On April 17, 2018 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported preclinical data on the immune activating antibody ATOR-1015 at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 taking place in Chicago, Illinois American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 taking place in Chicago, Illinois. ATOR-1015 is a first-in-class bispecific tumor-directed antibody, targeting CTLA-4 and OX40, designed to selectively activate the immune system in the tumor, without increasing systemic toxicity.

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The preclinical data demonstrate that ATOR-1015 physically localizes to the tumor and selectively activates the immune system in the tumor area, confirming the intended ATOR-1015 mechanism of action.

ATOR-1015 is primarily designed for combination therapy with a PD-1 blocking antibody, and the potential of this approach is supported with preclinical data reporting enhanced anti-tumor effect of ATOR-1015 in combination with an anti-PD-1 antibody, as compared to anti-PD-1 monotherapy. In addition, ATOR-1015 demonstrated superior efficacy compared to mono-targeting CTLA-4 and OX40 antibodies.

"The results presented in Chicago confirm that our CTLA-4 bispecific antibody ATOR-1015 selectively activates the immune system in the tumor area. This offers great potential for an improved benefit/risk profile for cancer patients. We are more and more excited about the significant prospects for this unique compound, particularly in combination with PD-1 blockers, and are looking forward to initiate clinical development later in the year", said Per Norlén CEO of Alligator Bioscience.

Alligator is planning to initiate an ATOR-1015 Phase I study during the second half of 2018.

A poster with the title "CTLA-4 x OX40 bispecific antibody ATOR-1015 induces anti-tumor effects through tumor-directed immune activation" is showcased today at 8-12 a.m. EDT and is also available on the company web page View Source

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 3 p.m. CEST on 17 April 2018.

On April 17, 2018 Seres Therapeutics, Inc. (NASDAQ:MCRB) reported that new preclinical data supporting the development of microbiome therapeutics for immuno-oncology (leveraging gut microbiota to impact tumor immunotherapy)1 will be presented today by Sceneay et al in the late breaking poster session at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) in Chicago (Press release, Seres Therapeutics, APR 17, 2018, View Source [SID1234530893]). The data presented provide new insights on the potential mechanism by which Seres’ microbiome therapies could improve the outcomes of cancer patients treated with immune checkpoint inhibitors.

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"The data presented at AACR (Free AACR Whitepaper) provide important new models and mechanistic insights that inform our planned development efforts to evaluate the ability of microbiome therapy to augment immune checkpoint inhibitors," said David Cook, Ph.D., Chief Scientific Officer and Executive Vice President of Research at Seres. "The insights described in this presentation will guide the continued development of SER-401, which we expect to enter clinical development later this year. Our objective is to use our microbiome therapeutic approach to improve the efficacy of immunotherapy in patients with life-threatening cancers."

Seres presented results from preclinical studies designed to evaluate the impact of various consortia of bacterial species on the anti-tumor immune response in murine models following treatment with an anti-PD-1 checkpoint inhibitor. Results demonstrated that both germ-free mice lacking a microbiome and antibiotics-treated mice with a dysbiotic microbiome, failed to mount an effective anti-tumor response following treatment with an anti-PD-1 checkpoint inhibitor. The response to anti-PD-1 was restored in germ-free as well as antibiotics-treated mice by introducing a diverse microbiome, and was driven by increased entry of tumor-infiltrating lymphocytes into the tumor; specifically, CD8+ T effector cells. Current pre-clinical efforts are focused on optimizing specific microbiome compositions based on functional and phylogenetic information to inform the development of therapeutic candidates.

Seres is developing SER-401, a preclinical stage oral microbiome therapy comprising a consortium of live bacteria to improve the efficacy and safety of immunotherapy. Through a collaboration with The University of Texas MD Anderson Cancer Center and the Parker Institute for Cancer Immunotherapy, Seres plans to initiate a clinical study in patients with advanced metastatic melanoma later this year. In a 2017 study published in Science, the MD Anderson research team, led by Dr. Jennifer Wargo, described a microbiome signature associated with response to checkpoint inhibitor therapy. A planned clinical trial will evaluate the impact of an anti-PD-1 checkpoint inhibitor with adjunctive microbiome therapy on patient outcomes.

On April 17, 2018 Elios Therapeutics, a biopharmaceutical company developing innovative particle-delivered, dendritic cell vaccines in oncology, reported initial open-label results from the ongoing Phase 2b clinical trial of the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine in patients with stage III and IV (resected) melanoma (Press release, Orbis Health Solutions, APR 17, 2018, View Source [SID1234529911]). Results were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting held April 14-18, 2018 in Chicago, Illinois.

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"We are encouraged by these initial open-label results from our Phase 2b trial which demonstrate a compelling safety profile and provide early evidence that the TLPLDC vaccine may enhance the efficacy of commonly used FDA-approved systemic therapies, including checkpoint inhibitors," said George E. Peoples, M.D., chief medical officer at Elios Therapeutics. "We look forward to continuing our assessment of the TLPLDC vaccine in this ongoing study as we evaluate opportunities for further clinical development of combination therapies."

In an ongoing prospective, randomized, double-blind, placebo-controlled Phase 2b trial, patients with resected Stage III and IV melanoma were randomized (2:1) to received either TLPLDC vaccine or placebo to prevent recurrence. All patients who recurred on the trial (met study endpoint) were then offered open-label TLPLDC along with standard of care therapy as determined by the patient’s treatment team.

The initial open-label results presented were from 22 patients. Seven patients had their recurrences resected and were treated with the TLPLDC vaccine to prevent a second recurrence. At 12.5 months of median follow-up, only one patient has recurred.

The remaining 15 patients were on a variety of FDA-approved systemic therapies for their non-resectable recurrences. Of these patients, two patients withdrew from the study and one was not treated. In the remaining 12 patients treated with the TLPLDC vaccine in combination with their standard of care systemic therapy, two patients had a complete response (median follow-up 8.6 months), seven had stable disease and two had progressive disease. One patient progressed initially on TLPLDC vaccine alone but was converted to a complete response once checkpoint inhibitor therapy was initiated. Importantly, the addition of the TLPLDC vaccine did not increase the toxicity of checkpoint inhibitors, BRAF/MEK inhibitors, or TVEC in these patients.

To view the full abstract, please visit the AACR (Free AACR Whitepaper) website at View Source

About TLPLDC
The TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine is an autologous, personalized, therapeutic cancer vaccine designed to stimulate the immune system to recognize tumor cells and fight a patient’s specific cancer. TLPLDC is made from the patient’s own tumor cells and dendritic cells – the most potent antigen-presenting cells in the body. Once TLPLDC is injected, the tumor lysate-loaded dendritic cells present the tumor antigens to the immune system, stimulating the induction of tumor-specific, activated T cells that are able to find and destroy tumor cells that may remain in the body. TLPLDC is currently being studied as a monotherapy and in combination with standard of care checkpoint inhibitor therapy in a Phase 2b clinical trial for the treatment of late-stage melanoma at leading academic cancer centers in the United States.

Genprex has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Genprex, 2018, APR 17, 2018, View Source [SID1234527531]).

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On April 17, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported updated durable response data from the Phase 1 study involving patients with high-grade glioma who received Toca 511 & Toca FC at the time of surgical resection will be presented at the 2018 American Academy of Neurology (AAN) Annual Meeting and 2018 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting. Previously disclosed clinical data will also be reviewed at these meetings (Press release, Tocagen, APR 17, 2018, View Source;p=RssLanding&cat=news&id=2342917 [SID1234525819]).

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Additionally, preclinical data describing the level of Toca 511 transduction required for an anti-tumor response will be presented at the 14th Annual PEGS: The Essential Protein Engineering Summit.

Details of the presentation at AAN, held April 21-27 in Los Angeles, are as follows. The full presentation will be placed on Tocagen’s website following the presentation.

Presentation Type: Oral presentation (Abstract: 1173)
Title: Toca 511 & Toca FC: Evaluation of durable response rate in the post-resection setting and association with survival in patients with recurrent high grade glioma
Presenter: Timothy Cloughesy, M.D., director of the University of California, Los Angeles, Neuro-Oncology Program
Date and Time: Tuesday, April 24, 2:00 p.m. – 2:12 p.m. PT

Details of the presentation at the AANS Annual Scientific Meeting, held April 28-May 2 in New Orleans, are as follows:

Presentation Type: Oral presentation (Abstract: 615)
Title: Evaluation of durable response rate in the post-resection setting and association with survival in patients with recurrent high grade glioma who received Toca 511 and Toca FC treatment
Presenter: Bob S. Carter, M.D., Ph.D., chief of the Massachusetts General Hospital department of neurosurgery
Date and Time: Tuesday, May 1, 11:32 a.m. – 11:42 a.m. CT

Details of the presentation at PEGS, held April 30-May 4 in Boston, are as follows. The full presentation will be placed on Tocagen’s website following the presentation.

Presentation Type: Oral presentation
Title: Replicating retroviruses for manipulation of the tumor immune ecosystem: preclinical and clinical outcomes
Presenter: Douglas Jolly, Ph.D., executive vice president of research and pharmaceutical development at Tocagen
Date and Time: Tuesday, May 1, 8:30 – 9:00 a.m. ET

About Toca 511 & Toca FC

Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprised of an investigational biologic, Toca 511, and an investigational small molecule, Toca FC. Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells in the tumor microenvironment resulting in anti-cancer immune activation and subsequent tumor killing.