On May 21, 2019 Nordic Nanovector ASA (OSE: NANO) reported that following a safety review of the first patients in the ongoing Archer-1 (LYMRIT 37-07) trial investigating Betalutin (177Lu-satetraxetan-lilotomab) in combination with rituximab (RTX) in second-line follicular lymphoma (2L FL), the Betalutin dose has been escalated to 15 MBq/kg for the next cohort of patients (Press release, Nordic Nanovector, MAY 21, 2019, https://www.nordicnanovector.com/investors-and-media/press-releases?page=/en/pressreleases/nordic-nanovector%253A-archer-1-phase-1b-betalutin%2528r%2529-rituximab-combination-trial-advances-to-next-cohort-1692267 [SID1234553451]).

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Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial to assess the safety and preliminary activity of combining CD37-targeted Betalutin with CD20-targeted RTX in 20-25 patients with relapsed/refractory FL who have received one or more prior therapies. Starting doses of Betalutin and lilotomab are 10MBq/kg and 40mg, respectively, with the option for dose escalation.

Following Betalutin dosing, patients will receive 375 mg/m2 RTX once per week for four weeks. The primary endpoint is safety, and secondary endpoints include overall response rate, duration of response, progression free survival and overall survival. Data read-out is expected during the second half of 2020.

Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, commented: "We are pleased to be moving ahead with the next group of patients in the study, which will enable us to recommend a dose for further evaluation of safety and preliminary efficacy in additional patients."

Rituximab is a CD20-targeting monoclonal antibody that is administered to patients with newly-diagnosed or relapsed FL as a single agent or in combination with chemotherapy. Over time, patients may develop resistance to RTX, thus alternative targets and new treatments are important. The combination of anti-CD37 and anti-CD20 modalities could therefore represent a novel dual immunotherapy approach for the treatment of 2L FL patients, and potentially avoid or delay the use of chemotherapy.

On May 21, 2019 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX) reported that Dror Bashan has been appointed to serve as the Company’s new President and Chief Executive Officer, and a director, effective June 30, 2019, replacing Moshe Manor, who is stepping down from those roles for personal reasons (Press release, Protalix, MAY 21, 2019, View Source;p=RssLanding&cat=news&id=2399232 [SID1234536497]). Mr. Manor will assist with the transition and continue to work with the Company on a consultant basis.

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"Dror brings valuable experience and knowledge in the pharmaceutical industry to our Company, and I am happy to welcome him to Protalix," said Shlomo Yanai, Chairman of Protalix’s Board of Directors. "Moshe has made a great contribution to our organization over the last four years, and has played a critical role in our development and success in advancing our pipeline. On behalf of Protalix and the Board of Directors, I would like to thank Moshe for his significant contributions and outstanding leadership and wish him great success in his future endeavors."

"I have the deepest gratitude to Protalix’s employees and its Board of Directors. I have decided that, for personal reasons unrelated to the Company, the time has come to hand over leadership to a new chief executive officer," said Mr. Manor. "I am very honored to have led this great organization and will continue to watch with excitement and anticipation as Protalix progresses in the development and commercialization of its promising pipeline."

"I am very proud to become Protalix’s President and Chief Executive Officer, and am looking forward to working with such a talented management team to continue the progress of Protalix’s future development," said Mr. Bashan. "I believe that my broad experience in the pharmaceutical industry, which covers a range of disciplines in the field, will be a valuable resource for the company. I am very excited about the potential path forward and glad to be part of Protalix’s future."

Mr. Bashan has over 20 years of experience in the pharmaceutical industry with roles ranging from business development, marketing, sales and finance providing him with both cross regional and cross discipline experience and a deep knowledge of the global pharmaceutical and health industries. From 1998 through 2018, he served in a number of senior positions at Teva Pharmaceutical Industries Ltd. Most recently, he served as Teva’s Senior Vice President, Global Business Development, and was involved in strategic alliances, cross-company strategic projects and the acquisition and divestiture of assets. Mr. Bashan holds a BA in Economics and Business Management from the Tel Aviv University in Tel Aviv, Israel, and an MBA from the Tel-Aviv University.

On May 21, 2019 RhoVac reported that a summary of the collaboration with Lund University has been published prior to the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting (American Society of Clinical Oncology) held in Chicago on May 31-June 4 (Press release, RhoVac, MAY 21, 2019, View Source [SID1234555930]).

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The primary objective of the study was to investigate whether RhoC is expressed to a greater extent in cancer stem cells in prostate cancer induced metastases in radiation exposed mice. The metastasis tissues were harvested, sectioned and analyzed by immunohistochemical methods, comparing the presence of different biomarkers. The biomarkers analyzed were for RhoC, Adenoreceptor (AR), CD 166 (cancer stem cell) and Ki67 (proliferation). The results showed, that RhoC is expressed to a greater extent in the metastatic tissue and, and that there is a subpopulation of RhoC-positive cells in the metastases, which are double-labeled with CD166 to the cancer stem cells.

Anders Ljungqvist, CEO: – It was satisfying to see that these results confirmed that RhoC was expressed to a greater extent in the metastasis tissue than in the tumor, and that a subpopulation of the RhoC-positive cells also has cancer stem cell character.

On May 21, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system to fight cancer, reported that it will be presenting at the Sachs Associates 5th Annual Immuno-Oncology BD&L and Investment Forum to be held May 31, 2019 in Chicago (Press release, Anixa Biosciences, MAY 21, 2019, View Source [SID1234536498]).

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Mike Catelani, COO and CFO of Anixa, will provide an overview of the company, its most recent accomplishments and upcoming milestones, with a focus on its chimeric endocrine receptor t-cell (CER-T) treatment for ovarian and other cancers. Management will also be available for one-on-one meetings with investors who are registered to attend the conference.

Details of Anixa’s presentation are as follows:

Event:

5th Annual Immuno-Oncology: BD&L and Investment Forum

Date:

Friday, May 31, 2019

Time:

12:10 p.m.

Location:

PR Track A – Room Sinclair Ballroom

Waldorf Astoria Chicago, Chicago, IL

The 5th Annual Immuno-Oncology BD&L and Investment Forum is designed to bring together thought leaders from cancer research institutes, patient advocacy groups, pharma and biotech to facilitate partnering, funding and investment.

On May 21, 2019 Seelos Therapeutics, Inc. (NASDAQ: SEEL), a clinical-stage biopharmaceutical company, provided an update on its pipeline (Press release, Apricus Biosciences, MAY 21, 2019, View Source [SID1234536499]).

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"We have made tremendous progress in our acquired programs as we are finalizing the phase 2b/3 design for Sanfilippo under a Seelos IND for SLS-005 and have initiated the in-vivo studies for SLS-007," said Raj Mehra, Ph.D., CEO of Seelos Therapeutics. "Additionally, due to the complex nature of the merger accounting, our first quarter financial report is taking longer than we anticipated but we wanted to update the street on our clinical and pre-clinical progress in the first quarter."

First Quarter Corporate Highlights

On January 24th, Seelos Therapeutics completed its merger with Apricus and began trading under the symbol "SEEL" on the NASDAQ. Seelos completed a capital raise in conjunction with the merger. Proceeds received at the closing were approximately $18 million, prior to payment of transaction costs.
In February, Seelos acquired the worldwide development and commercial rights to Bioblast’s proprietary Trehalose 90 mg/mL IV solution and all inventory of the drug. Seelos has named this program SLS-005.
In addition, in February, Seelos assumed a collaborative agreement with Team Sanfilippo Foundation (TSF) as part of the aforementioned acquisition.
In March, Seelos acquired a license to technology developed at UCLA that relates to a family of rationally-designed peptide inhibitors that target the aggregation of alpha-synuclein (α-synuclein). Seelos has named this program SLS-007.

Update on Pipeline Development

Seelos will webcast its presentation at the Jefferies 2019 Healthcare Conference at 8am (ET) on Friday, June 7th. Investors can access this presentation using this link:
View Source
SLS-002 (intranasal racemic ketamine)
In line with our investigational new drug (IND) program, preparations are underway to initiate our phase I in Q3 2019 to further evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interactions (DDI) of SLS-002 in patients with post-traumatic stress disorder (PTSD) at imminent suicide risk (suicidality).
SLS-005 (Trehalose)
Seelos is finalizing the protocol for an FDA/EMA open-label phase IIb/III trial in Sanfilippo syndrome type A and B patients.
Based on an overwhelming response from the Sanfilippo community worldwide, TSF, in collaboration with Seelos Therapeutics, has decided to expand inclusion of Sanfilippo type C and D patients as well as type A and B patients who do not meet the trial entry criteria into a separate expanded patient access study.
SLS-007 (Peptidic inhibitors)
Seelos has initiated this peptide-based approach targeting the NACore (nonamyloid component core) in Parkinson’s Disease (PD) in a proof of concept, in-vivo delivery of SLS-007 in a PD transgenic mice model in Q2 2019.