Positive Interim Results from Mitazalimab OPTIMIZE-1 Phase 2 Trial in Pancreatic Cancer Exceeding 50% Objective Response Rate Announced
“We are thrilled with these interim results, which demonstrate that mitazalimab combined with chemotherapy could offer a significant clinical benefit for pancreatic cancer patients over standard of care,” said Søren Bregenholt, CEO of Alligator Bioscience. “We are very keen to progress our lead asset through the next stage of its development as quickly as we […]
Initial update on Ph 2 PRESERVE 3 trial of 1L platinum-based chemotherapy and maintenance therapy with avelumab +/- trilaciclib in patients with untreated, locally advanced or metastatic urothelial carcinoma (mUC) announced
“The immunomodulatory mechanism of action of trilaciclib lends itself to longer term anti-tumor efficacy endpoints like PFS, as opposed to shorter term response rate endpoints, as was noted in the Phase 2 trial in triple negative breast cancer (TNBC),” said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. “We look forward to the results […]
Interim Data from Ph 1b/2 Study of Abequolixron (RGX-104) in Relapsed or Refractory Lung Cancer Announced
“The data thus far demonstrate that abequolixron is well tolerated in combination with full dose docetaxel, while showing encouraging clinical activity suggesting that this drug candidate could be a valuable addition to a current standard of care chemotherapy in heavily-pretreated patients with lung cancer,” said Hossein Borghaei, D.O., M.S., Chief of the Division of Thoracic […]
Positive Clinical Data Update for Zotatifin Provided
“We are making steady headway across all our clinical programs and look forward to a number of key data milestones in 2023 for both the zotatifin and tomivosertib programs,” remarked Steve Worland, Ph.D., president and chief executive officer of eFFECTOR. “With zotatifin, we continue to see activity across both ER+ BC expansion cohorts, and the […]
Positive Top-Line Results from IMerge Ph 3 Trial of Imetelstat in Lower Risk MDS Announced
“Today is a great day for lower risk MDS patients who are living with the burden of transfusions. The results from the IMerge Phase 3 study were resoundingly positive, presenting compelling durability of transfusion independence, delivering on the promise of imetelstat and telomerase inhibition for these patients,” said John A. Scarlett, M.D., Geron’s Chairman and […]
Results from INTRIGUE Ph 3 Clinical Study Demonstrate Substantial Clinical Benefit of QINLOCK® in 2L GIST Patients with Mutations in KIT Exon 11 and 17/18 Only
“We are extremely pleased by the exploratory analysis showing that QINLOCK, already the standard of care for fourth-line GIST patients, provided substantial clinical benefit to this subgroup of second-line patients compared to sunitinib. We look forward to presenting additional data from the overall ctDNA analysis at a medical meeting later this month,” said Matthew L. […]
BT8009 Gets FDA Fast Track Designation To Treat Urothelial Cancer
“FTD represents another positive step in the development of BT8009 and reflects the pressing need for a clinically meaningful, differentiated therapy compared to what is available for patients,” said Kevin Lee, Ph.D., Chief Executive Officer. “We believe this designation is a valuable component of our future clinical and regulatory strategy as we work to align […]
FDA Grants Priority Review to Glofitamab for People with Relapsed or Refractory Large B-Cell Lymphoma
“Unfortunately, people with relapsed or refractory large B-cell lymphoma have a poor prognosis and desperately need additional therapies that are immediately available at the time of relapse,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Even for patients whose cancer is rapidly progressing, glofitamab given for a fixed […]
NMPA formally accepts New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel)
Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech, said: “Meeting medical needs and serving patients around the world has always been the goal of Legend Biotech’s innovative research and development. Cilta-cel has been approved for marketing in the United States and Japan and has received conditional marketing authorization in Europe. We look forward to […]
BLA submitted to FDA for Cosibelimab as a Treatment for Patients with Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
“This is a major milestone for Checkpoint Therapeutics, representing our first submission of a marketing application for one of our investigational medications and furthering our evolution from a development-stage company to a fully integrated commercial organization to support the potential launch of cosibelimab,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “cSCC is […]
FDA gives go-ahead to clinical Ph 2b study for EVX-01
“Receiving a green light from the FDA is a tremendous boost for our personalized cancer vaccine program. EVX-01 is already actively enrolling patients in Australia, and the FDA approval expands our ability to move forward quickly with our lead program in malignant melanoma. Moreover, the FDA is a universally recognized national authority, and its endorsement […]
Patient dosing stopped in MGTA-117 Ph 1/2 Dose Escalation Clinical Trial in R/R AML and MDS
“Magenta Therapeutics today announces that, per the clinical trial protocol for the MGTA-117 Phase 1/2 Dose Escalation Clinical Trial in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), it has stopped dosing participants at the Cohort 4 dosing level (0.13 mg/kg) and plans to dose additional participants at the Cohort 3 dosing level (0.08 […]
Merck and Kelun-Biotech Announce Exclusive License and Collaboration Agreement for 7 Investigational ADC Candidates for the Treatment of Cancer
“Advances in ADC technologies are yielding a new generation of candidates designed to more precisely target and deliver potent anticancer agents to the tumor site,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We continue to augment our oncology pipeline and look forward to working with the Kelun-Biotech team to advance these candidates to […]
Kite To Acquire Tmunity Therapeutics To Pursue Next Generation CAR T-Cell Therapy Advancements In Cancer
“Kite has demonstrated an ability to globally scale cell therapy and address the unique challenges and opportunities that cell therapy represents, which are quite different in material ways than traditional pharmaceutical or biotech approaches,” said Tmunity Founder Carl June, MD, who is also the Richard W. Vague Professor of Immunotherapy in Penn’s Perelman School of […]
ORIC Pharmaceuticals Announces Clinical Development Collaboration with Pfizer for ORIC-533 in Multiple Myeloma and Concurrent $25 Million Equity Investment by Pfizer
“We continue to be encouraged by the potential of ORIC-533 as a first-in-class treatment for patients with multiple myeloma, and a natural next step is to explore ORIC-533 in combination with approved and emerging therapies, including BCMA directed therapies,” said Jacob M. Chacko, M.D., chief executive officer. “Given Pfizer’s strong commitment, extensive capabilities and deep […]
Gilead to Acquire All Remaining Rights to Potential First-in-Class Immunotherapy GS-1811 From Jounce Therapeutics
“We are pleased to announce the signing of this transaction with Gilead, who have a strong track record of developing and successfully commercializing leading brands in biotechnology,” said Richard Murray, Ph.D., Chief Executive Officer and President of Jounce. “This transaction allows us to extend our runway and remain focused on delivering meaningful and long-lasting benefits […]
Sanofi and Innate Pharma expand collaboration for natural killer cell therapeutics in oncology
Valeria Fantin, Ph.D., Global Head of Oncology Research at Sanofi, commented, “At Sanofi, we are exploring the potential of NK cells for cancer immunotherapy, a key pillar for our oncology strategy. Our relationship with Innate aligns with our commitment to work with promising French companies and supports our ambition to develop a diverse portfolio of […]
Jazz Pharmaceuticals and Zymeworks Announce Jazz has Confirmed Opt-in and Advances Partnership for Zanidatamab
“The compelling top-line clinical data from the pivotal trial in patients with BTC highlight zanidatamab’s potential to transform the current standard of care,” said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. “This important milestone strengthens our confidence in advancing this therapy for cancer patients with significant […]
Mersana Therapeutics Announces Research Collaboration and Commercial License Agreement with Merck to Develop Novel Immunosynthen ADCs
“Building on our deep expertise in the ADC space, we are focused on the discovery of next-generation state-of-the-art ADC drugs,” said Paul Lyne, Head of Research Unit, Oncology, Merck KGaA, Darmstadt, Germany. “An approach that can directly target the tumor microenvironment with an immunomodulatory ADC has the potential to bring the benefits of this immunotherapy […]
Anocca secures EUR 25 million from the European Investment Bank (EIB) to support clinical development of next-generation T-cell therapies for cancer
Anocca’s CEO and co-founder Reagan Jarvis said, “We’re delighted that the EIB has chosen to support us as we build a critical piece of advanced biotechnology capability and infrastructure in Sweden. Anocca’s mission is to expand the clinical and commercial reach of cell therapies by leveraging our proprietary analytical and manufacturing platforms. This financing supports […]
First Patient Dosed in PRESERVE-004 Ph 2 Clinical Trial of ONC-392 + KEYTRUDA® in Patients with Platinum-Resistant Ovarian Cancer
“We are pleased to be making progress on our ONC-392 clinical program with the dosing of our first patient in the PRESERVE-004 trial in the combination arm with KEYTRUDA. We are hopeful these results will build on the promising responses we’ve seen with ONC-392 as monotherapy,” said Pan Zheng, M.D., Ph.D. Chief Medical Officer and […]
CYAD-211 CAR-T program to be discontinued
“Based on a strategic and financial review, the Company has decided to discontinue the development of its remaining clinical program CYAD-211 (the allogeneic shRNA-based, anti-BCMA CAR T candidate for relapsed or refractory multiple myeloma (r/r MM)). There were no safety concerns leading to this decision and all patients previously treated with CYAD-211 will continue to […]
mOS of 21 Months in Advanced, Refractory Cancer Patients observed in Ph 2 trial of PDS0101-based triple combination therapy in advanced HPV-positive cancers
“The expanded data continue to demonstrate the durability and tolerability of the PDS0101-based triple combination therapy in advanced HPV-positive cancers, an extremely challenging population of refractory and previously untreatable HPV-positive patients,” stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “We are pleased to see the continued consistency in the data with […]
Positive Topline Data in Ph 2 Pivotal HERIZON-BTC-01 Trial of Zanidatamab announced
“We are thrilled to report these positive topline data from the HERIZON-BTC-01 clinical trial, which further support the potential of zanidatamab as a new chemotherapy-free therapeutic option for HER2-amplified and expressing BTC. These data demonstrate that zanidatamab, as a single agent, improves on the current standard of care for patients in a difficult-to-treat disease who […]
Complete Response Of The First Patient Treated In B-Cell Non-Hodgkin Lymphoma (B-NHL) Ph 1 Clinical Trial Of PMB-CT01 (BAFFR-CAR T Cells) announced
“Despite high initial efficacy of CD19-CAR T cell treatment for B-cell lymphoma and leukemia, there is a significant unmet medical need for those patients who unfortunately relapse,” said Larry W. Kwak, M.D., Ph.D., vice president and deputy director of City of Hope’s Comprehensive Cancer Center and PeproMene’s scientific founder and compensated chair of its Scientific […]
Positive Trial Result of I-SPY2 Trial for Oral Paclitaxel in Combination with PD-1 and Carboplatin in Neoadjuvant Breast Cancer reported
“We are very pleased that the Oral Paclitaxel combination regimen graduated from this prestigious program which has brought exciting and innovative treatments to neoadjuvant breast cancer patients. This study confirms our finding of less neuropathy for Oral Paclitaxel compared to intravenous paclitaxel in our metastatic breast cancer study. It’s reassuring to see that Oral Paclitaxel […]
FAILED TRIAL: PEARL Ph 3 trial for Imfinzi (durvalumab) monotherapy did not achieve statistical significance of improving OS vs chemo as a monotherapy treatment in PD-L1+ve mNSCLC patients
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “With PEARL, we set out to answer important scientific questions in the treatment of metastatic non-small cell lung cancer at a time when patient selection for immune checkpoint inhibitors was still evolving. We are encouraged to see patients in the metastatic setting at a higher level […]
BLA Review for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) by FDA remains pending
“Although toripalimab’s BLA review process has been impacted by the COVID-19 pandemic, we believe the impact is temporary,” said Dr. Sheng Yao, Senior Vice President of Junshi Biosciences. “Together with our partner Coherus, we are working with the FDA to expedite the facility inspection so it may be conducted safely as soon as possible in […]
Adagrasib (KRAZATI™) Receives Breakthrough Therapy Designation from FDA for Patients with Advanced, KRAS-Mutated CRC
“KRASG12C-mutations occur in 3-4% of colorectal cancers and are associated with poor outcomes. Few effective treatment options exist for these patients,” said Alan Sandler, M.D., Chief Medical Officer. “We are encouraged by this data, particularly adagrasib in combination with cetuximab. With the BTD status, we look forward to working together with the FDA to potentially […]
Positive follow-up Type C meeting with FDA regarding late-stage clinical development plans for eftilagimod alpha + SOC for the treatment of metastatic breast cancer (MBC)
Immutep CEO, Marc Voigt, commented: “As recently announced, our late-stage clinical development efforts for efti are now focused on frontline NSCLC in combination with anti-PD-1 therapy, given the large market opportunity and need for more durable and tolerable options. With this said, progress reported to date with the FDA and EMA provides Immutep and its […]
