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European Medicines Agency (EMA) Approves Bio-Thera Solutions’ BAT1706 (Avzivi®, bevacizumab), a biosimilar referencing Avastin

On July 30, 2024 Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, reported that the EMA has approved BAT1706 (bevacizumab), a biosimilar referencing Avastin (Press release, BioThera Solutions, JUL 30, 2024, View Source [SID1234645181]). Sandoz AG and its affiliates have rights to market BAT1706 in Europe under the brand name Avzivi. BAT1706 is Bio-Thera’s second EMA approved product and Bio-Thera’s second product to receive marketing authorization from NMPA, US FDA and EMA.

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"The EMA approval of BAT1706 is another significant accomplishment for Bio-Thera as it marks Bio-Thera’s second EMA approved product," said Shengfeng Li, CEO at Bio-Thera. "As our biosimilar pipeline continues to mature, we intend to seek more biosimilar approvals, expanding patient access to important therapies."

Bio-Thera and Sandoz AG entered into a license and commercialization agreement for BAT1706 (Avzivi) 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 European Union, the United States and other countries around the world.

About BAT1706 (Avzivi, bevacizumab)

BAT1706 (Avzivi, bevacizumab) 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 brand name for BAT1706 in the EU and the United States is Avzivi. In the Europe, Avzivi is indicated for the treatment of 1) Metastatic carcinoma of the colon or rectum, in combination with fluoropyrimidine-based chemo-therapy is indicated for treatment of adult patients, 2) Metastatic breast cancer, in combination with paclitaxel is indicated for first-line treatment of adult patients, 3) Metastatic breast cancer, in combination with capecitabine is indicated for first-line treatment of adult patients in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avzivi in combination with capecitabine. 4) Unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology, in addition to platinum-based chemotherapy is indicated for first-line treatment of adult patients, 5) Unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations, in combination with erlotinib, is indicated for first-line treatment of adult patients, 6) Advanced and/or metastatic renal cell cancer, in combination with interferon alfa-2a is indicated for first line treatment of adult patients, 7) Advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients, 8) Platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel in adult patients with first recurrence who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents, 9) Platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin in adult patients who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents, 10) Persistent, recurrent, or metastatic carcinoma of the cervix, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in adult patients who cannot receive platinum therapy.

Pinetree Therapeutics Closes $17 Million in Series A Funding to Advance AbReptor™ Protein Degradation Platform and Portfolio Programs

On July 30, 2024 Pinetree Therapeutics, Inc. ("Pinetree" or the "Company"), an emerging biotechnology company pioneering next-generation targeted protein degraders (TPD) to combat drug resistance in oncology and beyond, reported the successful completion of a Series A funding round, raising $17 million from new and existing investors (Press release, PineTree Therapeutics, JUL 30, 2024, View Source [SID1234645180]).

The investment was co-led by STIC Investments and DSC Investment. New investors include Atinum Investment, Quantum FA, and S&S Investment, joining existing investors DSC Investment, Schmidt, and SGI Partners. The proceeds will be used to leverage the Company’s AbReptor antibody degrader platform to advance its novel multispecific TPD development programs across multiple tumor types and targets in several oncology indications, with potential application in other therapeutic areas.

"We are pleased to announce the closing of this investment round to fuel Pinetree’s novel targeted degradation approach," said Dr. Hojuhn Song, Founder and CEO of Pinetree. "Our best-in-class multispecific antibody platform, AbReptor, leverages a novel mechanism of action to degrade surface and extracellular proteins to improve outcomes across therapeutics areas. This technology enables the development of effective and versatile protein degrader molecules, including our lead preclinical degrader candidate for EGFR-mutated cancers, for which we recently announced an exclusive option and global license agreement with AstraZeneca. With our first global partnership secured, this additional funding, and with the encouraging preclinical data generated to date from AbReptor, we are excited to continue applying our scientific approach to advance additional candidates in oncology and other indications."

"We are proud to provide our continued support as part of an exceptional syndicate for Pinetree, whose promising AbReptor platform has yielded novel programs with the potential to address unmet medical needs in people living with a range of treatment-resistant diseases," said Yohan Kim, Executive Director of DSC Investment. "Recent data from Pinetree’s degrader programs solidifies our confidence in the Company’s approach, and we look forward to continuing our support for Pinetree and its platform technology and pipeline."

AbReptor is a versatile antibody-based TPD platform that functions through co-engaging a surface-receptor or extracellular protein of interest together with another proprietary receptor target. Pinetree is advancing multiple preclinical candidates derived from its AbReptor TPD platform with potential in oncology and other therapeutics areas, including candidate degraders indicated for TKI-resistant tumors, immune checkpoint inhibitor-resistant tumors, and other disease targets.

Pillar Biosciences’ FDA Approved Solid Tumor NGS Kit oncoReveal™ CDx Launched at Molecular Pathology Laboratory Network, Inc.

On July 30, 2024 Pillar Biosciences, Inc., the leader in Decision Medicine, reported that Molecular Pathology Laboratory Network, Inc., (MPLN) is now the first national molecular reference laboratory to verify and launch oncoReveal CDx (Press release, Pillar Biosciences, JUL 30, 2024, View Source [SID1234645179]).

The oncoReveal CDx pan-cancer solid tumor IVD kit has been FDA PMA approved for general tumor profiling for 22 clinically relevant genes across all solid tumors, including CDx claims for KRAS (Erbitux & Vectibix) in colorectal cancer (CRC) and EGFR (TKI Class Approval) in non-small cell lung cancer (NSCLC). oncoReveal CDx has a rapid single-day workflow that can be performed by any clinical laboratory enabled with an Illumina MiSeq Dx platform with an integrated sample-to-report time of as little as 48 hours. Up to 46 clinical samples can be performed on a single MiSeq Dx run.

"We are proud to partner with Pillar Biosciences on the global launch this important IVD assay kit," said Dr. Roger Hubbard, Ph.D., Chief Executive Officer, Molecular Pathology Laboratory Network. "MPLN’s goal is to bring innovative technologies to diagnostic care and clinical trial studies. We see this diagnostic assay as an important clinical tool to help quickly select certain cancer patients for 1st line targeted therapy or clinical trials. Given this assay was an FDA approved kit, our laboratory team was quickly able to perform full IVD assay verification within 2 weeks of training. We look forward to working with our physician network and biopharma partners to implement this new solid tumor IVD product."

"The potential of increased FDA regulation on LDTs is putting immense pressure on CLIA-certified molecular reference laboratories," said Dan Harma, Chief Commercial Officer, Pillar Biosciences. "The launch of our oncoReveal CDx now enables these laboratories with an FDA approved solid tumor assay which can be quickly and easily verified and performed in any laboratory with an Illumina MiSeq Dx NGS platform to rapidly profile patients with solid tumors. We see this as a great opportunity to improve care and reduce the delay in patients receiving targeted therapy."

Replimune to Present at Two Upcoming Investor Conferences

On July 30, 2024 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, reported that members from the Replimune management team will host investor meetings at the following two conferences (Press release, Replimune, JUL 30, 2024, View Source [SID1234645170]):

BTIG Virtual Biotechnology Conference
Dates: August 5-6, 2024

2024 Wedbush PacGrow Healthcare Conference
Date: Tuesday, August 13, 2024

Processa Pharmaceuticals Announces FDA Clearance of IND Application for a Phase 2 Clinical Trial of NGC-Cap in Breast Cancer

On July 30, 2024 Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for Next Generation Capecitabine (NGC-Cap), its lead product candidate (Press release, Processa Pharmaceuticals, JUL 30, 2024, View Source [SID1234645169]). The IND supports the initiation of a Phase 2 clinical trial in patients with advanced or metastatic breast cancer, which is expected to begin enrollment this quarter.

"We are proud to achieve this significant milestone for NGC-Cap and look forward to entering the clinic for the treatment of advanced or metastatic breast cancer, where capecitabine is a standard of care. We previously demonstrated in our Phase 1b study that NGC-Cap is more potent than monotherapy capecitabine, providing up to 5-10 times more 5-fluorouracil exposure to cancer cells. This greater exposure resulted in a greater efficacy, with a safety profile better or similar to existing monotherapy with capecitabine," stated David Young, PharmD, Ph.D., President of Research and Development. "Initial data from the Phase 2 trial are expected mid-2025."

"Although capecitabine is among the most widely used chemotherapy drugs, particularly for the treatment of solid tumors, there remains the need for a more effective chemotherapy treatment with fewer or less-severe side effects," he added. "We believe that NGC-Cap can fulfill this need."

Breast cancer is the second most common cancer and a leading cause of cancer-related death. More than 2 million cases of breast cancer were diagnosed in 2022 with more than 665,000 deaths globally. The five-year survival rate for those diagnosed with metastatic disease is approximately 30%.

The Phase 2 study will be a global multicenter, open-label, adaptive design trial comparing two different doses of NGC-Cap to FDA-approved monotherapy capecitabine in approximately 60 to 90 patients with advanced or metastatic breast cancer. The trial is designed to evaluate the safety-efficacy profile of NGC-Cap versus monotherapy capecitabine, to determine the potential optimal dosage regimens of NGC-Cap as required by the FDA Project Optimus Initiative and to evaluate the possibility of personalizing NGC-Cap therapy. Processa expects to enroll the first patient into this trial in the third quarter of 2024.

About Capecitabine Administered with PCS6422 (NGC-Cap)

NGC-Cap combines the administration of PCS6422, the Company’s irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, with low doses of capecitabine. Capecitabine is the oral prodrug of 5-FU, and along with 5-FU is among the most widely used chemotherapy drugs, particularly for the treatment of solid tumors. When metabolized (after oral ingestion) it becomes 5-FU in the body, which, in turn, metabolizes to molecules called anabolites that actively kill duplicating cells, such as cancer cells, and to molecules called catabolites that only cause side effects. The presence of the DPD enzyme plays an integral role in the undesirable conversion of 5-FU to catabolites while simultaneously decreasing tumor exposure to 5-FU and it’s anabolites.

The NGC-Cap Phase 1b study evaluated ascending doses of capecitabine when combined with a fixed dose of PCS6422 in patients with advanced, relapsed or refractory progressive gastrointestinal tract cancer. These patients had to relapse from or fail all other treatments. NGC-Cap demonstrated greater 5-fluorouracil (5-FU) exposure and lower fluoro-beta-alanine (FBAL) exposure with a better or similar side effect profile compared with monotherapy capecitabine, as well as preliminary anti-tumor activity. In all evaluable patients who received one dose of PCS6422 and seven days of capecitabine, partial responses or stable disease was observed in 66.7% (8 out of 12) of patients with progression-free survival of approximately 5 to 11 months across these patients.