Genmab Reaches USD 10 Million Milestone in Daratumumab Collaboration with Janssen

On October 23, 2014 Genmab reported that it has reached the fourth milestone in its daratumumab collaboration with Janssen Biotech (Press release Genmab, OCT 23, 2014, View Source [SID:1234500865]). The USD 10 million milestone payment was triggered by progress in the ongoing Phase III study ("CASTOR" MMY3004) of daratumumab in combination with bortezomib and dexamethasone compared to bortezomib and dexamethasone alone for the treatment of relapsed or refractory multiple myeloma.

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"We are very pleased with the firm progress being made in the daratumumab development program under the direction of our strategic partner Janssen. At Genmab we are committed to developing differentiated therapeutics to fight cancer, and it is therefore rewarding to see one of our antibodies moving rapidly through clinical development," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

This milestone payment is included in Genmab’s 2014 financial guidance as published on August 13, 2014.

Epizyme Announces Notices of Allowance for US Patent Applications Covering PRMT5 Inhibitors and Methods of Cancer Treatment with PRMT5 Inhibitors

On October 23, 2014 Epizyme reported that the US Patent and Trademark Office has granted Notices of Allowance for US Patent Applications, Nos. 14/136,551 and 14/136,738, both entitled "PRMT5 Inhibitors and Uses Thereof" (Press release Epizyme, OCT 23, 2014, View Source [SID:1234500863]). The allowed claims cover inhibitors of PRMT5 and methods of cancer treatment with PRMT5 inhibitors. PRMT5 is implicated in several cancers, including blood cancers.

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Epizyme also announced the publication of 10 patent applications covering chemical matter targeting several additional HMTs: CARM1, PRMT1, PRMT3, PRMT6 and PRMT8. These additional HMT targets are implicated in a variety of solid tumors and hematologic malignancies.

"These notices of allowance and publications further solidify our leadership position in the HMT space, and we continue to advance our dominant intellectual property position. Epizyme now has patents and patent applications for 13 of the 20 prioritized targets that comprise the Company’s pioneering HMT platform, covering therapeutic and diagnostic methods, combination therapy methods and pharmaceutical compositions," said Robert Gould, Ph.D., President and Chief Executive Officer, Epizyme. "We believe these patents and pending applications place us in the strongest possible position to build our company over the long-term and accelerate our efforts to bring life-saving drugs to patients."

Sutro Biopharma and Celgene Corporation Enter Multi-Year Strategic Collaboration and Option to Acquire Agreement

On October 23, 2014 Sutro Biopharma reported it has entered into a strategic collaboration and option agreement with Celgene Corporation to discover and develop multispecific antibodies and antibody drug conjugates (ADCs) (Press release Sutro Biopharma, OCT 23, 2014, View Source [SID:1234500864]). This new agreement follows the December 2012 collaboration between the two companies and focuses on the field of immuno-oncology, while further broadening the Sutro platform for discovery, development, and manufacture of best-in-class biotherapeutics.

The scope of the collaboration allows the parties to systematically interrogate the immuno-oncology space, including established targets, such as PD-1 and PD-L1, as well as novel targets, using Sutro’s cell-free biologics development platforms, Xpress CF and Xpress CF+. During the collaboration, after an initial period, Celgene will have the exclusive option to acquire Sutro, including rights to all Sutro-owned programs at that time, on pre-specified terms. Under terms of the agreement, Sutro will receive upfront payments totaling $95 million, which includes an equity investment. Sutro may also receive up to an additional $90 million during the initial research term, including payments for manufacturing-related and productivity milestones. Celgene has the option to extend the collaboration beyond the initial research term in exchange for an additional payment. Across all product candidates Sutro is eligible to receive more than $1 billion in total payments, upon achievement of clinical and regulatory milestones for product candidates and royalties on product sales resulting from the collaboration.

During the collaboration, Sutro will be responsible for discovery and early pre-clinical development of all collaboration multispecific antibodies and ADCs, as well as the manufacturing of pre-clinical product candidates. The collaboration also contemplates a clinical and commercial supply agreement between Sutro and Celgene for collaboration products. Celgene may assume responsibility for global development and commercialization and will have worldwide rights to all collaboration products, with the exception of certain collaboration products for which Sutro retains U.S. development and commercialization rights, in the event Celgene does not exercise its option to acquire Sutro. For product candidates not licensed to Celgene under the collaboration, Sutro retains worldwide rights, in the event Celgene does not exercise its option to acquire Sutro.

“This multi-year collaboration agreement reflects Celgene’s commitment to our highly collaborative relationship, the significant progress we have made in exploring best-in class multispecific antibodies and ADCs using Sutro’s cell-free protein synthesis platform, and the value of our early pipeline of multispecific antibodies targeting immuno-oncology pathways,” said William Newell, chief executive officer of Sutro Biopharma. “Our platform and product development efforts bear enormous promise. We look forward to continuing and expanding our productive collaboration with Celgene and to accelerating the development of our own portfolio of mono- and bi-specific ADC pipeline candidates.”

Thomas Daniel, M.D., Celgene president, global research and early development, added, “Substantive progress and unique advantages of Sutro’s platform have led us to expand and extend our relationship, as a key capability supporting our emerging Immuno-Oncology pipeline. We see this collaboration as a unique opportunity to accelerate the evaluation and development of important products in this and other strategic areas of high potential impact. Sutro has been a strong partner expanding a potentially disruptive technology, and we look forward to building on the existing collaboration.”

In 2012, Sutro and Celgene entered into a collaboration to design and develop ADCs and bispecific antibodies for two undisclosed targets and to manufacture a proprietary Celgene antibody.

(Press release, Novogen, OCT 22, 2014, View Source [SID:1234506859])

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Astellas Announces Revision of Package Insert in Japan for XTANDI® (enzalutamide) Capsules, a Prostate Cancer Treatment

On October 22, 2014 Astellas Pharma reported the revision of the package insert for the oral androgen receptor signaling inhibitor XTANDI Capsules 40mg (generic name: enzalutamide, "XTANDI") (Press release Astellas, OCT 21, 2014, View Source [SID:1234500855]).

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Based on the results of the Phase 3 AFFIRM trial for the treatment of advanced castration-resistant prostate cancer ("CRPC") in patients who have previously received docetaxel (chemotherapy), XTANDI, which is being jointly developed and commercialized with US-based company Medivation Inc. (NASDAQ MDVN), obtained the marketing approval in Japan for use in CRPC treatment in March 2014 and went on sale in May 2014.

The Phase 3 PREVAIL trial evaluating XTANDI as compared to placebo in chemotherapy-naïve metastatic CRPC patients recognized the clinical benefits and favorable tolerability of XTANDI for metastatic CRPC patients who have not received chemotherapy. The item "Indication" of the package insert has been revised based on the results of the PREVAIL trial, which means the sentence, "The efficacy and safety of the drug have not been established in patients with prostate cancer who have not received chemotherapy", has been deleted from the "Precautions regarding indication" item. Also, the items "Side effects" and "Clinical results" of the package insert have been revised.
In addition to the revisions, "thrombocytopenia" has been added to the "Significant side effects" in the "Side effects" item in accordance with Authorities’ instruction.

The revision of the "Precautions regarding indication" item of the package insert triggers a $45 million milestone payment to Medivation under its collaboration agreement with Astellas.