Biotech Values

[DewDiligence]

ADXS 2016 News Flow

[The following are excerpts from ADXS’ PR on 1/8/15,
which was posted via link in #msg-119699974. As
noted in a prior post, ADXS has a lot of shots on goal
for a small biotech company.]


ADXS-HPV (a/k/a Axalimogene Filolisbac)

• Finish the Special Protocol Assessment process and initiate enrollment in a Phase 3 trial for the treatment of high-risk, locally advanced cervical cancer (AIM2CERV) in mid-2016.

• Complete enrollment of stage 2 of GOG 0265 study in patients with metastatic cervical cancer in 2016.

• Initiate Phase 2 study in combination with Incyte's epacadostat (IDO-1 inhibitor) for the treatment of early stage cervical cancer in the first half of 2016.

• Commence enrollment of Phase 2 trial in metastatic anal cancer (FAWCETT) in the first half of 2016.

• Complete enrollment in the combination Phase 1/2 study with [AZN’s] durvalumab for the treatment of HPV-associated head and neck and cervical cancer in late 2016.

—Following the successful completion of cohort 1 of the combination, which occurred in 2015, fully enroll cohort 2 (with a higher dose of durvalumab).

—Following completion of cohort 2, a dose determination will be made and enrollment in the expansion phase of the study will commence in the first half of 2016, with completion of enrollment by the end of 2016.

• Commence and complete enrollment of the Phase 2 dose-escalation study in recurrent cervical cancer (at 1x10^10 cfu) in the first half of 2016.

• Present data from a Phase 1/2 window of opportunity trial in HPV-positive head and neck cancer in the first half of 2016 at a major medical meeting.

• Commence enrollment of Phase 2 study in patients with HPV-positive, non-squamous, non-small cell lung cancer following first-line induction chemotherapy via partner [who?] in the first half of 2016.

• Commence investigator initiated studies for other HPV-associated cancers (e.g. penile and vaginal cancers).


ADXS-PSA

• Complete enrollment of Phase 1/2 study in combination with Merck's Keytruda for the treatment of advanced, metastatic castrate-resistant prostate cancer.

—Following the successful completion of dose escalation cohorts 1 and 2, which occurred in 2015, fully enroll cohort 3 (highest dose at 1x1010) in the first half of 2016.

—Once a dose determination is made, enrollment in the Part B combination arm with ADXS-PSA and Keytruda will commence in the first half of 2016, with completion of enrollment by the end of 2016.


ADXS-HER2

• Complete enrollment of Phase 1b dose-escalation study of ADXS-HER2 in patients with HER2-driven malignancies in the first half of 2016.

—Fully enroll Part A, which is designed to establish safe dosing levels in preparation for the expansion phase of the study in HER2-driven malignancies.

—Once a dose is selected from Part A, enrollment in a Part B expansion phase will commence in the second half of 2016.

• Following completion of Part A in the Phase 1b dose escalating study, commence collaboration and cooperative group trial with the Children’s Oncology Group in osteosarcoma.

• Initiate commercialization via Aratana Therapeutics (PETX) for the treatment of canine osteosarcoma following approval from the USDA.


ADXS-NEO

• MINE (My Immunotherapy Neo-Epitopes), a collaboration with Memorial Sloan Kettering Cancer Center, will progress toward the filing of an IND in 2016. MINE uses Advaxis’s Lm Technology to develop neoepitope immunotherapies based on an individual patient’s tumor.


ADXS-TNBC

• Finalize preclinical work for ADXS-TNBC, a multiple-antigen construct for Triple Negative Breast Cancer with the goal of filing an IND in 2016.