On July 6, 2021 Celleron Therapeutics, the UK-based company developing novel medicines for cancer patients, reported encouraging early clinical data from its Hong Kong Phase I study to develop CXD101 in patients suffering from peripheral T-cell lymphoma (PTCL), a rare type of blood cancer (Press release, Celleron, JUL 6, 2021, View Source [SID1234584614]).

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!

Previously, a Phase I trial in multiple tumour types conducted in the UK demonstrated that CXD101 has an excellent safety profile. A promising signal for efficacy in multiple tumour types was observed, which led to the grant of EU Orphan Drug Designation in PTCL.

The current Phase I bridging study conducted in Hong Kong is evaluating the safety and pharmacokinetics in Chinese patients with a range of tumour types which have progressed despite multiple previous chemotherapy treatments. Together with the approved Chinese IND application, the current results open the way for the roll out of a Phase II clinical trial commencing late 2021. Preliminary imaging measurements of tumour size indicated that all patients in the first cohort showed a response, with one patient demonstrating a complete clinical response.

Professor David Kerr, Chief Medical Officer of Celleron Therapeutics, commented: "This is an important step forward in the development of CXD101 for Chinese patients. We know that the drug is clinically active in a range of haematological malignancies which are resistant to conventional chemotherapy from earlier studies conducted in the UK. Even at this early stage, the pattern of response appears to be similar in the Hong Kong study. These are important and encouraging results which endorse our Chinese drug development strategy".

On July 6, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report second quarter 2021 financial results on Thursday, July 22, 2021, before the market opens (Press release, Quest Diagnostics, JUL 6, 2021, View Source [SID1234584613]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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 conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "7895081." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-360-3307 for domestic callers or 203-369-0162 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on July 22, 2021 until midnight Eastern Time on August 5, 2021.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

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.

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 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.