On September 26, 2019 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (the "Company") reported that Peter Greenleaf, President and Chief Executive Officer of Aurinia, will participate in a fireside chat at the 2019 Cantor Global Healthcare Conference on Wednesday, October 2, 2019 at 1:15 p.m. ET in New York, NY (Press release, Aurinia Pharmaceuticals, SEP 26, 2019, View Source [SID1234539813]).

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 presentation will be webcast live and can be accessed via the investor section of the Aurinia website, www.auriniapharma.com. A replay of the presentation will also be archived on the Company website for thirty days following the event.

On September 26, 2019 Samsung Bioepis Co., Ltd. reported results from the Phase 3 study evaluating the efficacy and safety of SB8, a bevacizumab biosimilar candidate, compared to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) (Press release, Samsung Bioepis, SEP 26, 2019, View Source [SID1234539830]).ii The study results will be presented for the first time today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress in Barcelona, Spain.

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!

"Data from this study showed that there were no clinically meaningful differences between SB8 and reference bevacizumab in terms of efficacy, safety, pharmacokinetics and immunogenicity," said Chul Kim, Senior Vice President and Head of Clinical Sciences Division, Samsung Bioepis. "We are committed to increasing access to high-quality, life-changing oncology medicines through the development of biosimilars to address some of oncology’s most pressing challenges."

The primary endpoint of the study was the overall response rate (ORR) by 24 weeks; risk ratio was analyzed in the full analysis set (FAS) with pre-defined equivalence margin of 0.737 to 1.357 and the risk difference was analyzed in the per-protocol set (PPS) with pre-defined equivalence margin of ±12.5%. The ORR in FAS was 47.6% for SB8 and 42.8% for reference bevacizumab; the risk ratio was 1.11 (90% CI: 0.975, 1.269). The ORR in PPS was 50.1% for SB8 and 44.8% for reference bevacizumab; the risk difference was 5.3% (95% CI: −2.2%, 12.9%). The median progression-free survival (8.5 months vs 7.9 months) and overall survival (14.9 months vs. 15.8 months) were comparable between SB8 and reference bevacizumab. The overall incidence of treatment-emergent adverse events (92.1% vs 91.1%) and the incidence of overall anti-drug antibodies (16.1% vs 11.0%) were also comparable between SB8 and reference bevacizumab.

Marketing Authorization Application (MAA) for SB8 was accepted for review by the European Medicines Agency (EMA) in July 2019.

The results of the SB8 Phase 3 study will be presented as a poster during ESMO (Free ESMO Whitepaper) as follows: [1565P] 12:00-13:00, September 28, Hall 4. Samsung Bioepis will also host a satellite symposium, titled ‘Quality Assurance to Optimize HER2+ Breast Cancer Treatment’, which will discuss the importance of quality maintenance in oncology biologics. The symposium will take place between 13:00-14:30 on September 30, 2019 in Toledo Auditorium, Hall 5, Fira Gran Via, Barcelona. Topics include:

Building confidence in biosimilars
Acknowledging importance of biologics quality in clinical practice
Reassuring biosimilarity based on clinical evidence
Interactive discussion: perspective on biosimilars in oncology
SB8 Phase 3 Study

The SB8 Phase 3 study is a randomized, double-blind, multicenter study evaluating the efficacy, safety, pharmacokinetics (PK), and immunogenicity of SB8 compared to reference bevacizumab in combination with paclitaxel and carboplatin in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). 763 patients were randomized (1:1) to receive SB8 or reference bevacizumab with paclitaxel and carboplatin Q3W followed by SB8 or reference bevacizumab maintenance therapy until disease progression, unacceptable toxicity, death, or 1 year from the randomization of the last patient. The primary endpoint is the overall response rate (ORR) which is defined as the proportion of patients whose best overall response by 24 weeks is either complete response or partial response. Secondary endpoints were progression free survival (PFS), overall survival (OS), duration of response (DOR), safety, PK, and immunogenicity.

On September 26, 2019 On September 26, 2019, XOMA (US) LLC (the "Company"), a wholly-owned subsidiary of XOMA Corporation, reported that it has entered into a royalty purchase agreement (the "Purchase Agreement") with Palo Biofarma, S.L. ("Palo"), a company organized and existing under the laws of Spain (Filing, 8-K, Xoma, SEP 26, 2019, View Source [SID1234552230]). Pursuant to the Purchase Agreement, the Company acquired the rights to potential royalty payments in low single digit percentages of aggregate Net Sales (as defined in the Purchase Agreement) associated with six drug candidates in various clinical development stages, targeting the adenosine pathway with potential applications in solid tumors, asthma/chronic obstructive pulmonary disease, inflammatory bowel disease, idiopathic pulmonary fibrosis, lung cancer, psoriasis and nonalcoholic steatohepatitis and other indications (the "Licensed Products") that are being developed by Palo. Novartis Pharma AG is a development partner on one of the Licensed Products (the "Licensee") and such Licensed Product is being developed pursuant to a license agreement between Palo and the Licensee.

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!

Under the terms of the Purchase Agreement, the Company will pay Palo $10 million (the "Payment") for the rights to potential royalty payments on future sales of the Licensed Products. The Company plans to partially finance the Payment by drawing a $5 million term loan under its Loan and Security Agreement with Silicon Valley Bank dated May 7, 2018, as amended on March 4, 2019, as previously filed as an exhibit to the Company’s Quarterly Reports on Form 10-Q for the three month period ending June 30, 2018 and the three month period ending March 31, 2019.

The Purchase Agreement also contains customary representations, warranties, covenants and indemnities. The Purchase Agreement will terminate six (6) months following the full satisfaction of any amounts due under any of the License Agreements (as defined in the Purchase Agreement) and receipt by the Company of all payments to which it is entitled under the Purchase Agreement.

The description of the Purchase Agreement contained herein does not purport to be complete, and is qualified in its entirety by reference to such Purchase Agreement, together with the exhibits thereto, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ending September 30, 2019.

On September 26, 2019 Black Diamond Therapeutics, Inc., a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies, reported that preclinical data defining the molecular mechanism for oncogenic activation of families of epidermal growth factor receptor (EGFR) allosteric mutations and showing activity of the Company’s lead product candidate BDTX-189 will be presented at the European Society for Medical Oncology Congress 2019, taking place from September 27 to October 1, 2019 in Barcelona, Spain (Press release, Black Diamond Therapeutics, SEP 26, 2019, View Source [SID1234539814]).

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!

Black Diamond’s presentation, entitled "Oncogenic Mutations at the Dimer Interface of EGFR Lead to Formation of Covalent Homo-dimers and Allosteric Activation of the Kinase Domain: A Mechanism Which Alters the Selectivity Profile of Oncogenic EGFR," will be presented Saturday, September 28, 2019 at 12:00 CEST, as part of the Developmental Therapeutics data session (Presentation 501P).

Elizabeth Buck, Ph.D., Co-Founder and Executive Vice President, Discovery and Translational Sciences said, "Despite clinical success with targeting EGFR ATP-site mutants, there are currently no drugs approved by the FDA to target allosteric EGFR mutations with a single therapy, including for patients with glioblastoma or lung cancer that express these mutations. Utilizing our Mutation-Allostery-Pharmacology, or MAP, platform, we defined the molecular mechanism for oncogenic activation of families of EGFR allosteric mutations and revealed how this mechanism decreases the efficacy of current generation of small molecule ATP-site inhibitors ineffective against these mutations."

"These preclinical data illustrate how BDTX-189, a novel ATP-site small molecule, selectively inhibits the activity of a broad range of allosteric EGFR and HER2 mutants, producing growth regression of allosteric EGFR mutant patient-derived tumors in vivo," added Dr. Buck.

MAP platform

Black Diamond’s Mutation-Allostery-Pharmacology (MAP) platform is built on three central pillars – discover, reveal, and target. The Company uses population-level cancer genetic data obtained from all tumor types to identify potential families of mutations that occur within individual oncogenes and rank the mutations for potential oncogenicity. Black Diamond then uses its MAP platform to understand the mechanism for oncogenic activation and its team of experienced medicinal chemists then develops mutation spectrum-selective drugs for the identified targets. Black Diamond’s MAP platform has generated a pipeline of orally available, potent and selective small molecule kinase inhibitors that target a range of driver mutations in cancer.

About BDTX-189

BDTX-189 is designed to be an orally available, irreversible small molecule inhibitor that targets undrugged oncogenic driver mutations of the ErbB kinases in epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2). These include extracellular domain allosteric mutations of HER2, as well as EGFR and HER2 domain exon 20 insertions, and additional activating oncogenic drivers of ErbB. The ErbB receptors are a group of receptor tyrosine kinases involved in key cellular functions, including cell growth and survival. Currently, there are no medicines approved by the U.S. Food and Drug Administration to target all of these oncogenic mutations with a single therapy. Black Diamond Therapeutics is completing investigational new drug (IND)-enabling activities for BDTX-189 and plans to start a combined Phase 1/2 clinical trial in the first half of 2020.

On September 26, 2019 Precision Optics Corporation, Inc. (OTCQB: PEYE), a leading designer and manufacturer of advanced optical instruments for the medical and defense industries, reported operating results on an unaudited basis for its fourth quarter and fiscal year ended June 30, 2019 (Press release, Precision Optics, SEP 26, 2019, View Source [SID1234539831]).

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!

Fourth quarter fiscal 2019 highlights:

Revenue for the quarter (ended June 30, 2019) was $2.4 million compared to $1.5 million in the same quarter of the previous fiscal year, an increase of 63% driven primarily by an increase in production revenue for medical devices that incorporate the Company’s Microprecision technology, as well as one month of contribution from Ross Optical.
Ross Optical contributed $656,000 to Precision Optics’ revenue during the month of June 2019.
Production revenue was $912,000 in the quarter, an increase of 18% compared to $770,000 in the same quarter of the previous fiscal year.
Gross margins of 36% in the quarter continued to improve sequentially for the second consecutive quarter.
Net loss of $109,000 during the quarter included $128,000 of business acquisition expenses and $117,000 of stock-based compensation.
Fiscal year 2019 highlights:

Revenue for the fiscal year (ended June 30, 2019) was $6.8 million compared to $4.0 million in the previous fiscal year, an increase of 69%.
Production revenue during the fiscal year increased 140% to $3.7 million compared to $1.5 million in the previous fiscal year.
Excluding the one-month contribution from Ross Optical, the fiscal year revenue was $6.1 million, an increase of 52% compared to the previous fiscal year.
Pro forma (assuming a full year of Ross Optical) financial highlight:

For the 12 months of fiscal year 2019 (ended June 30, 2019), pro forma financial results show a combined organization (Precision Optics and Ross Optical) with $10.5 million in sales and gross margin of approximately 36%.
Precision Optics’ CEO, Joseph Forkey, commented, "Our financial results from the fourth quarter and from fiscal year 2019 overall, continue to demonstrate the success of our business model. By utilizing our proprietary optical technology to develop and manufacture state-of-the art custom medical imaging products, we enable the world’s leading medical device companies to bring next generation, minimally invasive devices and 3D surgical robotic systems to market. The transition of a number of these Precision Optics enabled projects to commercialization by our customers drove a 140% increase in production revenues during fiscal 2019. Based on order visibility on currently commercialized products, as well as expected near-term commercialization of products currently in our pipeline, we believe fiscal 2020 should be another strong year for Precision Optics."

Dr. Forkey continued, "Fiscal 2019 was a milestone year for us also because of the acquisition of Ross Optical Industries. We completed this acquisition – the first ever for Precision Optics – on July 1st. One of the benefits of the acquisition is that it expands our readily accessible customer base, particularly in the defense industry, where we believe there are opportunities for use of our Microprecision micro optics and imaging systems. The acquisition also extends our product offering to include a wider range of lens and optical system sizes, drives economies of scale within our organization, and allows the combined company to leverage our technical proficiency in offering end-to-end solutions to the expansive Ross Optical customer base. We look forward to the many opportunities we believe are available to drive further growth and efficiencies in 2020 and beyond."

The following table summarizes the fourth quarter (unaudited) and year results for the periods ended June 30, 2019 and 2018:

Conference Call Details
The Company has scheduled a conference call to discuss the fiscal year end and fourth quarter 2019 financial results for Thursday, September 26, 2019 at 5:00 p.m. EDT.

Call-in Information: Interested parties can access the conference call by dialing (877) 317-6789 or (412) 317-6789.

Live Webcast Information: Interested parties can access the conference call via a live Internet webcast, which is available at View Source

Replay: A teleconference replay of the call will be available until October 3, 2019 at (877) 344-7529 or (412) 317-0088, confirmation #10135010. A webcast replay will be available at View Source