A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT

Inclusion Criteria:

- Histologically or cytologically confirmed non-muscle invasive bladder cancer [Ta, T1
or Tis (CIS)] that has been removed by transurethral resection

- Either: (i) high-risk disease, defined as T1 and/or high-grade and/or CIS or (ii)
intermediate-risk disease, defined as Ta low-grade with at least 3 of the following 4
risk factors: multiple tumors, tumor size > 3cm, early recurrence (<1 year from
previous staging procedure), or recurrence with a frequency of more than once in any
12 month period

- Not have received bacillus Calmette-Guérin (BCG) or have completed previous BCG
treatment > 12 months prior to the baseline staging procedure.

- Phase 2 Arms 1-3: Suitable to receive a 6-week course of BCG in the adjuvant setting
within 6 weeks following TURBT. Phase 2 Arm 4: Suitable for monotherapy vaccine
administration post-TURBT. For Phase 1 only: Has previously received 3-6 weekly doses
of BCG.

- Adequate laboratory parameters

Exclusion Criteria:

- Human immunodeficiency virus (HIV) infection or immunodeficiency disorders, either
primary or acquired

- Infections or intercurrent illness requiring active therapy

- Any condition requiring active steroid or other immunosuppressive therapy

- Active malignancies within the past 12 months except negligible risk of metastasis or
death treated with expected curative outcome.

- Prostate pelvic radiation within the past 12 months

- Significant cardiac impairment

- Current alcohol or chemical abuse, or mental or psychiatric condition precluding
protocol compliance

- Pregnant or nursing

- Allergy to soy, egg, or peanut products

- Receiving another investigational agent (30 day wash-out required prior to first dose)

- Neo-adjuvant therapy prior to baseline staging procedures for the current occurrence
of non-muscle invasive bladder cancer

- Prior treatment with a cancer vaccine for this indication

- Prior vaccination with BCG for tuberculosis disease

- Prior splenectomy