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[Tommi33]

XOMA Presents Positive Data from PTH1R Monoclonal Antibody Program

Unmet medical needs in parathyroid hormone-related hypercalcemia contribute to potential partnering value of overall portfolio

BERKELEY, Calif., April 18, 2017 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA), a pioneer in the discovery and development of therapeutic antibodies, announced today the presentation of positive data from pre-clinical studies investigating the activity of its anti-PTH1R antagonist monoclonal antibody (mAb). The antibody is a potential first-in-class therapeutic agent for the treatment of hyperparathyroidism (HPT) and humoral hypercalcemia of malignancy (HHM). These presentations were made at the American Association for Cancer Research (AACR) and the Endocrine Society (ENDO) annual meetings.

The PTH1R receptor is part of the B GPCR family and is the primary receptor of two ligands, parathyroid hormone (PTH) and parathyroid related protein (PTHrP). Hypercalcemia can occur when elevated levels of PTH, as seen in primary HPT, or elevated levels of PTHrP, as seen in HHM, lead to excessive activation of the PTH1R receptor. A potent and long-acting receptor antagonist could reverse hypercalcemia in all these conditions.

"Consistent with our new strategy, we are seeking partners with a deep commitment to and an expertise in drug development who are interested in licensing this first-in-class antibody and taking it through the clinical development process," said Jim Neal, Chief Executive Officer of XOMA. "There is a real need for better therapies that address hypercalcemia induced by hyperparathyroidism, and we are encouraged by these data, which demonstrate the efficacy of our anti-PTH1R approach as a potential treatment for patients suffering from HPT and HHM."

Data presented at the AACR and ENDO conferences between April 1-4, 2017 showed:

PTH1R antagonism in vitro by the anti-PTH1R mAb translated to potent in vivo activity
XOMA's anti-PTH1R antagonist mAb has the potential to become a first-in-class therapy for HHM, as the data demonstrated it ameliorated hypercalcemia and associated morbidities in pre-clinical models
XOMA's antibody libraries enabled the discovery of functional antibodies against a very complex target — i.e. the G-Protein Coupled PTH1Receptor
A high affinity fully human mAb to PTH1R has been selected and characterized
Proprietary antibody engineering resulted in antibodies with improved potency and manufacturing characteristics

"While hyperparathyroidism is a classic endocrine disorder, HHM spans both endocrine and oncology specialties. HHM is a life-threatening complication of many advanced cancers and is caused by tumor secretion of the PTH1R ligand, PTH-related peptide, which causes high calcium. Since current treatments often fall short of correcting hypercalcemia and many cancer patients die from such high calcium and associated metabolic complications, PTH1R antibodies could prove beneficial for the treatment of this devastating condition," said John Wysolmerski, MD, Professor of Medicine and Associate Section Chief for Research in the Section of Endocrinology and Metabolism, Yale School of Medicine.

The complete presentations can be found online at www.xoma.com/content/pipeline/publications.htm

[gerdass]

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[gerdass]

Antwort auf Beitrag Nr.: 54.773.962 von gerdass am 21.04.17 12:00:04

Zitat von gerdass: https://www.barchart.com/stocks/quotes/XOMA/opinion

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[Tommi33]

XOMA Announces Positive Results from its Phase 2 Proof-Of-Concept Study of Prolactin Inhibition

X213 shown to be safe and effective, demonstrating complete suppression of lactation in study participants

BERKELEY, Calif., April 24, 2017 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA), a pioneer in the discovery and development of therapeutic antibodies, today announced that it has achieved positive Phase 2 proof-of-concept results for X213 in physiological hyperprolactinemia (HPRL). X213 is a monoclonal antibody that neutralizes prolactin action.

"This proof-of-concept study was an important milestone in demonstrating the potential efficacy of this novel antibody. We believe that X213 could be a treatment option for a wide range of patients with hyperprolactinemia including prolactinoma and anti-psychotic induced HPRL as the signs and symptoms are similar irrespective of the etiology," said Jim Neal, Chief Executive Officer of XOMA. "Consistent with our business strategy, we intend to maximize the value of X213 for shareholders by seeking a license partner for the program."

The Phase 2 study was a multi-center, open-labelled, randomized, single-dose, controlled trial of intravenously administered X213 in women who wished to suppress lactation immediately post-partum. The results of the study indicate that X213, when given as a single 700mg intravenous infusion during the first day post-partum, was effective in suppressing milk secretion, as well as breast engorgement and pain in 100 percent of the treated women. In addition, none of the treated women experienced rebound breast symptomatology during the 21-day study period. While the study was not intended, or powered to show statistical significance, it demonstrated that X213 was: safe and well tolerated; caused no significant adverse events (SAEs); showed favorable pharmacokinetics with a terminal half-life of two weeks and; demonstrated target (prolactin receptor) engagement and mechanism of action confirmation by serum prolactin profiling.

"The findings from this proof-of-concept study are encouraging and confirm that X213 inhibits prolactin signaling and thus, may be effective in blocking effects of symptomatic hyperprolactinemia," said Dr. Shlomo Melmed, endocrinologist, Dean of the Medical Faculty and Professor of Medicine, Cedars-Sinai Medical Center, Los Angeles. "New classes of drugs such as X213 may offer benefit to the up to 20 percent of patients who do not respond to, or are intolerant of, current standard of care involving dopamine agonist medications."

Prolactin is a multifunctional hormone that is primarily secreted by the pituitary and whose best-known functions are related to lactation and reproduction. In pregnant women, excess prolactin secretion (hyperprolactinemia) occurs to enhance breast development and to induce lactation postpartum. Commonly encountered etiologies of hyperprolactinemia include prolactinoma, medication effect, kidney failure, cystic or granulomatous pituitary lesions, and disorders which interfere with hypothalamic inhibition of prolactin release. Prolactinomas, benign tumors of the pituitary gland, hypersecrete prolactin with significant medical consequences, particularly hypogonadism, infertility and osteoporosis.

www.xoma.com

[Tommi33]

XOMA Announces Transformational License Agreements for Gevokizumab and its IL-1 Beta Intellectual Property Portfolio


$31 million in upfront payments including $5 million equity investment
50 percent reduction in XOMA's outstanding debt through repayment of its €12 million obligation to Les Laboratoires Servier
Significant potential milestone payments plus tiered royalties on sales of gevokizumab
Maturity date on XOMA's debt to Novartis extended by two years

BERKELEY, Calif., Aug. 25, 2017 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq: XOMA), a pioneer in the discovery and development of therapeutic antibodies, today announced it has licensed the global commercial rights to gevokizumab, a novel anti-IL-1 beta allosteric monoclonal antibody, to Novartis. In a separate agreement, XOMA has granted Novartis a license to its intellectual property covering the use of IL-1 beta targeting antibodies in the treatment of cardiovascular disease.

Under these agreements, XOMA will receive $31 million in upfront payments, including a $5 million equity investment, and is eligible to receive significant pre- and post-commercialization milestone payments plus tiered high-single to mid-double-digit royalties on net sales of gevokizumab. XOMA is also eligible to receive low-single-digit royalties on canakinumab sales in cardiovascular indications rising to mid-single-digit royalties under certain circumstances. Novartis has agreed to settle XOMA's €12 million debt to Les Laboratoires Servier and extend the maturity date on XOMA's debt to Novartis from September 2020 to September 2022.

"Today, we achieved a significant milestone in the transformational change that we initiated in March of this year. The immediate impact of these licensing agreements for gevokizumab and our IL-1 beta intellectual property eliminates almost half of XOMA's outstanding debt, more than doubles our cash position, and generates potential recurring revenues through royalties. It also validates both the value of XOMA's scientific advances and our business strategy to build shareholder value by licensing our portfolio of assets and intellectual property to partners who will continue the asset's clinical development," stated Jim Neal, Chief Executive Officer of XOMA.


www.xoma.com

[Tommi33]

XOMA Announces Multiple New License Agreements for Proprietary Phage Display Libraries

Expands portfolio of partner-funded programs with potential for milestone and royalty payments

BERKELEY, Calif., Oct. 04, 2017 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA), a pioneer in the discovery, development and licensing of therapeutic antibodies, today announced it has entered into new non-exclusive license agreements with three different companies, Tizona Therapeutics, Inc., Torch Biosciences, Inc., and LakePharma, for use of XOMA's proprietary phage display libraries for antibody discovery. Phage display libraries are powerful tools to generate human recombinant antibodies with exquisite specificity and high affinity.

"Increasing our universe of licensees to XOMA's hallmark proprietary phage display libraries is one of our key strategic initiatives in 2017," stated Jim Neal, Chief Executive Officer of XOMA. "These new license agreements expand our portfolio of partner-funded programs and further advance our business strategy to drive shareholder value through future milestone and royalty payments to the Company."

Under these agreements, XOMA is eligible to receive development and regulatory milestone payments plus single-digit royalties on net sales of products. Additionally, the agreement with LakePharma, a U.S.-based biologics services company, enables it to develop its own antibodies using XOMA's library, as well as offer the Company's library to its broad customer base. XOMA is eligible to receive milestone and royalty payments for products developed by LakePharma and as part of its client programs.

XOMA's premier antibody discovery platform includes three phage display libraries, which are among the largest in the world. The Company believes access to multiple libraries offers a number of benefits to its partners. Most importantly, it enables screening of libraries in parallel to increase the probability of success in finding rare and unique antibodies directed to targets of interest.

www.xoma.com

[Tommi33]

XOMA Strengthens Leadership Team with Appointments of Chief Business Officer and General Counsel
Jan 08, 2018
PDF Version

EMERYVILLE, Calif., Jan. 08, 2018 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA), a pioneer in the discovery, development and licensing of therapeutic antibodies, today announced the appointments of Dee Datta, Ph.D., as Chief Business Officer and Danny Hart as Vice President, General Counsel. Dr. Datta and Mr. Hart will report to XOMA’s Chief Executive Officer, Jim Neal.

“Dee and Danny bring significant value to XOMA’s team as we continue to execute on our transformation into a royalty aggregator,” stated Jim Neal, Chief Executive Officer of XOMA. “Their expertise and experience will be invaluable as we expand our portfolio to drive revenue growth and create value for shareholders. We are excited they have chosen to join our team.”

Dr. Datta brings extensive leadership experience in business development, alternative financing strategies and corporate strategy. Prior to joining XOMA, Dr. Datta served as Vice President of Corporate Development at Forty Seven, Inc., where she managed business development, strategy and transactions, company financing and investor relations. Previously, Dr. Datta was the Senior Director of Business Development at XOMA. During her time at XOMA, she successfully closed multiple transactions, including licensing deals with Novartis and Novo Nordisk. Earlier in her career, Dr. Datta was a venture capitalist at The Column Group and Longitude Capital. As an investor, she has experience in alternative financing strategies, such as royalty monetization, in addition to formation and management of portfolio companies. Dr. Datta received her Ph.D. from California Institute of Technology and M.B.A. from Stanford University Graduate School of Business.

Mr. Hart brings a breadth of knowledge in corporate governance, securities law compliance, and mergers and acquisitions. Prior to joining XOMA, Mr. Hart was Vice President, Business Development at PDL BioPharma, Inc. (PDL), where he focused on the company’s investment activity by identifying, evaluating, structuring and completing alternative, non-dilutive financing investments (structured debt, synthetic royalty, royalty monetization) for late-stage pharmaceutical, device and diagnostic companies. Mr. Hart also served in various legal capacities at PDL, where he led PDL’s transactional efforts, completing over $1 billion in investment transactions during his tenure at PDL. Previously, Mr. Hart was an associate with Hogan & Hartson LLP (now Hogan Lovells US LLP), where his practice focused on securities, corporate governance and mergers and acquisitions, and he started his legal career at Skadden, Arps, Slate, Meagher & Flom LLP. Mr. Hart received his J.D. from Vanderbilt Law School and B.A. from the University of Washington in Seattle.

www.xoma.com

[Tommi33]

XOMA Acquires Royalty Interest Position from Agenus on Seven Assets Being Developed by Merck and Incyte
Sep 21, 2018
PDF Version

EMERYVILLE, Calif., Sept. 21, 2018 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), announced today that for $15.0 million, it has acquired from Agenus (NASDAQ: AGEN) a partial interest position in the rights to potential milestone and royalty payments associated with seven immuno-oncology antibodies currently being developed by Merck and Incyte under their collaborations with Agenus.

“This is an important deal reflecting our new royalty-aggregator strategy to acquire milestone and royalty payments associated with therapeutic candidates partnered by others. The basket of Agenus immuno-oncology assets is advancing in the hands of two of the leading companies in oncology drug development,” said Jim Neal, Chief Executive Officer at XOMA. “These assets possess all the characteristics we have established for our business model: outstanding development partners, mid-stage to early stage assets, important therapeutic categories, and sizable royalty commitments. We believe this investment could generate potential future cash flows over an extended period from milestones and royalties on some exciting potential commercial opportunities.”

The seven royalty interest antibodies are:

One Phase 1 antibody being developed by Merck on an undisclosed novel target;
Incyte’s INCAGN1876, a GITR agonist in Phase 1/2 studies;
Incyte’s INCAGN1949, an OX-40 agonist in Phase 1/2 studies;
Incyte’s INCAGN2385, a LAG-3 antagonist in Phase 1 studies;
Incyte’s INCAGN02390, a TIM-3 antagonist expected to enter the clinic in 2018; and,
Two preclinical antibodies being developed by Incyte on undisclosed targets.

Under the terms of the agreement, XOMA will receive low- to mid-single-digit royalties on future sales of these seven immuno-oncology assets. Additionally, XOMA is entitled to a portion of milestone payments associated with the assets. XOMA has drawn $7.5 million from its line of credit with Silicon Valley Bank (“SVB”) to partially fund this transaction.

http://investors.xoma.com/news-releases/news-release-details…