On July 17, 2023 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported that the independent directors serving on the Organization, Leadership and Compensation Committee of the Company’s Board of Directors approved the grant of non-qualified stock options to purchase an aggregate of 351,000 shares of the Company’s common stock to two new employees (the "Inducement Grants"), with grants made on July 10 and July 17, 2023 (the "Grant Dates") (Press release, C4 Therapeutics, JUL 17, 2023, View Source [SID1234633257]). The Inducement Grants were granted as inducements material to these individuals entering into employment with C4T in accordance with Nasdaq Listing Rule 5635(c)(4).

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The Inducement Grants have an exercise price per share that is equal to the closing price of C4T’s common stock on their respective Grant Dates. The Inducement Grants will vest over a four-year period, with 25% of the shares vesting on the first-year anniversary of the employee’s start date, and thereafter the remainder of the shares vesting in twelve equal quarterly installments, subject to each employee’s continued employment with C4T through each vesting date.

On July 17, 2023 Theradiag a company specializing in in vitro diagnostics of autoimmune diseases and theranostics, reported its half-revenue and cash position on June 30, 2023, data that is currently being audited (Press release, Theradiag, JUL 17, 2023, View Source [SID1234633256]).

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H1 2023 revenue of €6.7 million

Over the six monthsto June 30, 2023, Theradiag generated revenue of €6.7 million, compared with €6.3 million in the first half of 2022, representing growth of 6.8%. Growth accelerated slightly in the second quarter of 2023 thanks to strong sales performance in Theradiag two core businesses: +9.4% for Theranostics and +5.3% for In Vitro Diagnostics (IVD). Theranostics business recorded another semester of strong growth, with sales up 18.0% to almost €3.6 million at June 30, 2023. This strong growth was driven by very good export performance and solid growth in France, offsetting the decline in sales to the US market. As a reminder, this downturn on the US market is the consequence of the implementation of the Company’s new strategic plan to improve profitability. IVD recorded a slight decline in revenue of-3.7% to around €3.1 million at the end of June 2023. Business contracted in France, compared with an exceptional first-half of 2022 figure linked to non-recurring commercial opportunities. This slowdown on the domestic market is partly offset by commercial In thousands of euros Q2 2022 Q2 2023 Change H1 2022 H1 2023 Change Revenue 3,150 3,383 7.4% 6,264 6,688 6.8% Of which Theranostics revenue 1,578 1,727 9.4% 3,024 3,569 18.0% Of which IVD revenue 1,572 1,656 5.3% 3,240 3,119-3.7% developments in the main European markets. Theradiag recently extended its strategic partnership with Quotient, which will support the growth trajectory of this activity. Cash position At 30 June 2023, Theradiag had a net cash position of €5.7 million, above the company’s business plan, compared with €6.4 million at December 31, 2022. Simon Davière, CEO of Theradiag, commented: "During the first half 2023, Theradiag has maintained a solid sales momentum, particularly for its internally developed products, thanks to its technological lead in its two fast-growing markets. The deliberate slowdown in the United States has been offset by market share gains in new countries, mainly the major European markets. On the strength of our comfortable cash position, we intend to pursue the development and accelerate the marketing of our high-margin inhouse products over the coming months." Christian Policard, Chairman of the Board of Directors, added: "In addition to its strong commercial momentum, over the past few months Theradiag has been working to strengthen the collaboration with its shareholder and partner Biosynex. While synergies in purchasing are already underway, commercial synergies will need to become operational over the next six months in order to improve the performance of both companies. " Next financial press release :-2023 first-half results, on Monday 18, September 2023, before market open

On July 17, 2023 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial stage biopharmaceutical company pursuing life-changing therapies for certain cancers and rare diseases, reported the initiation of a randomized, investigator-initiated Phase 2 clinical trial in first line metastatic pancreatic cancer based on preliminary data from the single-arm pilot phase (Press release, BioLineRx, JUL 17, 2023, View Source [SID1234633255]). The combination drug trial includes the investigational candidate motixafortide. Sponsored by Columbia University, the amended study will modify a single-arm trial whose original design called for expansion to an additional 30 patients if data from a pilot phase of 10 patients was encouraging (defined as ≥3 patients with partial response by RECIST criteria). The amended randomized study will compare combination treatment with the Company’s CXCR4 inhibitor (motixafortide), a PD-1 inhibitor (cemiplimab), and chemotherapy (gemcitabine, nab-paclitaxel) to chemotherapy alone in a larger number of patients (n= 102).

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A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held June 2-6 in Chicago, Illinois (see abstract).

"Metastatic pancreatic cancer is a uniformly fatal disease for which current treatments result in limited benefits," said Tami Rachmilewitz, MD, Chief Medical Officer at BioLineRx. "Unfortunately, newer immunotherapy approaches, while beneficial against other solid tumor types, have had limited efficacy in pancreatic cancer due to immunosuppressive pathways. Combining checkpoint inhibitors, chemotherapy, and a CXCR4 inhibitor has shown promise in earlier preclinical and clinical studies, including an earlier single arm study using motixafortide as the CXCR4 inhibitor (COMBAT/KEYNOTE-202) in patients receiving second line treatment for pancreatic cancer, and we are very encouraged by the results seen in the initial pilot phase of the study in patients receiving first line treatment. We look forward to continuing the clinical research of this treatment regimen in this randomized trial."

"Working with our collaborators, we are excited to be advancing the clinical development of motixafortide in pancreatic cancer and look forward to the presentation of data from the pilot phase of the randomized trial later this year," said Philip Serlin, Chief Executive Officer of BioLineRx. "This is an important area of growth for the company, alongside the potential approval and U.S. commercialization of motixafortide this year in stem cell mobilization for autologous transplantation in multiple myeloma."

Data from the pilot stage of the Phase 2 study is planned for submission to a congress later this year. The primary endpoint of the randomized trial is progression free survival (PFS). Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival.

The U.S. Food and Drug Administration has accepted the company’s New Drug Application for motixafortide in stem cell mobilization for autologous transplantation in multiple myeloma and assigned the NDA a PDUFA date of September 9, 2023.

About Pancreatic Cancer
Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2023, an estimated 64,050 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths. Worldwide, an estimated 495,773 people were diagnosed with the disease in 2020. In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%. About 12% of people are diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%. For the 52% of people who are diagnosed after the cancer has spread to a distant part of the body, the 5-year relative survival rate is 3%.[i] These data highlight the need for the development of new therapeutic options.

About Motixafortide in Cancer Immunotherapy
Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor. Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth. By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile.

On July 17, 2023 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported completion of the first dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1001-A (liposomal Grb2) in patients with solid tumors, including ovarian, endometrial, pancreatic and breast cancer (Press release, Bio-Path Holdings, JUL 17, 2023, View Source [SID1234633254]).

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"We are delighted to have completed the first cohort of this first-in-human Phase 1/1b study of BP1001-A as it further demonstrated the drug’s favorable safety profile, which is critical for the treatment of these very vulnerable cancer patients," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Importantly, this achievement enables us to advance to the second cohort of this important study in solid tumor cancers, for which we hope to complete enrollment by year end 2023."

The dose escalation portion of the Phase 1/1b clinical trial is ongoing at more than eight leading cancer centers in the United States, including The University of Texas MD Anderson Cancer Center, The Mary Crowley Cancer Research Center, and Karmanos Cancer Center. Initially, a total of nine evaluable patients are scheduled to be treated with BP1001-A monotherapy in a standard 3+3 design, with a starting dose of 60 mg/m2 and continuing with 90 mg/m2 and 135 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study will commence after successful completion of BP1001-A monotherapy cohorts and will assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors, and BP1001-A with gemcitabine in patients with metastatic pancreatic tumors.

Three patients were enrolled into the first dose cohort of BP1001-A at 60 mg/m2 at three different centers in the study, including one patient with hepatic lesions (and lung metastases) and two with advanced gynecologic lesions. All three patients had undergone extensive previous chemotherapies and/or surgeries for their disease prior to enrollment in this Phase 1 study. No patient experienced any treatment related adverse events or any adverse events deemed related to the study drug.

About BP1001-A

BP1001-A is a modified drug product with the same drug substance as Bio-Path’s lead drug candidate, prexigebersen, but includes formulation enhancements to produce smaller drug nanoparticles. The goal of this product enhancement is to produce smaller drug nanoparticles that can pass through vasculature pore spaces, thereby enabling release of the drug product into the interior of the tumor to enhance drug effectiveness. In preclinical testing in mice, results clearly demonstrated that the reduced size formulation produced a reduction in tumor burden, evidence that the drug product effectiveness was improved with the smaller drug product nanoparticles.

On July 17, 2023 Adcentrx Therapeutics ("Adcentrx"), a biotechnology company dedicated to revolutionizing Antibody-Drug Conjugate (ADC) therapeutics for cancer and other life-threatening diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application of ADRX-0706 for the treatment of select advanced solid tumors (Press release, Adcentrx Therapeutics, JUL 17, 2023, View Source [SID1234633253]).

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"The FDA’s acceptance of our IND application is an exciting milestone for Adcentrx," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "As our first program to receive FDA clearance, we are one step closer to bringing our novel ADC technology to patients in need across the oncology landscape."

Nectin-4 is an attractive target for ADCs due to its high expression in multiple solid tumors and limited expression in normal tissues. It plays a crucial role in tumor progression and has been associated with poor prognosis and resistance to conventional therapies. By specifically targeting Nectin-4 with ADRX-0706, potent anti-cancer activity can be achieved with a lower toxicity profile, offering a promising alternative over current therapeutic approaches.

"ADRX-0706 demonstrated a remarkable efficacy and safety profile in preclinical studies," added Pia Challita-Eid, Ph.D., Chief Scientific Officer of Adcentrx. "We are thrilled to be progressing our first program into the clinic as we continue to apply our optimized ADC platform on a robust and differentiated product pipeline."

The first-in-human Phase 1a/1b clinical trial of ADRX-0706 will be an open-label, multicenter, non-randomized dose escalation and dose expansion study. The study will enroll patients with select advanced solid tumors. The primary objectives of the study will be to characterize the safety and tolerability and to determine the optimal dose of ADRX-0706. The company expects the first patient to be enrolled in the second half of 2023, with an initial data readout in the middle of 2024.

About ADRX-0706

ADRX-0706 is an ADC product candidate discovered by Adcentrx. The antibody component targets Nectin-4, a cell surface adhesion protein over-expressed in multiple human cancers and associated with poor disease prognosis. The ADC is manufactured using a proprietary conjugation technology and novel tubulin inhibitor payload to generate an ADC with a drug-antibody ratio of eight (DAR 8). ADRX-0706 has demonstrated a favorable pharmacokinetic and safety profile in preclinical models, in addition to demonstrating significant efficacy across a variety of tumor indications.