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TransThera announces an oral presentation of tinengotinib clinical data in breast cancer at SABCS 2023

On December 7, 2023 TransThera Sciences (Nanjing) Inc., a clinical-stage biopharmaceutical company focused on inventing differentiated drugs for global patients, reported that an oral presentation of tinengotinib clinical data in breast cancer was delivered at 2023 San Antonio Breast Cancer Symposium (SABCS) annual meeting (Press release, TransThera Biosciences, DEC 7, 2023, View Source;transthera-announces-an-oral-presentation-of-tinengotinib-clinical-data-in-breast-cancer-302008583.html [SID1234638267]).

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Rapid-Fire Mini-Oral Presentation, Abstract #RF01-07

Title: The efficacy and safety of tinengotinib in patients with advanced or metastatic HR+/HER2- breast cancer or TNBC
Presenter: Sarina A. Piha-Paul, MD
Presentation time: December 6, 2023, 12:15 PM – 1:00 PM (CT)

Results: As of October 1, 2023, 36 patients (pts) with heavily pretreated (median 5 prior lines) metastatic breast cancer (BC) were treated.

Promising clinical benefit:
28 pts receiving tinengotinib monotherapy were efficacy evaluable. 11 pts with HR+/HER2- BC achieved overall response rate (ORR) of 45%, clinical benefit rate (CBR, CR+PR+SD ≥ 24 weeks) of 64%, disease control rate (DCR) of 82% and median progression-free survival (mPFS) of 5.68 months. Partial responses were observed in 3 pts with HER2-zero and 2 pts with HER2 low (1+/2+) pts, respectively. One patient has been on the treatment for over 17 months and is still on-going. 17 pts with TNBC had ORR of 24%, CBR of 29%, DCR of 71% and mPFS of 2.73 months. Notably, 5 TNBC patients who were originally diagnosed as HR+/HER2- breast cancer had achieved 3 partial responses and 2 stable diseases.
Among 6 pts treated with tinengotinib in combination with nab-paclitaxel, 1 TNBC patient achieved PR and the treatment duration lasted for 6.5 months. 3 patients achieved stable diseases.
About tinengotinib

Tinengotinib is an innovative, global phase III stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells and improving the tumor microenvironment. Ongoing clinical trials in the US and China have revealed the potential of tinengotinib to be efficacious in various solid tumors. It was granted the Orphan-Drug Designation and Fast Track Designation by the FDA for the treatment of CCA. In July 2023, tinengotinib was granted the Breakthrough Therapy Designation (BTD) by NMPA in China.

FDA Approves Bio-Thera Solutions’ Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin

On December 7, 2023 Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, reported that the United States Food and Drug Administration (FDA) has approved Avzivi (bevacizumab-tnjn), a biosimilar referencing Avastin (Press release, BioThera Solutions, DEC 7, 2023, View Source [SID1234638265]). Avzivi is Bio-Thera’s second USFDA approved product and is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA approval in the United States.

The FDA approval of Avzivi was based on a comprehensive analytical, non-clinical and clinical data package submitted by Bio-Thera to the FDA. Extensive analytical characterization between BAT1706 and US and EU Avastin was conducted on structural, physicochemical, and biological properties to support biosimilarity of BAT1706. A randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety, and immunogenicity of BAT1706 with both the US and EU Avastin in healthy volunteers. A randomized, double-blind, three-arm parallel phase III study compared BAT1706 with Avastin for efficacy, safety, and immunogenicity in subjects with advanced non-squamous non-small cell lung cancer. The totality of the evidence demonstrated that BAT1706 has similar efficacy, safety, immunogenicity and quality as the reference product bevacizumab.

"Bevacizumab has been widely used in the treatment for lung and colorectal cancers and many other cancers around the world," commented professor Li Zhang, leading investigator for global phase III study of Avzivi. "The global phase III clinical trial has confirmed that Avzivi is highly similar to Avastin in terms of efficacy, safety and immunogenicity. The approval of Avzivi by the FDA will provide lung and colorectal cancer patients a new cost-effective treatment option. We hope Bio-Thera continues to make more high-quality biosimilars available to patients around the world."

"The approval of Avzivi is another landmark accomplishment for Bio-Thera as it marks Bio-Thera’s second FDA approved product in the United States," said Shengfeng Li, CEO at Bio-Thera. "As our biosimilar pipeline continues to mature, we intend to seek more approvals of biosimilars, expanding patient access to important therapies."

Bio-Thera and Sandoz entered into a license and commercialization agreement for Avzivi (BAT1706) in September 2021. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Sandoz is responsible for the commercialization of Avzivi in the United States and other countries around the world.

About Avzivi (bevacizumab-tnjn)
Avzivi (bevacizumab-tnjn) is a humanized monoclonal antibody that targets VEGF. It specifically binds to VEGF and blocks the binding of VEGF to its receptor, thereby reducing neovascularization, inducing the degradation of existing blood vessels, and thereby inhibiting tumor growth. The original company name for Avzivi is BAT1706. In the United States, Avzivi is indicated for the treatment of 1) Metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment, 2) Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (Limitation of Use: not indicated for adjuvant treatment of colon cancer), 3) Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment, 4) Recurrent glioblastoma in adults, 5) Metastatic renal cell carcinoma in combination with interferon alfa, 6) Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan, 7) Epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens.

Regor Announces Promising Safety And Single Agent Efficacy Data Evaluating RGT-419B In HR+/HER2- Advanced Breast Cancer Patients Who Have Progressed On CDK4/6 Inhibitors And Endocrine Therapy

ON December 7, 2023 Regor Therapeutics Group ("Regor"), a global innovator powered by cutting-edge drug discovery engine and differentiated clinical development pipeline, reported the results from Phase 1A single agent dose escalation study of RGT-419B, a next generation CDK4 inhibitor, in HR+ HER2- ABC patients who have progressed on prior CDK4/6is and ET (Press release, Regor Therapeutics, DEC 7, 2023, View Source;advanced-breast-cancer-patients-who-have-progressed-on-cdk46-inhibitors-and-endocrine-therapy-302009555.html [SID1234638264]). These results (cutoff date September 26, 2023) were presented today in poster session by Dr. Seth Wander from Massachusetts General Hospital at the San Antonio Breast Cancer Symposium (SABCS) taking place December 5-9, 2023, in San Antonio, Texas. The poster titled "First-in-human Phase 1A study of RGT-419B, a next generation CDK4 inhibitor, in patients with HR+/HER2- ABC who have progressed on prior CDK4/6 inhibitors (PO3-18-06; NCT05304962)", highlighted that:

Across 12 patients with HR+HER2- ABC who have progressed on CDK4/6is and ET, RGT-419B administered as oral (PO) monotherapy in continuous 28-day cycles was safe and well-tolerated with no dose-limiting toxicities. No patients discontinued treatment with RGT-419B due to an adverse event.
The exposure of RGT-419B was dose proportional with long half-life and small peak to trough ratio at steady state.
RGT-419B demonstrated single agent efficacy in the heavily pretreated HR+/HER2- ABC patients who have progressed on CDK4/6i and ET. Three patients achieved partial responses and are still on treatment. 6 patients received treatment > 24 weeks.
The promising single agent efficacy of RGT-419B is consistent with the preclinical data from CDK4/6i resistant breast cancer models.
"RGT-419B demonstrates its potential to be the best-in-class next generation CDK4 inhibitor for HR+/HER2- breast cancer. The results presented today is encouraging because RGT-419B is not only safe and well tolerated, but also demonstrated single agent efficacy in heavily pre-treated HR+ HER2- ABC patients who progressed on the approved CDK4/6i and ET." said Xiayang Qiu Ph.D., Chief Executive Officer of Regor Therapeutics Group. "These data show that RGT-419B has monotherapy opportunity in HR+ HER2- ABC patients resistant to the approved CDK4/6i and ET. With the favorable safety profile and promising monotherapy efficacy, RGT-419B has best-in-class potential as a single agent or in combination in HR+HER2- BC patients resistant to CDK4/6i, and in earlier lines of treatments. Clinical studies of single agent dose expansion and combination of RGT-419B with ET are underway."

The Phase 1 trial (NCT05304962) is a multicenter, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of RGT-419B given as monotherapy or in combination with ET in patients with HR+HER2- ABC who have progressed on CDK4/6i and ET.

Copies of the posters are available on Regor’s website under the Science section.

Bugworks Research Inc. to Present Poster at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2023, in Geneva, Switzerland

On December 7, 2023 Bugworks Research Inc., a clinical-stage biopharmaceutical company, reported that it is presenting the research findings on its novel, best-in-class, dual-acting adenosine antagonists BWC2094 and BWC2562 with the potential to treat a variety of hard-to-treat cancers, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2023 in Geneva, Switzerland on 7th December (Press release, Bugworks Research, DEC 7, 2023, View Source [SID1234638263]).

The poster highlights two lead molecules discovered from structure and property-guided drug discovery platform. The molecules demonstrate potent A2A/A2B dual antagonism across a variety of pathologically relevant models that recapitulate the high adenosine driven immunosuppression found in the tumour microenvironment (TME) across several cancers. To build differentiation and improve clinical translation, AI/ML driven virtual trials were employed to identify potential combination drugs, and to guide in patient selection during clinical development. BWC2094 and BWC2562 demonstrate synergistic activity in combination with approved cancer drugs in human peripheral blood assays and proprietary patient-derived ex vivo tumor explant platform as measured by a reduction in the tumor density and increased apoptosis/necrosis. Additionally, these molecules demonstrate good oral bioavailability in rodents and dogs and were found to be well tolerated for 14 days in dose-range finding toxicological studies in preclinical species. Based on the totality of evidence, BWC2094 is ready for IND submission.

Bugworks Research is at the forefront of developing novel small molecule drugs to combat hard-to-treat cancers and drug-resistant bacterial infections. The company is building a deep pipeline of differentiated oncology programs that target critical pathways involved in cancer progression and treatment evasion.

The ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress is an annual event offering a forum to present the latest scientific and clinical developments in immunotherapy to diverse stakeholders with an interest to deliver innovative treatments for cancer. Attendees are invited to visit the Bugworks poster on December 7th, 2023, between 12.00-1.00 CET.

APDN Announces Fourth Quarter Fiscal Year 2023 Financial Results

On December 7, 2023 Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, reported consolidated financial results for its fourth quarter ended September 30, 2023 (Press release, Applied DNA Sciences, DEC 7, 2023, View Source [SID1234638262]).

"Our fiscal fourth quarter concludes a productive year during which we took a number of critical steps that place us firmly in the execution phase of our pivot to a biotherapeutic manufacturing-first growth strategy," stated Dr. James A. Hayward, president and CEO of Applied DNA. "We closed on the strategic acquisition of Spindle Biotech that empowered the launch of our Linea IVT platform, initiated the build-out of an initial GMP manufacturing footprint to produce critical mRNA starting materials, acquired what we believe to be an enviable base of early-phase customers for both our Linea DNA and Linea IVT platforms, and affirmed our capacity for the rapid production of multi-gram quantities of Linea DNA. Cumulatively, these steps expand our relevance into the growing and diverse value chain of genetic medicine manufacturing with a near-term focus on enabling our customers to produce better mRNA faster.

"At our ADCL clinical lab and supply chain traceability segments, progress has been slower than hoped for due to the ongoing review of our pharmacogenomics assay and testing service by New York State Department of Health’s and as we pursue initiatives to migrate our seasonal cotton tagging business into a year-around revenue stream, respectively."

Continued Dr. Hayward, "Looking ahead to fiscal 2024, we believe that continued biotherapeutics segment momentum and anticipated continued expansion in genetic medicine manufacturing demand, particularly for mRNA, can drive segment growth in the coming fiscal year. Our optimism is founded in our proprietary Linea IVT platform that enables the cell-free, enzymatic production of critical mRNA starting materials with unprecedented flexibility, speed, scale, and costs. We believe that this platform offers the industry the ability to outperform conventional mRNA production processes at the exact time the industry is seeking differentiation and is embracing next-generation, fully enzymatic workflows."

"Furthermore, our planned GMP capacity for critical mRNA starting materials is expected to now come online in the first half of calendar 2024, subject to the availability of financing, that will for the first time enable us to support current and new customers’ migration to the clinic with mRNA drug candidates. We believe this capacity will be a catalyst for our procurement of larger-scale supply agreements for our platforms. Additionally, we will continue to invest for the future with a focus on platform optimization and data generation to enhance Linea DNA’s standing as an alternative source of DNA for all genetic medicines. While we expect fiscal 2024 to be a milestones-driven year for us given the biotherapeutics industry’s ongoing investment in mRNA, longer term, we believe the future of our Linea DNA platform is not constrained to critical starting materials for mRNA production and have already secured research use only orders and are starting to build a backlog for in vitro diagnostics, gene editing/therapy and adoptive cell therapy applications."

Summary Fourth Quarter Fiscal 2023 Financial Results:

Total revenues were approximately $780 thousand for the three-month period September 30, 2023, compared to $3.6 million for the same period in the prior fiscal year. The decrease in revenue of approximately $2.8 million was due to an expected decline in COVID-19 testing services revenue of $2.4 million driven primarily by cancellation of the testing contract with City University of New York (CUNY) in June 2023. The decrease was also due to a reduction in product revenue of $341 thousand. The decline in product revenues is primarily related to a decrease in the textiles market due to a decline year-over-year in cotton DNA tagging revenue.
Gross profit for the three-month period ended September 30, 2023, was $79 thousand, compared to $417 thousand for the three-month period ended September 30, 2022. The gross profit percentage was 10% and 12% for the three-month periods ended September 30, 2023, and 2022, respectively. The decline in gross profit year-over-year is due to a higher percentage of COVID-19 surveillance testing services revenue in the three-months ended September 30, 2022, that generated a higher gross profit compared to the same period in the current fiscal year.
Operating loss decreased to $4.2 million for the three-month period ended September 30, 2023, as compared to $4.3 million for the fourth quarter of fiscal 2022. The decrease in operating loss is the result of lower operating expenses during the fourth quarter of fiscal 2023 by $419 thousand, offset by the decline in revenue discussed above. The decrease in operating expenses was primarily due to a decrease in payroll and insurance expenses.
Net loss was $3.6 million for the three-month period ended September 30, 2023, compared to $665 thousand for the fourth quarter of 2022.
Excluding non-cash expenses, Adjusted EBITDA was a negative $3.5 million for the three-month period ended September 30, 2023, compared to a negative $3.4 million for the same period in fiscal 2022.
Cash and cash equivalents stood at $7.2 million on September 30, 2023, compared with $10.8 million as of June 30, 2023.
Fourth Quarter Fiscal 2023 Conference Call Information
The Company will hold a conference call and webcast to discuss its fourth quarter of fiscal year 2023 financial results on Thursday, December 7, 2023, at 4:30 PM ET. To participate in the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, not all questions may be answered.

To Participate, please ask to be joined to the ‘Applied DNA Sciences’ call:

Domestic callers (toll free): 844-887-9402
International callers: 412-317-6798
Canadian callers (toll free): 866-605-3852
Live and replay of webcast: View Source