NEO7LOGIX

Personal Peptide Therapy

PBIMA-PES™ (Precision Based ImmunoMolecular Augmentation – Personalized Edited Sequence) is an investigational, personalized peptide therapy for the treatment of cancer, autoimmune, inflammation-driven and neurodegenerative disease that has returned or has not responded to treatment. Precision targeted peptides can create an appropriate immune system response that is a potent therapy for disease.

PBIMA-PES™ is individualized therapy to “reboot” and re-engage the immune system to fight and regulate disease. This is achieved in four simple steps.

Neo7Logix delivers reliable, high quality precision design peptide therapy with innovative PBIMA-PES technology.

For Physician Information only.

The focus of PBIMA-PES™ therapy is not disease-centered, meaning it is not designed to treat a single disease diagnosis. PBIMA-PES™ therapy provides the augmentation to redirect the patient’s own immune system to better manage any disease process.

PBIMA-PES™ Administration

Physician/healthcare practitioner will enroll the patient and direct patient to the Neo7Logix patient portal (https://portal.neo7logix.com) for ordering of PBIMA-PES™ personalized peptide therapy. Neo7Logix will assign a unique patient ID which will be used from sample process to all the way to delivery.

PBIMA-PES™ 4 step process

Step 1

Turnaround time of testing samples is 3-6 weeks.

Sample Requirements: Blood, urine, tissue. Physician/healthcare practitioner will obtain blood, urine, and tumor tissue or existing stored tissue sample from patient. These will then be sent to our selected laboratories; see website’s Physician Portal Login for more information.

Blood Tube Requirements: Two blood tubes will be sufficient. We can accept ambient (stable for ~48 hours) or on ice. Preferably send blood tubes with ice pack overnight. BD 367861 Vacutainer EDTA Tubes 13 x 75 mm, 4.0 mL, Hemogard™, K2EDTA 7.2 mg.

Fresh Tumor Sample for Analysis: Physician/ Institution should purchase RNAlater from Thermo Fisher. RNAlater is a stable media that allows for preservation and transit of tissue maintaining the integrity of both DNA and RNA. Send tumor tissue sample in RNAlater overnight. Please see “Storage” on other side of this brochure for more information.

Paraffin Tumor Tissue Block (FFPE): It should be freshly cut sections of FFPE tissue as 4 sections, thickness 10-20 µm, and surface area of up to 150 mm2 per preparation. FFPE samples are not desirable and will produce a less precise genomics analysis than the RNALater. They should be used for NGS analysis only if fresh biopsy of primary tumor or its metastasis is not possible. Pathology lab may be able to prepare fresh cut sections in advance to send.

Urine sample collection: Obtain a 24-hour continuously refrigerated urine sample from patient. At the end of the 24-hour collection period, shake storage container and then dispense 20 milliliters each into three separate specimen jars with secure lids and freeze. Send sample on dry ice overnight to our selected laboratory.

Step 2

Turnaround time of data processing from test sample is 3-4 days. After receiving test sample data, Neo7Logix will analyze it to develop the PBIMA-PES™ personalized peptide sequences though a patented, sophisticated mapping and selection system. All data is analyzed and ranked according to the immunological status of the patient with regards to the patient’s disease process. A precision design is then engineered from this analysis called PBIMAPES™.

Step 3

Turnaround time for manufacturing a patient’s peptide sequences is 5-7 weeks. Neo7Logix sends information for the proper peptide sequences to our manufacturer. The peptide manufacturing is completed according to US FDA approved cGMP quality and is unique to the patient’s own immune compatibility and programming.

Step 4

Turnaround time for delivery and administration is 1-2 weeks. Peptide sequences will be supplied with sterile PES-SOL™ solution and administered by injection for 21 days and continue for 4 cycles 6-12 weeks apart over a 12-18 month period. Healthcare professional will select the route of administration, typically 0.5 ml subQ and 1.5 ml IM. Healthcare professional will also monitor and follow up on patient’s progress which may require further imaging, blood testing, and collection of other specified markers.

NOTE: Healthcare professionals may decide to integrate additional regenerative modalities including integrative intravenous therapy, cell therapies, supplements, and other effective adjunctive treatments.

PBIMA is currently not an FDA approved and commercially available product; it is under investigational development for safety and efficacy. Neo7Logix has obtained IRB approval for PBIMA use in patients by ANRI/NORI IRB #822019 in Arizona, USA. PBIMA quality is guaranteed by approved cGMP manufacturers. Physicians, practitioners, and institutions are administering PBIMA under informed consent, consistent with their standards of care in clinical practice and at their own risk.

Highly Potent
Precision Approach

Storage

Peptide sequences will be shipped with dry ice in lyophilized form, which is highly stable for 1 year at -20°C.

After reconstitution, keep the vial in the refrigerator (2°C) for each cycle use. For longterm storage, PBIMA-PES™ and PES-SOL™ is best if stored at -80°C with desiccant in sealed containers to minimize content degradation. Under these conditions, peptide material can be stored for several years. This type of storage prevents degradation, oxidation, and the formation of secondary structures.

Directions

Upon receiving the Neo7Logix pack, store it at 20°C.

Prior to opening, one Neo7Logix pair of vials should be brought to room temperature in a desiccator. Failure to warm the vials beforehand can cause condensation to form on the product when the vial is opened (product tends to be hygroscopic). This will reduce the stability of the peptides.

Before reconstitution with PES-SOL™ solution, centrifuge one PBIMA-PES™ peptide vial at 12,000 x g for 20 seconds. This will help pellet the lyophilized material for reconstitution.

Administration:

The Neo7Logix pack will contain PBIMA-PES™ in 4 amber vials of lyophilized powder, and PESSOL™ solution for reconstitution in 4 vials, and a 5 ml glass injector. This injector can be reused
upon sterilization.

Neo7Logix Pack = 4 PBIMA-PES™ vials + 4 PES-SOL™ vials + one 5 ml injector

Each PBIMA-PES™ vial contains 16 mg of peptide sequences and each PES-SOLTM vial contains 42 ml of solution. Prepare material for 1 cycle by reconstituting 1 vial of peptide material and refrigerating it.

Reconstitute 16 mg PBIMA-PES™ with 42 ml PES-SOL™ solution in a sterile space. After reconstitution, shake the vial gently 10 times and then administer 2 ml of PBIMA-PES™ PESSOL™ solution (0.8mg/dose/day) to the patient once daily as 0.5 ml subcutaneous and 1.5 ml intramuscular. Monitor the patient’s disease condition and administer for 21 days each cycle. Continue administration for 4 cycles 6-12 weeks apart over a 12-18 month period.

Guidelines:
1. https://mms.mckesson.com/product/321837/BectonDickinson-367842
2. https://www.bd.com/documents/brochures/specimen-collection/PAS_BC_Vacutainer-Plus-K2EDTAtubes_BR_EN.pdf
3. https://www.thermofisher.com/order/catalog/product/AM7020
4. https://www.zymoresearch.com/collections/dna-rnashield

For questions, please contact Neo7Logix:
539 W. Commerce St., #2886
Dallas, TX 75208

Tel: 469-619-7252
Email: info@neo7logix.com