CONFERENCE COVERAGE: 2022 San Antonio Breast Cancer Symposium (SABCS)
Kite And Arcellx Announce Strategic Collaboration To Co-Develop And Co-Commercialize Late-Stage Clinical CART-DdBCMA In Multiple Myeloma
“The collaboration with Arcellx enables Kite to expand into a new area of high unmet need and bring a potentially best-in-class cell therapy to help many patients,” said Christi Shaw, Chief Executive Officer of Kite. “Cell therapy has proven it can change the way cancer is treated by creating a potentially curative therapy for an […]
Replimune Enters into Clinical Collaboration Agreement with Roche for the Development of RP3 In CRC and HCC
“This collaboration announcement is in keeping with our philosophy of partnering with industry leaders in oncology and in indications where our immunotherapies have the potential to become a key cornerstone of treatment,” said Pamela Esposito, Ph.D., Chief Business Officer of Replimune. “With similar collaborations already in place for our lead candidate RP1 with Regeneron and […]
Nykode Therapeutics Announces Clinical Collaboration with MSD to Evaluate VB10.16 + KEYTRUDA® in Patients with HPV16-Positive Head and Neck Cancer
“We are thrilled to collaborate with MSD, a global leader in immuno-oncology, and to work with their highly experienced and talented scientific team,” stated Agnete Fredriksen, Chief Business Officer & Co-founder of Nykode Therapeutics. “We see great potential for Nykode’s cancer vaccine in combination with MSD’s anti-PD-1 therapy to generate a potent immune response in […]
Caris Life Sciences and Hummingbird Bioscience Enter Into Collaboration to Advance Clinical Development of Anti-HER3 Therapy
“Caris’ partnership with Hummingbird Bioscience aligns with our goal of leveraging molecular and clinical data to power and accelerate the development of precision therapies,” said Brian Lamon, Ph.D., Chief Business Officer at Caris Life Sciences. “Our partnership will help evaluate biomarkers to better understand the clinical utility for this novel therapy, drive patient recruitment and […]
Aarvik Therapeutics Announces a Global Novel Payload Agreement with NJ Bio, Inc.
“We are excited to secure a set of novel payloads for our ADC programs from NJ Bio and to benefit from NJ Bio’s deep chemistry and bioconjugation expertise with ADCs,” said Jagath Reddy Junutula, Ph.D., Co-founder, President, and CEO of Aarvik Therapeutics. “NJ Bio will be an excellent research, development, and manufacturing partner for Aarvik. […]
Summit Therapeutics Partners with Akeso Inc. in Deal for Up to $5 Billion to In-License Breakthrough Innovative Bispecific Antibody Ivonescimab
“The partnership between Summit Therapeutics and Akeso is a strategically compelling opportunity,” stated Robert W. Duggan, Chairman and Chief Executive Officer of Summit. “It represents bringing together Akeso’s extraordinary team, which has built an innovation engine capable of creating novel bispecific technologies, and the talented members of Team Summit with their proven track record of […]
Immunocore and Gadeta Announce Agreement to Develop First Gamma Delta (γδ) TCR ImmTAC for Solid Tumors
“Immunocore pioneered TCR therapy with the launch of KIMMTRAK and we continue to push the edge of TCR science, including researching non-HLA restricted TCR therapies, both internally and through collaborations that complement our platform,” said David Berman, Head of Research and Development of Immunocore. “We are very pleased to collaborate with Gadeta to combine their […]
Revolution Medicines to Regain Global Rights to RMC-4630 following Sanofi’s Termination of SHP2 Inhibitor Development and Commercialization Collaboration
“We remain committed to studying RMC-4630 as a potentially important RAS Companion Inhibitor in our cohesive pipeline focused on novel targeted therapies for RAS-addicted cancers, and fully intend to continue as planned our ongoing Phase 2 clinical trial evaluating RMC-4630 in combination with sotorasib for patients with NSCLC bearing a KRASG12C mutation,” said Mark A. […]
Guardant Health Announces Collaboration With AstraZeneca to Develop Companion Diagnostic to Identify Patients With ESR1-mutated Metastatic Breast Cancer
“We’re pleased to collaborate with AstraZeneca on this important study for breast cancer patients,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “We look forward to exploring the potential benefit of early comprehensive genomic profiling using a simple blood draw, which can provide faster results than a tissue biopsy and enable clinicians to consider earlier […]
Kite and Daiichi Sankyo Announce Changes to YESCARTA® CAR T-Cell Therapy Licensing Agreement in Japan
“We are confident that these changes will benefit patients in Japan by increasing capacity and support broader patient access to this important treatment for blood cancer patients and we remain committed to working together with Kite to ensure a smooth transfer during this transitional period,” said Shoji Hirashima, Senior Executive Officer, Head of Japan Business […]
FDA Lifts Clinical Hold on the Investigational New Drug Application for BEAM-201
“The FDA’s clearance of our IND for BEAM-201 is an exciting moment for Beam and for the field of gene editing, as it represents the first IND clearance for a multiplex-base edited investigational drug,” said John Evans, chief executive officer of Beam. “We believe the future of cell therapy involves high levels of cell engineering, […]
First Patient Dosed in Ph 3 VIKTORIA-1 Clinical Trial of Gedatolisib for the Treatment of HR+/HER2- Advanced Breast Cancer
“We are excited to begin enrolling patients in the VIKTORIA-1 trial and advancing towards our ultimate goal of providing a transformative therapeutic option for patients with breast cancer,” said Igor Gorbatchevsky, M.D. Chief Medical Officer of Celcuity. “We look forward to generating robust data with the goal of supporting a future regulatory submission.”
Discontinuation of Zandelisib Development Outside of Japan Following Recent FDA Meeting announced
“Based on the most recent guidance received from the FDA at a late November meeting, we have jointly decided with Kyowa Kirin to discontinue development of zandelisib outside of Japan. We are very disappointed to share this decision in light of our belief in the potential of zandelisib to benefit patients and meet the ongoing […]
Independent Data Monitoring Committee Recommends Galinpepimut-S REGAL Trial to Continue as Planned
“Following a prespecified review of unblinded data by the IDMC in accordance with its charter, its recommendation to continue the REGAL study as is, and with trial conduct and integrity intact, is outstanding news. As we have previously reported, we have seen, based on a blinded review of the data conducted this fall, that patients […]
Pluvicto™ shows statistically significant and clinically meaningful rPFS benefit in patients with PSMA–positive mCRPC
“With the announcement of these positive topline Phase III results, Pluvicto becomes the first PSMA-targeted radioligand therapy to demonstrate significant and clinically meaningful benefits for people living with this type of prostate cancer who have not received taxane-based chemotherapy,” said Shreeram Aradhye, M.D., President, Global Drug Development and Chief Medical Officer, Novartis. “We look forward […]
PERLA Ph 2 trial of Jemperli (dostarlimab) plus chemotherapy shows positive results in 1L mNSCLC
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: “The head-to-head data from the PERLA trial showed that dostarlimab combined with chemotherapy provided robust anti-tumour activity in patients with previously untreated metastatic non-squamous non-small cell lung cancer. The positive results from this trial inform our future development plans and highlight the potential […]
New Data from the OPTIMA II Study Shows mDOR of 24.4 Months for UGN-102 in patients with Low-Grade, Intermediate-Risk Non-Muscle Invasive Bladder Cancer
“LG-IR-NMIBC is a challenging disease to treat because of the high recurrence rate managed by repetitive surgeries,” says William C. Huang, M.D., FACS, Professor and Vice Chair of Urology at NYU Langone Health and Principal Investigator of the OPTIMA II trial. “The OPTIMA II Phase 2b trial showed significant tumor response benefit for patients using […]
70% complete response (CR) with NKX019 announced in patients with relapsed or refractory non-Hodgkin lymphoma (NHL)
“NKX019 continues to demonstrate impressive single-agent activity, preliminary durability and an encouraging safety profile as an off-the-shelf, on-demand cell therapy for heavily pre-treated patients with NHL,” said Paul J. Hastings, President and CEO of Nkarta. “Based on this initial success, we recently opened dose expansion cohorts to explore combination and single-agent regimens in patients with […]
Preliminary Results from Ongoing Potentially Pivotal Trial Evaluating Berubicin for the Treatment of Recurrent GBM announced
“Although data are still early, we are pleased with these results in terms of recruiting a balanced patient population to compare Berubicin to Lomustine in the treatment of GBM, which may highlight Berubicin’s potential to provide a better therapeutic option for patients after first-line therapy for their disease. We remain steadfast in our efforts to […]
FAILED TRIAL: Ph 3 CONTACT-01 trial of cabozantinib + atezolizumab in IO- and chemo-treated mNSCLC patients did not meet its primary endpoint of OS
Howard Mayer, M.D., Executive Vice President, Head of Research and Development at Ipsen, said: “The results from the CONTACT-01 clinical trial have shown the challenge of treating NSCLC patients after prior lines of treatment have failed. While the findings of the study have not met the primary endpoint in this setting, we remain confident in […]
U.S. FDA Breakthrough Therapy Designation Granted for Revumenib for the Treatment of Patients with R/R KMT2A- Rearranged (MLLr) Acute Leukemia
“The Breakthrough Therapy Designation underscores revumenib’s potential as a first- and best-in-class therapy to meaningfully change the treatment paradigm for patients with R/R KMT2Ar acute leukemia, whether it presents clinically as acute myeloid leukemia (AML) or acute lymphocytic leukemia (ALL), in adults or children,” said Michael A. Metzger, Chief Executive Officer. “Revumenib has the potential, […]
BLA submitted to U.S. FDA for Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
“Despite the therapies that have been developed for the treatment of multiple myeloma, there remains persistent unmet needs for patients who relapse or become refractory,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “Through our discovery and development of talquetamab, a novel GPRC5DxCD3 bispecific antibody, we remain relentlessly […]
Immutep Enters into 2nd Clinical Trial Collaboration Agreement with Merck & Pfizer for New trial of Eftilagimod Alpha and Avelumab to Treat Urothelial Cancer
“We are very pleased to be deepening our collaboration with Merck KGaA, Darmstadt, Germany and Pfizer through this new study in patients with urothelial cancer, the sixth most common cancer in the US, who are in need of treatment options,” said Immutep CEO, Marc Voigt. “INSIGHT-005 builds on the encouraging clinical efficacy and safety previously […]
AstraZeneca to acquire Neogene Therapeutics
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “This acquisition represents a unique opportunity to bring innovative science and leading experts in T-cell receptor biology and cell therapy manufacturing together with our internal oncology cell therapy team, unlocking new ways to target cancer. Neogene’s leading TCR discovery capabilities and extensive manufacturing experience complement the […]
Nectin Therapeutics Announces Extended Series A Financing to Over $25M and Initiation of Patient Dosing in Ph 1 Trial of NTX1088 for Treatment of Patients with Advanced Solid Tumors
“PVR blockade by NTX1088, with its first-in-class differentiated mechanism of action, has demonstrated compelling preclinical anti-tumor activity both as a monotherapy and in combination with other cancer immunotherapies,” said Dr. Pini Tsukerman, Co-Founder and Chief Scientific Officer of Nectin. “Importantly, NTX1088 has potent activity in ICI refractive models where TIGIT or PD-1 blockade has failed […]
Erasca Announces Clinical Trial Collaboration and Supply Agreement with Pierre Fabre to Evaluate ERAS-007 and Encorafenib Combination
“We are excited to work with Pierre Fabre, a leader in precision oncology, on an international collaboration to explore ERAS-007 in combination with encorafenib and cetuximab in BRAF mCRC,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “This partnership complements our existing CTCSA with Pfizer for encorafenib within the United States and other […]
Carrick Therapeutics Announces $35 Million Investment From Pfizer
“Given Pfizer’s deep expertise in developing treatments for breast cancer, we are delighted to welcome them as an investor and collaborator in developing samuraciclib,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. “We believe Pfizer’s investment further underscores the potential of samuraciclib to be a first- and best-in-class treatment for patients with advanced breast […]
Ph 1 Trial of E6201 + Dabrafenib initiated in Patients with CNS Metastases from BRAF V600 Mutated Metastatic Melanoma
“E6201 is a potent MEK1 inhibitor. Exceptional responses were seen with E6201 monotherapy in patients with melanoma brain metastases in our prior Phase 1 studies. By utilizing a targeted drug against BRAF- or MEK-mutated melanoma CNS metastases with excellent brain penetration and retention, we hope to provide a more effective therapeutic in combination with dabrafenib […]
SAPPHIRE Ph 3 study of sitravatinib + nivolumab in patients with chemo- and IO-resistant 2L/3L NSQ-NSCLC will continue to the study’s final analysis
“We remain committed to developing our portfolio of oncology candidates and advancing our lung cancer strategy to positively impact the lives of patients with cancer. We look forward to providing an update based on the full analysis of the SAPPHIRE study in mid-2023,” said Charles Baum, M.D., Ph.D., president, founder and head of research and […]
