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]).

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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.

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]).

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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."

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]):

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

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

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.

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"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.

On July 30, 2024 PharmaMar Group (MSE: PHM) reported a total revenue of €80.8 million, representing a 1% increase compared to the €80.2 million reported in the first half of 2023 (Press release, PharmaMar, JUL 30, 2024, View Source [SID1234645168]). Recurring revenue, which results from net sales plus royalties received from our partners, increased by 2% to €68.5 million, compared to €67.3 million for the same period of the previous year.

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Oncology sales totalled €42.0 million compared to €43.3 million in the previous year. This difference, which has been offset by the increase in royalties, is mainly due to Yondelis sales, which totalled €9.8 million up to June 30th 2024, compared to €14.2 million recorded in the same period of the previous year.

Revenue from lurbinectedin in Europe under the early access amounted to €12.3 million in the first half of 2024, compared to €21.0 million recorded up to June 30th, 2023.

As of June 2023, the income under this program (€21.0 million) reflected the positive effect of the accounting reversal made in the first half of 2023 due to the excess provision for deductions corresponding to the 2022 fiscal year. If we eliminate this effect, lurbinectedin revenue in Europe under the early access would have increased by approximately 16% in the first half of this year.

Additionally, there have been commercial sales of Zepzelca in Europe amounting to €4.7 million.

Revenue from the sale of API (raw materials) for both Zepzelca and Yondelis to our partners also increased significantly during the first half of this year. Thus, as of June 30th, sales of raw materials reached €15.2 million, representing an 85% growth compared to the same period of the previous year. This increase reflects our partners’ preparation for commercial activity.

As of June 30th, 2024, royalty income amounted to €26.5 million, representing a 16.2% increase compared to the same period of the previous year. This income includes royalties received from our partner Jazz Pharmaceuticals for Zepzelca sales in the U.S., which increased by 15% to €24.2 million. The royalties for the second quarter of 2024 are an estimate, as the information on sales made by Jazz is not available at the time of publication of this report. Any discrepancies will be corrected in the next quarter.

In addition to the royalties received from Jazz Pharmaceuticals, there are royalties from Yondelis sales from our partners in the U.S. and Japan amounting to €2.3 million in the first half of 2024, compared to €1.8 million recorded in the same period of the previous year.

Regarding non-recurring income from license agreements, at the end of the first half of 2024, it amounted to €12.3 million, of which €11.5 million correspond to the portion of deferred income from the 2019 agreement with Jazz Pharmaceuticals related to Zepzelca.

R&D investment reached €51.3 million in the first half of 2024, representing a 10% increase compared to the previous year. Of the total R&D investment in these first six months of 2024, the amount allocated to the oncology segment increased by 20% to €46.7 million, compared to €39.0 million recorded in the first half of 2023. This increase is directly related to the progress of activities related to ongoing clinical trials, mainly the LAGOON trial (phase III clinical development for Small Cell Lung Cancer) and the SaLuDo trial (phase IIb/III clinical development for Leiomyosarcoma); both with lurbinectedin. Additionally, the Company continues to invest in the clinical development of other molecules at earlier stages. In this regard, there are two phase II clinical trials underway with ecubectedin in solid tumors, as well as phase I clinical trials with PM534 and PM54 for the treatment of solid tumors.

In the first half of 2024, the net profit was €3.5 million.

As of June 30th, 2024, the PharmaMar Group has cash and equivalents amounting to €139.6 million and has reduced total debt by 8.8% since December 2023, to €36.3 million. Thus, the net cash position stands at €103.3 million.

PharmaMar management will host a conference call and webcast for investors and analysts on July 31st, 2024, at 13:00 CET (07:00 AM, New York time) as follows: The numbers to connect to the teleconference are 1 646 664 1960 (from USA or Canada), +34 91 901 16 44 (from Spain) and +44 20 3936 2999 (other countries). Participants’ access code: 805724. Interested parties can also follow the conference call live via the following link: View Source

The recording of the teleconference will be available for thirty days and it can be accessed on PharmaMar’s website by visiting the Events Calendar section of the Company’s website www.pharmamar.com