engineering. Our partners really benefit from our deep domain expertise and get to access all our capabilities."

"In an industry that is used to exaggerated claims, we have proven time and time again that we deliver the highest quality therapeutic leads," added Tillman Gerngross, Chief Executive Officer and Co-Founder of Adimab. "To date more than 80% of our partners have expanded their partnership with Adimab, which is a meaningful indicator of the quality of our work."

Over the past five years, Adimab has worked with an increasing number of smaller companies, backed by leading venture capital firms. Following successful antibody discovery campaigns, many of these companies have gone on to partner their programs with larger pharmaceutical companies. Publicly announced transactions include: Tizona and Abbvie (2019), Dragonfly and Merck (2018), Tusk and Roche (2018), Scholar Rock and Gilead (2018), Alector and Abbvie (2017), Dragonfly and Celgene (2017), Mersana and Takeda (2016), Surface Oncology and Novartis (2016), Potenza and Astellas (2015, 2018), and Innovent and Lilly (2015).

"Roche was very thorough in their diligence, and the quality of the leads and the data from Adimab made the process much smoother," said Luc Dochez, former Chief Executive Officer of Tusk Therapeutics.

"Investors and partners invariably conduct extensive diligence on the structural and pharmacological properties of our drug leads," said Arnon Rosenthal, Co-Founder and Chief Executive Officer of Alector. "Adimab data and the support of the Adimab team were critical elements in developing compelling product candidates."

"Adimab has been a fantastic partner. The Adimab team is comprised of leading scientists, using state of the art technology, who have a sense of urgency towards their collaborators. I cannot praise them highly enough," said Bill Haney, Co-Founder and Chief Executive Officer of Dragonfly Therapeutics.