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(Press release, Prolynx, MAR 27, 2014, View Source [SID:1234504740])

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Betalutin™ successful completion of phase I part of phase I/II study

On March 27, 2014 Nordic Nanovector reported that its lead product candidate Betalutin has achieved the two major objectives from the Phase I portion of the ongoing Phase I/II clinical trial (NCT01796171) (Press release Nordic Nanovector, MAR 27, 2014, View Source [SID:1234500623]). The ongoing trial has demonstrated that Betalutin is safe and well tolerated in patients suffering from Non-Hodgkin Lymphoma and that the product has a clinically relevant effect in this patient population.

"We are pleased that the ongoing trial already has demonstrated that Betalutin is safe and well tolerated in patients suffering from Non-Hodgkin Lymphoma" stated Jan A. Alfheim, CEO of Nordic Nanovector.

"We are furthermore excited to note that the product candidate has shown a clinically relevant antitumor effect at all dose levels administered to date."

The positive results from Phase I has enabled the company to establish the dose interval for the Phase II part of the clinical trial, which will assess the efficacy of Betalutin in patients suffering from relapsed Non-Hodgkin Lymphoma.

Final Data Confirms Successful PAT-SM6 Clinical Trial

On 27 March, 2014 Patrys reported the final results from its Phase I/IIa, open-label study in patients with refractory or relapsed multiple myeloma (MM) (Press release Patrys, MAR 27, 2014, View Source [SID:1234500542]).
This trial was conducted in 12 patients (10 male and 2 female, median age 71 years) with refractory or relapsed MM. On average each patient had received five prior lines of therapy, including proteasome inhibitors, immunomodulatory (IMID) drugs or stem cell transplantation.
Twelve patients (3 in each cohort) received 4 intravenous infusions of PAT-SM6 at 0.3mg/kg, 1mg/kg, 3mg/kg or 6mg/kg per dose. All patients were then assessed for a response at 36 days post final treatment.
The primary endpoint of the study was safety and tolerability. At all dose levels tested, PAT-SM6 was well tolerated with no serious adverse events (SAEs) or dose limiting toxicities being reported. A maximal tolerated dose (MTD) was not reached.
Secondary endpoints were designed to measure efficacy as determined by a series of well-established laboratory assays. Overall, 4/12 patients (33%) treated with PAT-SM6 showed evidence of stable disease (SD) according to the International Myeloma Working Group (IMWG) criteria. One patient who received 3mg/kg of PAT-SM6 was stable for 138 days before additional therapy was needed whilst another patient, who received 6mg/kg of PAT-SM6, has been stable for 154 days and is currently therapy free.
These data compare favorably with another antibody (Elotuzumab) currently in Phase 3 combination trials for MM. When tested in a Phase I trial, 26.5% (9/35) patients treated with increasing doses of Elotuzumab (0.5– 20mg/kg) responded with SD. Like PAT-SM6, this antibody was used as a single agent. The information on the clinical efficacy of Elotuzumab is publicly available.
Importantly, patients treated with PAT-SM6 had a mean time to next therapy of 51 days which is considered clinically significant.
Patients who had received prior treatment with proteasome inhibitors responded much better to PAT-SM6 treatment than patients who had been previously treated with IMIDs or other chemotherapeutics. This observation is very exciting as it indicates that PAT-SM6 may act synergistically with proteasome inhibitors (such as Carfilzomib) to induce better clinical responses. Such a hypothesis will be tested in Patrys’ next clinical trial in which PAT-SM6 will be used in combination with Amgen’s Carfilzomib.
11/ 12 patients went on to receive additional salvage therapy after completing the PAT-SM6 clinical trial. Remarkably, 7/ 11 patients responded very positively with a partial response (PR) while 3 others responded with SD indicating that PAT-SM6 treatment may make cancer cells more sensitive to killing by other chemotherapeutics.
Analysis of blood samples collected during the trial confirmed that no patient generated a significant adverse immune response to PAT-SM6 (immunogenicity). This is an important finding as adverse immune reactions to existing marketed antibodies is known to limit the effectiveness of these treatments.
Pharmacokinetic analysis demonstrated linear dose proportional increases in maximum serum concentration (Cmax) of PAT-SM6. Systemic exposure to the drug, demonstrated by area under the curve (AUCt) was in line with Cmax and showed similar linear behavior. Patients displayed apparent linear pharmacokinetics with a rapid distribution phase followed by a slower disposition phase and a half-life of about 7 hours. The parameters of half-life, volume of distribution and clearance were consistent across the dose levels and between cycles, indicating that higher doses do not affect the general pharmacokinetic properties of PAT-SM6.
Post treatment with PAT-SM6, malignant cells were isolated from the patient’s blood or bone marrow and analysed for the presence of the infused antibody. It was shown conclusively that PAT-SM6 specifically targeted and bound to the myeloma cells. Furthermore analysis of patient’s immune systems indicated that PAT-SM6 is capable of inducing an immune response by both stimulating and increasing the absolute number of CD8+, NK and regulatory T-cells. These cells are specifically capable of regulating the growth and dissemination of tumours. Such changes were more significant in patients who had experienced stable disease post treatment with PAT-SM6. These data may indicate specific crosstalk between PAT-SM6 and immune cells, a previously unreported finding that warrants further investigation.

Cancer Research UK drug launched in its first clinical trial

On March 27, 2014 Cancer Research UK reported that a new cancer drug, based on further development of a discovery originally made by Cancer Research UK, has entered a clinical trial to target a wide range of cancers (Press release, Cancer Research Technology, MAR 27, 2014, View Source [SID1234523228]).

Cancer Research Technology, the commercial arm of Cancer Research UK, licensed the monoclonal antibody called PR1A3 to Roche. PR1A3 was discovered in Sir Walter Bodmer’s laboratory when he was director of the Imperial Cancer Research Fund*. Roche has subsequently engineered the antibody and incorporated it into its proprietary immunocytokine drug platform to generate the final drug candidate. Clinical trials have then been initiated.

Sir Walter Bodmer, head of the Cancer and Immunogenetics Laboratory at the University of Oxford, said: "It’s very exciting to see that a drug based on our monoclonal PR1A3 antibody is now going into the clinic. By combining these discoveries we make in the lab with the latest developments in immunotherapy, we’re expanding our arsenal of cancer drugs at a greater pace – which will ultimately benefit more patients, sooner."

Dr Phil L’Huillier, Cancer Research Technology’s director of business management, said: "We’re delighted to see the trial launch of this promising new drug, which harnesses the power of the immune system, and that potentially could treat a range of cancers.

"This drug is particularly exciting because it homes in on a new target only accessible on the surface of cancer cells, increasing its potency while sparing healthy cells. We hope that the early clinical trials prove this is a safe and effective new treatment for cancer patients – ultimately saving more lives from the disease."

Cancer Research UK drug launched in its first clinical trial

The drug, RG7813, delivers a cytokine (engineered IL2) to a specific part of the carcinoembryonic antigen (CEA) protein which is exposed only on the surface of cancer cells, resulting in a narrowly-targeted treatment (Press release Cancer Research UK, MAR 27, 2014, View Source [SID:1234500343]).
Cancer Research Technology, the commercial arm of Cancer Research UK, licensed the monoclonal antibody called PR1A3 to Roche. PR1A3 was discovered in Sir Walter Bodmer’s laboratory when he was director of the Imperial Cancer Research Fund. Roche has subsequently engineered the antibody and incorporated it into its proprietary immunocytokine drug platform to generate the final drug candidate. Clinical trials have then been initiated.
It is in a Phase I study for the treatment of solid tumors (Filing Annual 2013, Hoffmann-La Roche, JAN 30, 2014, View Source [SID:1234500028]). Design: Single and multiple dose escalation study with extension cohorts. Primary endpoint: Safety, PK, PD. Number of patients: 110.
It was previously licensed to Antisoma; however, this agreement was terminated (Company prospectus, Antisoma, DEC 1998; Direct communication, CRT, MAY 2008).