Press Release: Basilea partners oncology drug candidate lisavanbulin with Glioblastoma Foundation

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.globenewswire.com/Tracker?data=AAJrfG0KuWhPnGqZxEGIRdPECPVN33ikJ2z3sLj8EGhEoyMt0Kxnyr_zx7Ry2ynokOH09g-QdDEKzJDTkkjQqnldCe7BoFnkNDKPLZUb5gNybLjjTrJ0anfAEWa3zcBU.

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.globenewswire.com/Tracker?data=mKoX-uM63CdrjyjGoDwx70K_yAGlCQa4lA3uZeHRAvEaVauLWdj1kxQfbadSWPM1MVxUhQ9wxWo-HgadAtdRfQ==.

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

E-mail media_relations@basilea.com

investor_relations@basilea.com

This press release can be downloaded from 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

Press release (PDF) https://www.globenewswire.com/Tracker?data=99g6I4lno1FE2VhGK5cPwlh5UqaLHnVTeJbATZg0VRJjHaIxema4CvziNd8DA-1mIyMOn6-Ri6xy-ER4f6AmejwUZkRPqgXFR8F702k09UaAwnAE9H08rf9l4-2ZOSUaV8PlUU3r4a5MVKD5f7oLfrdt4CQb5MFATTA9eB1748kWt9XtCCCik039VAOF_iK6

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June 20, 2024 01:15 ET (05:15 GMT)