PDC*line Pharma Presents Interim Clinical Results From Last Cohort of Patients in Phase I/II Trial with PDC*lung01 Cancer Vaccine [AACR 2024]

Intermediary results of high dose PDC*lung01 combined with pembrolizumab show mild safety profile, immunological activity and promising tumor response in Non-Small Cell Lung Cancer patients

 

Combination of high dose PDC*lung01 with pembrolizumab in 19 evaluable patients resulted in objective response rate of 63.2% and median progression-free survival of 10.9 months

Liège, Belgium, and Grenoble, France, April 8, 2024 – PDC*line Pharma, a clinical-stage biotech company developing a new class of potent and scalable active immunotherapies for cancers, announces the interim results from the last cohort of patients in its phase I/II clinical trial (PDC-LUNG-101, NCT03970746) with PDC*lung01.

PDC*lung01 is the company’s off-the shelf therapeutic cancer vaccine candidate for Non-Small Cell Lung Cancer (NSCLC). The preliminary data on the last cohort of patients was presented through both an oral presentation and a poster at the American Association for Cancer Research (AACR) Annual Meeting 2024. This data revealed that the high dose PDC*lung01 combined with pembrolizumab shows an immunological activity in a majority of patients and a promising antitumor response in stage IV NSCLC with a mild safety profile.

The phase I/II trial (PDC-LUNG-101) aimed to assess the safety, tolerability, immunogenicity and preliminary clinical activity of PDC*lung01 in NSCLC patients, alone or in combination with anti-PD-1 treatment. PDC*lung01 was administered weekly through both subcutaneous and intravenous routes, in six consecutive doses. The trial was conducted across 17 clinical sites in France, Belgium, Germany, the Netherlands and Poland. PDC*lung01 was administered to a total of 67 evaluable HLA-A*02:01 positive NSCLC patients, at two dose levels and settings:

• As a single agent in the adjuvant setting (cohorts A1: Low Dose, A2: High Dose)
• Combined with standard of care anti-PD-1 monotherapy in first-line stage IV (metastatic) NSCLC patients with a PD-L1 tumor proportion score of ≥50% and no targetable driver mutation (cohorts B1: Low Dose, B2: High Dose)

Clinical activity parameters such as Objective Response Rate (ORR) and Progression-Free Survival (PFS) were assessed only in cohorts B1 and B2. The B2 cohort included 45 patients. PDC*Line is reporting preliminary efficacy results for 19 evaluable patients in the B2 cohort that reached the 9-month PFS mark... PDC*line Pharma's Press Release - 

Affimed Provides Clinical Response Update on AFM24-102 Trial in EGFR-wildtype Non-Small Cell Lung Cancer

• Data update from AFM24-102 Phase 1/2a combination study includes 15 heavily pre-treated patients from the EGFR-wildtype (wt) non-small cell lung cancer (NSCLC) expansion cohort
• Follow-up shows three of the initially reported responses have now been confirmed (1 CR, 2 PR) and one still awaiting a confirmatory scan
• Study to be expanded to a total of 40 EGFRwt NSCLC patients
• Enrollment in the EGFR-mutant (mut) NSCLC cohort is ongoing
• Data from both the EGFRwt and EGFRmut cohorts expected in H1 2024

MANNHEIM, Germany, Jan. 08, 2024 — 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, today provided an update on the clinical response data for the ongoing AFM24-102 phase 1/2a study in EGFRwt NSCLC.

As of January 4, 2024, updated information on the 4 responses in the 15 patients treated in the EGFRwt NSCLC cohort, now show 1 confirmed complete response (CR), 2 confirmed partial responses (PR) and 1 unconfirmed PR awaiting confirmation. Initial data as presented on December 11, 2023, showed 1 confirmed PR as well as 1 unconfirmed CR, and 2 unconfirmed PRs. The patients enrolled in the Phase 1/2a AFM24-102 in the EGFRwt NSCLC cohort of the trial previously had a median of 2 prior lines of therapy, were heavily pretreated, and all patients had progressed on PD-[L]1 targeted therapy.

Based on the promising response data from the EGFRwt NSCLC cohort, Affimed will expand enrollment to 40 patients. Additionally, the Company reported that enrollment of the EGFRmut NSCLC cohort is ongoing. Data from both cohorts are expected in H1 2024.

“We are encouraged by the responses in these patients who had all progressed on PD1 targeting therapy and made the strategic decision to expand this patient cohort,” said Dr. Andreas Harstrick, CMO and interim Chief Executive Officer of Affimed. “There is a significant unmet need for these patients who have exhausted all previous lines of therapy and did not respond to any therapies, including PD-1/PD-L1 treatment. We look forward to sharing more updates in the first half of 2024.”... Affimed's Press Release -

European Medicines Agency Validates Bristol Myers Squibb’s Application for Repotrectinib for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer and NTRK-Positive Solid Tumors

Application based on data from the registrational TRIDENT-1 and CARE trials showing robust responses and durable activity in these patient populations

If approved, repotrectinib will offer a potential best-in-class treatment for patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer and a new option for patients with NTRK-positive solid tumors, in the European Union

PRINCETON, N.J.- Bristol Myers Squibb (NYSE: BMY) announced that the European Medicines Agency (EMA) has validated its marketing authorization application for the next-generation tyrosine kinase inhibitor (TKI) repotrectinib as a treatment for ROS1 TKI-naïve and -pretreated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and TKI-naïve and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors. The application was based on results from the registrational Phase 1/2 TRIDENT-1 trial (adult patients with ROS1-positiveNSCLCor NTRK-positivesolid tumors) and CARE study (pediatric patients with NTRK-positivesolid tumors). Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.

“While there are existing TKIs for the treatment of ROS1-positive non-small cell lung cancer and NTRK-positive solid tumors, there is still an undeniable need for new options that may offer patients more durable responses, including those with metastatic disease to the brain, and may address the issue of treatment resistance for patients with these aggressive and rare tumors,” said Joseph Fiore, executive director, global program lead, repotrectinib, Bristol Myers Squibb. “The clinical trial results with repotrectinib highlight the potential for this next-generation therapy to become a best-in-class option for patients with tumors harboring ROS1 fusions and a new option for those with NTRK-fusion positive tumors, two groups who each continue to face a high unmet medical need. Today’s validation by the European Medicines Agency brings us another step closer to our goal of making this new targeted therapy available to patients in Europe.”

In the TRIDENT-1 and CARE trials, repotrectinib demonstrated clinically meaningful response rates in patients across ROS1-positive NSCLC and NTRK-positive solid tumor cohorts. Durability of response was robust and intracranial responses were observed in both settings, as well as in patients whose tumors harbor common resistance mutations. The safety profile of repotrectinib was well characterized and generally manageable with routine standard-of-care treatments. The study remains ongoing to assess long-term outcomes and additional endpoints across patient populations with ROS1-positive locally advanced or metastatic NSCLC and NTRK-positive locally advanced or metastatic solid tumors.

Additionally, in November 2023 the U.S. Food and Drug Administration approved Augtyro™ (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

Bristol Myers Squibb thanks the patients and investigators involved with the TRIDENT-1 and CARE clinical trials.

Turning Point Therapeutics is a wholly owned subsidiary of the Bristol-Myers Squibb Company. As of August 2022, Bristol Myers Squibb acquired the company, including its asset repotrectinib... Bristol Myers Squibb’s Press Release -

FDA Grants Priority Review to Amgen's Tarlatamab Application for Advanced Small Cell Lung Cancer

Currently There are no Approved Therapeutic Options for Third-Line Treatment of Advanced SCLC1

If Approved, Tarlatamab Would be the First BiTE® Therapy for a Major Solid Tumor

FDA Target Action Date is June 12, 2024

THOUSAND OAKS, Calif., Dec. 13, 2023 / - Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company's Biologics License Application (BLA) for tarlatamab.

Tarlatamab is a potential first-in-class, investigational delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE®) therapy for the treatment of adult patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.  

"The FDA's Priority Review designation for this application underscores the urgency to provide new treatment options for patients with advanced SCLC who have progressed following treatment with platinum-based chemotherapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "While first-line treatments often show strong responses, patients can experience aggressive recurrences and long-term survival remains a challenge.2,3 Unfortunately, for patients who relapse, there are limited treatment options, emphasizing the importance of bringing new therapies to this patient population with advanced disease."

The FDA grants Priority Review to applications for medicines that offer, if approved, significant improvements over available options or may provide a treatment option where no adequate therapy currently exists. Based on the Priority Review designation, the Prescription Drug User Fee Action (PDUFA) date for tarlatamab is June 12, 2024.

The BLA is based on the Phase 2 results from the DeLLphi-301 clinical trial that studied patients with advanced SCLC with disease progression on or after platinum-based chemotherapy. Results from the study were recently featured as part of a late-breaking presentation during the 2023 European Society for Medical Oncology (ESMO) Congress and simultaneously published in the New England Journal of Medicine.4,5 The data presented demonstrated antitumor activity with a durable response and encouraging survival outcomes in previously treated SCLC. The safety profile was consistent with the Phase 1 trial.6

Tarlatamab is being investigated in multiple studies including DeLLphi-302, a Phase 1b study evaluating tarlatamab in combination with an anti-PD-1 therapy in second-line or later SCLC; DeLLphi-303, a Phase 1b study investigating tarlatamab in combination with standard of care therapies in first-line SCLC; DeLLphi-304, a randomized Phase 3 trial comparing tarlatamab monotherapy with standard of care chemotherapy in second-line treatment of SCLC that is enrolling patients; DeLLphi-306, a recently-initiated, randomized Phase 3 trial of tarlatamab following chemoradiotherapy in earlier settings of SCLC; and DeLLpro-300, a Phase 1b study of tarlatamab in de novo or treatment-emergent neuroendocrine prostate cancer.7 Amgen also plans to initiate an additional Phase 3 study of tarlatamab in first-line treatment of SCLC.

In October, tarlatamab was granted Breakthrough Therapy Designation by the FDA. The application is being reviewed by the FDA under the Project Orbis framework and Real Time Oncology Review (RTOR). Project Orbis is an initiative from the FDA Oncology Center of Excellence that provides a framework for concurrent submission of oncology products among certain countries...Amgen's Press Release - NCT05060016 -

Geron : Phase 2 Trial of GRN1005 in Brain Metastases From Lung Cancer

December 22, 2011 - Geron Corporation (Nasdaq: GERN) announced the initiation of GRABM-L (GRN1005 Against Brain Metastases - Lung cancer), a Phase 2 clinical trial to evaluate GRN1005 in patients with brain metastases arising from non-small cell lung cancer (NSCLC). GRN1005 is the company's lead LRP-directed peptide-drug conjugate (LRP-directed PDC) and consists of the cytotoxic drug paclitaxel linked to a peptide (Angiopep-2) that targets the LRP receptor to cross the blood-brain barrier (BBB) and to target tumors in the brain.

"With the treatment of the first patient in the GRABM-L study, we have initiated both of the planned Phase 2 clinical trials of GRN1005 in patients with cancer metastases in the brain, a significant unmet medical need for which there are currently no approved drug therapies," said Stephen M. Kelsey, M.D., Geron's Executive Vice President, Head of R&D and Chief Medical Officer. "We have been encouraged by the preliminary evidence of anti-tumor activity against brain metastases observed in the Phase 1 study of GRN1005, and we hope to confirm these results in our Phase 2 trials."

Phase 2 Clinical Trial Design (GRABM-L) 

The purpose of the Phase 2 study is to assess the efficacy, safety and tolerability of GRN1005 in patients with brain metastases from NSCLC. The trial plans to enroll 50 patients.

GRN1005 will be administered at a dose of 650 mg/m2 by intravenous (IV) infusion every three weeks. The primary efficacy endpoint for the trial is overall (intra-cranial and extra-cranial disease) objective response rate. Key secondary endpoints include duration of overall objective response, duration of overall progression-free survival and six month overall survival....Geron's Press Release -

Calypso Medical Technologies : FDA Grants Calypso Medical IDE Approval for Pivotal Lung Cancer Study

Sept. 27, 2011—Calypso Medical Technologies, Inc., developer of real-time localization technology used for precise tumor tracking, announced that the U.S. Food and Drug Administration (FDA) granted Investigational Device Exemption (IDE) approval for its clinical study evaluating real-time tracking of lung cancer tumors during radiation delivery. Patient enrollment is planned at Washington University in St. Louis, and the Cancer Treatment Centers of America in Tulsa, Oklahoma. Investigators in the United States will implant three anchored Beacon® transponders in patients’ lungs and use the Calypso® System to precisely track tumor location and movement during lung cancer radiation therapy.

“We are very pleased to see Calypso begin the U.S. portion of this important clinical study to assess the clinical experience and safety of anchored transponders in the small airways of patients with lung cancer,” said Daniel Nader, DO, FCCP, national clinical director, pulmonary/critical care and interventional pulmonologist at the Cancer Treatment Centers of America at Southwestern Regional Medical Center in Tulsa, Okla. “The five-year survival rate for lung cancer is grim at just 16 percent; however, with the Calypso System’s ability to track this high-velocity repetitive motion, treatment options for lung cancer patients may expand to include earlier and more aggressive radiation treatment.”

Calypso began the pivotal study in October 2010 at Tygerberg Hospital, affiliated with the University of Stellenbosch, in South Africa, located outside of Cape Town. The multi-center study is also underway at the University of Heidelberg in Germany, and the University Hospital Basel in Switzerland. Early data on the implantation of the electromagnetic transponders in lung cancer patients, and the use of the Calypso System for real-time tracking in these patients will be presented at the upcoming American Society of Radiation Oncology (ASTRO) meeting in Miami... Calypso Medical Technologies' Press Release -

Aethlon Medical : Sarcoma, Lung Cancer, Prostate Cancer, Metastatic Melanoma, and Head and Neck Cancer Studies

Aug. 24, 2011 -- Aethlon Medical, Inc. (OTCBB:AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced that it has entered into an agreement with the Sarcoma Oncology Center to study the ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients. Exosomes released by cancer have recently emerged as a novel therapeutic target in cancer care, as they have been implicated in cancer survival, growth, and metastasis. Researchers have also identified that cancer-released exosomes may assist tumors in evading the response of the immune system. At present, there is no therapeutic drug candidate to inhibit the deleterious roles of cancer-released exosomes. The Aethlon Hemopurifier® is a first-in-class medical device with broad-spectrum capabilities against viral pathogens, including HIV and Hepatitis C virus. The device has also demonstrated the ability to capture cancer-released exosomes from cell culture and human ascites fluids [...]

 "The opportunity to test the ability of our Hemopurifier® to remove exosomes from the blood of cancer patients represents an important step in our effort to improve cancer care," stated Aethlon Chairman and CEO, Jim Joyce. "Additionally, we will have the privilege of working with Dr. Sant Chawla, a leading authority in the sarcoma oncology field and his team at the Sarcoma Oncology Center."

 The study will be conducted in collaboration with The Sarcoma Oncology Center based in Santa Monica, California. The Sarcoma Oncology Center is one of the most sought after research centers for the clinical testing of new therapeutic candidates against sarcomas and other forms of cancer. [...] The lead investigator of the study is Dr. Sant P. Chawla (About Dr. Chawla). Dr. Chawla noted, "This clinical histological study is a critical validation step in Aethlon's Hemopurifier® strategy for cancer that we hope will set the stage for planned therapeutic trials in cancer patients. The concept of 'subtractive therapy', eliminating a major mechanism of tumor progression and resistance to drugs, represents a potential breakout solution that needs to be tested in the clinic." The initial study will quantitate and capture exosomes ex-vivo, from blood samples of patients with advanced cancers. The study will evaluate 25 patients, five patients with metastatic cancer of the following types; non-small cell lung cancer, prostate cancer, melanoma, head and neck cancer, and sarcoma... Aethlon Medical's Press Release -

Helsinn : Global Pivotal Phase III Clinical Program to Evaluate Anamorelin in Non-Small Cell Lung Cancer-Associated Anorexia/Cachexia

Aug. 23, 2011 -- Helsinn, a Swiss-based pharmaceutical company, announced that its US subsidiary, Helsinn Therapeutics, has enrolled the first patient in the company's pivotal Phase III clinical program of anamorelin HCl for the treatment of anorexia/cachexia in patients with advanced non-small cell lung cancer (NSCLC).

The anamorelin clinical program includes two pivotal Phase III studies to be run in parallel, named ROMANA-1 and ROMANA-2. Each is a randomized, double-blind, placebo controlled, multicenter global trial that is expected to enroll up to 477 patients. In addition, patients will have the option of continuing treatment in a 12-week safety extension study called ROMANA-3. The primary efficacy endpoints of ROMANA-1 and 2 include a measure of difference in the change in lean body mass and muscle strength in patients with advanced NSCLC-associated weight loss. Pharmacokinetic and additional safety measures will also be evaluated... [PDF] Helsinn's Press Release -

QIAGEN and Pfizer partner to develop companion diagnostic for novel compound in global clinical trials for lung cancer

August 16, 2011 - QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) announced it has entered into a partnership with Pfizer Inc. (NYSE: PFE) for the development of a companion molecular diagnostic test for use with an investigational Pfizer compound in global clinical development for treatment of non-small cell lung cancer (NSCLC). Financial terms of the agreement were not disclosed.

Pfizer's investigational compound, dacomitinib (PF-00299804), is an oral inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases. The HER (human epidermal growth factor receptor) signaling pathway plays a role in the complex process of cell growth and metastasis, making it a target for anti-cancer drugs.

 QIAGEN's proposed companion diagnostic will be based on its proprietary KRAS assay technology, which reliably detects mutations of the KRAS gene that are frequently found in human cancers. Because EGFR inhibitors are generally effective in patients without these KRAS mutations, the QIAGEN assay can be useful in identifying patients most appropriate for EGFR-inhibitor therapies. QIAGEN recently submitted the application for Premarket Approval (PMA) for KRAS companion diagnostics to the FDA for use with two other, separate drugs targeting metastatic colorectal cancers. The Pfizer drug companion diagnostic test is being specifically developed for use in lung cancer tissue. It uses the same core assay component as the therascreen KRAS RGQ kit for colorectal cancers but varies in the workflow to allow for lung tissue-specific sample technology in a fully automated workflow... QIAGEN's Press release -

Cerulean Pharma : First Patients in Randomized Phase 2 Clinical Study of CRLX101 in Non-Small Cell Lung Cancer

July 12, 2011 - Cerulean Pharma Inc., a leader in designing and developing tumor-targeted nanopharmaceuticals, announced the dosing of the first patients with CRLX101 in a randomized, controlled non-small cell lung cancer (NSCLC) Phase 2 clinical trial.

The initiation of this Phase 2 study marks a major milestone in the clinical advancement of nanopharmaceuticals,” said Oliver Fetzer, Ph.D., president and chief executive officer of Cerulean. “Cerulean is excited to develop CRLX101 as a potential new therapy for lung cancer patients who otherwise have limited treatment options.”

The primary objective of the Phase 2 study is to assess the efficacy and safety of CRLX101 in advanced NSCLC patients whose disease has progressed following one or two prior regimens of therapy. Approximately 150 patients are anticipated to be enrolled in this study at 26 clinical trial sites in Russia and Ukraine. Patients will be randomized 2:1 to receive either CRLX101 plus best supportive care or best supportive care, respectively. Patients will be evaluated for overall survival, progression-free survival, tumor response, and pharmacokinetic parameters... [PDF] Cerulean Pharma's Press Release -

Verisante Technology : Pilot Study Results for Lung Cancer Detection System

July 6, 2011 - Verisante Technology, Inc. (TSX-V: VRS; OTCQX: VRSEF) is pleased to announce that the results of a pilot study on lung cancer detection will be published in the prestigious Journal of Thoracic Oncology in July. The results of the pilot study indicate that the Company’s system technology could set a new standard for the early detection of lung cancer.

The Company owns, co-owns, or has the exclusive rights to all of the technology used in the pilot study, which was generously funded by the Canadian Institutes of Health Research (“CIHR”) and the Canadian Cancer Society.

Verisante is currently developing a commercial prototype of the laser Raman system, the Verisante Core™, licensed from the BC Cancer Agency which, when combined with the ClearVu™ and ClearVu Elite™ systems recently acquired from Perceptronics Medical Inc., reduces false positives by over 75% compared to current endoscopic methods.

The ClearVu™ system is a simultaneous white light and fluorescence real time video accessory which is used with a fiberoptic bronchoscope for lung cancer examinations. The ClearVu Elite™ has the addition of real time reflectance and fluorescence spectral analysis to assess the malignancy potential of suspicious lesions. The technology is complementary to the Verisante Core™ which uses rapid Raman spectral analysis for the detection of lung cancer... Verisante Technology's Press Release -

MolMed : Results of three Phase II trials in lung cancer indications confirm safety and antitumour activity of NGR-hTNF

June 2011 - Promising clinical activity in a randomised trial in non small cell lung cancer - Prolonged clinical benefits in small-cell lung cancer - Long-term advantage of a more frequent administration in mesothelioma – MolMed S.p.A. (Milan:MLM) reports new clinical data of its investigational anticancer drug NGR-hTNF in three different lung cancer indications, which will be presented on 4 June at the 47th ASCO Annual Meeting in Chicago. Initial analysis of a randomised Phase II trial in non-small cell lung cancer, along with top line results of a Phase II trial in small-cell lung cancer and long-term follow up of a Phase II trial in mesothelioma, confirm the favourable safety profile as well as the promising antitumour activity of NGR-hTNF.
Claudio Bordignon, MolMed’s chairman and CEO, comments: "These new data represent another important milestone in the development of NGR-hTNF and show our commitment in the treatment of pulmonary tumours, from mesothelioma to non-small cell and small cell lung cancers. These are the results of a intense and diversified effort in clinical development: we have now ongoing several trials including a pivotal Phase III trial in mesothelioma and a randomised Phase II trial in non-small cell lung cancer. In the treatment of mesothelioma, we expect to have the final results of the Phase III study in 2013, while the results of the long-term analysis of the completed Phase II study confirm the efficacy of our treatment-intensification strategy. In non-small cell lung cancer, the first evaluation of the randomised Phase II trial suggests antitumour activity that is particularly evident in patients with squamous histology, and in patients with adenocarcinoma who received maintenance treatment with NGR-hTNF after completion of chemotherapy. These are important results, because this evidence, together with the lack of cumulative toxicity, led us to explore a new treatment option for NGR-hTNF as maintenance therapy. The first application of this new approach is represented by a randomised Phase II trial of first-line therapy in mesothelioma now open for patient accrual." [PDF] MolMed's Press Release -

Scancell : new vaccine for the treatment of lung cancer

Scancell Holdings Plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, announces that a treatment utilising a DNA vaccine based on its ImmunoBody® technology, in combination with Homspera®, an adjuvant developed by ImmuneRegen BioSciences, Inc.® has produced encouraging anti-tumour results in animal models.

The vaccine, known as SCIB2, stimulates immune responses to the lung cancer antigen NY-ESO-1 and may also have potential utility in oesophageal, liver, gastric, prostate, ovarian and bladder cancers. Unlike classical adjuvants, Homspera® did not enhance the SCIB2 systemic immune response but did make it more effective at the tumour site. This could have profound implications for cancer vaccine therapy.


Scancell is currently conducting a Phase I clinical trial utilising its SCIB1 vaccine which is being developed for the treatment of melanoma. SCIB1 is a novel DNA vaccine which is also being developed using Scancell’s patented ImmunoBody® technology. ImmunoBody® vaccines generate the high-avidity T-cells that kill cancer cells... Scancell's Press Release - ImmuneRegen BioSciences' Press Release -

Cephalon : Encouraging Results of Obatoclax in Extensive-Stage Small Cell Lung Cancer at ASCO Annual Meeting

June 7, 2011 – Cephalon presented new phase 2 data on an investigational compound, obatoclax, at the 47th Annual Meeting of the American Society of Clinical Oncology in Chicago, Ill. The data show that patients with extensive-stage small cell lung cancer receiving obatoclax in addition to standard chemotherapy demonstrated a trend toward improved overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) when compared to chemotherapy alone. This is the first presentation of solid tumor data for the Company following its acquisition of Gemin X in March 2011, which developed the drug. Obatoclax expands the Cephalon portfolio in oncology beyond hematologic malignancies.
“Small cell lung cancer is a deadly and fast-growing tumor type. Approximately 65 percent of patients with this type of lung cancer have extensive disease at presentation and new approaches to treatment are needed,” said Lesley Russell, Chief Medical Officer at Cephalon. “The results of this study, suggest that obatoclax could be a new treatment option for patients if these treatment effects are replicated in a larger phase 3 study.”... Cephalon's Press Release -

CytRx Increases Clinical Sites to 15 in Tamibarotene Phase 2b Clinical Trial in 1st Line Non-Small-Cell Lung Cancer to Expedite Patient Recruitment

Apr 20, 2011 - Clinical Trial Data Could Be Available in Second Half of 2012 - Development of Tamibarotene for Potential Multibillion Dollar Market is Major Priority for CytRx - CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, has expanded enrollment to 15 clinical sites in its Phase 2b clinical trial with tamibarotene in combination with chemotherapeutical agents for the treatment of patients with advanced non-small-cell lung cancer (NSCLC). The large number of sites is expected to accelerate recruitment, and full enrollment of the approximately 140 patients is now anticipated in 12 months.
"We have opened enrollment in 15 clinical sites in the U.S. and Mexico for our tamibarotene clinical trial in 1st line NSCLC to expedite recruitment for an indication that could represent a blockbuster opportunity," said CytRx CEO Steven A. Kriegsman. "We expect these additional sites will accelerate enrollment, which means we could have data from this Phase 2b clinical trial by the end of 2012. What makes NSCLC so compelling is that it is responsible for more deaths than breast, prostate and ovarian cancers combined."
Daniel Levitt, MD, Ph.D., CytRx's Chief Medical Officer, said, "Tamibarotene is 10 times more potent than all trans retinoic acid (ATRA), while simultaneously showing properties that suggest it may lead to fewer adverse effects than ATRA. Recent published clinical data demonstrated that ATRA in combination with chemotherapeutical agents was statistically significant as a treatment for advanced NSCLC, which may open the door for tamibartotene based on its greater potency and lower side effect profile than ATRA."
In December 2010, CytRx initiated the Phase 2b clinical trial in patients with advanced NSCLC at a single clinical site. In this randomized clinical trial, patients with advanced NSCLC are treated with paclitaxel plus carboplatin and either tamibarotene or placebo. The primary objective of this trial is to determine the objective response rate (complete and partial responses) and progression-free survival. Secondarily, the trial will evaluate overall survival, quality-of-life and examine the pharmacokinetics of tamibarotene in this population, among other measures... CytRx's Press Release -

Sanofi-aventis and Regeneron : Top-line Results from Phase III Study with aflibercept (VEGF Trap) in Second-Line Non-Small Cell Lung Cancer

March 10, 2011 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced results from the Phase III VITAL trial evaluating the investigational agent aflibercept (VEGF Trap) for the second-line treatment of non-small cell lung cancer (NSCLC). The data showed that adding aflibercept to the chemotherapy drug docetaxel did not meet the pre-specified criteria for the primary endpoint of improvement in overall survival compared with a regimen of docetaxel plus placebo (HR=1.01, CI: 0.868 to 1.174). The addition of aflibercept to docetaxel demonstrated activity as measured by key secondary endpoints of the study: progression free survival (PFS) (HR=0.82, CI: 0.716 to 0.937) and an overall objective response rate (ORR) of 23.3% in the aflibercept arm compared to 8.9 percent in the placebo arm.


The treatment emergent adverse events (AEs) on the aflibercept arm with an incidence that was 10 percent greater than the control arm were stomatitis, weight decrease, hypertension, epistaxis and dysphonia. Grade 3 or 4 AEs that occurred at a frequency of at least 5 percent in patients who received aflibercept were fatigue, stomatitis, disease progression, hypertension, febrile neutropenia, dyspnea, neutropenia, and asthenia. AEs leading to treatment discontinuation occurred in 27.2 percent of patients in the aflibercept arm compared to 14.6 percent in the placebo arm. The types and frequencies of AEs reported in the aflibercept treatment arm were generally consistent with those reported in previous studies with anti-VEGF agents... [PDF] Sanofi-aventis' Press Release - Regeneron Pharmaceuticals' Press Release -

Helix BioPharma: European Clinical Trial Application For A Phase I/II Study Of Its Lung Cancer Drug Candidate L-DOS47

February 24, 2011 – Helix BioPharma Corp. (TSX, NYSE Amex, FSE: “HBP”), a developer of biopharmaceutical drug candidates for the prevention and treatment of cancer,announced that it has filed a clinical trial application (“CTA”) with the Central Register of Clinical Trials at the Polish Ministry of Health seeking approval to perform its planned Phase I/II clinical safety, tolerability and preliminary efficacy study of its lung cancer drug candidate L-DOS47.
L-DOS47 is Helix’s first therapeutic immunoconjugate drug candidate under development based upon the Company’s novel DOS47 technology, which is designed to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction.L-DOS47 is intended to offer an innovative approach to the first-line treatment of inoperable, locally advanced, recurrent or metastatic, non-small cell lung cancer (“NSCLC”)... [PDF] Helix BioPharma's Press Release -

APP Pharmaceuticals : Approval and Launch of Topotecan for Injection

Nov 30, 2010 - APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market Topotecan for Injection, and plans to launch immediately.

Topotecan for Injection is therapeutically equivalent to the reference-listed drug Hycamtin(R), which is currently marketed by the innovator GlaxoSmithKline, plc. According to IMS data, U.S. sales of Hycamtin(R), in 2009 were $157.1 million.

Topotecanfor Injection is indicated for small cell lung cancer sensitive disease after failure of first-line chemotherapy, and is also indicated for use in combination therapy with Cisplatin for stage IV-B, and for recurrent, or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. APP will market Topotecanfor Injection in 4 mg single dose vials; the product is bar-coded and preservative-free... APP Pharmaceuticals' Press Release -

IsoRay : Its Revolutionary Internal Radiation Therapy for Lung Cancers is Focus of National Study

October 13, 2010 -… IsoRay, Inc. (Amex: ISR) announced the initiation of a multi-institutional study of Cesium-131 brachytherapy seeds (internal radiation therapy) for use in Non Small Cell Lung Cancers (NSCLC). A number of institutions and physicians will be working to collect scientific data to further the use of Cesium-131 internal radiation therapy in conjunction with surgery for NSCLC. The study expands participation in the application of the breakthrough internal radiation treatment. It allows doctors to aggressively treat lung cancer using a single procedure upon tumor removal that is demonstrating its impact as a new vital weapon in the war on cancer.
Lung cancer continues to be the leading cause of cancer deaths worldwide. There are two main types of lung cancer - Small Cell Lung Cancer and Non Small Cell Lung Cancer. Non Small Cell Lung Cancer is the most common type of lung cancer. Some 8 to 9 out of 10 cases of all lung cancer cases are non small cell type. This year alone, an estimated 225,000 cases of lung cancer will be diagnosed of which some 80% will be Non Small Cell Lung Cancer... [PDF] IsoRay's Press Release -

China Medical Technologies : SFDA Approval for its First Self-Developed PCR-based EGFR Assay for Lung Cancer Targeted Drugs

Nov. 10, 2010 - China Medical Technologies, Inc. (the "Company") (Nasdaq: CMED), a leading China-based advanced in-vitro diagnostic ("IVD") company, announced that it has received approval for its real-time PCR-based Epidermal Growth Factor Receptor ("EGFR") Assay (the "EGFR PCR Assay") for the use of lung cancer targeted drugs from the State Food and Drug Administration of China (the "SFDA").

The EGFR PCR Assay is used for the detection of the 28 most common somatic mutations in the EGFR gene of patients with non-small cell lung cancer ("NSCLC") and provides a qualitative assessment of mutation status to determine the use of lung cancer targeted drugs for patients.

With its own internal research and development efforts, the Company has successfully developed its first PCR-based assay related to companion diagnostic tests for personalized medicines for cancer patients. The Company's EGFR PCR Assay is the first PCR-based EGFR assay for the use of lung cancer targeted drugs approved by the SFDA... China Medical Technologies' Press Release -