BioNTech SE’s Post

🚀 𝑬𝒙𝒄𝒊𝒕𝒊𝒏𝒈 𝑵𝒆𝒘𝒔 𝒊𝒏 𝑪𝒂𝒏𝒄𝒆𝒓 𝑰𝒎𝒎𝒖𝒏𝒐𝒕𝒉𝒆𝒓𝒂𝒑𝒚!! 🚀 BioNTech SE and Regeneron Pharmaceuticals have achieved an early win for their mRNA cancer vaccine candidate, BNT111. In a phase 2 trial, the combination of BNT111 and Regeneron’s checkpoint inhibitor Libtayo demonstrated a better response rate than a historical control in patients with melanoma. Here are the key highlights: 🔬 Study Details: - Patients: 184 individuals with anti-PD-(L)1 refractory or relapsed, unresectable advanced melanoma. - Treatment Arms: - Combination Arm: BNT111 + Libtayo - Monotherapy Arms: BNT111 alone and Libtayo alone Results: - The combination arm showed a statistically significant improvement in overall response rate compared to historical control data. - Both monotherapy arms also exhibited clinical activity, with Libtayo performing in line with the historical control. 🌟 What’s Next? - BioNTech and Regeneron plan to discuss these promising results with regulators. - The combination of BNT111 and Libtayo has FDA fast-track status in the melanoma population enrolled in the study. 🔍 About BNT111: - BNT111 uses a different mRNA format than BioNTech’s COVID-19 vaccine. - It triggers T-cell responses against NY-ESO-1, MAGE-A3, tyrosinase, and TPTE—antigens expressed in over 90% of cutaneous melanomas. - BNT111 aims to reenergize anti-cancer attacks in patients who have failed single-agent checkpoint inhibitors. Stay tuned for more updates as BioNTech and Regeneron continue their groundbreaking work in cancer immunotherapy! 🌟 Credit: Fierce Pharma #ContractResearch #ClinicalData #Clinicalresearch #CRO #Pharmaceuticals #Lifescience #Cancer #Immunotherapy

Endometrial Cancer: Landmark Approval for AstraZeneca's Imfinzi/Lynparza Combination Therapy AstraZeneca has received European Commission approval for its combination therapy of Imfinzi, a PD-L1 inhibitor, and Lynparza, a PARP inhibitor, for the treatment of patients with primary advanced or recurrent endometrial cancer with mismatch repair proficient disease. This marks the first approval of an immunotherapy combined with a PARP inhibitor for endometrial cancer, offering new treatment options for patients with limited alternatives. The approval is based on the DUO-E trial, which demonstrated significant efficacy in reducing the risk of progression or death, particularly for pMMR patients. This breakthrough positions AstraZeneca against competitors like GSK and Merck, which are also advancing in the endometrial cancer treatment market. Regulatory reviews are ongoing in other countries, signaling a major shift in the cancer treatment landscape. For more details please click the link! https://lnkd.in/dS7Kitre #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Cancer Research Focuses on 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

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

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

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

🚀 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

Combining a new Melanoma Vaccine with an Existing Drug Significantly Reduced the Risk of the Cancer Recurring and Spreading: Results from human trials coupling a new melanoma vaccine with an existing cancer drug showed that, at the three-year mark, the combination treatment reduced the risk of melanoma recurring by 49% and the risk of it spreading by 62% compared with the drug alone. The vaccine, developed by Moderna and called mRNA-4157 (V940), was given in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, to 157 patients with high-risk (stage III-IV) melanoma that had been surgically removed. Both boost the immune system’s cancer-fighting abilities. The vaccine is an individualized neoantigen therapy (INT), meaning that it uses the unique DNA signature of a person’s tumor to create a treatment that helps their immune system produce an anti-tumor response. Keytruda blocks the PD-1 pathway that cancer uses to hide in the body, helping the immune system detect and fight cancer cells. #cancer #oncology #melanom #skincancer #drugdiscovery #vaccine #genetherapy #celltherapy #immunotherapy #medicine #drugdevelopment #innovation #biotech Moderna

Lung Cancer Breakthrough: Patritumab Deruxtecan Significantly Improves Progression-Free Survival in EGFR-Mutated Non-Small Cell Lung Cancer The HERTHENA-Lung02 phase 3 trial revealed that patritumab deruxtecan significantly improved progression-free survival in patients with EGFR-mutated non-small cell lung cancer who had previously received EGFR tyrosine kinase inhibitor treatment. The trial showed that patritumab deruxtecan outperformed standard platinum and pemetrexed chemotherapy, offering hope to patients with limited second-line options. Despite most adverse events being low grade, two grade 5 interstitial lung disease events occurred. Results will be presented at an upcoming medical conference, and regulatory discussions are planned, with potential global approval in collaboration between Daiichi Sankyo US and Merck. For more details please click the link! https://lnkd.in/dSVE4Hhb #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical