Allschwil, Switzerland, June 20, 2024
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage
biopharmaceutical company committed to meeting the needs of patients with severe
bacterial and fungal infections, announced today that it has entered into an
asset purchase agreement with the Glioblastoma Foundation Inc., for Basilea's
oncology drug candidate lisavanbulin (BAL101553), which has been developed as a
potential therapy for glioblastoma, the most common type of primary brain
cancer.(1)
Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: "Glioblastoma is
one of the most lethal types of brain cancer and available therapeutic options
are very limited. Partnering lisavanbulin with the Glioblastoma Foundation is
important to us, as it enables patients to continue having access to this
promising anticancer drug candidate, now that Basilea has changed its strategic
focus to anti-infectives."
Dr. Gita Kwatra, Chief Executive Officer of the Glioblastoma Foundation, said:
"We are delighted to partner with Basilea and take over the development of
lisavanbulin for glioblastoma patients. Lisavanbulin has shown excellent
activity against glioblastoma in PDX preclinical models as well as efficacy in
phase 1 and 2 studies. We strongly believe that lisavanbulin will be effective
in a subset of glioblastoma patients and we are looking forward to initiating
clinical trials of lisavanbulin in the US."
Under the terms of the agreement, Basilea sells and transfers all rights to
lisavanbulin to the Glioblastoma Foundation for an undisclosed initial purchase
price. In addition, Basilea will participate in future proceeds from any
potential commercial partnerships at a fixed double-digit percentage. The
Glioblastoma Foundation will continue the post-trial access program for patients
from previous clinical studies to continue to receive lisavanbulin. Also, the
Glioblastoma Foundation will further explore the therapeutic value of
lisavanbulin for the treatment of glioblastoma.
About lisavanbulin (BAL101553)
Lisavanbulin (BAL101553, the prodrug of BAL27862)(2), has been investigated as a
potential therapy for glioblastoma in clinical phase 1 and 2
studies.(3)(, )(4)(, )(5) In preclinical studies, lisavanbulin demonstrated in-
vitro and in-vivo activity against diverse treatment-resistant cancer models,
including tumors refractory to conventional approved therapeutics and
radiotherapy.(6)(, )(7)(, )(8) Lisavanbulin efficiently distributes to the
brain, with anticancer activity in glioblastoma models.(9)(, 1)(0) The active
moiety, BAL27862, binds to the colchicine site of tubulin, with distinct effects
on microtubule organization,(1)(1) resulting in the activation of the "spindle
assembly checkpoint" which promotes tumor cell death.(1)(2) Lisavanbulin has
been granted Orphan Drug Designation by the US Food and Drug Administration
(FDA) for the treatment of malignant glioma (brain cancer), including
glioblastoma.
About Glioblastoma Foundation
The mission of the Glioblastoma Foundation is to transform the standard of care
for glioblastoma. It is based in Durham, North Carolina (USA) and supports the
development of new drugs and other effective therapies for glioblastoma. Because
each glioblastoma is different, it is likely that no one drug will work for
everyone, and any therapies for glioblastoma will need to be targeted. The
Glioblastoma Foundation supports the development of targeted therapies for
glioblastoma. The organization also provides support for patients, and raises
awareness of glioblastoma. For more information, please visit
glioblastomafoundation.org (https://www.glioblastomafoundation.org).
About Basilea
Basilea is a commercial-stage biopharmaceutical company founded in 2000 and
headquartered in Switzerland. We are committed to discovering, developing and
commercializing innovative drugs to meet the needs of patients with severe
bacterial and fungal infections. We have successfully launched two hospital
brands, Cresemba for the treatment of invasive fungal infections and Zevtera for
the treatment of bacterial infections. In addition, we have preclinical and
clinical anti-infective assets in our portfolio. Basilea is listed on the SIX
Swiss Exchange (SIX: BSLN). Please visit basilea.com (https://www.basilea.com).
Disclaimer
This communication expressly or implicitly contains certain forward-looking
statements, such as "believe", "assume", "expect", "forecast", "project", "may",
"could", "might", "will" or similar expressions concerning Basilea Pharmaceutica
Ltd, Allschwil and its business, including with respect to the progress, timing
and completion of research, development and clinical studies for product
candidates. Such statements involve certain known and unknown risks,
uncertainties and other factors, which could cause the actual results, financial
condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil
to be materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements. Basilea Pharmaceutica
Ltd, Allschwil is providing this communication as of this date and does not
undertake to update any forward-looking statements contained herein as a result
of new information, future events or otherwise.
For further information, please contact:
Peer Nils Schröder, PhD
Head of Corporate Communications & Investor Relations
Basilea Pharmaceutica International Ltd, Allschwil
Hegenheimermattweg 167b
4123 Allschwil
Switzerland

 Phone  +41 61 606 1102
        media_relations@basilea.com (mailto:media_relations@basilea.com)

E-mail investor_relations@basilea.com (mailto:investor_relations@basilea.com)
This press release can be downloaded from www.basilea.com
(https://www.basilea.com/).
References

  1. B. M. Alexander, T. F. Cloughesy. Adult Glioblastoma. Journal of Clinical
     Oncology 2017 (35), 2402-2409
  2. J. Pohlmann, F. Bachmann, A. Schmitt-Hoffmann et al. BAL101553: An
     optimized prodrug of the microtubule destabilizer BAL27862 with superior
     antitumor activity. Cancer Research 2011, 71 (8 supplement), abstract 1347
  3. ClinicalTrials.gov identifier: NCT03250299
  4. ClinicalTrials.gov identifier: NCT02895360; M. Joerger, T. Hundsberger, S.
     Haefliger et al. Safety and anti-tumor activity of lisavanbulin
     administered as 48-hour infusion in patients with ovarian cancer or
     recurrent glioblastoma: a phase 2a study. Investigational New Drugs 2023
     (41), 267-275
  5. ClinicalTrials.gov identifier: NCT02490800; J. S. Lopez, S. Häfliger,
     R. Plummer et al. Evaluation of response-predictive biomarkers for
     lisavanbulin: A phase II study in patients with recurrent glioblastoma.
     ESMO Open 2023, Vol 8, 1, Suppl 2, 100941.
  6. A. Sharma, A. Broggini-Tenzer, V. Vuong et al. The novel microtubule
     targeting agent BAL101553 in combination with radiotherapy in treatment-
     refractory tumor models. Radiotherapy Oncology 2017 (124), 433-438
  7. G. E. Duran, H. Lane, F. Bachmann et al. In vitro activity of the novel
     tubulin active agent BAL27862 in MDR1(+) and MDR1(-) human breast and

ovarian cancer variants selected for resistance to taxanes. Cancer Research 2010, 70 (8 supplement), abstract 4412
8. F. Bachmann, K. Burger, G. E. Duran et al. BAL101553 (prodrug of BAL27862):

     A unique microtubule destabilizer active against drug refractory breast
     cancers alone and in combination with trastuzumab. Cancer Research
     2014, 74 (19 supplement), abstract 831
  9. A. Schmitt-Hoffmann, D. Klauer, K. Gebhardt et al. BAL27862: a unique
     microtubule-targeted agent with a potential for the treatment of human
     brain tumors. Molecular Cancer Therapeutics 2009, 8 (12 supplement), C233

10. A. C. Mladek, J. L. Pokorny, H. Lane et al. The novel tubulin-binding
'tumor checkpoint controller' BAL101553 has anti-cancer activity alone and
in combination treatments across a panel of GBM patient-derived xenografts. Cancer Research 2016, 76 (14 supplement), abstract 4781
11. A. E. Prota, F. Danel, F. Bachmann et al. The novel microtubule-

     destabilizing drug BAL27862 binds to the colchicine site of tubulin with
     distinct effects on microtubule organization. Journal of Molecular Biology
     2014 (426), 1848-1860

12. F. Bachmann, K. Burger, H. Lane. BAL101553 (prodrug of BAL27862): the

     spindle assembly checkpoint is required for anticancer activity. Cancer
     Research 2015, 75 (15 supplement), abstract 3789

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