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.

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.

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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."

On July 3, 2019 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its second quarter 2019 financial results on Tuesday, July 16, 2019 after the close of financial markets (Press release, Seattle Genetics, JUL 3, 2019, View Source [SID1234537368]). Following the announcement, management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

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LIVE access on Tuesday, July 16, 2019

1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 800-458-4121 (domestic) or +1 323-794-2093 (international); conference ID 3271918
Webcast with slides available at www.seattlegenetics.com in the Investors section
REPLAY access

Telephone replay will be available beginning at approximately 4:30 p.m. PT on Tuesday, July 16, 2019 through 5:00 p.m. PT on Friday, July 19, 2019 by calling 888-203-1112 (domestic) or +1 719-457-0820 (international); conference ID 3271918
Webcast replay will be available on the Seattle Genetics website at www.seattlegenetics.com in the Investors section

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.

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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.

On July 3, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported updated interim results from the biliary cancer cohort of SUMMIT, an ongoing Phase II basket trial examining the efficacy of neratinib in HER2-mutated cancers, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer 2019, currently taking place in Barcelona, Spain (Press release, Puma Biotechnology, JUL 3, 2019, https://investor.pumabiotechnology.com/press-release/puma-biotechnology-presents-interim-results-biliary-tract-cohort-its-phase-ii-summit-b [SID1234537375]). "Treating HER2-mutant Biliary Tract Cancer with Neratinib: Benefits of HER2-directed Targeted Therapy in the Phase 2 SUMMIT ‘Basket’ Trial" was an oral presentation by James J. Harding, MD, Assistant Attending, Gastrointestinal Oncology and Early Drug Development Service, Memorial Sloan Kettering Cancer Center on July 3rd at 6:10 p.m. CEST. In addition, a poster presentation summarizing the trial results will be presented on July 4 beginning at 11:05 a.m. CEST. The slides and poster presentation will be available on the Puma website.

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The Phase II SUMMIT ‘basket’ trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating, somatic HER2 mutations. The biliary cancer cohort comprised 20 patients with advanced and/or metastatic disease treated with neratinib monotherapy. More specifically, 9 patients had cholangiocarcinoma, 9 had gallbladder cancer and 2 had cancer of the Ampulla of Vater. Patients received a median of 2 (range 0-7) prior systemic regimens before entering this trial. Most patients had received a gemcitabine-based regimen (n=18, 90%), 11 patients (55%) had undergone prior surgery, and 4 patients (20%) received prior radiation therapy. The confirmed objective response rate was 10% (95% CI: 1.2–31.7). The clinical benefit rate was 30% (95% CI: 11.9–54.3) and included 2 patients with confirmed partial responses and 4 patients with stable disease that lasted ≥ 16 weeks. The median progression-free survival was 1.8 months (95% CI: 0.9–3.7).

The safety profile observed in the neratinib-treated biliary tract cancer cohort is consistent with that previously reported for all HER2-mutated cancer patients in the SUMMIT trial. The most frequently observed adverse event was diarrhea, any grade (n=10, 50%) including 4 (20%) patients with grade 3 diarrhea. None of the diarrhea events resulted in dose discontinuation within the biliary tract cancer cohort; 2 patients reduced study drug due to diarrhea events.

"Somatic HER2 mutations represent a distinct class of oncogenic driver mutations that appear to be clinically actionable for a subset of metastatic biliary tract cancers. A subset of cholangiocarcinoma and gallbladder cancer patients had tumor shrinkage or extended disease control suggesting anti-tumor activity in this rare population. These early findings in targeting HER2 in advanced bile duct cancers warrant further clinical and translational investigation." said Dr. Harding.

Alan H. Auerbach, CEO and President of Puma Biotechnology, added, "We are very pleased with the initial activity seen with neratinib in this cohort of patients with biliary tract cancer. We look forward to the further enrollment of patients in the SUMMIT trial and further development of neratinib in this HER2-mutated patient population."