EGFR positive Adenocarcinoma of Lung

Study designed to explore novel markers for identifying responders with immune checkpoint inhibitors in patients resistant to targeted therapies WALTHAM, Mass.--(BUSINESS WIRE)-- BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, and Saga University located in Saga, Japan and known for its commitment to educating and training researchers and professionals in the medical and healthcare fields, announced today the launch of a collaboration aimed at discovering biomarkers for immunotherapy (IO) treatment response and treatment-related toxicity in advanced non-small cell lung cancer (NSCLC) patients. This press release features multimedia. View the full release here: EGFR-TKI treatment effectively targets EGFR mutation-positive NSCLC. Still, acquired resistance often leads to recurrence within 1 to 2 years, presenting a challenge for post-treatment optimization. Immune checkpoint inhibitors (ICIs) are standard therapy for NSCLC, but the efficacy in EGFR mutation-positive cases is limited. However, combination therapy with ICIs and anti-angiogenic agents has shown promise in EGFR-positive lung cancer. This study will evaluate the tumor microenvironment (TME) utilizing the BostonGene Tumor Portrait™ test in tissue samples collected before EGFR-TKI treatment and before ICI administration in patients with EGFR-positive lung adenocarcinoma. The study aims to examine the relationship between TME characteristics and the effectiveness of ICIs in these patients and investigate TME changes resulting from EGFR-TKI therapy. Furthermore, researchers will review cases where small-cell transformation occurred as a mechanism of EGFR-TKI resistance, aiming to elucidate the molecular mechanisms underlying this transformation within the TME context. By addressing these objectives, we enhance our understanding of TME dynamics and its implications for treatment response, ultimately informing improved therapeutic strategies for EGFR-positive lung adenocarcinoma. “We are dedicated to advancing medical research directly impacting patient care. By partnering with BostonGene, we aim to uncover novel biomarkers to revolutionize how we approach immunotherapy treatment in EGFR-positive lung cancer, ultimately improving patient outcomes,” said Dr. Naoko Aragane, Professor of Saga University. “Our collaboration with Saga University underscores our dedication to advancing the standard of care in Japan by bringing novel technologies to the region. The study marks an opportunity to delve deep into the complexities of the tumor microenvironment in EGFR-positive lung cancer patients, equipping oncologists with more targeted and effective immunotherapy strategies for their patients,” said Nathan Fowler, MD, Chief Medical Officer at BostonGene. BostonGene, NEC Corporation and Japan Industrial Partners established BostonGene Japan Inc., a joint venture leveraging BostonGene's advanced molecular technology and NEC's biocomputational algorithms in 2023. The company aims to deliver its industry-leading personalized tests to cancer patients in Japan and collaborate with academic and industry partners to accelerate the development of targeted therapies. About BostonGene Corporation BostonGene has a mission to provide transformative, AI-integrated molecular analytics and biomarker discovery for precision matching of therapies to improve the lives of patients living with cancer and other immune-related diseases. BostonGene’s concierge-service model provides customized client solutions using a multi-omic approach prioritized for real-world impact to optimize standard-of-care therapies, accelerate research and provide cost-effective, measurable data-driven results. BostonGene’s tests reveal key drivers of each patient’s unique disease profile, including an in-depth pro the immune microenvironment, actionable mutations, biomarkers of response to diverse therapies, and recommended therapies. Through these comprehensive analyses, BostonGene’s tests generate a personalized roadmap for therapeutic decision-making for each patient. For more information, visit BostonGene at .

Data update from AFM24-102 Phase 1/2a combination study includes 15 heavily pre-treated patients from the EGFR-wildtype non-small cell lung cancer (NSCLC) expansion cohort Responses observed in 4 of 15 patients, including 1 confirmed partial response (PR), 1 unconfirmed complete response (CR) awaiting confirmation, 2 unconfirmed PRs awaiting confirmation; an additional 7 of 15 patients exhibiting stable disease (SD) leading to a disease control rate of 73%Tumor shrinkage observed in 7 of 15 (47%) patientsAll patients were pretreated with and ultimately progressed while on PD-[L]1 targeting therapyThe majority of patients experienced only mild to moderate treatment-related adverse events, confirming a well-manageable safety profile in combination with atezolizumabCompany to host a conference call / webcast today at 4:30 p.m. EST to discuss the data MANNHEIM, Germany, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced interim safety and efficacy data on its innate cell engager (ICE®) AFM24 from the ongoing AFM24-102 combination study with atezolizumab, an anti-PD-L1 checkpoint inhibitor, in patients with advanced EGFR-expressing solid tumors. The data update as of December 6th, 2023, includes 15 patients from the EGFR-wildtype NSCLC cohort with a median of 2 prior lines of therapy. Importantly, all patients were pretreated with and ultimately progressed while on PD-[L]1 targeting therapy. The combination of AFM24 with atezolizumab showed encouraging signals of clinical activity, including 1 unconfirmed CR, 3 PRs (1 confirmed, 2 unconfirmed) and 7 patients exhibiting SD. All eleven patients with a confirmed response, unconfirmed response or stable disease (73%) are continuing treatment, with 4 patients exceeding 3 months of therapy; 2 patients improved from SD at the first scan to PR at the second scan based on RECIST criteria. “Most patients with advanced NSCLC will need additional treatment after first-line therapy, and currently available options for patients in the 2L+ setting provide only modest response rates and short progression-free survival,” said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. “Given the severity of this cancer and the urgent need for new treatments, we are very encouraged by the early safety and efficacy results demonstrated by the combination of AFM24 and atezolizumab in this cohort. We look forward to seeing the data in this cohort mature as well as to sharing data from the EGFR-mutant NSCLC cohort, anticipated in the first half of 2024.” Affimed’s ICE® AFM24, in combination with atezolizumab, has the potential to reactivate the innate and consequently the adaptive immune system to recognize and destroy EGFR-positive NSCLC tumors. Considering the low ORR reported on atezolizumab monotherapy in checkpoint inhibitor-relapsing and refractory patients, Affimed believes the clinical activity observed in AFM24-102 is likely due to the synergy of AFM24 with atezolizumab. AFM24 has demonstrated a positive safety and tolerability profile as both a monotherapy and in combination therapy. The combination with atezolizumab has not led to unexpected toxicity, and the toxicity observed to date is in line with the toxicity profile of the individual agents alone. The majority of patients experienced only mild to moderate treatment-related adverse events. Affimed also announced that it has discontinued enrollment in AFM24-102 into the gastric cancer cohort and the basket cohort evaluating pancreatic cancer, biliary tract cancer and hepatocellular carcinoma. While clinical activity was observed in both cohorts, neither cohort is likely to achieve response rates that would meet the Company’s efficacy hurdle and the Company’s strategic focus is to advance the NSCLC program as fast as possible. The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the “Webcasts” section on the “Investors” page of the Affimed website at https://www.affimed.com/investors/webcasts-and-corporate-presentation/. To access the call by phone, please use link https://register.vevent.com/register/BIb2258d6c5f5a474cad74869a7b7b1bb5, and you will be provided with dial-in details and a pin number. Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call. About the AFM24-102 Phase 1/2a Study AFM24-102 is a Phase 1/2a open-label, non-randomized, multicenter, dose escalation, and expansion study evaluating AFM24 in combination with atezolizumab in patients with selected EGFR-expressing advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies (NCT05109442). The Company also announced data from the phase 1/2 data study of acimtamig in combination with allogeneic NK in relapsed/refractory Hodgkin Lymphoma patients conducted at the University of Texas MD Anderson Cancer Center. The Company will host a call today at 1:30 p.m. PST / 4:30 p.m. EST / 22:30 CET to discuss both the acimtamig and AFM24 clinical data updates and to provide an update on the status of the acimtamig LuminICE-203 study. About AFM24 AFM24 is a tetravalent, bispecific innate cell engager (ICE®) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK® platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. In addition to studying AMF24 in combination with the checkpoint inhibitor atezolizumab, Affimed is also evaluating options for a combination of AFM24 with an allogeneic off-the-shelf NK cell product that the Company expects to be well suited for heavily pretreated patient populations. About Affimed N.V. Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s proprietary ROCK® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK® platform predictably generates customized innate cell engager (ICE®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE®. Headquartered in Mannheim, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, AFM28 and the Company’s other product candidates, the value of its ROCK® platform, its ongoing and planned preclinical development and clinical trials, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict, the fact that the current clinical data of AFM13 in combination with NK cell therapy is based on AFM13 precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AlloNK® and other uncertainties and factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future. Affimed Investor Relations Contact Alexander FudukidisDirector, Investor RelationsE-Mail: a.fudukidis@affimed.com Tel.: +1 (917) 436-8102 Affimed Media Contact Mary Beth Sandin Vice President, Marketing and CommunicationsE-Mail: m.sandin@affimed.com

On track to provide clinical update from dose-escalation portion of Phase 1 clinical trial of EGFR MasterKey inhibitor BDTX-1535 in the second half of 2023 FDA clearance of IND application for BDTX-4933 in the first quarter of 2023, a brain-penetrant RAF MasterKey inhibitor for the treatment of all-class RAF and RAS mutant tumors; initiation of Phase 1 clinical trial expected in the first half of 2023 Presented new preclinical data demonstrating the potential of MasterKey programs BDTX-1535 and BDTX-4933 at the 34th EORTC-NCI-AACR Symposium Cash, cash equivalents, and investments of $122.8 million as of December 31, 2022; expected to be sufficient to fund operations into the third quarter of 2024 CAMBRIDGE, Mass. and NEW YORK, March 09, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology medicine company developing MasterKey therapies designed to overcome limitations of existing therapies by targeting families of oncogenic driver mutations in patients with genetically defined cancers, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a corporate update. “We expect 2023 to be a catalyst rich year for Black Diamond following tremendous progress for our two novel MasterKey inhibitors, with BDTX-1535 continuing to advance through our Phase 1 clinical trial and BDTX-4933 meeting critical milestones to further progress toward the clinic. The clearance of the Investigational New Drug (IND) application for BDTX-4933 by the U.S. Food and Drug Administration (FDA) earlier this year marks our third IND allowance in three years and demonstrates the strength of our MAP drug discovery engine along with the expertise of our research and clinical teams. We are driven by the clear unmet need for next-generation precision medicines to treat cancers by overcoming resistance, minimizing on-target and wild-type mediated toxicities, and addressing brain disease. We’ve designed a robust pipeline of products with brain penetration properties to address these key challenges,” said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond. “We anticipate a clinical update for BDTX-1535 in the second half of 2023. We also expect to initiate the Phase 1 clinical trial of BDTX-4933 in the first half of this year and to progress our FGFR program and another undisclosed program toward development candidate nominations in 2023. As we continue to mature our pipeline, we are acutely focused on delivering meaningful benefit to patients and we believe that our approach has the potential to strengthen the treatment landscape for genetically defined cancers.” Recent Developments & Upcoming Milestones: BDTX-1535: BDTX-1535, an epidermal growth factor receptor (EGFR) MasterKey inhibitor, is being developed to treat genetically defined cancer in patients whose tumors are positive for EGFR MasterKey mutations in glioblastoma multiforme (GBM), as well as in non-small cell lung cancer (NSCLC). BDTX-1535 is fourth generation EGFR inhibitor designed to be irreversible (covalent) and brain-penetrant, and is unique in that it targets a family of driver mutations in addition to acquired resistance mutations arising from the use of third generation EGFR inhibitors to treat EGFR-positive NSCLC. In April 2022, Black Diamond dosed the first patient in its Phase 1 global clinical trial of BDTX-1535 for the treatment of NSCLC, including in patients with brain metastases, and GBM. The dose-escalation portion of the Phase 1 clinical trial is actively recruiting and enrolling patients, and the Company remains on track to provide a clinical update on BDTX-1535 in the second half of 2023. In October 2022, Black Diamond presented two posters at the 34th European Organisation for Research and Treatment of Cancer—National Cancer Institute—American Association for Cancer Research (EORTC-NCI-AACR) Symposium in Barcelona, Spain, with new preclinical data. The Company detailed anti-tumor activity of BDTX-1535 in preclinical models and highlighted that BDTX-1535 is designed using Black Diamond’s proprietary MAP drug discovery engine to target EGFR mutations of both NSCLC and GBM. Black Diamond also showcased BDTX-1535’s ability to achieve potent anti-tumor activity against EGFR alterations and amplification across preclinical models of NSCLC classical driver, intrinsic resistance and acquired resistance EGFR mutations and GBM, including intercranial patient derived xenograft models. BDTX-4933: BDTX-4933 is designed as a brain-penetrant, small molecule MasterKey reversible oral inhibitor of oncogenic BRAF Class I, II and III active RAF dimers promoted by upstream oncogenic alterations expressed by human cancers, while also avoiding paradoxical activation. In the first quarter of 2023, Black Diamond received allowance of its IND application from the FDA. The Company expects to initiate a Phase 1 clinical trial of BDTX-4933 in patients with tumors harboring all-class BRAF or RAS mutations in the first half of 2023. In October 2022, Black Diamond presented a poster at the 34th EORTC-NCI-AACR Symposium highlighting preclinical data showing BDTX-4933 to be a brain-penetrant RAF MasterKey inhibitor active against tumors that are driven by a Class I, II, or III BRAF mutation, as well as by other oncogenic RAS pathway alterations that promote constitutive RAF dimer activation. BDTX-4933 demonstrated potent, on-target inhibition of the RAF-MEK-ERK signaling pathway and anti-tumor activity in multiple preclinical models, including intracranial tumor models. Discovery-Stage Pipeline and MAP Drug Discovery Engine: Black Diamond continues to leverage its MAP drug discovery engine to advance its discovery-stage pipeline to bring therapies to underserved patients. Black Diamond anticipates progressing its fibroblast growth factor receptor (FGFR) program towards development candidate nomination and nomination of a development candidate against an undisclosed target in 2023. Corporate: In June 2022, Black Diamond appointed Sergey Yurasov, M.D., Ph.D., as its Chief Medical Officer, bringing over 25 years of oncology drug development experience and regulatory expertise. In December 2022, Black Diamond announced that existing board member, Mark Velleca, M.D., Ph.D., was appointed to succeed Robert (Bob) A. Ingram as the Chairman of the Board of Directors. In December 2022, Black Diamond announced the spinout of Launchpad Therapeutics, Inc. (Launchpad), an antibody-focused precision oncology company incorporating Black Diamond’s undisclosed early discovery stage antibody programs enabled by the MAP drug discovery engine. In conjunction with the transaction, a $30 million Series A financing was co-led by Versant Ventures and New Enterprise Associates (NEA) to fund discovery and development activities of the new company. Black Diamond retains a minority equity interest in Launchpad to enable further value creation. Financial Highlights Cash Position: Black Diamond ended 2022 with approximately $122.8 million in cash, cash equivalents, and investments compared to $209.8 million as of December 31, 2021. Net cash used in operations was $85.1 million for the year ended December 31, 2022 compared to $100.1 million for the year ended December 31, 2021. Research and Development Expenses: Research and development (R&D) expenses were $14.6 million for the fourth quarter of 2022, compared to $19.7 million for the same period in 2021. Research and development expenses were $64.4 million for the year ended December 31, 2022, compared to $96.8 million for the year ended December 31, 2021. The decrease in R&D expenses was primarily due to reduced clinical trial activities stemming from the discontinuation of the development of BDTX-189 to focus on upcoming milestones for our pipeline programs, BDTX-1535 and BDTX-4933. General and Administrative Expenses: General and administrative (G&A) expenses were $7.2 million for the fourth quarter of 2022, compared to $6.4 million for the same period in 2021, and $28.4 million for the year ended December 31, 2022, compared to $30.0 million for the year ended December 31, 2021. The decrease in G&A expenses was primarily due to a decrease in legal and other professional fees. Net Loss: Net loss for the fourth quarter of 2022 was $21.1 million, as compared to $25.9 million for the same period in 2021. Net loss for the year ended December 31, 2022 was $91.2 million compared to $125.6 million for the year ended December 31, 2021. Financial Guidance Black Diamond ended 2022 with approximately $122.8 million in cash, cash equivalents and investments, which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the third quarter of 2024. About Black Diamond Therapeutics Black Diamond Therapeutics is a clinical-stage precision oncology medicine company focused on the development of MasterKey therapies that target families of oncogenic mutations in clinically validated targets. Black Diamond leverages a deep understanding of cancer genetics and onco-protein structure and function, to discover and develop innovative MasterKey therapies. The Company’s MasterKey therapies are designed to overcome resistance, minimize on-target, wild-type mediated toxicities, and be brain-penetrant to address significant unmet medical needs of patients with genetically defined cancers. The Company is advancing a robust pipeline with lead clinical-stage program BDTX-1535, targeting MasterKey mutations in both EGFR mutant-positive non-small cell lung cancer (NSCLC) and in glioblastoma multiforme (GBM), and BDTX-4933, a program targeting RAF MasterKey mutations in solid tumors, as well as discovery-stage research programs. The Company’s proprietary Mutation-Allostery-Pharmacology, or MAP drug discovery engine, is designed to allow Black Diamond to analyze population-level genetic sequencing tumor data and validate MasterKey mutations. For more information, please visit Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the continued development and advancement of BDTX-1535 and BDTX-4933, including the ongoing Phase 1 clinical trial and the expected timing for data updates for BDTX-1535 and the timing for initiating a Phase I clinical trial of BDTX-4933, the continued development of the FGFR program, including plans for nominating a development candidate, in addition to plans to disclose an additional development candidate against a new target, the continued development of the MAP drug discovery engine and the Company’s expected cash runway. Any forward-looking statements in this statement are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include those risks and uncertainties set forth in its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the United States Securities and Exchange Commission and in its subsequent filings filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Black Diamond Therapeutics, Inc. Condensed Consolidated Balance Sheet Data (Unaudited) (in thousands) December 31, 2022 2021 (in thousands) Cash, cash equivalents, and investments $ 122,807 $ 209,786 Total assets $ 156,255 $ 247,682 Accumulated deficit $ (334,989 ) $ (243,820 ) Total stockholders’ equity (deficit) $ 115,695 $ 195,900 Black Diamond Therapeutics, Inc. Consolidated Statements of Operations (Unaudited) (in thousands, except per share data) Three Months Ended December 31, Year Ended December 31, 2022 2021 2022 2021 Operating expenses: Research and development $ 14,609 $ 19,664 $ 64,437 $ 96,829 General and administrative 7,243 6,416 28,391 30,043 Total operating expenses 21,852 26,080 92,828 126,872 Loss from operations (21,852 ) (26,080 ) (92,828 ) (126,872 ) Other income (expense): Interest income 677 588 2,031 3,464 Other income (expense) 115 (375 ) (354 ) (2,188 ) Gain on sale of IP 2,232 — 2,232 — Total other income (expense), net 3,024 213 3,909 1,276 Equity in (losses) of unconsolidated entity (2,250 ) — (2,250 ) — Net loss $ (21,078 ) $ (25,867 ) $ (91,169 ) $ (125,596 ) Net loss per share, basic and diluted $ (0.59 ) $ (0.71 ) $ (2.52 ) $ (3.47 ) Weighted average common shares outstanding, basic and diluted 36,389,492 36,229,809 36,325,586 36,189,002 Contact: Julie Seidel, Stern Investor Relations (212) 362-1200 investors@bdtx.com media@bdtx.com