On August 31, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the National Medical Products Administration of China (NMPA, formerly known as CFDA or CDA) has accepted the new drug application (NDA) for tislelizumab, an investigational anti-PD-1 antibody, as a potential treatment for patients with relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL) (Press release, BeiGene, AUG 31, 2018, View Source [SID1234529218]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The acceptance of our first NDA for tislelizumab represents an important milestone for BeiGene and for Chinese patients with Hodgkin’s lymphoma. Patients who relapse or don’t respond to standard treatment with chemotherapy or radiation often have poor prognoses. We are encouraged by the potential for tislelizumab to provide a new treatment option for these patients," said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene.

The NDA is supported by a clinical and non-clinical data package, including the results from a pivotal Phase 2 study of tislelizumab in Chinese patients with R/R cHL. A recent independent review of data from all 70 enrolled patients in an intent-to-treat analysis showed that with a minimum of 24 weeks of follow-up and a median follow-up time of 7.85 months at the data cutoff, overall response rate (ORR) was 85.7 percent, including 61.4 percent complete response (CR). Frequency and severity of adverse events were generally consistent with previously reported Phase 1 safety and tolerability data for tislelizumab, or, in the case of certain immune-related events such as hypothyroidism and fever, consistent with previous reports of other PD-1 antibodies for the treatment of cHL. Full results of the study are planned to be presented at an upcoming medical conference.

"We are excited by the response rates, including high complete response rates we have seen in our pivotal study in R/R cHL, and look forward to working closely with the NMPA to make tislelizumab available to patients in China as quickly as possible," said Wendy Yan, Global Head of Regulatory Affairs at BeiGene.

In addition to the pivotal Phase 2 clinical trial in R/R cHL, tislelizumab is also being studied in global Phase 3 trials in a number of malignancies, including non-small cell lung cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma; as well as two global Phase 2 trials in patients with previously treated hepatocellular carcinoma or with R/R mature T- and NK-cell lymphomas, and an additional pivotal Phase 2 trial in China in urothelial cancer.

About Classical Hodgkin’s Lymphoma
Hodgkin’s lymphoma is one of the two major types of lymphoma that begin in the lymph nodes and tissues of the lymphatic system. All other lymphomas are classified as non-Hodgkin’s lymphomas. Classical Hodgkin’s lymphoma, the most common form representing about 95 percent of the patients with Hodgkin’s lymphoma, is characterized by the presence of very large cells called Reed-Sternberg cells. There were approximately 2,100 diagnosed cases of Hodgkin’s lymphoma in China in 2012.i Although the cancer can occur in both children and adults, it is most commonly diagnosed in young adults between the ages of 15 and 35 and in older adults over age 50.

About Tislelizumab
Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. Discovered by BeiGene scientists in Beijing, tislelizumab is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is potentially differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells, based on preclinical data. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).

On August 31, 2018 Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported that Chief Scientific Officer Takashi Kei Kishimoto, Ph.D. will present on the poster entitled Ongoing Phase 2 Clinical Trial of SEL-212 Shows Sustained Reduction of Serum Uric Acid by Mitigating Formation of Anti-Uricase Antibodies at the 20thAsia Pacific League of Associations for Rheumatology Congress (APLAR), taking place 6-9 September 2018 at the Kaohsiung Exhibition Centre, Taiwan (Press release, Selecta Biosciences, AUG 31, 2018, View Source [SID1234529216]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On August 31, 2018 Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, reported its unaudited interim Financial Results for the six months ended June 30, 2018, which have been prepared in accordance with IAS 34 as adopted by the European Union (Press release, Kiadis, AUG 31, 2018, View Source [SID1234529210]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Arthur Lahr, CEO of Kiadis Pharma, commented: "We have made tremendous progress in the last six months: ATIR101 is now very close to potential CHMP opinion in 2018, we are on track with our Phase 3 trial, and obtained further confirmatory data from our Phase 2 trials. To allow us to ramp up our Phase 3 trial and prepare for commercialization in the EU we also raised substantial equity and debt facilities that extended our cash runway into the third quarter of 2019, and, upon positive CHMP opinion, potentially into the first quarter of 2020. We have also significantly strengthened our organization in medical, operations, commercial and finance functions. Kiadis is in great shape and well positioned to deliver on the promise of ATIR101."

Operating highlights – ATIR101 (including post reporting period)

European marketing authorization application for ATIR101:
Responses to the Day 120 List of Questions submitted in March 2018;
Day 180 List of Issues received in May 2018 and responses submitted in August 2018;
On track to obtain CHMP opinion from the European Medicines Agency in the fourth quarter of 2018.
Phase 3 trial CR-AIR-009, comparing ATIR101 against the post-transplant cyclophosphamide (PTCy) or ‘Baltimore’ protocol:
Progress in line with internal plans: 14 clinical sites are currently open for recruitment, 16 patients have been enrolled;
Protocol amendment submitted to regulatory authorities: number of patients increased to 250 to further increase power [80% power to detect 16% Graft-versus-host-disease-free and Relapse-Free Survival (GRFS) difference]; interim analysis to occur after 2/3 of GRFS events to increase chance of positive read out, now expected in the second half of 2020; conditioning regimens harmonized between the two treatment arms to reduce heterogeneity.
Phase 2 trial CR-AIR-008 (‘008’): The last patient received a single dose of ATIR101 in January 2018.
Pooled analysis: Further analysis of 1-year Phase 2 pooled data [Intention-To-Treat (ITT), 37 patients] from studies CR-AIR-007 and single dose CR-AIR-008 shows GRFS 53% [95% confidence interval (CI), 39%-72%]; Overall Survival (OS) 58% (95% CI, 44%-77%), in line with Phase 2 CR-AIR-007 trial. For the PTCy/Baltimore protocol, single site data from Johns Hopkins (McCurdy et al. 2017) and Atlanta (Solh et al, 2016) show a disease-risk index (DRI) normalized 1-year GRFS value of 40% and 30%, respectively.
Operating highlights – Organization (including post reporting period)

Robbert van Heekeren resigned as Chief Financial Officer and as member of the Management Board.
Scott A. Holmes appointed as new Chief Financial Officer.
Organization strengthened across all functions, comprises 73 employees, up from 51 a year ago. Key new appointments include head of Medical US (former Iovance/ Dendreon), head of Medical EU (former Genzyme/ AstraZeneca), head of market access EU (former Genzyme/ Novo Nordisk), head of pharmacovigilance (former Astellas), head of facilities (former Merck/ Douwe Egberts).
Otto Schwarz, former Chief Operating Officer of Actelion and Mr. Subhanu Saxena, former Chief Executive Officer of Cipla and former member of the senior executive team of Novartis, were appointed as Supervisory Board members of the Company at the Annual General Meeting of shareholders in June 2018. Mr. Stuart Chapman resigned from the Supervisory Board following the shareholders’ meeting.
Financial highlights (including post reporting period)

In the first six months of 2018, the Company did not generate any revenues. Total operating expenses increased by EUR2.9 million from EUR8.2 million in the first six months of 2017 to EUR11.1 million in the same period of 2018. This increase was primarily caused by a further expansion of the workforce in all areas of the organization, the move to a larger building which includes a commercial manufacturing facility, laboratories and office space, and consultancy expenses for business development and market access.
In the first six months of 2018, net financial result came in at EUR3.0 million compared to EUR0.4 million for the same period of 2017. Higher finance costs were mainly the result of higher interest expenses on loans and borrowings, and a net foreign exchange loss in the first six months of 2018 compared to a net foreign exchange gain in 2017.
The net loss for the six months ended June 30, 2018 came at a level of EUR14.1 million compared to a loss of EUR8.5 million for the six months ended June 30, 2017. Operating expenses and net result for the first six months of 2018 were in line with management expectations.
The Company ended the first six months of 2018 with EUR41.7 million in cash and cash equivalents. In March 2018, the Company issued 2.6 million shares and raised EUR23.4 million in gross proceeds.
On July 31, 2018, the Company received a new debt facility from Kreos Capital V (UK) Ltd providing the Company with up to EUR20 million of additional financing.

On August 30, 2019 GT Biopharma Inc. (GTBP) (Euronext Paris: GTBP.PA) is an immuno-oncology biotechnology company reported on innovative treatments based on the company’s proprietary NK-engager and Bispecific Antibody Drug Conjugate platforms (Press release, GT Biopharma , AUG 30, 2018, View Source [SID1234539523]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Monday was a monumental and reassuring day for those of us involved in the Natural Killer cell (NK) immuno-oncology field. For years, if not decades, visionary researchers such as Dr. Jeffrey Miller at the Masonic Cancer Center, University of Minnesota, understood the potential of NK cells in the treatment of cancers. They remained committed to this concept even as T-cells became the most focus upon immune cell leading to T-cell platforms such as Iovance’s TILs, Amgen’s BiTEs as well as Juno and Kite’s CAR-T. However, each of these platforms and individual therapies has their limitations whether they be safety issues, burden on patients, accessibility issues or cost. Fortunately, a few companies, including GT Biopharma, stayed true to the NK cell hypothesis and continued to drive the science behind this concept.

The recent collaboration, $96M upfront with $5B in milestone/royalty payments, announced on August 27th between Affimed and Roche/Genentech not only provides validation of the NK cell hypothesis but more specifically of the NK cell – engager concept. GT Biopharma, since its inception on September 1, 2017 has been diligently working, along with our colleagues at the Masonic Cancer Center, on bringing our TriKE and TetraKE NK cell-engager platforms into and through the regulatory pathway and into clinical development.

Although there are many similarities between Affimed and GT Biopharma, there are significant differences. Both platforms utilize fusion proteins with one end binding to NK cells and the other targeting a tumor antigen. Significant differences in the platforms reside in the way the proteins are constructed and how they address the NK activation and proliferation issue. Like first-generation CAR-T, without a specific stimulatory agent, the cells become exhausted as their numbers dwindle. GT Biopharma’s innovative NK cell-engager platform incorporates IL-15, a potent activator and proliferator of NK cells. No other, including Affimed’s, NK cell technology has this.

I believe that the NK cell field, much like the T-cell field did some years ago, is about to explode onto the scene with rapid advances in both the science and the clinical development spheres. I also believe that GT Biopharma will be leading that charge and bringing to the clinic innovative and formidable new NK cell-engager based therapies.

On August 30, 2018 the Norwegian biotech company Ultimovacs AS took over the immunotherapy technology business of the Swedish company Immuneed AB last month (Press release, Ultimovacs, AUG 30, 2018, View Source [SID1234536998]). The complementary technologies of the two companies provide a unique platform for development of novel vaccine solutions for treatment and possibly prevention of cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The acquired business has been named Ultimovacs AB and is now a fully-owned Swedish subsidiary of Ultimovacs AS. The business is located in Uppsala and has two employees.

"In Ultimovacs, we have been looking for an adjuvant technology that can further improve cancer vaccines. Simultaneously, Immuneed has been searching for a peptide based vaccine platform for further testing of their technology. This is a perfect match", says Øyvind Kongstun Arnesen, CEO of Ultimovacs.

Ultimovacs is a Norwegian pharmaceutical company developing novel immunotherapies against cancer. The lead product candidate is UV1, a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is currently in clinical testing in the US. The purchase price of the technology business of Immuneed AB was NOK 50.4 million, corresponding to SEK 54.5 million, which was paid partly in cash and partly in shares in Ultimovacs AS. "We are very excited about this merger. By joining forces with Ultimovacs, with their promising cancer vaccine and significant experience from clinical development, we believe the potential of the TET platform technology can be realized and benefit patients faster and better", says Camilla Huse Bondesson, Chairman of the Board of Immuneed AB.

The value of the Immuneed technology to Ultimovacs

Based on an exclusive license agreement with the Leiden University Medical Centre, Immuneed has developed technology (named the ‘TET-platform’) that Ultimovacs believes can attractively complement the cancer vaccine under development by Ultimovacs.

The TET-platform addresses the general challenge of so called "adjuvants" that enhance the desired response of the immune system to a vaccine. It makes it possible to incorporate adjuvant and the vaccine itself into one molecule. When using the technology from Immuneed, the antibodies formed by a previous vaccine can function as adjuvant for a new vaccine. This principle is general and can be applied as an adjuvant for many different vaccines. The principle and the technology have been successfully validated in different pre-clinical models.

Ultimovacs considers the TET-platform technology as a promising and general strategy to strengthen and increase T cell responses against cancer vaccine peptides. In parallel with the continued development of the therapeutic cancer vaccine UV1, Ultimovacs will therefore pursue the development of a new first-in-class cancer vaccine solution based on the proprietary TET-platform technology.