Avid Bioservices Inc (CDMO)

[sunstar]

The current PPHM pipeline is a real headsUP for investors IMO.

Phase 3 SUNRISE, with 161 trial sites is reaching for full enrollment (582 patients) and an early look-in in the near term months. Bavituximab doubled survival time in the phase 2 trial. I would not be surprised if the first look-in shows continued safety for Bavi plus efficacy in the order of 2 Docetaxel events for 1 Bavi event, OR better.

The low ECOG rating for patients in SUNRISE should help both arms exceed their performance over the phase 2 data. Docetaxel could do as well as 7 months survival. I would not be surprised if the scoreboard read Doce 7 months, Bavi 14 months. Not a prediction, but a real possibility.

Question is, what does the DMC, PPHM and FDA do/say if this is what is seen at the first look-in? Is this clear separation of curves in a 500+ patient trial stat sig? In my view this is a very possible outcome for SUNRISE.

The Pipeline:

Peregrine mid stage clinical trials have been very focused on two cancer fields, lung cancer and breast cancer. I note that these indications are the two most common cancers worldwide, and therefore the largest pharmaceutical oncology markets. This has been, and remains, Peregrine’s central market focus.

Peregrine has announced that two mid stage trials will start enrolling this second half of 2015. One will be a phase 2/3 trial in metastatic breast cancer HER2 NEG.

This second half of 2015 will also see a combo immunotherapy phase 2 trial, combining Bavituximab with Bristol-Myers', Opdivo (anti-PD-1) in NSCLC.

Along with the recent announcement of a collaboration of Peregrine with AstraZeneca, comes the announcement of a phase I and Ib trial that will evaluate the safety and efficacy of bavituximab in combination with durvalumab, an anti-PD-L-1, in multiple solid tumors.

In another immunotherapy combination clinical trial in advanced melanoma, Bavi is being combined with another Bristol-Myers' immunotherapy anti-CTLA-4, Yervoy, already approved for melanoma treatment. One of Peregrine’s goals here will be to demonstrate Bavi’s ability to upgrade the historically low response rates of anti-CTLA-4. This could move on to an advanced trial in melanoma. We could see early data from this trial in the months ahead.

Any of these three trials carry the possibility of receiving an FDA “Breakthrough Designation” if the results are notable.

The current Peregrine pipeline:

http://www.peregrineinc.com/pipeline/overview.html

“The Cancer Drug Market Just Hit $100 Billion And Could Jump 50% In Four Years”

The above headline came from Forbes this year.

We know that Bavi is a broad spectrum targeting mAb, and has the potential to target the multitude of solid cancers. It also can be combined with the other treatment agents, like radiation, chemotherapies and other immunotherapies. With the safety and efficacies that we have already seen in the clinical trials, and early big pharma interest starting to show, Peregrine's bavituximab seems now to be on the verge of FDA approval and commercialization, and mass production through Peregrine’s wholly owned and recently expanded bio-manufacturing facility Avid Bioservices.

This $100 billion plus drug market for cancer, will offer huge development opportunities for Peregrine’s Bavi, anti-PS broad spectrum technology platform.

The following list of cancer indications readily shows us the multitude of opportunities that lie ahead for Peregrine’s program.

IMO

sunstar


A
Acute lymphoblastic leukemia (ALL)
Acute myeloid leukemia
Adrenocortical carcinoma
AIDS-related cancers
AIDS-related lymphoma
Anal cancer
Appendix cancer
Astrocytoma, childhood cerebellar or cerebral
B
Basal-cell carcinoma
Bile duct cancer, extrahepatic (see Cholangiocarcinoma)
Bladder cancer
Bone tumor, Osteosarcoma/Malignant fibrous histiocytoma
Brainstem glioma
Brain cancer
Brain tumor, cerebellar astrocytoma
Brain tumor, cerebral astrocytoma/malignant glioma
Brain tumor, ependymoma
Brain tumor, medulloblastoma
Brain tumor, supratentorial primitive neuroectodermal tumors
Brain tumor, visual pathway and hypothalamic glioma
Breast cancer
Bronchial adenomas/carcinoids
Burkitt's lymphoma
C
Carcinoid tumor, childhood
Carcinoid tumor, gastrointestinal
Carcinoma of unknown primary
Central nervous system lymphoma, primary
Cerebellar astrocytoma, childhood
Cerebral astrocytoma/Malignant glioma, childhood
Cervical cancer
Childhood cancers
Chronic bronchitis
Chronic lymphocytic leukemia
Chronic myelogenous leukemia
Chronic myeloproliferative disorders
Chronic obstructive pulmonary disease (COPD)
Colon Cancer
Cutaneous T-cell lymphoma
D
Desmoplastic small round cell tumor
E
Emphysema
Endometrial cancer
Ependymoma
Esophageal cancer
Ewing's sarcoma in the Ewing family of tumors
Extracranial germ cell tumor, Childhood
Extragonadal Germ cell tumor
Extrahepatic bile duct cancer
Eye Cancer, Intraocular melanoma
Eye Cancer, Retinoblastoma
G
Gallbladder cancer
Gastric (Stomach) cancer
Gastrointestinal Carcinoid Tumor
Gastrointestinal stromal tumor (GIST)
Germ cell tumor: extracranial, extragonadal, or ovarian
Gestational trophoblastic tumor
Glioma of the brain stem
Glioma, Childhood Cerebral Astrocytoma
Glioma, Childhood Visual Pathway and Hypothalamic
Gastric carcinoid
H
Hairy cell leukemia
Head and neck cancer
Heart cancer
Hepatocellular (liver) cancer
Hodgkin lymphoma
Hypopharyngeal cancer
Hypothalamic and visual pathway glioma, childhood
I
Intraocular Melanoma
Islet Cell Carcinoma (Endocrine Pancreas)
K
Kaposi sarcoma
Kidney cancer (renal cell cancer)
L
Laryngeal Cancer
Leukemias
Leukemia, acute lymphoblastic (also called acute lymphocytic leukemia)
Leukemia, acute myeloid (also called acute myelogenous leukemia)
Leukemia, chronic lymphocytic (also called chronic lymphocytic leukemia)
Leukemia, chronic myelogenous (also called chronic myeloid leukemia)
Leukemia, hairy cell
Lip and Oral Cavity Cancer
Liposarcoma
Liver Cancer (Primary)
Lung Cancer, Non-Small Cell
Lung Cancer, Small Cell
Lymphomas
Lymphoma, AIDS-related
Lymphoma, Burkitt
Lymphoma, cutaneous T-Cell
Lymphoma, Hodgkin
Lymphomas, Non-Hodgkin (an old classification of all lymphomas except Hodgkin's)
Lymphoma, Primary Central Nervous System
M
Macroglobulinemia, Waldenström
Male breast cancer
Malignant Fibrous Histiocytoma of Bone/Osteosarcoma
Medulloblastoma, Childhood
Melanoma
Melanoma, Intraocular (Eye)
Merkel Cell Carcinoma
Mesothelioma, Adult Malignant
Mesothelioma, Childhood
Metastatic Squamous Neck Cancer with Occult Primary
Mouth Cancer
Multiple Endocrine Neoplasia Syndrome, Childhood
Multiple Myeloma/Plasma Cell Neoplasm
Mycosis Fungoides
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Myelogenous Leukemia, Chronic
Myeloid Leukemia, Adult Acute
Myeloid Leukemia, Childhood Acute
Myeloma, Multiple (Cancer of the Bone-Marrow)
Myeloproliferative Disorders, Chronic
N
Nasal cavity and paranasal sinus cancer
Nasopharyngeal carcinoma
Neuroblastoma
Non-Hodgkin lymphoma
Non-small cell lung cancer
O
Oral Cancer
Oropharyngeal cancer
Osteosarcoma/malignant fibrous histiocytoma of bone
Ovarian cancer
Ovarian epithelial cancer (Surface epithelial-stromal tumor)
Ovarian germ cell tumor
Ovarian low malignant potential tumor
P
Pancreatic cancer
Pancreatic cancer, islet cell
Paranasal sinus and nasal cavity cancer
Parathyroid cancer
Penile cancer
Pharyngeal cancer
Pheochromocytoma
Pineal astrocytoma
Pineal germinoma
Pineoblastoma and supratentorial primitive neuroectodermal tumors, childhood
Pituitary adenoma
Plasma cell neoplasia/Multiple myeloma
Pleuropulmonary blastoma
Primary central nervous system lymphoma
Prostate cancer
R
Rectal cancer
Renal cell carcinoma (kidney cancer)
Renal pelvis and ureter, transitional cell cancer
Retinoblastoma
Rhabdomyosarcoma, childhood
S
Salivary gland cancer
Sarcoma, Ewing family of tumors
Sarcoma, Kaposi
Sarcoma, soft tissue
Sarcoma, uterine
Sézary syndrome
Skin cancer (nonmelanoma)
Skin cancer (melanoma)
Skin carcinoma, Merkel cell
Small cell lung cancer
Small intestine cancer
Soft tissue sarcoma
Squamous cell carcinoma – see Skin cancer (nonmelanoma)
Squamous neck cancer with occult primary, metastatic
Stomach cancer
Supratentorial primitive neuroectodermal tumor, childhood
T
T-Cell lymphoma, cutaneous – see Mycosis Fungoides and Sézary syndrome
Testicular cancer
Throat cancer
Thymoma, childhood
Thymoma and Thymic carcinoma
Thyroid cancer
Thyroid cancer, childhood
Transitional cell cancer of the renal pelvis and ureter
Trophoblastic tumor, gestational
U
Unknown primary site, carcinoma of, adult
Unknown primary site, cancer of, childhood
Ureter and renal pelvis, transitional cell cancer
Urethral cancer
Uterine cancer, endometrial
Uterine sarcoma
V
Vaginal cancer
Visual pathway and hypothalamic glioma, childhood
Vulvar cancer
W
Waldenström macroglobulinemia
Wilms tumor (kidney cancer), childhood