Replies to post #17128 on Ayala Pharmaceuticals Inc (ADXS)

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Anybody see this article from March 16, 2017? An excerpt mentioning ADXS - from BioCentury:

:27 PM CDT | MAR 16, 2017 | BC INNOVATIONS | PRODUCT R&D
NEO WAVE
WHY THE NEOANTIGEN FIELD THINKS IT WON’T GO THE WAY OF TRADITIONAL CANCER VACCINES
BY KAREN TKACH, SENIOR WRITER
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The central thesis in the increasingly hot field of neoantigens is to pick mutations from patient tumors and turn them into personalized immunotherapies. While companies are staking out their space by defining how they will identify and deliver the neoantigens, they share the goal of generating responses that distance the new class from the poor results of traditional cancer vaccines.

The field will get its first hints this year, as clinical data read out from front-runner companies.

BioNTech AG is preparing to publish results from its Phase I melanoma trial for IVAC mutanome, an RNA vaccine encoding multiple patient-specific neoantigens.

And Neon Therapeutics Inc.'s academic partners have submitted for publication Phase I results for NeoVax, a precursor to the company's synthetic long peptide vaccine NEO-PV-01, in an adjuvant setting for resected melanoma. In 2018, Neon expects to have Phase I results for NEO-PV-01 in combination with Bristol-Myers Squibb Co.'s Opdivo nivolumab.

Agenus Inc. has begun recruiting for a Phase I trial of its neoantigen vaccine AutoSynVax, and two more companies, Advaxis Inc. and Aduro Biotech Inc., have submitted INDs for their candidates. At least eight more have programs in preclinical stages -- a sign of the growing belief that neoantigens are key to the future of cancer immunotherapy.

"We recognize that oncology is going in this direction. The concept of elaborate, highly personalized therapies, I just think that's where oncology's going," said Thomas Woiwode, managing director at Versant Ventures, which co-led a $102 million series A round for Gritstone Oncology Inc., a preclinical neoantigen vaccine startup.

The field's first charge is to show neoantigens pack more punch than traditional cancer vaccines, which target wild-type self proteins, such as embryonic or testes proteins, that are expressed abnormally on tumors and minimally elsewhere. By contrast, neoantigens are newly formed non-self antigens arising from mutations.

Despite decades of work, the traditional approach has yet to deliver a potent approved therapy.

"We spent a lot of time and effort with bioprocess consultants and others to get to the point where we were convinced we could do it, and it would be commercially viable. We're not looking at extending patient lives by a month or two. We're aiming for big transformative differences in patients.”
Cary Pfeffer, Third Rock

Gritstone CEO Andrew Allen thinks neoantigen vaccines are in a "different immunological universe" from their predecessors, which is why companies and investors are willing to move into the field.

"You'd be a fool to jump into cancer vaccines without acknowledging that they've had a difficult history. So you have to believe that we're going to do something different," said Allen.

He and seven other stakeholders told BioCentury that biomarker studies give reason to believe boosting neoantigen responses will make a substantial impact in immunotherapy. More than six studies have suggested T cell responses to neoantigens are a key component of successful checkpoint inhibitor and tumor-infiltrating lymphocyte (TIL) responses.

To optimize the approach, companies will have to sort through the wide range of neoantigen selection methods and immunization modalities under development (see "Delivery Mode" and "Pick and Deliver").

SIDEBAR: DELIVERY MODE
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