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Anixa Biosciences Announces Genesis Research to Join Cchek™ Prostate Cancer Study

On November 26, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported the addition of Genesis Research, LLC to the ongoing Cchek prostate cancer detection study (Press release, Anixa Biosciences, NOV 26, 2019, View Source [SID1234551680]).

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Genesis Research, LLC the research arm of Genesis Healthcare Partners, based in San Diego, CA, joins a large and growing team of collaborators advancing Anixa’s Cchek artificial intelligence driven liquid biopsy technology toward commercialization. Genesis Research will provide patient samples in support of clinical validation of Anixa’s Cchek Prostate Cancer Confirmation test.

Study enrollment will be led by Genesis Research’s Medical Director, Dr. Paul Dato. Dr. Dato commented, "This is an exciting opportunity for research personnel at Genesis Healthcare Partners to collaborate with Anixa and explore the potential of immune cells to detect the presence of Prostate Cancer."

Dr. Franklin Gaylis, Chief Scientific Officer at Genesis Healthcare Partners, has endorsed the collaboration between the two organizations and commented, "Genesis Healthcare Partners has an active research program focused on the early detection of Prostate Cancer. Our collaboration with Anixa provides a great opportunity to explore the potential for developing a liquid biopsy for detecting Prostate Cancer."

Amit Kumar, Ph.D., Chief Executive Officer of Anixa stated, "We are pleased to have Genesis Research join our expanding group of Cchek collaboration partners. Our team of collaborators have been and continue to be instrumental in the development of our early cancer detection technology. We look forward to Genesis Research’s participation as we prepare for commercial launch of the Cchek Prostate Cancer Confirmation test in the coming weeks."

About Cchek
Cchek is an early cancer detection technology, that measures a patient’s immunological response to a malignancy by analyzing immune system cells in peripheral blood. The goal is to utilize the technology to determine a patient’s cancer status from a simple blood draw, eliminating the need for a biopsy, which can be an expensive, painful and invasive procedure. Further, conventional methods using current cancer screening tests often lack accuracy and reliability. Anixa’s orthogonal approach using flow cytometry coupled with artificial intelligence provides an alternative method that offers improved affordability, efficacy and efficiency. To date, Anixa has successfully used Cchek to detect the presence of 20 different cancers including lung, colon, breast and prostate. The robust cancer detection performance of Cchek makes it a platform from which multiple cancer diagnostic tests may be developed. The first such test, a prostate cancer confirmation test, is slated for commercial launch by the end of 2019.

Genesis Research, LLC
Genesis Research is the wholly owned research subsidiary of Genesis Healthcare Partners, San Diego’s largest premier multi-specialty independent private physician practice, dedicated to the diagnosis and treatment of urologic conditions, digestive health issues and many cancers. With 15 offices located throughout San Diego County, Genesis Healthcare Partners’ team of medical professionals provides access to cutting-edge technology and minimally invasive treatments. Additional information is available at www.mygenesishealth.com.

Alpine Immune Sciences to Participate in Fireside Chat at 31st Annual Piper Jaffray Healthcare Conference

On November 26, 2019 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported participation in an analyst-led fireside chat at the 31st Annual Piper Jaffray Healthcare Conference on Tuesday, December 3, 2019 at 3:00 p.m. Eastern Time in New York, NY (Press release, Alpine Immune Sciences, NOV 26, 2019, View Source [SID1234551679]).

A live webcast of the fireside chat will be available online in the investor relations section of the company’s website at View Source A replay of the presentation will be available on the company website for 90 days following the webcast.

Granting of the Marketing Authorisation for Ivozall

On November 26, 2019 ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of paediatric drugs in the fields of oncology and neurology, reported that the European Commission has granted Ivozall an European Marketing Authorisation (MA) (Press release, ORPHELIA Pharma, NOV 26, 2019, View Source [SID1234551678]).

Ivozall is a solution for infusion containing 1 mg/ml of clofarabine and is supplied in 20 ml-vials. Clofarabine is an essential medicine for the treatment of relapsed or refractory Acute Lymphoblastic Leukaemia (ALL) in children. Ivozall will be the first generic form of clofarabine to be authorised under the European centralized procedure.

« This approval is a significant milestone for ORPHELIA Pharma as Ivozall is the first medicine in a series of oncology products we plan to launch. We believe it addresses important pediatric needs and will meaningfully improve children’s care », comments Jeremy Bastid, Chief Development Officer. « We will now focus on launching Ivozall throughout Europe and building relationships with distribution partners to bring Ivozall to patients with ALL ».

« This MA will allow the company to strengthen its product portfolio with this first oncology medicine in which we have great expectations » says Hugues Bienaymé, Founder and General Manager. « We anticipate to make Ivozall available to hospital centres treating ALL patients in some countries from March 2020. Other countries will be handled by ORPHELIA’s distributors, to be selected in the course of 2020 ».

About Acute Lymphoblastic Leukaemia

ALL is a cancer associated with the uncontrolled proliferation of lymphoblasts that invade the bone marrow. The disease progresses rapidly and aggressively and requires immediate treatment. ALL is a rare disease, with around 7,000 people diagnosed each year in Europe. The majority of ALL cases occurs in children. Although rare, ALL is the most common type of childhood cancer. Clofarabine is indicated for the treatment of ALL in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.

Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA) Approval based on Asian PREVAIL study of men with metastatic castration-resistant prostate cancer

On November 26, 2019 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that the China National Medical Products Administration (NMPA) approved a new drug application (NDA) for XTANDI (enzalutamide) on November 18 for the treatment of adult men with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) in whom chemotherapy is not yet clinically indicated (Press release, Astellas, NOV 26, 2019, View Source [SID1234551656]).

The approval by the NMPA was based on the results of an Asian multinational Phase 3, randomized, double-blind, placebo controlled efficacy and safety study of enzalutamide in asymptomatic or mildly symptomatic patients with progressive metastatic prostate cancer who had disease progression despite ADT and a single-dose pharmacokinetic study in healthy Chinese volunteers (Protocol 9785-CL-0013).1

The study, Asian PREVAIL (also known as 9785-CL-0232), evaluated oral enzalutamide (160 mg/day) versus placebo plus gonadotropin-releasing hormone (GnRH) therapy or after bilateral orchiectomy. The study, involving Asian patients including approximately 200 Chinese patients, showed consistent results with those in the global pivotal Phase 3 PREVAIL study in the same target population.2

"Currently the treatment options are limited in China for men with metastatic castration-resistant prostate cancer," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development, Astellas. "The approval of enzalutamide in China brings us one step closer to offering physicians a meaningful treatment option in an area where there is a high medical need."

Patients treated with enzalutamide demonstrated a statistically significant reduction in the risk of Prostate Specific Antigen (PSA) progression (Hazard Ratio of 0.38 [95% confidence interval: 0.27, 0.52], P < 0.0001). The median time to PSA progression was 8.31 months in the enzalutamide group versus 2.86 months in the placebo group. Treatment with enzalutamide also resulted in a statistically significant reduction in risk of radiographic disease progression or death compared with treatment with placebo with a Hazard Ratio (HR) of 0.31 (95% confidence interval: 0.20, 0.46; P<0.0001). Additionally, treatment with enzalutamide showed a statistically significant improvement in overall survival compared to treatment with placebo, with a 67% decrease in the risk of death (HR 0.33, [95% CI: 0.16, 0.67]; P=0.0015).

The safety profile observed in the Asian PREVAIL study was generally consistent with previous clinical studies in patients with metastatic CRPC.2 The most common adverse reactions (≥10%) that occurred more frequently (≥2% over placebo) in the enzalutamide-treated patients from the randomized placebo-controlled clinical trials were asthenia/fatigue, decreased appetite, hot flush, arthralgia, dizziness/vertigo, hypertension, headache, and decreased weight.

In addition to the Asian PREVAIL data involving a Chinese sub-population, the approval was supported by results from the global Phase 3 PREVAIL trial, which were published in the New England Journal of Medicine in 2014. The Phase 3 PREVAIL trial was a randomized, double-blind, placebo-controlled, multi-national trial that enrolled more than 1,700 patients at sites in the United States, Canada, Europe, Australia, Russia, Israel and Asia including Japan.2

Enzalutamide is a standard of care for men with metastatic CRPC in countries where it is available. Since 2012, it has been prescribed to more than 420,000 patients worldwide.3 Prostate cancer is the second most common cancer in men worldwide4 and in China it has become the most common tumor in male urinary malignancies.5

"The approval of enzalutamide is an important milestone. Tens of thousands of Chinese patients with metastatic castration-resistant prostate cancer could potentially benefit from the reduced risk of disease progression and death found in the Asian PREVAIL study," said Hiroshi Hamaguchi, President, Astellas Greater China Commercial. "The approval also demonstrates a significant step forward for Astellas, with enzalutamide being the first Astellas oncology treatment approved in China."

Ferring and Blackstone Life Sciences invest over $570 million USD in novel investigational gene therapy for bladder cancer patients

On November 25, 2019Ferring Pharmaceuticals and Blackstone Life Sciences reported the joint investment of over $570 million USD in nadofaragene firadenovec (rAd-IFN/Syn3), an investigational novel gene therapy in late stage development for patients with high-grade, Bacillus Calmette-Guérin (BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC) (Press release, FerGene, NOV 25, 2019, View Source [SID1234587859]).

FerGene, a new gene therapy company and Ferring subsidiary, has been created to potentially commercialize nadofaragene firadenovec in the US and to advance the global clinical development. FerGene’s goal is to bring this promising therapy to a patient population which has seen little improvement in their standard of care over the past twenty years. Blackstone will invest $400 million USD and Ferring will invest up to $170 million USD in FerGene. Ferring will also potentially launch and commercialize nadofaragene firadenovec outside of the US.

"Bringing a novel gene therapy to the market requires dedicated focus and capabilities, and FerGene, a Ferring company, will have the resources and team needed to help us potentially bring nadofaragene firadenovec to patients," said Frederik Paulsen, Chairman, Ferring Pharmaceuticals. "Through this new joint financing model between Ferring and Blackstone Life Sciences, we aim to ensure more people with high-grade, BGC unresponsive, non-muscle invasive bladder cancer may benefit from this novel gene therapy if approved."

Nadofaragene firadenovec, currently in late Phase 3 development, has been granted Breakthrough Therapy designation and had its Biologics License Application (BLA) accepted for filing and granted Priority Review by the FDA.

"This innovative partnership with Ferring illustrates the unique value of Blackstone Life Sciences in bringing transformative therapies to market. Our expertise and experience in hands-on clinical development and early commercialization will help further advance this promising therapy for bladder cancer patients in the US and around the world," said Nick Galakatos, Ph.D., Head of Blackstone Life Sciences.

"Through FerGene, Blackstone and Ferring’s goal is to successfully commercialize and further develop this adenovirally mediated interferon alfa-2b gene therapy, a potential breakthrough treatment for high-grade, BCG unresponsive, non-muscle invasive bladder cancer patients," said Paris Panayiotopoulos, Blackstone Life Sciences Managing Director.

Phase 3 clinical trial results will be presented at the Society of Urologic Oncology (SUO) 20th Annual Meeting in Washington, DC on December 5, 2019 by Dr. Colin Dinney, Professor and Chairman of the Department of Urology at the University of Texas MD Anderson Cancer Center (MDACC) and a founder and past president of the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC). Dr Dinney pioneered the development of nadofaragene firadenovec and co-heads the development program alongside Dr. Nigel Parker6 of FKD Therapies Oy (FKD). Upon the potential FDA approval, FerGene will hold the marketing authorization of nadofaragene firadenovec.

FKD is a specialist gene therapy company based in Finland focused on the development and regulatory filing of nadofaragene firadenovec, which has been studied in the Phase 3 trial in 33 centers across the US, in conjunction with the SUO-CTC.

"We are excited to present the Phase 3 data at the upcoming SUO meeting," said Dr. Stephen A. Boorjian, the Coordinating Investigator for the trial and the Carl Rosen Professor of Urology at Mayo Clinic in Rochester, Minnesota. "This trial expands the search for effective alternatives to radical cystectomy for those patients with high-grade, BCG unresponsive, non-muscle invasive bladder cancer, and offers the potential to meaningfully improve future patient care."