The present Glioblastoma multiforme (GBM) market has several unmet needs. Poor prognosis, 10-15 months median survival rate, no curative treatment to the patients, limited treatment options, drug resistance, incapability of therapies to cross BBB (blood-brain-barrier), intratumor heterogeneity, and a high mortality rate are among them.
The cardinal approach is always surgery followed by radiation therapy with chemotherapy BiCNU (carmustine), Avastin (bevacizumab), and Temodar (temozolomide) as an adjunct. Further, no standard of care is available in the market for recurrent GBM market.
However, over the turn of the decade, with advances in medical science, efforts into clinical and basic research, the GBM market has witnessed several therapies showing promising results in the clinical trials. The Glioblastoma multiforme market constitutes a robust and diverse pipeline backing up its growth in the coming years. Advanced medical technology has further helped in receiving a clearer picture of the disease as well as in making a prompt diagnosis.
Several companies are clinically testing the efficacy and safety of a wide range of therapeutic products differing in the mechanism of actions and routes of administration. DelveInsight’s Glioblastoma multiforme market forecast analysis demonstrates notable companies, including Bristol Myers Squibb, VBL Therapeutics, DelMar Pharmaceuticals, VBI Vaccines, Diffusion Pharmaceuticals, Ziopharma, Apogenix, DNAtrix, Immunomic Therapeutics, Kazia Therapeutics, Medicenna Therapeutics, among others, are investing their funds, time, and efforts in accelerating the Glioblastoma multiforme market.
Emerging Pipeline Therapies to watch out for in the GBM Market
The companies are weaving in a wide range of novel therapeutic agents as well as agents for adjunct therapies to supplement the existing therapies, in the GBM pipeline to facilitate better patient outcomes. One such approach under scrutiny is Gene therapy. Realizing the lack of potential of surgery and chemos in recurrent Glioblastoma multiforme, VBL Therapeutics, led the clinical trials exploiting its gene therapy VB-111 (Ofranergene obadenovec) against Glioblastoma multiforme. Despite falls and frustrations that came in the way of evaluation of its gene therapy, which feasts on the blood vessels that cancerous cells flourish on, in GLOBE trial (NCT02511405), the company is running a randomized, controlled, clinical trial with rGBM undergoing a second surgery (NCT04406272).
To harness the might of immune response, Ziopharma designed its therapy Veledimex to regulate the immune system to attack cancerous cells. The company is running a Phase II trial of its drug Veledimex to switch on and off Ad-RTS-hIL-12 (Controlled IL-12) as a monotherapy in two studies and in combination with a PD-1 inhibitor (Libtayo) in a third one (NCT04006119). So far, the company seems to be very optimistic about its drug Veledimex, which can cross the BBB. The company is also investigating Controlled IL-12 in combination with Opdivo in the Phase I trial.
Another class of treatment option proliferating as an antineoplastic regimen in the Glioblastoma market landscape is Therapeutic Vaccines. It is not news that GBMs are notorious for their immunosuppression. However, Vaccines offer a personalized therapeutic approach unique to individual GBM patients’ to achieve immune response stimulated against tumors. In the present GBM market, several vaccines or immunotherapy candidates are undergoing rigorous testing to assess their safety and efficacy in GBMs. VBI Vaccines recently dosed the first patient in the second study arm in the ongoing Phase 2a clinical study of VBI-1901 in combination with either GlaxoSmithKline’s GM-CSF or AS01B as immunomodulatory adjuvants (NCT03382977). In the race is also Aivita Biomedical with its immunotherapeutic vaccine AV-GBM-1, which has managed to improve overall survival rate at 15 months by 76% as compared to 48% in the control arm in an ongoing Phase 2 clinical trial in patients with newly diagnosed glioblastoma (NCT03400917). TVAX Biomedical is another contender in the Glioblastoma multiforme market that has received the US FDA Fast Track Designation for the use of its vaccine-enhanced adoptive T cell therapy (VACT), TVI-Brain-1 for treatment of glioblastoma multiforme, based on the impressive results of Phase 1 and Phase 2 studies. Immunomic Therapeutics (ITI-1000) and DNAtrix (DNX-2401) are also proactively running clinical trials evaluating their immunotherapies in the Glioblastoma multiforme space.
Besides gene therapies and immunotherapies, the Glioblastoma multiforme market space is also experiencing several other therapeutic agents such as multi-kinase inhibitors PD-1/PD-L1 inhibitor, monoclonal antibodies, a selective antagonist of dopamine receptor D2 (DRD2), and ClpP agonists undergoing trials. For instance, DelMar Pharmaceuticals is developing VAL-083, and announced positive interim data from its two Phase 2 trials showcasing improved outcomes over the current standard of care as both a first-line treatment and for recurrent GBM (NCT02717962).
A novel proteasome inhibitor, marizomib, is under Phase III clinical supervision by Celgene combined with standard temozolomide-based radiochemotherapy vs. standard temozolomide-based radiochemotherapy alone in patients with newly diagnosed Glioblastoma (NCT03345095). Celgene’s pipeline therapies won the weightage hereafter BMS acquired it in a blockbuster deal, which was no less than horse-trading. This implies the amount of faith BMS has put into Celgene and its pipeline therapies.
In the Phase III trial, there is Diffusion Pharmaceuticals with its contender Trans Sodium Crocetinate for primary Glioblastoma multiforme, with the ability to increase survival in inoperable glioblastoma multiforme (GBM) patients in open-label, dose-escalation study (NCT03393000). Intending to bring in a vetted PI3K inhibitor class of drugs, Kazia Therapeutics introduced its paxalisib in the GBM market space, which has recently bagged the USFDA fast track designation. Just like Kazia, Denovo Biopharma is also among those to have received Fast Track designation for DB102 (enzastaurin) for newly-diagnosed glioblastoma. On the other hand, WPD Pharmaceuticals has struck gold as it received hefty funds from the Polish National Center for Research and Development (NCRD) to develop WPD101, a recombinant fusion protein helping in the treatment of GBM.
Even so, there are several candidates in the Glioblastoma multiforme pipeline, and the early results look promising enough; however, it is not wise to celebrate early. It is yet to see which candidate reaches the finish line keeping in mind the disappointing results of the Rindopepimut, a therapeutic vaccine of Celldex Therapeutics, in Phase III trials (NCT01480479), in EGFRvIII-positive recurrent glioblastoma multiforme. Similarly, AbbVie’s decision to halt the Phase 3 INTELLANCE-1 evaluating its novel antibody-drug conjugate (ADC) depatuxizumab mafodotin (Depatux-M) for the treatment of newly diagnosed glioblastoma (GBM) owing to lack of survival benefit. Not to forget the hard-crash of BMS’s Opdivo had in patients with MGMT methylation GBM.
On a brighter side, the results so far of the GBM pipeline therapies look promising and shall sure-shot expedite the present Glioblastoma multiforme market size. Increasing incidence and interest of pharma companies, as well as a particular focus in addressing the needs prevalent in the rare diseases, shall further provide a much-needed momentum to treat such immune-cold tumors.