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MacroGenics Announces Presentation at 30th Annual SITC Meeting 2015

On October 01, 2015 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported that interim results of an ongoing Phase 1 dose escalation study of MGA271 will be presented by the Company in the late-breaking abstract session at the 2015 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, MD (Press release, MacroGenics, OCT 1, 2015, View Source [SID:1234507629]). The 30th Anniversary Annual Meeting is being held November 4-8, 2015 at the Gaylord National Hotel & Convention Center. Presentation details include:

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Title: Interim Results of an Ongoing Phase 1, Dose Escalation Study of MGA271 (Fc-optimized Humanized Anti-B7-H3 Monoclonal Antibody) in Patients with Refractory B7-H3-Expressing Neoplasms or Neoplasms Whose Vasculature Expresses B7-H3

Session: Late-Breaking Abstract Session

Time: Saturday, November 7, 2015, from 12:00 pm – 12:15 pm ET

Presented by: MacroGenics, Inc.

Background on MGA271

MGA271 is a humanized, Fc-optimized monoclonal antibody that targets B7-H3, a member of the B7 family of molecules that are involved in immune regulation. B7-H3 is over-expressed by a wide variety of solid tumor cells as well as cancer stem-like cells and the supporting tumor vasculature. MGA271 is currently undergoing Phase 1 testing both as monotherapy and in combination with checkpoint inhibitors including ipilimumab and pembrolizumab across a wide range of solid tumors.

Kancera provides operational update on the ROR and Fractalkine projects

On October 1, 2015 Kancera reported ithat in the ROR project, follow-up studies of the pharmaceutical properties of KAN0439834 show that they probably are better than previously assumed with respect to uptake and penetration of the substance to the cancer (Press release, Kancera, OCT 1, 2015, View Source;releaseID=1055733 [SID:1234507628]). The new studies indicate that dosing 2-3 times a day at 65-300 mg gives a concentration in the body that may be sufficient to exert an effect on solid tumors. However, the effect of KAN0439834 on solid tumors cannot be demonstrated in mice since the substance is metabolized too quickly in that species. Therefore, KAN0439834 and related substances will be tested against human solid tumors in an established zebra fish model for tumor growth and metastasis. This will allow effect studies of the ROR inhibitors at concentrations that are expected to be achievable in humans.

Further, the effects of KAN0439834 and three new drugs have been evaluated in tumor cells isolated from blood, lymph and bone marrow from nine patients. The background to this study is that new drugs such as Ibrutinib and Idelalisib give effect in 70-80% of patients with chronic lymphocytic leukemia (CLL). However, a so-called complete remission (the disappearance of symptoms) has only been reached in limited number of these patients. The lack of effect is particularly evident in the bone marrow. Since complete remission in cancer is generally linked to a longer survival, there is a need for drugs that work in a new way. Kancera has previously shown that the candidate drug KAN0439834 effectively kills patient CLL cells from blood and lymph in the laboratory and also in animal studies of the human disease. The present study, conducted by Prof. Håkan Mellstedt’s team at the Karolinska Institute, shows that Kancera’s ROR inhibitors are also effective in killing CLL cells from bone marrow which is a capacity wanted as a complement to the currently registered drugs against CLL.

In the Fractalkine project, Kancera has now established the network of leading cancer and pain scientists that in a collaborative project will evaluate the drug candidate KAN0440567 (AZD8797) in an advanced animal model closely resembling the human form of pancreatic cancer. Further, Kancera has synthesized and quality controlled the salt form of the drug candidate that will be used in the collaborative project and conducted a dosing study in mice. The results from this study support that an effective dose of the drug candidate can be achieved in mice via oral administration.

About the ROR project
ROR is a family of receptors, ROR1 and ROR2. The ROR receptors mediate signals for growth and survival. Originally ROR was linked to fetal development, but it is now known that they also contribute to cancer cell development and proliferation. Professor Håkan Mellstedt, Kancera´s co-founder and professor at the Karolinska Institute, and his colleagues have shown that Kancera´s ROR inhibitors have the ability to kill cells from tumors in pancreas, and leukemia cells. Professor Mellstedt and his colleagues as well as independent researchers have shown that ROR is also active as a target in prostate, breast, skin and lung cancer.

Because ROR primarily generates a survival and growth signal to tumor cells but is inactive in healthy cells in adults, there are good prospects that a drug directed against ROR hit the tumor much harder than the surrounding healthy cells. Kancera and Professor Mellstedt have shown that inhibition of ROR leads to that cancer cells eliminate themselves by cellular suicide. Against this background, there are reasons to anticipate that a ROR-targeted drug is both safer and more effective than several chemotherapies currently used to treat cancer.

CEL-SCI REPORTS AUGUST PATIENT ENROLLMENT FOR ITS PHASE 3 HEAD AND NECK CANCER TRIAL

On October 1, 2015 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that in the month of September it has enrolled 30 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, OCT 1, 2015, View Source [SID:1234507626]). Total patient enrollment is now 570 as of September 30, 2015 in the world’s largest Phase 3 study in head and neck cancer.

A total of 880 patients are expected to be enrolled in over 20 countries.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has also entered into two co-development agreements with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

Merck Presents Details on Immuno-Oncology Program Including First-in-Man Milestone with Investigational Bi-Functional Immunotherapy

On October 1, 2015 Merck, a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials, reported an update on key immuno-oncology and oncology research and development projects, illustrating visible progress across all pipeline stages (Press release, Merck KGaA, OCT 1, 2015, View Source [SID:1234507627]).

Among others, the company announced that it started investigating a novel, potential first-in-class bi-functional immunotherapy in clinical trials with the potential to offer an alternative therapy to anti-PD-1/anti-PD-L1 and other immunotherapies. Merck also showed good progress in its avelumab development program, which it is driving together with Pfizer. If successful, the companies expect the first potential commercial launch for avelumab in 2017, and are working toward at least one additional potential launch per year through 2022.

"We have a focused and differentiated pipeline in immuno-oncology, oncology and immunology that has the potential to make a substantial difference in the lives of patients," said Luciano Rossetti, Head of Global R&D at the biopharmaceutical business, Merck Serono, in an investor call following presentations at this year’s European Cancer Congress (ECC) in Vienna, which took place Sept. 25 – 29. "Our priorities include accelerating high-priority programs and ensuring launch success to secure long-term growth."

Merck has been rebuilding its research and development organization over the past four years, with new leadership and improved R&D operating model. Rigorous project prioritization, increased efficiency and more agile decision making has allowed the company to progress its R&D productivity. Merck is on track to deliver a continuous flow of innovative specialty medicines in areas of high unmet medical need, including several promising earlier stage assets.

Merck expects more than 3,000 patients treated with Avelumab by 2016
Regarding the avelumab clinical development program, Merck said it is on track to meet its 2015 goals of collaborating on up to 20 clinical programs, including initiating up to six pivotal trials. By the end of 2016, Merck expects more than 3,000 patients to be treated across more than 15 tumor types and lines of therapy.

In September, the US Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for avelumab in Merkel cell carcinoma (MCC). MCC is a very rare disease in which malignant (cancer) cells form in the skin. This orphan drug designation does not guarantee market approval, but could imply seven years of market exclusivity upon approval and other incentives.

Beyond avelumab, Merck today also disclosed details on other key immuno-oncology programs aimed at helping patients fight difficult-to-treat cancers. These projects include its CAR-T/Intrexon T-cell therapies, which could form the next cornerstone of cancer immunotherapy. The innovative chimeric antigen receptor t-cell treatments modulate the immune system’s natural ability to fight tumors.

In addition, Merck gave details on its investigational molecule, M7824, for which it has initiated and treated the first patient in a phase I, open-label, multiple-ascending clinical trial, targeting to enroll 106 patients. This potential first-in-class bi-functional immunotherapy is designed to simultaneously block two immuno-inhibitory pathways that are commonly used by cancer cells to evade the immune system, thereby controlling tumor growth by restoring and enhancing anti-tumor immune responses.

"The initiation of the M7824 clinical trial marks the next milestone in Merck’s strategy to build an innovative portfolio of cancer immunotherapies that may work synergistically to potentially maximize patient benefit," Rossetti said. "This is the first phase I trial industry-wide for this class of molecule and we expect to see key data during the second half of 2016."

In the broader field of oncology, Merck reiterated that it expects to have key data on its oncology treatment evofosfamide, a hypoxia-activated pro drug currently tested in clinical phase III trials in soft tissue sarcoma and pancreatic cancer, during the fourth quarter of 2015. In addition, the company disclosed details of its tepotinib program, an investigational small molecule inhibitor of the c-met receptor tyrosine kinase, as well as its DNA-PK inhibitor M3814, which has the potential for a first-in-class orally administered selective DNA-PK inhibitor.

The webcast can be followed live here (starting at 14:00 CEST), the presentation will be available at the Investor Relations section of our website.

XOMA Announces Development and Commercialization Agreement for First-in-Class Anti-TGF-beta Antibody Program in Immuno-Oncology

On October 1, 2015 XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, reported it has exclusively licensed the global development and commercialization rights to its anti-transforming growth factor-beta (TGFb) antibody program to Novartis. Under the terms of the agreement, XOMA will receive $37.0 million in the form of an upfront payment and is eligible to receive up to $480.0 million if all development, regulatory, and commercial milestones are met (Press release, Xoma, OCT 1, 2015, View Source [SID:1234507625]).

In addition, XOMA is eligible to receive royalties on product sales that range from the mid-single digits to the low double digits. In connection with this license agreement, Novartis has agreed to extend the maturity date on the approximately $13.5 million of outstanding debt under the secured note agreement, which bears interest at the six-month LIBOR plus 2% (currently 2.53%), to September 30, 2020. XOMA has also agreed to reduce the royalty rate to XOMA associated with Novartis’ clinical stage anti-CD40 antibodies.

"XOMA and Novartis have worked closely together for several years to develop new product candidates. When they expressed interest in our anti-TGFb program, we knew Novartis was the best company to bring this exciting potential therapy to the patients whom it may help," stated John Varian, Chief Executive Officer of XOMA. "Novartis is recognized as a leader in oncology, where an anti-TGFb molecule has real potential either as monotherapy or in combination with other therapeutic options.

"We had said we did not plan to raise equity capital at our recent stock price in order to fund the development of our very exciting endocrine portfolio. With this non-dilutive liquidity of essentially $50.5 million, we currently project this capital, in combination with our planned cost savings measures, will fund operations into 2017. We remain on track to begin our XOMA 358 Phase 2 clinical program this fall and fully anticipate we will have the data from these studies during that timeframe," concluded Mr. Varian.

About TGF-beta

Transforming growth factor-beta (TGFb) is a potent immune suppressive cytokine that is involved in many cellular processes, including inhibition of cell growth and immune suppression. While TGFb is essential for normal tissue homeostasis, elevated levels of TGFb may drive the progression of numerous diseases, including advanced metastatic cancer and fibrosis.

Three isoforms of TGFb exist in humans: TGFb1, 2 and 3. TGFb1 is overexpressed in many cancers and is believed to increase the likelihood of metastasis. Inhibiting TGFb1 and 2 while sparing TGFb3 may reduce tumor-protecting regulatory T cells, while allowing for the development of cytotoxic immune responses enhanced by TGFb3, improving the therapeutic index of TGFb inhibitors. Given the role of the TGFb pathway in cancer, it has become an attractive target for cancer drug development.

About XOMA 089

Discovering the TGFb antibody program was made possible because of XOMA’s proprietary antibody discovery technology platform. XOMA 089 is a fully human, high-affinity, late preclinical monoclonal antibody that neutralizes TGFb1 and 2 while sparing TGFb3. Data have shown this compound to be both active against tumor growth in preclinical models of head and neck cancer as well as breast cancer and breast cancer metastasis. Preclinical data also suggest that it may be synergistic with PD1 inhibition and work highlighting these results was recently presented at the 2015 FASEB meeting on the TGFb Superfamily: Signaling in Development and Disease. XOMA has made significant progress regarding this lead compound on both the understanding of its activity, mechanism of action, as well as preclinical toxicology and manufacturing. Other antibodies included in this license agreement inhibit TGFb1, which may be a more appropriate approach to certain indications. These antibodies have potential in immuno-oncology either as a monotherapy and may be particularly amenable to combination therapies, especially with immune checkpoint inhibitors.