On July 6, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported preliminary, unaudited revenue for the month of June 2021 (Press release, Biofrontera, JUL 6, 2021, View Source [SID1234584610]).

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 Company’s preliminary, unaudited revenue from product sales in June 2021 amounted to approximately EUR 2,626 thousand, compared to EUR 1,701 thousand in June 2020, an increase of 50%.

Preliminary revenues from product sales in the US were around EUR 1,375 thousand compared to EUR 1,235 thousand in June 2020, an increase of 11%. In Germany, revenues from product sales amounted to approximately EUR 417 thousand, compared to EUR 370 thousand in June 2020, an increase of 12%. In the rest of Europe, the Company generated product sales of around EUR 834 thousand, compared to EUR 96 thousand in June 2020, a plus of 770%. Sales in June this year include the first batch of Ameluz for reintroduction in the Scandinavian market by Galenica AB.

Preliminary unaudited revenues

Due to commercial rounding, rounding differences may occur in tables.

Due to the pandemic, the monthly and quarterly sales development is compared with sales in 2019 for increased transparency. As such, an increase of 19% in June 2021 total product sales was achieved in all markets compared to June 2019. In more detail, June 2021 sales were up by 35% in Germany and by 131% in the remaining European markets compared to June 2019. In the USA, product sales decreased by 10%. The decline was mainly caused by no or lower sales of Aktipak and Xepi, respectively, while sales of Ameluz were at a comparable level.

In Q2 2021, product sales in all markets were up by around 10% compared to Q2 2019. Sales in Q2 2021 increased by around 19% in Germany and by almost 83% in the rest of the European market compared to Q2 2019. Revenue in the US market was down 4%, mainly due to the lack of or lower sales of Aktipak and Xepi, while sales of Ameluz showed a slight increase compared to Q2 2019.

On July 6, 2021 Eureka Therapeutics, Inc. reported that Eureka and Memorial Sloan Kettering Cancer Center (MSK) entered into a license agreement with Sanofi for the non-CAR use of a novel, human binding domain targeting GPRC5D (G Protein-Coupled Receptor Family C Group 5 Member D). The GPRC5D binding domain was discovered using Eureka’s proprietary E-ALPHA antibody discovery platform and developed under a collaboration agreement between Eureka and MSK.

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!

"GPRC5D is a novel target that has emerged as a promising option for the treatment of multiple myeloma, particularly for patients who have relapsed from other therapies," said Dr. Eric L. Smith, myeloma physician-scientist and an inventor on the patents.

"We are delighted to contribute technology for the development of next generation therapies against multiple myeloma," said Dr. Cheng Liu, President and Chief Executive Officer of Eureka Therapeutics. "Targeting GPRC5D has the potential to improve the durability of response from current therapies and to improve the long-term clinical benefits for patients."

Under the terms of the agreement, Sanofi has exclusive rights to the GPRC5D binder for non-CAR use. Eureka and MSK are eligible to receive an upfront payment and over $1 billion of potential development, regulatory and sales milestone payments. Eureka and MSK are also eligible to receive tiered royalties on net sales.

ABOUT MULTIPLE MYELOMA

Multiple myeloma is a cancer that affects a type of white blood cells called plasma cells that are specialized mature B-cells, which secrete antibodies to combat infections. Multiple myeloma is characterized by the uncontrolled proliferation of neoplastic plasma cells in the bone marrow, where they overcrowd healthy blood cells. Multiple myeloma is the second most common hematologic cancer and affects approximately 130,000 people. Each year, about 32,000 people in the US are diagnosed with multiple myeloma.

On July 6, 2021 Y-mAbs Therapeutics, Inc. ("Y-mAbs", NASDAQ: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that SciClone Pharmaceuticals (Holdings) Limited ("SciClone Pharmaceuticals") has submitted the Biologics License Application ("BLA") for DANYELZA (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma to the National Medical Products Administration ("NMPA") of China (Press release, Y-mAbs Therapeutics, JUL 6, 2021, View Source [SID1234584611]).

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!

Zhao Hong, the Chief Executive Officer and president of SciClone Pharmaceuticals, said: "Thanks to NMPA’s reform to accelerate the launch of global innovative drugs in China, we are excited that within just seven months after FDA’s approval of DANYELZA, we have been able to submit our BLA to the NMPA in China. We are very pleased about the progress we are making and look forward to providing this innovative therapy to pediatric patients in China as quickly as possible."

"We are pleased with the development capabilities of SciClone Pharmaceuticals resulting in accelerated timelines for submitting the DANYELZA BLA in China. We believe this BLA submission marks another important milestone in our aim to make DANYELZA globally available and address a clear unmet medical need for families in China. We look forward to working closely with SciClone Pharmaceuticals on the production and logistic planning of DANYELZA, if approved by the NMPA, to make sure it will be in the market soon," commented Thomas Gad, founder, Chairman and President at Y-mAbs.

Researchers at MSK developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

On July 6, 2021 Biocept, Inc. (NASDAQ: BIOC), a leading provider of molecular diagnostic assays and services, reported that it has been awarded a South Korean Patent for its Primer-Switch technology, which detects rare mutations in circulating tumor DNA (ctDNA) using real-time PCR and associated analysis methods (Press release, Biocept, JUL 6, 2021, View Source [SID1234584627]). The patent (No. 2252447) is titled Methods for Detecting Nucleic Acid Sequence Variants.

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!

This is the fourth issued patent for the technology, which identifies rare cancer biomarkers found in tissue, blood, and cerebrospinal fluid (CSF). Primer-Switch provides a unique method for specifically enriching patient specimens for mutations of interest. It can be used to enhance the performance and specificity of the PCR method, the most widely used amplification approach for research and clinical diagnostic applications. It also enables the interrogation of fragmented DNA that is often found in biological fluids.

"Primer-Switch methodology adds to the capabilities of our Switch-Blocker technology used in our Target Selector assays, providing key information about cancer biomarkers to aid physician decision-making, with the goal of improving outcomes for patients with cancer," said Michael Nall, Biocept’s President and CEO. "Our strong and growing intellectual property portfolio enables Biocept to develop and commercialize our highly differentiated technologies and testing services."

Biocept’s core technologies and products are protected by more than 70 issued patents in the U.S., EU, Australia, China, Japan, and South Korea, as well as other countries. This includes worldwide patent protection on its highly sensitive methods for detecting cancer biomarkers that are used by physicians for treatment decisions.

On July 6, 2021 Sirnaomics, Inc., a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that the company’s IND application for a systemic siRNA (small interfering RNA) drug candidate STP707 received the U.S. Food and Drug Administration (FDA) acknowledgment "Study May Proceed", in patients with advanced solid tumors (Press release, Sirnaomics, JUL 6, 2021, View Source [SID1234584612]). This "Phase 1 Multicenter, Open-Label, Dose Escalation Study and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of STP707 Administered Intravenously in Subjects with Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy" is expected to begin enrolling in coming months.

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!

Sirnaomics’ lead product candidate, STP707, is an anti-cancer siRNA (small interfering RNA) therapeutic. It takes advantage of a dual-targeted inhibitory property and a proprietary polypeptide nanoparticle (PNP)-enhanced targeted delivery to solid tumors and metastatic tumors via systemic administration. Initial preclinical study has demonstrated that knocking down TGF-β1 and COX-2 gene expression simultaneously in tumor microenvironment increases active T cell infiltration. A further combination study demonstrated a synergistic antitumor activity between STP707 and PD-L1 antibody using a mouse orthotopic liver cancer model.

"The IND green light from the US FDA for Sirnaomics’ first IV oncology drug, STP 707, represents another major milestone for the company’s mission in discovery and development of novel siRNA therapeutics for unmet clinical needs. Sirnaomics’ drug target selection and tumor targeting delivery should support a high rate of success for novel anticancer siRNA therapeutics, which have been verified in our clinical and preclinical studies" said the Founder and CEO of the company, Dr. Patrick Y. Lu. "Sirnaomics is currently in a strong position to lead the RNAi community in the development of novel oncology therapeutics."

"This IND approval represents a sentinel moment for the company as we can now expand our therapeutic reach in IV administration. This will allow more opportunities to target critical diseases with high unmet clinical need," stated Chief Medical Officer, Michael Molyneaux M.D. "We expect that our rigorous oncology basket clinical study design will enable us to gain great insights into the impact of STP707 on multiple solid tumor types. Our IND enabling non-clinical studies with STP707 demonstrated an excellent safety profile as well as very good efficacy in multiple tumor types."

About STP707

STP707 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively, formulated in nanoparticles with a Histidine-Lysine Co-Polymer (HKP+H) peptide as the carrier. The specific carrier peptide is distinct from the carrier used in Sirnaomics’ STP705 product. Each individual siRNA was demonstrated to inhibit the expression of their target mRNAs, and combining the two siRNA’s produces a synergistic effect that diminishes pro-inflammatory factors. The drug substances in STP707 are two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively. Over-expressions of TGF-β1 and COX-2 have been well-characterized in playing key regulatory roles in tumorigenesis. In preclinical studies with STP707, intravenous (IV) delivery resulted in knock-down of TGF-β1 and COX-2 gene expressions in various organs including liver and lung. In addition, in preclinical models STP707 had antitumor activity in various solid tumor types.