Nascent Biotech to begin Phase 1 Human Trials for Brain Cancer Drug

Glioblastoma is a type of brain cancer, It’s the most common type of malignant brain tumor among adults, and it is usually very aggressive, which means it can grow fast and spread quickly.

Glioblastoma multiforme is the most aggressive variant of malignant brain cancer.

It has a poor prognosis with low rate of survival, a median of one year.

The primary brain tumor happens due to uncontrolled cell division and developments in the brain.

The tumors can be found in the glial cells or the neuron. The one which develops in the glial cells (astrocytes and oligodendrocytes) is called glioma, the commonest forms of brain tumor.

Moreover, the fact that glioma stem cells resist conventional treatments also raises urgent need for alternative treatment therapies for glioblastoma multiforme thus driving the market.

Increasing R&D in gene therapy and molecular biotechnology for the treatment of CNS associated disorders. Although there is no cure, there are treatments to help ease symptoms.

Active biotech companies with recent developments include: Nascent Biotech, Inc., Mersana Therapeutics, Inc.Agenus Inc.GlaxoSmithKline plcPfizer Inc.

Presently, the goal of glioblastoma treatment is to slow and control tumor growth and help you live as comfortably and as well as possible.

In many cases, surgery is recommended in combination with one or more other treatment techniques.

The best possible treatment for you will depend on many factors that are unique to you, which is why it is important that you receive a treatment plan that’s tailored to your individual needs. Researchers are continually working to improve the glioblastoma survival rate.

Patients have a wider range of treatment options than ever before, and new therapies are being introduced on a regular basis.

Additionally, clinical studies are providing better insight into how different cancers and cell types respond to treatment, allowing oncologists to recommend more effective therapies for each patient.

For instance, researchers have identified a specific protein that makes glioblastomas less responsive to a commonly prescribed chemotherapy drug; oncologists can test patients for this protein to determine if a different medication might be more effective before treatment even begins.

Nascent Biotech (the “Company” or “Nascent”) pleased to announce that the Company will soon  begin Phase 1 clinical trials for a treatment of Brain Cancer, including, glioblastoma (GBM), the deadliest form of brain cancer.

The study will employ Nascent’s monoclonal, antibody, Pritumumab (“PTB”) and will be conducted in collaboration with a Southern CA Cancer Center as noted in their release.

Nascent’s lead therapeutic asset, PTB, is a natural human antibody that works by binding to ectodomain vimentin (EDV), a protein expressed on the surface of epithelial cancers.

The PTB antibody is used as a targeted immunotherapy, which unlike chemotherapy, targets only the cancer cells without damaging healthy cells.

Because EDV is found in a variety of cancers, these important clinical trials of PTB could have implications for a broad range of more common cancers, such as breast, colon and lung.

The current Phase 1 trials have been uniquely designed to ultimately treat a variety of brain cancers from gliomas and other primary brain tumors to brain metastases and leptomeningeal cancers arising from breast, lung and other solid tumors.

Other industry developments from around the markets include:

Mersana Therapeutics, Inc. recently reported interim safety, tolerability and efficacy data from the ongoing expansion portion of the Phase 1 study evaluating XMT-1536, its first-in-class ADC candidate targeting NaPi2b, in patients with ovarian cancer and non-small cell lung (NSCLC) adenocarcinoma.

The Company will host a conference call and webcast today, Wednesday, May 27, 2020, at 8:00 a.m. ET during which investigator Debra L. Richardson, MD, Associate Professor of Gynecologic Oncology at the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center and the Sarah Cannon Research Institute and members of the Mersana executive team will present and discuss these data.

These data will also be presented in a poster session at the American Society of Clinical Oncology 2020 Virtual Scientific Program on Friday, May 29, 2020 starting at 8:00 a.m. ET.

Anna Protopapas, President and CEO of Mersana Therapeutics

“These data demonstrate not only that XMT-1536, our first-in-class Dolaflexin ADC targeting NaPi2b, can deliver confirmed complete responses, partial responses and durable stable disease in platinum-resistant ovarian cancer, but also that these responses can deepen over time in a patient population with poor prognosis and limited treatment options.

XMT-1536 continues to demonstrate that it is generally well tolerated, without the dose-limiting toxicities of other ADC platforms such as severe neutropenia, neuropathy and ocular toxicity.

These are encouraging signals as we look forward to reporting more mature data in the second half of the year and continuing to advance XMT-1536 for both platinum-resistant ovarian cancer and NSCLC adenocarcinoma patients,” said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics.

Agenus Inc. an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers and infections, announced that it will present data on AGEN1181 at the American Society of Clinical Oncology (ASCO) upcoming ASCO2020 Virtual Scientific Program to be held May 29-31, 2020.

AGEN1181 is a multifunctional Fc-engineered next generation anti-CTLA-4 antibody which has been designed to improve upon the safety and efficacy shown with first-generation CTLA-4 antibodies.

The virtual presentation will be made by Dr. Steven J. O’Day, the Executive Director of the John Wayne Cancer Institute and Cancer Clinic, and Director of Providence Los Angeles Regional Research.

Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body’s immune system to fight cancer and infections.

The Company’s vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its AgenTus Therapeutics subsidiary), and proprietary cancer vaccine platforms.

The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA.

GlaxoSmithKline plc and Samsung Biologics have entered into a partnership to provide GSK with additional capacity to manufacture and supply GSK’s innovative biopharmaceutical therapies.

Under the terms of the agreement, Samsung Biologics will provide GSK with additional capacity for large-scale biopharmaceutical product manufacturing.

This capacity will be flexible depending on GSK’s future needs and will supplement GSK’s existing manufacturing network.

Regis Simard, President, Pharmaceuticals Supply Chain, GSK

Regis Simard, President, Pharmaceuticals Supply Chain, GSK, said, “Today’s agreement with Samsung Biologics complements and reinforces our existing world-class pharmaceutical manufacturing capability and will help ensure we can continue to deliver the transformative medicines that patients need.”


Dr. Tae Han Kim, CEO of Samsung Biologics

“We are very proud and excited to announce this long-term agreement with GSK.

Samsung Biologics entered the biopharma industry with the goal to help our clients bring valuable biological medicines to patients faster.

We are thrilled to partner with GSK, a company who shares the vision,” said Dr. Tae Han Kim, CEO of Samsung Biologics.

Pfizer Inc. recently announced updated Phase 1b clinical data on PF-06939926, an investigational gene therapy being developed to treat Duchenne muscular dystrophy (DMD).

The preliminary data from 9 ambulatory boys with DMD, aged 6 to 12 (mean age: 8 years) indicate that the intravenous administration of PF-06939926 was well-tolerated during the infusion period, with encouraging efficacy and manageable safety events, even when considering those adverse events that were more severe in nature.

The treatment provided durable and statistically significant improvements across multiple efficacy-related endpoints measured at 12 months post-infusion, including sustained levels of mini-dystrophin expression and improvements on the North Star Ambulatory Assessment (NSAA) rating scale, which is a validated measure of muscle function.

Three serious adverse events (SAEs) were recorded, two of which reflected likely complement activation.

While these two SAEs were severe in nature, all three events fully resolved within 2 weeks, providing encouragement that close monitoring and early intervention can help mitigate the effects of complement activation.

This new dataset, which includes updated 12-month results on safety, dystrophin expression, and exploratory functional endpoints for 3 additional boys, was presented for the first time during a virtual oral session today at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting.

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