BioNTech SE’s Post

Management of patients with HER2-positive metastatic breast cancer after trastuzumab deruxtecan failure The current treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer (ABC) has been greatly impacted in the past decade by the introduction of antibody-drug conjugates (ADCs), which represent a relatively novel therapeutic class with the peculiar ability to deliver otherwise overtly toxic chemotherapeutics to tumor sites by exploiting the specificities of monoclonal antibodies. Indeed, drug engineering refinements in ADC design, such as through the introduction of cleavable linkers and hydrophobic payloads, resulted in improved patient outcomes in recent years. Two different ADCs, namely trastuzumab emtansine (T-DM1) and trastuzumab deruxtecan (T-DXd), have already entered clinical practice for the treatment of HER2-positive ABC. In this scenario, T-DXd has shown to portend better survival outcomes compared to T-DM1, while leaving a large unsought area of unmet medical need upon T-DXd failure. Treatment decision and benefit of cancer drugs following T-DXd still represent an area of clinical controversy, where a preclinical investigation and clinical development should be prioritized. As the pace of innovation is currently accelerating, and with novel ADC formulations advancing in early-phase clinical trials, the whole BC field is changing at an unprecedented rate, with potential broadenings of therapeutic indications. In this review, we present the clinical landscape of HER2-positive advanced BC and discuss our vision on how to tackle T-DXd resistance, providing a perspective on the priority areas of the cancer research in this setting. https://lnkd.in/gR5fAU-J

Eli Lilly has entered into a definitive agreement to acquire Point Biopharma for $1.4bn, giving the company access to a pipeline of clinical and preclinical-stage radioligand therapies being developed to treat cancer. Radioligand therapy can enable the precise targeting of cancer by linking a radioisotope to a targeting molecule that delivers radiation directly to cancer cells, Lilly explained in a statement. Point currently has two lead programmes in late-stage development, including a somatostatin receptor-targeted radioligand therapy, PNT2003, being evaluated for use in patients with gastroenteropancreatic neuroendocrine tumours. The second is a prostate-specific membrane antigen-targeted radioligand therapy, PNT2002, being developed for patients with metastatic castration-resistant prostate cancer who have experienced disease progression after hormonal therapy. Jacob Van Naarden, president of Loxo@Lilly, the oncology unit of Eli Lilly and Company, said: "Over the past few years, we have seen how well-designed radiopharmaceuticals can demonstrate meaningful results for patients with cancer and rapidly integrate into standards of care, yet the field remains in the early days of the impact it may ultimately deliver. "We are excited by the potential of this emerging modality and see the acquisition of Point as the beginning of our investment in developing multiple meaningful radioligand medicines for hard-to-treat cancers, as we have done in small molecule and biologic oncology drug discovery and development." Under the terms of the agreement, Lilly will commence a tender offer to acquire all outstanding shares of Point for a purchase price of $12.50 per share in cash, amounting to approximately $1.4bn. Lilly will also get access to Point’s manufacturing campus for radiopharmaceuticals in Indianapolis, US, as well as a research and development centre in Toronto, Canada. Read more: https://lnkd.in/eMNBZqeQ

In a paper newly published in mAbs, Bristol Myers Squibb authors describe CC-96673 (BMS-986358), an affinity-tuned anti-CD47 and CD20 bispecific antibody with fully functional fc, selectively targets and depletes non-Hodgkin’s lymphoma. From the abstract: CC-96673, a humanized IgG1 bispecific antibody co-targeting CD47 and CD20, is designed to bind CD20 with high affinity and CD47 with optimally lowered affinity. As a result of the detuned CD47 affinity, CC-96673 selectively binds to CD20-expressing cells, blocking the interaction of CD47 with SIRPα. This increased selectivity of CC-96673 over monospecific anti-CD47 approaches allows for the use of wild-type IgG1 Fc, which engages activating crystallizable fragment gamma receptors (FcγRs) to fully potentiate macrophages to engulf and destroy CD20+ cells, while sparing CD47+CD20− normal cells. The combined targeting of anti-CD20 and anti-CD47 results in enhanced anti- tumor activity compared to anti-CD20 targeting antibodies alone. Furthermore, preclinical studies have demonstrated that CC-96673 exhibits acceptable pharmacokinetic properties with a favorable toxicity profile in non-human primates. Collectively, these findings define CC-96673 as a promising CD47 × CD20 bispecific antibody that selectively destroys CD20+ cancer cells via enhanced phagocytosis and other effector functions. #mabs https://lnkd.in/ebSJEgYY

Roche and Exelixis' Tecentriq-Cabometyx Combo Triumphs in Advanced Prostate Cancer Despite Past Setbacks Roche's Tecentriq and Exelixis' Cabometyx have made strides in treating challenging prostate cancer cases after clinical trial setbacks. Phase 3 CONTACT-02 trial achieved positive results, extending progression-free survival in pretreated metastatic castration-resistant prostate cancer patients. While one primary endpoint was met, overall survival displayed a promising trend. Safety profiles aligned with established standards. This success could revolutionize treatment, combining a tyrosine kinase inhibitor with immunotherapy. Ipsen's EVP Howard Mayer emphasized groundbreaking nature, raising hope for patients in advanced stages. Regulatory assessment and potential benefits lie ahead, holding promise for the challenging disease stage and turning the tide for the combination. For those looking to explore the full details of this breakthrough and stay updated on the Latest Pharma News, visit Pharmtales. #pharma #pharmaceutical #pharmtales #latestnews #pharmanews #pharmaceuticalindustry #pharmaceuticalcompanies #prostatecancer #cancer https://lnkd.in/d4z97X3H

Gastric Cancer Breakthrough: Merck’s KEYTRUDA® Achieves Success in Phase 3 KEYNOTE-811 Trial Merck has achieved a significant milestone in gastric cancer treatment with successful results from its Phase 3 KEYNOTE-811 trial. The study evaluated the efficacy of Merck's anti-PD-1 therapy, KEYTRUDA, in combination with trastuzumab and chemotherapy for the first-line treatment of patients with HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma. The trial met its primary endpoint of overall survival, showing a significant improvement in survival rates compared to existing treatments. This offers a new treatment option for patients with this type of cancer. The combination therapy has been granted accelerated approval based on its ability to improve response rates, but further analysis is needed for ongoing approval. Merck's clinical development program aims to evaluate the effectiveness of KEYTRUDA in various gastrointestinal cancers. Gastric cancer is a challenging cancer to treat, and there is a need for more effective treatment options. For more details please click the link! https://lnkd.in/gN-tWnmj #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

🚀 The Future is Here: Tackling Solid Tumours with Next-Gen ADCs A monumental shift is upon us in cancer treatment! The latest buzz? Antibody-drug conjugates (ADCs) specially designed to target solid tumors, a challenge now being addressed head-on by the pharma industry. From the AACR conference in San Diego comes groundbreaking data hinting at a significant advancement. Imagine, 25 years post the first ADC approval, we're now witnessing the rise of the second generation, promising enhanced efficacy against notoriously resistant solid tumors. The fusion of monoclonal antibodies with potent cytotoxic molecules could finally outsmart cancer cells' defenses, guided by a new understanding of payload potency. Revolutionary topoisomerase inhibitors, like Gilead's Trodelvy and AstraZeneca's Enhertu, have paved the way with remarkable results. Now, AstraZeneca's next candidate, Dato-DXd, awaits FDA approval, potentially setting a new standard in precision oncology. But advancing beyond payloads, the focus now also includes novel linker technologies and the critical bystander effect. Each component is being fine-tuned, promising to enhance patient outcomes while minimising side effects. Researchers are not stopping there; dual payloads and an array of innovative drug mechanisms stand at the forefront, expanding the arsenal against the toughest of solid tumors. This third generation of ADCs promises a more precise and devastating blow to cancers that once seemed invincible. The battle is far from over, but with companies like Elevation Oncology and Tubulis leading the charge, hope is on the horizon for those affected by the most elusive cancers.🎯 #CancerResearch #InnovationInOncology #ADCsRevolution

Cancer Research Focuses on Growing Tumor Cells Outside the Human Body: One of the great barriers to improving the fight against cancer has been the problem of growing human cancer cells for drug testing so they behave as if they were inside the patient. To answer this, pharmaceutical companies are beginning to grow human tumors in mice. But mice are not human, so the tests often lead to dead ends. And while it’s possible to grow tumor cells in petri dishes, they rarely behave like actual cancers. But now this problem is being solved by a company called Precision Therapeutics Inc (NASDAQ:AIPT), formerly Skyline Medical Inc (NASDAQ:SKLN), and its partner, Helomics. Precision Therapeutics and Helomics, through a subsidiary named TumorGenesis, are pioneering an approach that takes cancer cells from a patient, then analyzes the tumors’ genes and proteins. That information is crucial because it guides the selection of nutrients and other substances that the cells need. The final step is putting the cancer cells not in a petri dish, but rather on a special scaffold that’s bathed in the nutrient-rich media.The result: “For the first time, it will be possible to grow tumors outside the body that closely mimic those in the body,” explains Dr. Carl Schwartz, CEO of Precision Therapeutics. That, in turn, will bring major benefits for cancer treatment and drug discovery. Cancer is actually many thousands of different diseases, each with different underlying DNA mutations.That’s why drugs that are effective against one person’s ovarian cancer may fail utterly against another’s. But with the ability to grow the cancer cells from patients outside the body, doctors will be able to test drug combinations to discover what works before treating the patient, thus saving people from debilitating side effects from ineffective drugs.Equally important, pharmaceutical companies will have a far better and lower-cost way to test drug candidates than testing on mice. It’s yet another key step towards personalized cancer treatment that will give every patient a much better chance of long-term survival. #healthcarenews #DoctorsBusinessNetwork #medicalnews

Clinical Trials Updates: AstraZeneca announces positive phase III results for Tagrisso in NSCLC as a maintenance treatment. How does the AZ blockbuster drug work? Tagrisso is a medication designed to target mutated forms of the EGFR protein, specifically addressing common mutations like exon 19 deletions and exon L858R mutations found in certain types of non-small cell lung cancer (NSCLC). These mutations often result in uncontrolled cell growth and proliferation. EGFR, a cell surface receptor, normally activates signals that promote cell division and survival. However, in cancer cells with EGFR mutations, this signaling pathway becomes excessively active. Tagrisso works by inhibiting the tyrosine kinase activity of mutated EGFR, effectively blocking the signals that drive the growth of cancer cells. Moreover, Tagrisso not only targets sensitizing EGFR mutations but also addresses acquired resistance mutations. Over time, some cancer cells can develop resistance to other EGFR inhibitors, but Tagrisso is specifically designed to counteract these resistance mechanisms. By disrupting the abnormal signaling caused by mutated EGFR, Tagrisso plays a crucial role in slowing down or halting the growth of cancer cells. It provides targeted therapy for patients with EGFR-mutated NSCLC. It's essential to emphasize that Tagrisso is prescribed based on the specific EGFR mutations identified in a patient's cancer through an FDA-approved test. Tagrisso has multiple indications in NSCLC, including first-line treatment, adjuvant therapy post-resection, and treatment for metastatic disease post-prior EGFR-TKI therapy. The choice of treatment depends on the specific EGFR mutations identified through an FDA-approved test. #pharma #medicalaffairs #clinicaldevelopment #FDA #clinicaltrials #clinicalcareers #medicalprofessionals https://lnkd.in/g_ZK4dYS

This past Sunday was #WorldCancerDay. To mark it, my PhRMA colleague Michael Ybarra, MD shared in this blog his excitement around antibody drug conjugates (ADCs) which are helping to change the trajectory of cancer. Two things separate ADCs from other approaches to fighting cancer. First, they largely focus on cancer targets and avoids healthy cells. This has the benefit of lessoning the load from often highly toxic chemotherapy. Second, ADCs have shown promise in targeting solid cancerous tumors. One study found that an ADC prolonged overall survival in advanced ovarian cancer patients by 33% - that is something we can all celebrate! As we continue to fight cancer, ADCs are an exciting approach with more than 100 of the cancer medicines currently in development being ADCs, and more advancements are expected in the next few years as biopharmaceutical researchers focus efforts on this exciting class of drugs. #Cancer #drugdevelopment https://lnkd.in/dVK2MHUs

#cancerresearch #oncology #cancertreatment #immunology https://lnkd.in/eG_NPHWU Abstract Bispecific #antibodies (bsAbs) enable novel mechanisms of action and/or therapeutic applications that cannot be achieved using conventional IgG-based antibodies. Consequently, development of these molecules has garnered substantial interest in the past decade and, as of the end of 2023, 14 bsAbs have been approved: 11 for the treatment of cancer and 3 for non-oncology indications. bsAbs are available in different formats, address different targets and mediate anticancer function via different molecular mechanisms. Here, we provide an overview of recent developments in the field of bsAbs for cancer therapy. We focus on bsAbs that are approved or in clinical development, including bsAb-mediated dual modulators of signalling pathways, tumour-targeted receptor agonists, bsAb–drug conjugates, bispecific T cell, natural killer cell and innate immune cell engagers, and bispecific checkpoint inhibitors and co-stimulators. Finally, we provide an outlook into next-generation bsAbs in earlier stages of development, including trispecifics, bsAb prodrugs, bsAbs that induce degradation of tumour targets and bsAbs acting as cytokine mimetics.