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Cellectar Reports Recent Corporate Highlights and 2018 First Quarter Financial Results

On May 11, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported recent corporate highlights and financial results for the three months ended March 31, 2018 (Press release, Cellectar Biosciences, MAY 11, 2018, View Source [SID1234526526]).

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Recent Corporate Highlights

·Received orphan drug designation and rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for CLR 131 to treat neuroblastoma.

·Received orphan drug designation from the FDA for CLR 131 to treat rhabdomyosarcoma, a rare pediatric cancer.

·Presented Phase 1 study results at the 12th World Congress of the World Federation of Nuclear Medicine and Biology demonstrating that CLR 124 is able to cross the blood-brain barrier and achieve uptake in brain tumors. The company believes these data have positive read through for CLR 131 which varies only by the radionuclide delivered.

·Initiated the diffuse large B-cell lymphoma cohort of the company’s Phase 2 clinical trial of CLR 131. This cohort is the fourth and final in the study for patients with R/R B-cell hematologic cancers.

·Initiated cohort 5 in the Phase 1 study of CLR 131 in highly pretreated R/R multiple myeloma patients. This is the first cohort in the trial to use a fractionated dosing schedule.

·Presented two late-breaking poster presentations at the AACR (Free AACR Whitepaper) Annual Meeting. The posters highlighted the potential benefits of fractionated dosing regimens of CLR 131 and the ability of the company’s Phospholipid Drug Conjugates (PDCs) to provide improved targeting of tumor cells and the intracellular trafficking of these molecules.

·Granted seminal U.S. patent for phospholipid-ether analogs covering composition of matter and method of use for proprietary PDCs in combination with anti-cancer agents.

·Issued U.S. patent entitled "Alkylphosphocholine analogs for multiple myeloma imaging and therapy," covering the use of CLR 131 in multiple MM and received a composition of matter patent in Japan.

"The first quarter and recent weeks brought significant progress on both the clinical and regulatory fronts. We advanced both Phase 1 and Phase 2 studies for CLR 131, presented new data at major scientific conferences, and received orphan drug designation and rare pediatric disease designation from the FDA to treat neuroblastoma in pediatric patients, as well as an orphan drug designation to treat rhabdomyosarcoma," said James Caruso, president and CEO of Cellectar Biosciences. "We are particularly excited to begin our upcoming Phase 1 study to explore CLR 131 as a treatment option for children with life-threatening rare pediatric cancers."

First Quarter 2018 Financial Results

Research and development expense for the first quarter of 2018 was $2.1 million, compared with $1.9 million for the first quarter of 2017. The year over year increase is attributable to higher preclinical and clinical project costs, manufacturing, and general research and development costs.

General and administrative expense for the first quarter of 2018 was $1.3 million, compared with $1.0 million for the first quarter of 2017. The year over year increase is attributable to higher consulting, legal and marketing fees, as well as one-time personnel costs incurred in connection with the decision to outsource our manufacturing.

The net loss attributable to common stockholders for the first quarter of 2018 was $3.5 million, or $0.21 per share based on 16.8 million shares outstanding, compared with a net loss attributable to common stockholders for the first quarter of 2017 of $2.9 million, or $0.24 per share based on 12.0 million shares outstanding.

Cash and cash equivalents as of March 31, 2018 were $6.8 million, compared with $10.0 million as of December 31, 2017.

Recently Presented Preclinical Data Show Potential for ADXS-NEO as Anti-Cancer Immunotherapy Agent

On May 11, 2018 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported on recently presented preclinical data demonstrating the anti-cancer potential of their Lm vector that presents tumor neoantigens, and is being evaluated in the ADXS-NEO program (Press release, Advaxis, MAY 11, 2018, View Source [SID1234526525]). ADXS-NEO is derived from the Company’s proprietary Lm Technology and is being developed in partnership with Amgen.

These preclinical findings were discussed in poster presentations at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Additionally, portions of these data were presented by Amgen at a podium presentation during the European Neoantigen Summit 2018.

The first study, as discussed in a poster presentation at AACR (Free AACR Whitepaper) entitled "Neoantigens that fail to elicit measurable T cell responses following peptide immunization can control tumor growth when delivered using a Listeria-based immunotherapy platform," showed that ADXS-NEO generates T cell responses against neoantigen peptides that control tumor growth, even when they were identified as "non-immunogenic" using a conventional peptide-adjuvant immunization. The poster is available here: View Source

In the second study, discussed in a poster presentation at AACR (Free AACR Whitepaper) entitled "Targeting frameshift mutations with a Listeria monocytogenes immunotherapy drives neoantigen-specific antitumor immunity in MC38 and CT26 mouse tumor models," Advaxis’ Lm platform was shown to target frameshift mutations and generate T cells to multiple neoantigens per frameshift in MC38 and CT26 mouse tumor models. The poster is available here: View Source

"The results of these studies highlight the therapeutic potential of targeting neoantigens and suggest that ADXS-NEO could impact the way we approach treatment across a range of cancers," said Ken Berlin, President and CEO of Advaxis. "We look forward to our continued collaboration with Amgen, and to moving into the clinic with this product candidate."

"These preclinical findings provide foundational rationale suggesting that ADXS-NEO has the potential to generate immune responses against multiple neoantigens with the ability to control tumor growth. This is a personalized approach that uses a patient’s own immune system to recognize and eliminate cancer cells harboring multiple mutations that caused their malignancy," said Robert G. Petit, Ph.D., Chief Scientific Officer and Executive Vice President of Advaxis. "We also saw potent immune responses targeting frameshift mutations and control of tumor growth via multiple complementary mechanisms. This is important because frameshift mutations are observed to generate up to nine times more neoantigens per mutation than in-frame mutations" according to Turajlic, et al.

About ADXS-NEO

ADXS-NEO is a personalized Listeria monocytogenes (Lm)-based immunotherapy designed to generate immune response against mutation-derived tumor-specific neoantigens. The program focuses on creating a customized treatment with neoantigens specifically selected based on a biopsy of the patient’s tumor. The approach enables the development of tailored immune-therapies. ADXS-NEO is being evaluated in collaboration with Amgen.

The AngloNordic Life science conference

On May 10, 2018 MonTa Biosciences reported that attend the AngloNordic Life science conference in London on Mya 24th to meet investors and network with other European biotechs and investors (Press release, MonTa Biosciences, MAY 10, 2018, View Source [SID1234618633])

STORM Therapeutics to present at Bio€quity Europe 20

On May 10, 2018 STORM Therapeutics, the drug discovery company focused on the discovery of small molecule therapies modulating RNA epigenetics, reported that it will be giving a company presentation at Bio€quity Europe 2018, Ghent, Belgium, 14 – 16 May 2018 (Press release, STORM Therapeutics, MAY 10, 2018, View Source [SID1234561044]).

Keith Blundy, CEO of STORM Therapeutics will be presenting on Wednesday, 16 May 2016 at 9:10am CEST in Rector Gillis Suit, Level 1, Het Pand, Onderbergen 1, Ghent, Belgium.

Now celebrating its 19th meeting, Bio€quity Europe is the seminal industry event for financial dealmakers looking for investor-validated life science companies positioning themselves to attract capital, and for pharmaceutical licensing professionals to assess top prospects. Bio€quity Europe has showcased more than 700 leading European companies to thousands of investment and pharma business development professionals.

10-Q – Quarterly report [Sections 13 or 15(d)]

Osiris Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .