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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

The CEACAM5-targeting ADC was initially created by ImmunoGen and licensed to Sanofi as part of a broad research collaboration (Filing 10-K , ImmunoGen, AUG 28, 2014, View Source [SID:1234500837]).
IMGN779 is a CD33-targeting antibody with a DNA-acting payload agent, DGN462, which is under development by ImmuGen for the treatment of acute myeloid leukemia.

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OncoMed Pharmaceuticals Announces Removal of Partial Clinical Hold by the FDA for Vantictumab

On August 28, 2014 OncoMed Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on enrollment in the company’s vantictumab (anti-Fzd7, OMP-18R5) Phase 1 clinical trials (Press release OncoMed, AUG 28, 2014, View Source [SID:1234500712]). Vantictumab is being studied in combination with standard-of-care chemotherapy in three Phase 1b clinical trials in patients with advanced non-small cell lung cancer (NSCLC), advanced HER2-negative breast cancer and advanced pancreatic cancer. Enrollment and dosing of new patients is expected to resume within the next few weeks as the study sites’ institutional review boards (IRBs) receive and approve the revised trial protocols.

“We are pleased by the FDA’s action to allow the resumption of enrollment in the vantictumab clinical trials,” said Jakob Dupont, MD, OncoMed’s Chief Medical Officer. “Patient safety is our top priority. The revised protocols were developed with input from the vantictumab clinical investigators and academic bone experts and are intended to mitigate the risks of future adverse events as we seek an optimal efficacious dose to take forward in the development of this first-in-class WNT pathway inhibitor.”

The partial clinical hold occurred on July 1, 2014 following the company’s voluntary halt to its Wnt pathway programs due to observed on-target mild-to-moderate bone-related adverse events. The FDA removed the partial clinical hold to permit the enrollment of vantictumab clinical trials following its review of a substantial clinical safety and efficacy data package and revised study protocols submitted by the company. The amendments for the Phase 1b combination trials include modified dosing regimens, risk mitigation measures, such as increased monitoring and bone protection strategies, and modified enrollment criteria.

“The diligence and dedication of OncoMed’s clinical development team to temporarily halt the vantictumab studies and submit a comprehensive response to the FDA has led to a prompt action by the agency,” said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed. “We look forward to proceeding with the vantictumab Phase 1b clinical studies, and to the potential opt in by our partner Bayer based on data from these trials, to realize the future potential of this novel first-in-class WNT pathway inhibitor.”

BeiGene Enrolls First Patient in Phase 1 Study of BGB-3111

On August 26, 2014 BeiGene reported that it has dosed the first patient in a Phase 1 study of BGB-3111 for the treatment of cancer (Press release BeiGene, AUG 26, 2014, View Source [SID:1234501202]). BGB-3111 is an investigational, oral, highly selective and potent inhibitor of Bruton tyrosine kinase (BTK), a critical component of B-cell receptor (BCR) signaling which plays an important role in B-cell malignancies.
"We are excited to begin this first-in-human trial of BGB-3111, which we feel has the potential to be a best-in-class BTK inhibitor based on our preclinical results to date," said Dr. Jason Yang, Senior Vice President and Head of Clinical Development at BeiGene. "With the strong support of our experienced team of investigators, we look forward to conducting this study and assessing dosing, PK and safety results, with the potential for early anti-tumor activity as we move toward the trial’s expansion phase later this year."
The Phase 1a dose escalation portion of study will be conducted at 4 Australian sites, followed by a 1b expansion phase which will enroll disease-specific cohorts at the maximally-tolerated or biologically-relevant dose. BeiGene currently expects to finish the dose escalation portion in the second quarter of 2015, with data readout for the expansion stage expected by the end of 2015 or beginning of 2016.
"I am very pleased to be involved in the clinical development of this exciting new anti-cancer drug," commented Dr. Constantine Tam, lead investigator for the trial at the Peter MacCallum Cancer Centre in Melbourne. "BTK inhibitors have demonstrated impressive clinical activity in several B-cell malignancies, and BGB-3111 shows the potential for significant advantages over previous BTK inhibitors in preclinical studies. We hope these advantages will continue to translate into a stronger activity and safety profile as BGB-3111 advances through the clinic."
"We have continued to rapidly accelerate our research development plan, with three promising candidates against different targets entering the clinic within the past 9 months," commented John V. Oyler, CEO of BeiGene. "As our first wholly-owned program to enter clinical studies, BGB-3111 is yet another validation of our novel translational research platform and a reflection of our ability to execute on significant
clinical milestones – both on our lead partnered programs and our proprietary compounds. We look forward to advancing our additional promising preclinical candidates in the months ahead, and expect to bring up to several new small molecules/biologics into the clinic within the next year."
BeiGene is currently investigating two other small molecule inhibitors in clinical development as part of a strategic partnership with Merck Serono: BGB-283, a second-generation B-RAF inhibitor which entered a Phase 1 study in November 2013; and BGB-290, a PARP inhibitor which entered a Phase 1 study in July 2014.

Pfizer and Merck to Collaborate on Study Evaluating Novel Anti-Cancer Combination Regimen

On August 26, 2014 Pfizer and Merck & Co reported that they have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s crizotinib (XALKORI) with Merck’s investigational anti-PD-1 antibody pembrolizumab, in a Phase 1b clinical study evaluating the safety and tolerability of the combination in patients with ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC) (Press release Merck & Co, AUG 26, 2014, View Source [SID:1234500710]). The financial terms of the agreement were not disclosed.

“This collaboration between Pfizer and Merck is just one example of the willingness of sponsors to work together in an effort to accelerate progress against some of the most difficult-to-treat cancers,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. “Understanding the effects of combining one drug, XALKORI, which inhibits an abnormally activated enzyme in patients with ALK-positive metastatic lung cancer, with the investigational drug, pembrolizumab, which harnesses the body’s immune system to fight cancer, is vital if we are to continue to advance the care of lung cancer patients.”

This multi-center, open-label clinical study is expected to begin in 2015. Pfizer will conduct the study.

“We are pleased to build upon our ongoing collaboration with Pfizer to evaluate potential combination regimens incorporating Merck’s investigational immunotherapy pembrolizumab,” said Dr. Eric Rubin, vice president, Oncology, Merck Research Laboratories. “Evidence from early studies of pembrolizumab monotherapy together with XALKORI’s proven targeted therapeutic approach provides the scientific rationale for evaluating this combination for the treatment of lung cancer.”

Both companies previously announced plans to evaluate the safety and efficacy of pembrolizumab in combination with Pfizer’s small molecule kinase inhibitor axitinib (INLYTA) in patients with renal cell carcinoma. Separately, pembrolizumab plus Pfizer’s PF-05082566 (PF-2566), an investigational immuno-oncology agent that targets the human 4-1BB receptor, will be evaluated in multiple cancer types. These studies are expected to begin enrollment later this year.

Janssen Affiliate Cilag GmbH International Acquires Covagen AG

On August 25, 2014 Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson & Johnson, reported that it has acquired Covagen AG (Press release Johnson & Johnson, AUG 25, 2014, View Source [SID:1234501612]). The opportunity was identified and facilitated through the Johnson & Johnson Innovation Center in London. The company’s lead product, COVA 322, a bispecific anti-tumor necrosis factor (TNF)-alpha/anti-interleukin (IL)-17A FynomAb, is in Phase 1b study for psoriasis and holds potential as a treatment for a broad range of inflammatory diseases including rheumatoid arthritis. Covagen develops FynomAbs, multi-specific protein therapeutics, by fusing its fully human Fynomer binding proteins to antibodies. Fynomers are small binding proteins engineered to bind to target molecules with the same affinity and specificity as antibodies. The tailored architecture and novel mode of action of FynomAb therapeutics may offer enhanced efficacy in the treatment of a broad range of inflammatory diseases and other conditions. Financial terms of the transaction have not been disclosed.

"Our goal is to translate advancements in immunology science into next-generation therapies that improve patient outcomes," said Susan B. Dillon, Ph.D., Global Therapeutic Area Head, Immunology, Janssen Research & Development, LLC. "Our interest in Covagen stems from the company’s scientific acumen, their novel FynomAb platform, and the potential of COVA 322, a bispecific designed to achieve better control of inflammation by blocking two key cytokines that have been implicated in disease pathogenesis and progression. We look forward to progressing COVA 322 development, and to further expanding the potential of multispecific biologics for immunologic and other diseases. This exciting opportunity underscores the value of co-locating scientific innovation leads at our regional hubs in thriving life science communities as part of our strategy to identify and realize new opportunities and build long-term competitive advantage."

Covagen will maintain a research presence in Zurich-Schlieren, Switzerland, and will continue to focus on the further development and application of the Fynomer technology. "We are very excited to further develop our pipeline and innovative FynomAb platform as part of Janssen," said Julian Bertschinger, Ph.D., co-founder and former CEO of Covagen. "Janssen’s tremendous knowledge in the research and development of biologics provides us with a great environment to develop novel FynomAb-based therapeutics addressing unmet medical needs."

Covagen was co-founded in 2007 by Julian Bertschinger, Ph.D., and Dragan Grabulovski, Ph.D. as a spin-off company of ETH Zurich, Switzerland.