Biotech Companies with Recent and Near-Term Potential Catalysts

Northwest Biotherapeutics, Inc. (OTCQB: NWBO), a biotechnology company focused on developing DCVax®, personalized immune therapies for solid tumor cancers discussed their pipeline progress at the annual ASCO Conference last month.

Highlights included the following:

DCVax-Direct

Follow-up data reveal that in the Phase I trial, 76% of the evaluable patients in the Phase I trial exceeded their expected survival time by an average of about 14 months.

DCVax-Direct produces very large quantities of cytokines, and this correlates with patient survival.  The cytokines cause rapid influx of T cells into the tumors, massive tumor cell death and mobilization of systemic anti-tumor T cell responses. 

Importantly, there has been no cytokine release syndrome or similar toxicity with DCVax-Direct, unlike with certain other types of cell therapies.

The Company has been preparing for multiple new DCVax-Direct clinical trials, building on the encouraging results of the Phase I trial.  The first 2 of these trials will address severe unmet medical needs:  brain metastases of lung and breast cancer, and DIPG (cancer involving the brain stem) in children.

These 2 trials are anticipated to start in the coming months at leading cancer centers.  For example, the brain metastases trial has been designed together with the Mayo Clinic and will be conducted there.  The brain metastases trial has already been cleared by FDA, and the DIPG trial is in the process of FDA review and clearance.

DCVax-L Phase III Trial for Glioblastoma

The Company is progressing through each of the stages of work needed to reach unblinding of the Phase III trial for Glioblastoma, in accordance with the roadmap provided by the Company in its November 19, 2018 announcement following the Society for Neuro-Oncology meeting.

After 5 months of work with independent statisticians, the draft Statistical Analysis Plan (SAP) is nearly complete at this point.  (The SAP contains all of the planned analyses for the data that will emerge from the Phase III trial.)  This has been the most labor-intensive stage for the Company on the road to unblinding of the Phase III trial data.  

To save time to the finish line, the independent CRO that manages the Phase III trial has been checking and validating all of the trial data, in parallel with the Company’s work on the SAP.  This involves checking all of the data points in hundreds of pages of case report forms for each of the 331 patients.  The process has generated thousands of “queries” relating to any missing data or data questions, as is typical in a large trial.  This task is also nearly complete, too, with only a few hundred queries remaining to be resolved.

As soon as the SAP is finished (including review by advisers), it will be submitted to the regulatory agencies for each of the 4 countries where the trial was conducted, for their comment and buy-in.  As soon as the SAP process is completed with the 4 regulatory agencies, and the simultaneous data checking is finished, the trial will be unblinded and the data analysis stage will take place and result in top line data.

Follow-up survival data from the Information Arm patients who did not qualify for the Phase III trial are encouraging and appear consistent with the blinded interim data from the trial.  In the group of 25 Information Arm patients who had actual or apparent early tumor recurrence, the follow-up data showed that 40% of the patients lived for 3 years or more, 20% of the patients lived for 5 years or more, and 12% of the patients are still alive at 7 years.

This Information Arm survival data is especially encouraging since this group included patients who already had actual tumor recurrence as well as others who had the appearance of tumor recurrence but who could not be definitely determined.

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Kraig Biocraft Laboratories, Inc. (OTCQB: KBLB) works in cooperation with leading universities in the fields of genetics and genetic engineering to develop new recombinant fibers and materials, particularly spider silk-based fibers.

In late May, the company announced the creation of the next generation of recombinant spider silk using the Company’s new design, gene editing, and incorporation approaches. This is the material science breakthrough that the Company has been pushing for since establishing the Dragon Silk line; this new transgenic was specifically engineered for high strength and significantly higher protein expression levels.

These developments open the door for the Company to deploy this new methodology towards a variety of tailored spider silk designs. Kraig Labs expects these new recombinant spider silk fiber lines will open up broader commercial opportunities and complement the Company’s existing Monster Silk™ and Dragon Silk™ technologies.

This month the company sent a senior member of its leadership team to Vietnam to oversee operations at the Company’s subsidiary Prodigy Textiles Ltd., construction at the Company’s new facility, and to coordinate the transfer of silkworms from the temporary facility into their permanent home.

The company has been awarded an increased investment license for expansion of its recombinant spider silk production at Prodigy Textiles.

Under the new license, the Vietnamese government increased the Company’s potential investment cap, to as high as $50 million USD. This significantly increased investment limit will now allow the Company to prepare for the second phase expansion, planned for a 123-acre site located near Prodigy Textiles’ existing facility, and is part of the Company’s systematic and structured plan to expand capacity.

During this trip, a senior official from Kraig Labs plans to interview and select candidates for several key positions, including operational and financial leadership roles within Prodigy Textiles. Management has also set aside time to meet with its Vietnamese bankers to outline and discuss a collaborative agreement as Prodigy Textiles prepares to grow rapidly.

Anavex Life Sciences Corp. (NASDAQ: AVXL) is a clinical stage biopharmaceutical company, engaged in the development of drug candidates for the treatment of central nervous system diseases

The company’s lead drug candidate is ANAVEX 2-73, which has completed Phase 2a clinical trial for Alzheimer’s disease; and preclinical clinical trials to treat Parkinson’s disease, Rett syndrome, epilepsy, infantile spasms, Fragile X syndrome, Angelman syndrome, multiple sclerosis, and tuberous sclerosis. It is also developing ANAVEX 3-71 to treat Alzheimer’s disease; ANAVEX 1-41, a sigma-1 agonist; ANAVEX 1066, a mixed sigma-1/sigma-2 ligand for the potential treatment of neuropathic and visceral pain; and ANAVEX 1037 to treat prostate and pancreatic cancer.

June was a busy month for Anavex. The first patient, who completed the Phase 2 clinical trial ANAVEX®2-73-RS-001 voluntarily moved into the extension study and was dosed in the extension study for the treatment of Rett syndrome.

The open label, 12-week extension study is designed to evaluate long term safety, tolerability, and the effect of ANAVEX®2-73 on Rett syndrome patients following the completion of the Phase 2 study.

Patients who are eligible to be enrolled in the extension study are those who have completed 7 weeks of treatment in the ANAVEX®2-73-RS-001 trial in the U.S.

All eligible patients will be treated with oral liquid ANAVEX®2-73 formulation given once daily for additional 12 weeks. The extension study might be further extended.

ANAVEX®2-73 has already received orphan drug designation from the FDA for the treatment of Rett syndrome.

Amarin Corporation plc (NASDAQ: AMRN) is a pharmaceutical company, working on therapeutics for the treatment of cardiovascular diseases.

The company’s lead product is Vascepa, a prescription-only omega-3 fatty acid capsule, used as an adjunct to diet for reducing triglyceride levels in adult patients with severe hypertriglyceridemia. It is also involved in developing Vascepa for the treatment of patients with high triglyceride levels who are also on statin therapy for elevated low-density lipoprotein cholesterol levels.

The company said in a recent business update it was raising its 2019 revenue guidance to a range of between $380 million and $420 million, up from $350 million previously.

AMRN recently advised the FDA will grant priority review for Amarin’s heart drug derived from fish oil, Vascepa, which is already being used to treat patients with very high triglycerides, a certain type of fat in the blood that can often be a sign of other conditions that increase the risk of heart disease.

The FDA plans to review Vascepa within six months instead of the usual 10, with a decision on approval expected sometime in late September.

Vascepa is already approved in the United States as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia

Recent data from the late-stage cardiovascular outcomes study – REDUCE-IT. In March, Amarin presented updated data from the study, which showed that the drug led to a significant reduction in cardiovascular risk in patients with LDL-C controlled by statin therapy. The relative risk of major adverse CV events (“MACE”) was reduced by 30% upon treatment with Vascepa compared to placebo.

Vascepa also led to a 26% reduction in key secondary composite endpoint of cardiovascular death, heart attacks and stroke. The study also achieved the additional secondary endpoints including reductions in cardiovascular death (20%), fatal or nonfatal heart attacks (31%), fatal or nonfatal stroke (28%), urgent or emergent coronary revascularization (35%) and hospitalization for unstable angina (32%).

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