On April 5, 2023 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage cancer, reported that it will ring the Nasdaq Stock Market closing bell this afternoon to commemorate the Company’s 2022 initial public offering (IPO) (Press release, BioAffinity Technologies, APR 5, 2023, View Source [SID1234629827]).

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"Thank you to Nasdaq for giving us the opportunity to participate in one of Wall Street’s most time-honored traditions," bioAffinity Technologies President and CEO Maria Zannes said. "When we ring the bell this afternoon, we will be celebrating the many milestones and scientific discoveries that led to the development of our first commercial product, CyPath Lung, which can detect lung cancer at the earliest stages when treatment options are more effective and lead to longer, healthier lives."

The Nasdaq Stock Market closing bell ceremony will run from approximately 3:45 to 4:05 p.m. Eastern time. A live stream of the event will be available at View Source and on the Nasdaq Facebook and Twitter pages.

On April 5, 2023 Astrazeneca reported Positive high-level results from a planned interim analysis of the DUO-O Phase III trial showed treatment with a combination of Lynparza (olaparib), Imfinzi (durvalumab), chemotherapy and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus chemotherapy plus bevacizumab (control arm) in newly diagnosed patients with advanced high-grade epithelial ovarian cancer without tumour BRCA mutations (Press release, AstraZeneca, APR 5, 2023, View Source [SID1234629814]). Patients were treated with Imfinzi in combination with chemotherapy and bevacizumab followed by Imfinzi, Lynparza and bevacizumab as maintenance therapy.

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In an additional arm, Imfinzi, chemotherapy plus bevacizumab showed a numerical improvement in PFS versus the control arm but did not reach statistical significance at this interim analysis.

At the time of this planned interim analysis, the overall survival (OS) and other secondary endpoints are immature and will be formally assessed at a subsequent analysis.

Ovarian cancer is one of the most common gynaecologic cancers.1 Over two thirds of patients are diagnosed with advanced disease which can progress quickly, often within two years, diminishing their quality of life despite treatment. Unfortunately, 50-70% of patients with advanced disease die within five years.2-5

Philipp Harter, Director, Department of Gynaecology and Gynaecologic Oncology, Evangelische Kliniken Essen-Mitte, Germany and principal investigator for the trial, said: "DUO-O showcases the power of academia and industry collaboration in advancing new treatment combinations for patients with ovarian cancer. I’m grateful for the academic cooperative study groups and patients around the world that made this trial possible and look forward to sharing the results with the clinical community."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "While there has been significant progress for patients with advanced ovarian cancer, an unmet need still remains. These data from the DUO-O trial provide encouraging evidence for this Lynparza and Imfinzi combination in patients without tumour BRCA mutations and reinforce our continued commitment to finding new treatment approaches for these patients. It will be important to understand the key secondary endpoints as well as data for relevant subgroups."

The safety and tolerability of these combinations are broadly consistent with that observed in prior clinical trials and the known profiles of the individual medicines.

The data will be presented at forthcoming medical meetings and shared with health authorities.

Notes

Ovarian cancer
Ovarian cancer is the eighth most common cancer in women worldwide with more than 314,000 new patients diagnosed with ovarian cancer in 2020 and over 207,000 deaths. This number is expected to rise by almost 42% by 2040 to over 445,000 newly diagnosed patients and 314,000 deaths.6

DUO-O
DUO-O is a Phase III randomised, double-blind, placebo-controlled, multi-centre trial to evaluate the efficacy and safety of Imfinzi in combination with platinum-based chemotherapy and bevacizumab followed by maintenance treatment with Imfinzi and bevacizumab with or without Lynparza in newly diagnosed patients with advanced ovarian cancer without tumour BRCA mutations.

Patients were randomized 1:1:1 to: Arm 1 (control), induction therapy with platinum-based chemotherapy in combination with bevacizumab and placebo followed by maintenance treatment with bevacizumab plus placebo; Arm 2, induction therapy with platinum-based chemotherapy in combination with bevacizumab and Imfinzi followed by maintenance Imfinzi and bevacizumab plus placebo; or Arm 3, induction therapy with platinum-based chemotherapy in combination with bevacizumab and Imfinzi followed by maintenance Imfinzi and bevacizumab plus Lynparza. In all arms, platinum-based chemotherapy was administered every 3 weeks (q3w) for up to 6 cycles, bevacizumab was administered q3w for up to 15 months, Imfinzi or placebo was administered q3w for up to 24 months, and Lynparza or placebo was administered twice daily for up to 24 months.

The primary endpoint of the trial is PFS as assessed by investigator for Arm 3 compared to Arm 1 (control) in the overall trial population which included patients without tumour BRCA mutations and in the subset of these patients with HRD positive disease. Key secondary endpoints include PFS as assessed by investigator in Arm 2 compared to control, as well as comparisons for OS. DUO-O enrolled over 1200 patients across all treatment arms at 179 study locations. For more information about the trial, visit ClinicalTrials.gov.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiation therapy based on the PACIFIC Phase III trial. Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small cell lung cancer (SCLC) based on the CASPIAN Phase III trial. Additionally, Imfinzi is approved in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC in the US, EU and Japan based on the POSEIDON Phase III trial.

In addition to its indications in lung cancer, Imfinzi is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer in the US, EU, Japan and several other countries; in combination with Imjudo in unresectable hepatocellular carcinoma in the US, EU and Japan; and in previously treated patients with advanced bladder cancer in a small number of countries.

Since the first approval in May 2017, more than 150,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, several gastrointestinal cancers, ovarian cancer, endometrial cancer and other solid tumours.

Lynparza
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR), such as those with mutations in BRCA1 and/or BRCA2, or those where deficiency is induced by other agents (such as new hormonal agents [NHAs]).

Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.

Lynparza is currently approved in a number of countries across multiple tumour types including maintenance treatment of platinum-sensitive relapsed ovarian cancer and as both monotherapy and in combination with bevacizumab for the 1st-line maintenance treatment of BRCA-mutated (BRCAm) and homologous recombination deficiency (HRD)-positive advanced ovarian cancer, respectively; for germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer (in the EU and Japan this includes locally advanced breast cancer); for gBRCAm, HER2-negative high-risk early breast cancer (in Japan this includes all BRCAm HER2-negative high-risk early breast cancer); for gBRCAm metastatic pancreatic cancer; in combination with abiraterone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated (in the EU) and as monotherapy in HRR gene-mutated mCRPC in patients who have progressed on prior NHA treatment (BRCAm only in the EU and Japan). In China, Lynparza is approved for the treatment of BRCA-mutated mCRPC, as a 1st-line maintenance therapy in BRCA-mutated advanced ovarian cancer as well as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, has been used to treat over 75,000 patients worldwide. The companies develop Lynparza in combination with their respective PD-L1 and PD-1 medicines independently. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

On April 3, 2023 Imugene Limited (ASX: IMU), a clinical stage immunooncology company, reported that its Phase 1 MAST (metastatic advanced solid tumours) study evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has dosed the first patients in the intravenous (IV) and intratumoral (IT) arms in cohort 3 of the monotherapy dose escalation trial (Press release, Imugene, APR 5, 2023, View Source [SID1234629813]).

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As noted below, the study continues its progression on schedule having now dosed patients in cohort 3 of the IV and IT arms of the monotherapy dose escalation, as well as cohort 1 of the study in combination with Pembrolizumab.

Imugene MD & CEO Leslie Chong said: "Still being less than 12 months since the very first patients were dosed, we’re now well advanced on amassing the critical data we require to publish on the outcomes of this study, and we remain very positive on the potential benefit to patients."

The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models¹. Overall the study aims to recruit up to 100 patients across approximately 10 trial sites in the United States and Australia.

The clinical trial is titled "A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)." The trial commenced in May 2022 and is anticipated to run for approximately 24 months while being funded from existing budgets and resources.

Full study details can also be found on clinicaltrials.gov under study ID: NCT05346484.

On April 4, 2023 BroadenBio reported the company will present the preclinical data of BB3008 will be presented in the poster session on April 19, 2023 (Poster, BroadenBio, APR 4, 2023, View Source [SID1234640203]). The information has been published on the AACR (Free AACR Whitepaper) official website.

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Detailed Information

Title: BB3008, a potent and selective small molecular HPK1 inhibitor effective in multiple syngeneic tumor models

Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 3

Session Date and Time: Wednesday Apr 19, 2023 9:00 AM – 12:30 PM

Location: Poster Section 35

Poster Board Number: 15

Abstract Presentation Number: LB324

About AACR (Free AACR Whitepaper)

The American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting is one of the largest worldwide academic conferences on international cancer research. The conference focuses on the latest progress in various fields of cancer research, releases innovative target research, preclinical data and early clinical trial results, and promotes exchanges and cooperation among cancer researchers around the world. The 2023 annual meeting will be held at the Orange County Convention Center in Orlando, Florida, U.S. from April 14 to 19, 2023.

On April 4, 2023 Heidelberg Pharma AG reported on the first three months of fiscal year 2023 (1 December 2022 – 28 February 2023) and the Group’s financial figures (Press release, Heidelberg Pharma, APR 4, 2023, View Source [SID1234638924]).

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Dr. Jan Schmidt-Brand, CEO and CFO of Heidelberg Pharma AG, commented: "A significant event for our company was the presentation of initial safety data from the first clinical trial with our ATAC candidate HDP-101 at the renowned ASH (Free ASH Whitepaper) conference in December 2022. We are also encouraged that the substance has so far proven to be safe and well tolerated.

Our partner Magenta stopped its trial with ATAC candidate MGTA-117 due to serious side effects and is in the process of strategically realigning its business operations. We have entered into a termination agreement with Magenta under which all licensed ATAC rights as well as some patents will be acquired by Heidelberg Pharma. The safety review of our own study data does not indicate that the side effects experienced at Magenta could be a class effect of all Amanitin-based ADCs. Nevertheless, we have decided to include additional measures in the study protocol of the trial with HDP-101 for the safety of our patients. The implementation of the changes and regulatory approval will delay the continuation of the study with the 4th patient cohort for several months. The financial figures developed as planned. Cash outflow was increased due to special effects in the first quarter but is in line with planning for the year."

Important operational developments and achievements
HDP-101 (BCMA ATAC) development program: The candidate is being evaluated since February 2022 in a Phase I/IIa clinical trial for treatment of relapsed or refractory multiple myeloma (MM). MM is a cancer affecting bone marrow and is the second most common hematologic cancer; it represents a major unmet medical need where new, more effective therapies are urgently needed. The first part of this trial is a Phase I dose escalation study involving up to 36 patients to determine a safe and optimal dosage of HDP-101 for the Phase IIa part of the study.
At the 64th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2022, Heidelberg Pharma presented preliminary safety data from the clinical trial with HDP-101. At the end of the reporting period, the first three patient cohorts and dose levels were concluded and has so far been shown to be safe and well tolerated. Six trial centers are up and running in the United States and Germany, and further centers in Europe are about to initiate. Because of events at partner Magenta Therapeutics, Cambridge, MA, USA, (Magenta), Heidelberg Pharma will implement additional safety measures in the HDP-101 clinical trial. Further details can be found in the paragraph "Events after the reporting period".
Partnership with Binghamton: In December 2022, Heidelberg Pharma Research has entered into a research and exclusive option agreement with Binghamton University, State University of New York, Binghamton, NY, USA, related to a novel and proprietary immunostimulatory technology platform. The platform includes potent novel immunostimulatory compounds and Antibody Drug Conjugate (ADC) technology for the specific delivery of these compounds to tumor tissue. The resulting immunostimulatory ADCs have the potential to harness the patient’s own immune system to attack and eliminate malignancies. These immunostimulatory agents are synergistic with cytotoxic agents, including ADCs generated by Heidelberg Pharma’s ATAC technology.

Development at the partner Magenta: Magenta announced on 25 January 2023 that in the third dose level of the MGTA-117 clinical trial, a grade 5 serious adverse event resulting in death occurred that deemed to be possibly related to MGTA-117. For safety reasons, Magenta subsequently paused dosing in the clinical trial until further notice. On 2 February 2023, Magenta announced that it has completed a review of its business, including the status of its programs and resources. Magenta halted further development of its programs and conducts a comprehensive review of strategic alternatives. At the end of February 2023, the Amanitin linker supply contract was terminated by Magenta, which will result in Heidelberg Pharma losing sales revenue in the low single-digit million range for fiscal year 2023. After the reporting period, a termination agreement was signed with Magenta in April 2023, under which all licensed ATAC rights and some MGTA patents will be taken over by Heidelberg Pharma.
Events after the reporting period
Adaptation of the study protocol of HDP-101: Following completion of the third dose level, in March 2023, a data review was conducted by the Safety Review Committee (SRC). The SRC concluded that treatment with HDP-101 is safe and well tolerated in these first three cohorts and recommended to escalate the dose.
Patient safety remains as the top priority for Heidelberg Pharma. Together with the Safety Review Committee, and based on the body of available data, it was decided as an extra precaution to implement further safety measures for our patients, especially regarding the identification and exclusion of those patients who might be prone to develop respiratory events. Additional examination will be also included to detect any similar events early on. These additional measures will be included in the study and shall be implemented with the fourth cohort at the trial sites after approval by the authorities.
Results of operations, financial position and net assets

The Heidelberg Pharma Group – as of the reporting date comprising Heidelberg Pharma AG and its subsidiary Heidelberg Pharma Research GmbH – reports consolidated figures. The reporting period referred to below concerns the period from 1 December 2022 to 28 February 2023 (Q1 2023).

In the first three months of fiscal year 2023, the Group generated sales revenue and income totaling EUR 2.2 million (previous year: EUR 0.8 million). This figure includes sales revenue of EUR 2.1 million (previous year: EUR 0.7 million), which is made up of a roughly equal share of sales from ATAC technology and deferred sales.

Other income amounted to EUR 0.1 million (previous year: EUR 0.1 million) and primarily consisted of the reversal of unutilized provisions.

Operating expenses including depreciation and amortization totaled EUR 8.7 million in the reporting period (previous year: EUR 7.9 million). Cost of sales increased to EUR 1.4 million (previous year: EUR 0.6 million) and concern costs directly related to sales revenue. Research and development costs increased slightly year-on-year to EUR 5.8 million (previous year: EUR 5.7 million) as planned due to cost-intensive external manufacturing for all three ATAC projects as well as the ongoing clinical trial with HDP-101. At 66% of operating expenses, R&D was the largest cost item. Administrative costs decreased to EUR 1.1 million in the first quarter of fiscal year 2023 compared to the prior-year period (EUR 1.4 million), also as a result of transaction-related consulting costs. Among others, this figure includes holding company costs and costs related to the stock market listing. Other expenses, comprising the costs incurred for business development, marketing and commercial market supply, doubled from EUR 0.2 million to EUR 0.4 million year-on-year.

The Heidelberg Pharma Group’s net loss for the first three months of the fiscal year decreased to EUR 6.6 million, as planned (previous year: EUR 7.2 million). Basic earnings per share based on the weighted average number of shares issued during the reporting period improved from EUR -0.21 in the previous year to EUR -0.14 in the reporting quarter as a result of the higher number of shares and the lower loss.

Total assets as of 28 February 2023 amounted to EUR 86.5 million and were lower compared to the 30 November 2022 reporting date (EUR 100.6 million) in particular due to the lower cash. At EUR 60.2 million, equity was also significantly lower compared to the end of fiscal year 2022 (EUR 66.6 million). This corresponds to an equity ratio of 69.6 % (30 November 2022: 66.3 %). No corporate actions were implemented during the reporting period. The share capital of Heidelberg Pharma AG therefore remained steady at EUR 46,584,457, divided into 46,584,457 no par value bearer shares.

Cash as of the end of the quarter amounted to EUR 65.0 million (30 November 2022: EUR 81.3 million). The disproportionate cash outflow is due to both a repayment of EUR 5 million and the annual interest payment on the shareholder loan from the majority shareholder dievini Hopp BioTech holding & Co. KG, Walldorf, Germany, in the amount of EUR 0.9 million. The loan amount thus still amounts to EUR 10 million, which bears interest of 8% p.a. This represents an average monthly cash outflow of EUR 3.8 million in the first quarter of the fiscal year (previous year: EUR 2.2 million).

Financial outlook for 2023

The Executive Management Board expects the Heidelberg Pharma Group to generate between EUR 7.0 million and EUR 10.0 million in sales revenue and other income (2022: EUR 19.9 million) in the 2023 fiscal year. Sales revenue generated by Heidelberg Pharma Research GmbH (especially from ATAC technology), as well as deferred revenue and potential milestone payments to Heidelberg Pharma AG will contribute to this figure in roughly equal measure. Sales revenue from major new license agreements was not included in this planning.

Based on current planning, operating expenses are expected to be in the range of EUR 37.0 million to EUR 41.0 million, slightly higher than in the reporting year (EUR 37.0 million). Earnings before interest and taxes (EBIT) in the 2023 fiscal year are expected to be between EUR -28.5 million and EUR -32.5 million (2022: EUR -17.2 million)

If income and expenses develop as anticipated, financing requirements in the 2023 fiscal year for Heidelberg Pharma AG’s business operations are expected to increase considerably compared to 2022 (EUR 8.9 million excluding the capital increase and the shareholder loan from the main shareholder dievini Hopp BioTech holding GmbH & Co. KG). Funds used will be in the range of EUR 32.5 million to EUR 36.5 million. This corresponds to an average monthly use of cash of EUR 2.7 million to EUR 3.1 million (2022: EUR 0.7 million).

The Group’s financing is secured until mid-2025 based on current planning.

Heidelberg Pharma will not host a conference call on this interim management statement. The complete figures for the interim financial statements can be downloaded from View Source "Press & Investors > Announcements > Financial Reports > Interim management statement on the first three months of 2023.