discovery and dev of antiviral antibodies

Question 1

key elements of a development plan

Answer 1

-right target
-right tissue
-right safety
-right patient
-right commercial

Question 2

Key elements of a target product profile (TPP)

Answer 2

-efficacy
-safety
-dosing/formulation

Question 3

step 1 in pre clinical

Answer 3

identify an opportunity

Question 4

step 2 in pre clinical:

Answer 4

identify a solution

Question 5

step 2 in pre clinical: identify a solution

Answer 5

1. Identify the target
2. Understand the mechanism of action/impact on host
3. Antibody must meet key components of the TPP
   * Potency
   * Mechanism
   * Ability to manufacture

Question 6

MoA-based Discovery

Answer 6

Incorporate ACE2-blocking
into the pipeline:
* Donor selection
* B cell sorting
* mAb screening

Question 7

Aims of Nonclinical Safety Studies

Answer 7

• Predict likelihood of toxicity in humans
• Identify target organs for toxicity
• Investigate reversibility of any toxic effects
• Recommend an appropriate starting dose for Phase I studies
• Identify safety parameters for clinical monitoring
• Provide information on mechanism of action
• Investigate fate of the molecule

Question 8

what is the purpose of transition to the clinical phase

Answer 8

Purpose: Communicate to health authorities the pre-clinical data supporting first in human studies

Question 9

what are the key sections of the clinical phase

Answer 9

• Animal Pharmacology
• Toxicology
• Manufacturing information (composition, stability, controls)
• Clinical protocols

Question 10

clinical protocols are focused on what

Answer 10

This is primarily focused on the initial-phase trials, although it is an opportunity to gain feedback on plans for the
complete clinical development plan

Question 11

Traditional antibody manufacturing requires
massive (…..) tanks to produce
sufficient drug substance.

Answer 11

10K liter

Question 12

Cells produce the antibody, which is harvested, …

Answer 12

filteres, purified and frozen

Question 13

Operations (the manufacturing group) is also responsible for:

Answer 13

• Testing stability and determining shelf-life of both frozen and non-frozen drug
  substance
• Producing drug product (the final packaged form)
• Delivery and supply to global markets

Question 14

what are the clinical phase

Answer 14

-1: is it safe
-2: does it work
-3: does it work better than the normal drugs
-4: how is it going

Question 15

Regulators play an essential role in ensuring that…

Answer 15

a non-biased party reviews the benefit/risk of any product

Question 16

Communication with health authorities begins even before…

Answer 16

the IND (pre-IND meeting)

Question 17

what are the key meetings/touch points of the pre ind meeting

Answer 17

• Pre-IND
• Post Phase 1
• Post Phase 2
• Pre-BLA (US)/Pre-MAA (EU/RoW

Question 18

Commercial and Medical teams input into the TPP from the start of the program, and work in parallel with the R&D
organization to:

Answer 18

• Educate on un-met medical need
• Curate external experts who provide guidance on target
  patient populations, lead ad-boards, etc.
• Work with scientific societies to ensure
  recommendations
• Access – build the reimbursement/supply/operational systems to bring the medicine to patients

Question 19

life cycle management

Answer 19

• New indications (treatment, prevention, post exposure)
• New formulations (pre-filled syringe, nebulizer, oral)