Cellular Biomedicine Group Initiates Patient Recruitment for Clinical Trial in B Cell Maturation Antigen (Anti-BCMA) Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Targeting Multiple Myeloma (MM)

On January 8, 2019 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported the initiation of patient recruitment to support the study of anti-BCMA CAR-T therapy targeting relapsed and refractory Multiple Myeloma in China (Press release, Cellular Biomedicine Group, JAN 8, 2019, View Source [SID1234532588]).

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"China has seen a substantial increase in the incidence of Multiple Myeloma. As a drug development company, BCMA is the first of multiple assets that CBMG is advancing amongst our oncology pipeline beyond our collaboration with a global leader in cell therapy," commented Tony (Bizuo) Liu, Chief Executive Officer of the Company. "We plan to provide updates in the near future on the progress of our other proprietary technologies, including anti-CD22 and anti-CD20 CAR-T targeting relapsed Acute Lymphoblastic Leukemia (ALL) and Diffuse Large B-cell Lymphoma (DLBCL) patients post anti-CD19 CAR-T treatment, Alpha Fetoprotein T-cell Receptor (AFP-TCR-T) for Hepatocellular Carcinoma, and next generation Tumor Infiltrating Lymphocytes (TIL) for the treatment of non-small cell lung cancer (NSCLC) and other solid tumor indications. We hope to be able to provide expeditious, safe and effective therapies to cancer patients who currently have limited treatment options."

About the Study
This Phase I clinical study will enroll 22 patients to evaluate the safety and efficacy of C-CAR088 (anti-BCMA Chimeric Antigen Receptor T-Cell therapy) in patients with relapsed and/or refractory Multiple Myeloma.

About Multiple Myeloma in China
It is estimated that there are 27,800 new cases of Multiple Myeloma, a cancer derived from plasma cells, diagnosed in China each year. With the acceleration of the aging process in China, it is predicted that Multiple Myeloma, with a rapid growth in incidence, will become one of the more significant diseases that affect people’s health in the country. (Source: Blood Cancer J. 2014 Aug 15;4:e239. doi: 10.1038/bcj.2014.55)

OBI Pharma, Inc. to Present at the J.P. Morgan Healthcare Conference

On January 8, 2019 OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), reported that Amy Huang, General Manager, will present a company overview at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2019 at 9:00 a.m. PST/12 noon EST, in San Francisco, CA (Press release, OBI Pharma, JAN 8, 2019, View Source [SID1234532589]).

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ImmunoGen Announces Sale of Residual Kadcyla Royalties

On January 8, 2019 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the sale of its residual rights to receive royalty payments on commercial sales of Kadcyla (ado-trastuzumab emtansine) to OMERS, the defined benefit pension plan for municipal employees in the Province of Ontario, Canada, for $65 million (Press release, ImmunoGen, JAN 8, 2019, View Source [SID1234553884]).

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"ImmunoGen played a key role in the generation and early development of Kadcyla, the first ADC approved for the treatment of HER2-positive breast cancer, and we are pleased to see the continued progress of this important therapy in the market," said Mark Enyedy, President and Chief Executive Officer. "As ImmunoGen evolves into a fully-integrated company with our proprietary portfolio, this transaction further strengthens our balance sheet as we execute on our strategic priorities and work to deliver more good days to people living with cancer."

This transaction entails the sale of the residual interest held by ImmunoGen from a prior transaction with Immunity Royalty Holdings, L.P. (IRH). In 2015, ImmunoGen announced a $200 million non-dilutive royalty transaction through which ImmunoGen sold the right to receive 100% of the royalty revenue on Kadcyla commercial sales to an undisclosed threshold amount, subject to certain conditions. Once the applicable threshold was met, ImmunoGen would receive 85% of the Kadcyla royalty revenue and the original purchaser would receive 15% for the remaining term of the royalty. With this transaction, OMERS now owns 100% of ImmunoGen’s rights to receive Kadcyla royalties.

MTS Health Partners, L.P. acted as exclusive financial advisor to ImmunoGen and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. acted as special transactional counsel to ImmunoGen.

ABOUT KADCYLA ROYALTIES

Genentech, a member of the Roche Group, developed Kadcyla (ado-trastuzumab emtansine) using ADC technology licensed from ImmunoGen under a 2000 agreement established between the companies. This agreement entitles ImmunoGen to receive royalties ranging from 3-5% on Kadcyla sales in countries where ImmunoGen holds valid patents covering Kadcyla, and 2% in countries without relevant ImmunoGen patents. ImmunoGen is entitled to receive royalties on commercial Kadcyla sales in each country for ten years after the launch of Kadcyla in that country. This period extends to twelve years for each country in which ImmunoGen has valid claims in relevant patents on the tenth anniversary of the commercial launch of Kadcyla in that country.

BerGenBio to present company overview at Biotech Showcase 2019 during annual J.P. Morgan Conference in San Francisco

On January 8, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors to treat multiple cancer indications, reported that the Company will be presenting a corporate overview at the Biotech Showcase 2019 in San Francisco today at 10:00 am PST (Press release, BerGenBio, JAN 8, 2019, https://www.bergenbio.com/bergenbio-to-present-company-overview-at-biotech-showcase-2019-during-annual-j-p-morgan-conference-in-san-francisco/ [SID1234532590]).

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The presentation will webcast live and the presentation is available for download at the Company’s website: www.bergenbio.com/investors/presentations/

Details for the presentation are as follows:

Biotech Showcase
Date: Tuesday, January 8, 2019
Time: 10:00 am PST
Room: Franciscan A (Ballroom Level)
Venue: Hilton San Francisco Union Square Hotel, 333 O’Farrell Street

END

Contact
Richard Godfrey, CEO, BerGenBio ASA
+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA
[email protected]
+47 917 86 513

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

Astellas Announces Approval in Japan for the treatment of prostate cancer, Gonax® for partial changes (addition of dosage and administration) and addition of Gonax® 240 mg

On January 8, 2019 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that gonadotrophin-releasing hormone (GnRH) receptor antagonist, Gonax received approval for partial changes for the additional dosage and administration of Gonax for the treatment of prostate cancer at 12-week intervals, and obtained manufacturing and marketing authorization for Gonax 240 mg in Japan (Press release, Astellas, JAN 8, 2019, View Source [SID1234534620]).

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Gonax is a GnRH receptor antagonist with a subcutaneously injectable formulation. Astellas acquired exclusive development and commercialization rights of Gonax for the use of prostate cancer treatment in Japan from Ferring Pharmaceuticals in January 2006, and launched Gonax for the indication of prostate cancer in Japan in October 2012.

GnRH is a hormone synthesized and released from the hypothalamus in the brain and is involved in the production of the male hormone testosterone thorough binding to the GnRH receptors in the pituitary gland. Although testosterone is an important hormone that plays a central role in the maintenance of male function, it also stimulates prostate cancer to grow and to spread out and in result, often aggravates symptoms in prostate cancer patients. Gonax competitively inhibits the binding of GnRH to the GnRH receptors and controls the growth of prostate cancer by suppressing the testosterone.

Astellas believes that adding the maintenance dose of Gonax 480 mg at 12-week intervals to the maintenance dose of Gonax 80 mg at 4-week intervals will improve convenience for patients and reduce the burden on patients and further contribute to the treatment of prostate cancer.

Astellas reflected the impact from this approval in its financial forecasts of the current fiscal year ending March 31, 2019.