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RhoVac’s reports positive results from the 12 months follow-up of the company’s phase I/II clinical study

On July 4, 2019 RhoVac AB ("RhoVac") reported positive top-line results on safety and immune response in the long-term follow-up of the Company’s phase I/II clinical trial RhoVac-001 (Press release, RhoVac, JUL 4, 2019, View Source [SID1234555928]).

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In total 22 prostatectomised cancer patients received RV001 treatment over a period of approximately 30 weeks. Following completion of treatment, all patients were monitored over a 12 months follow-up period. At 3, 6, 9 and 12 months after completion of treatment with RV001, the patients were evaluated for treatment related reactions and for immunological response. In summary, the results from the long-term follow-up evaluation can be concluded as follows:

All 22 patients recruited to the study completed the follow-up phase and during this phase no treatment related adverse events were reported.
Of the 18 patients showing significant treatment related immunological response at completion of treatment, all 18 patients still showed significant response at 3-, 6- and 9-months follow-up. At the 12-months follow-up 17 out of the 18 responding patients showed significant immunological response.
The over-all conclusion of the RhoVac-001 study including the long-term follow-up phase is that that treatment with RV001 is safe and well tolerated by prostate cancer patients. It is also concluded that a product mediated, significant, robust and long-lasting immune response is established following treatment with RV001.

Comments from RhoVac´s CEO, Anders Ljungqvist

-Receiving the results from the long-term follow-up phase of our first-in-humans clinical trial and experiencing the excellent results is fantastic. The follow-up data confirms that our product has a very good safety profile and is well tolerated by prostate cancer patients. The results also show that the immune response, which we knew was significant and robust, is also long-lasting. I don’t think anyone could have asked for better results than this and it confirms that we took the right decision, when we decided to accelerate preparation for the next clinical study. The platform for the further development of RV001 has now been completed and I am looking forward to continuing this development. Again, I must thank everyone in the company and all our collaborators outside the company for the dedicated work. A special thanks, as always, to the patients for participating in this long clinical trial. Without your commitment to the project we would never have reached this point of progress where we now are starting the phase IIb study.

BioInvent Receives Milestone Payment Related to TAK-169 Investigational New Drug Application

On July 4, 2019 BioInvent International AB (BINV) reported it will receive a $0.5 million milestone payment related to the acceptance by the U.S. Food and Drug Administration of the Investigational New Drug (IND) application for TAK-169, a first-in-class CD38-targeted fusion protein (Press release, BioInvent, JUL 4, 2019, View Source [SID1234537382]). The IND was filed by Takeda Pharmaceutical Company Limited under a co-development agreement with Molecular Templates. This milestone relates to BioInvent’s proprietary n-CoDeR antibody library and its role in the discovery of the investigational compound.

Takeda is developing TAK-169 under a royalty and milestone agreement with XOMA Corporation (NASDAQ: XOMA). BioInvent and XOMA have a long-standing cross-licensing agreement covering BioInvent’s proprietary n-CoDeR antibody library and XOMA’s bacterial protein expression technology.

Martin Welschof, CEO of BioInvent, said, "This is validating that our n-CoDeR platform not only yields highly promising drug candidates for BioInvent’s proprietary programs, but is also helping our partners in building their own pipelines."

JAB-3312, Jacobio’s Second Innovative Drug, has Obtained FDA’s Approval for Clinical Study

On July 3, 2019, Jacobio reported that JAB-3312, an oral small-molecule anti-tumor drug has obtained FDA’s approval for clinical study (Press release, Jacobio Pharmaceuticals, JUL 3, 2019, View Source [SID1234538526]). JAB-3312 was independently designed and developed by Jacobio which owns its intellectual property right worldwide. This is the second small-molecule anti-tumor drug approved for clinical research after JAB-3068 ,which has been in phase IIa clinical study.

JAB-3312 can block the KRAS-MAPK signaling pathway and can be used for the treatment of multiple solid tumors, including non-small-cell lung cancer, colorectal cancer and pancreatic cancer. Meanwhile, it can also attenuate the tumor immunosuppressive microenvironment and enhance the efficacy of existing tumor immunotherapies.

Onco360® Selected to Dispense XPOVIO™ (selinexor)

On July 3, 2019 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it was selected to be a specialty pharmacy network partner for Karyopharm’s new product XPOVIO (selinexor) a nuclear export inhibitor indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (Press release, Onco360, JUL 3, 2019, View Source [SID1234537380]).

"Onco360 is excited to be selected as a specialty pharmacy provider for XPOVIO patients," said Paul Jardina, President and CEO, Onco360. "The recent approval of XPOVIO unlocks a new treatment option for relapsed or refractory multiple myeloma patients who have failed previous lines of treatment. As a provider of this key treatment, Onco360 can support the highly specialized needs of relapsed or refractory multiple myeloma and their physicians across the states."

Multiple myeloma is an incurable hematological malignancy involving plasma cells. Only 50 percent of patients diagnosed with multiple myeloma survive past five years following initial diagnosis. The National Cancer Institute estimates that in 2018, approximately 30,770 new patients were diagnosed with multiple myeloma in the U.S.1 Unfortunately, most multiple myeloma patients will relapse following the first complete remission and often require continuous treatment to prevent disease progression. Previously, there were no U.S. Food and Drug Administration (FDA)-approved products or regimens for patients with relapsed or refractory multiple myeloma who failed treatment with lenalidomide, pomalidomide, bortezomib, carfilzomib, and/or daratumumab.

XPOVIO is manufactured by Karyopharm Therapeutics, and was approved by the U.S. FDA on July 3, 2019 based on positive clinical trial results from the Phase IIb STORM Trial which demonstrated a 21% overall response rate in heavily-pretreated multiple myelmoma patients.2 XPOVIO is the first and only nuclear export inhibitor that blocks XPO1. For full prescribing information, visit XPOVIO.com.

FDA approves new treatment for refractory multiple myeloma

On July 3, 2019 The U.S. Food and Drug Administration reported that it has granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (Press release, US FDA, JUL 3, 2019, View Source [SID1234537379]).

"While there is no cure for multiple myeloma, there are FDA-approved treatments to target the cancer and slow down the spread of the disease. Sadly, often over time, patients can exhaust all available treatments and still see their disease progress," said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "Today we approved a treatment under our accelerated approval program that provides a treatment option for patients with multiple myeloma with no available therapy."

Multiple myeloma is cancer that begins in plasma cells (white blood cells that produce antibodies) and may also be referred to as plasma cell myeloma. Abnormal plasma cells build up in the bone marrow, forming tumors in many bones of the body. As more antibodies are made, it can cause blood to thicken and keep the bone marrow from making enough healthy blood cells. The exact causes of multiple myeloma are unknown, but it is more common in older people and African Americans.

Efficacy was evaluated in 83 patients with RRMM who were treated with Xpovio in combination with dexamethasone. At the end of the study, the overall response rate was measured at 25.3%. The median time to first response was four weeks, with a range of one to ten weeks. The median duration of response was 3.8 months. The efficacy evaluation was supported by additional information from an ongoing, randomized trial in patients with multiple myeloma.

Common side effects of patients taking Xpovio in combination with dexamethasone include a low white blood cell count (leukopenia), a low count of neutrophils, a type of white blood cell (neutropenia), low count of platelets (thrombocytopenia) and low amount of red blood cells (anemia). Patients also reported vomiting, nausea, fatigue, diarrhea, fever, decreased appetite and weight, constipation, upper respiratory tract infections and low blood sodium levels (hyponatremia).

Health care professionals are advised to monitor patients for low blood counts, platelets and sodium levels. Patients should avoid taking Xpovio with other medications that may cause dizziness or confusion and avoid situations where dizziness may be a problem. Health care professionals are advised to optimize the patient’s hydration status, blood counts and other medications to avoid dizziness or confusion. The FDA advises health care professionals to tell females of reproductive age and males with a female partner of reproductive potential to use effective contraception during treatment with Xpovio. Women who are pregnant or breastfeeding should not take Xpovio because it may cause harm to a developing fetus or newborn baby. Xpovio must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

Xpovio in combination with dexamethasone was granted accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on an endpoint that is reasonably likely to predict a clinical benefit to patients. Further clinical trials are required to verify and describe Xpovio’s clinical benefit.

The FDA granted this application Fast Track designation. Xpovio also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. The FDA granted the approval of Xpovio to Karyopharm Therapeutics.

For more information:

National Cancer Institute: Multiple myeloma
FDA: Office of Hematology and Oncology Products
FDA: Approved Drugs: Questions and Answers
FDA: Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.