On September 26, 2016 Cambrex Corporation (NYSE: CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported that it has agreed to acquire PharmaCore Inc., a privately-owned company specializing in developing, manufacturing and scaling up small molecule APIs for clinical phase projects, for approximately $25 million (Press release, Cambrex, SEP 26, 2016, View Source [SID:SID1234515425]). PharmaCore was founded in 1999 and occupies a 35,000 sq. ft. GMP site in High Point, North Carolina, USA.

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PharmaCore develops and produces complex APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100 kg to support clinical trials from Phase I to Phase III. The company is licensed with the US Drug Enforcement Administration (DEA) to manufacture Schedule II to Schedule V controlled substances. PharmaCore has more than 60 full time employees, focused on projects at laboratory and pilot plant scale, with nearly 40 lab-based Process and Analytical Chemists, the majority of whom hold PhDs.

The acquisition will enhance Cambrex’s portfolio of small molecule API services and complements its existing large scale, multi-purpose manufacturing facilities in the US and Europe. PharmaCore is currently generating $15 to $17 million per year in revenues and just over two million dollars per year in EBITDA. Cambrex expects the transaction, net of deal fees, to have a neutral impact on earnings per share in 2016 and to be accretive in 2017.

"We are excited to announce our acquisition of PharmaCore, which we believe underlines our commitment to continually enhancing our service offering to our global pharmaceutical and biotech customers. The acquisition will provide the capability and expertise to efficiently develop early clinical phase products and new technologies. We expect PharmaCore’s substantial customer base and robust project pipeline to broaden our potential late stage clinical development and commercial manufacturing opportunities," commented Steven Klosk, CEO of Cambrex.

He added, "Through the end of 2016, Cambrex will have invested over $200 million in capital projects within our existing facilities, including a recently completed $50 million production and warehousing expansion of our large scale US API facility in Charles City, Iowa, and a $9 million investment to expand large scale manufacturing capacity at our Karlskoga facility in Sweden, which we expect will be completed shortly."

Rob Maddox, President of PharmaCore added, "PharmaCore is proud of the reputation we have developed, both as a trusted CMO and a company with a strong track record of innovative chemistry. We are thrilled to be joining Cambrex’s global network and to have the opportunity to participate in Cambrex’s growth strategy."

PharmaCore’s NC facility has a 15,000 sq. ft. chemistry laboratory and a 13,000 sq. ft. pilot plant, with reactor capacity ranging from 20L to 2000L, with supporting GMP analytical services.

The completion of the transaction is subject to customary closing conditions, and is expected to occur within 30 days. PharmaCore was advised on this transaction by Wombat Capital Markets, LLC.

On September 26, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported three poster presentations have been accepted by the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 31st Annual Meeting & Associated Programs taking place from Nov. 9-13 at Gaylord National Hotel & Convention Center in National Harbor, Md (Press release, Advaxis, SEP 26, 2016, View Source [SID:SID1234515427]). The poster presentations showcase the potential of Advaxis’ Lm Technology immunotherapies for monotherapy and combination therapy in difficult-to-treat cancers.

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The poster presentations featuring Advaxis immunotherapies at SITC (Free SITC Whitepaper) 2016 include:

"AIM2CERV: a randomized Phase 3 study of adjuvant AXAL immunotherapy following chemoradiation in patients who have high-risk locally advanced cervical cancer (HRLACC)"
"A Phase 1/2 study of durvalumab alone or in combination with AXAL in recurrent/persistent or metastatic cervical or human papillomavirus (HPV)+ squamous cell cancer of the head and neck (SCCHN): preliminary Phase 1 results"
"Combination of Listeria-based human papillomavirus (HPV) E7 cancer vaccine (AXAL) with CD137 agonist antibody provides an effective immunotherapy for HPV-positive tumors in a mouse model"

On September 26, 2016 Cellerant Therapeutics, Inc., a clinical-stage company developing innovative cell- and antibody-based immunotherapies for hematologic malignancies (blood cancers) and other blood-related disorders, reported that the National Cancer Institute has awarded the Company a $1.5 million Small Business Innovation Research (SBIR) Phase II contract to support preclinical development of CSC012-ADC, a novel antibody drug-conjugate to treat acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) (Press release, Cellerant Therapeutics, SEP 26, 2016, View Source [SID:SID1234515417]). CSC012-ADC targets the interleukin 1 receptor accessory protein (IL1RAP), which has been shown to be expressed on leukemic cancer stem cells, but not on normal hematopoietic stem cells. The award will fund preclinical studies and other activities over the next two years which, if successful, will position the Company to pursue an Investigational New Drug application for CSC012-ADC.

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"We are very pleased to receive this award to support the development of CSC012-ADC and address a high unmet medical need," said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant. "Our studies to date show IL1RAP to be a promising target for the treatment of AML and MDS, which are aggressive diseases with low survival rates, particularly among elderly patients. We believe our approach of targeting and killing the leukemic cancer stem cells with an IL1RAP antibody drug-conjugate has the potential to improve outcomes for AML and MDS patients."

This contract was awarded by the National Cancer Institute under the Small Business Research Innovation Research Program Contract Topic 326, "Development of Novel Therapeutic Agents that Target Cancer Stem Cells." IL1RAP has been shown to be expressed on leukemic cancer stem cells and on tumors from several solid cancers. The Company was previously awarded an SBIR Phase 1 contract to support research and development of IL1RAP antibodies.

On September 26, 2016 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical-stage oncology drug development company, reported that its lead antibody development program, HuMab 5B1, was featured in three separate presentations at the recently held World Molecular Imaging Congress (WMIC) in September (Press release, MabVax, SEP 26, 2016, View Source [SID:SID1234515400]). The presentations were made by investigators from the Department of Radiology at Memorial Sloan Kettering Cancer Center (MSK) describing the novel use of MabVax’s lead antibody as a PET imaging agent and as a radioimmunotherapy agent targeting pancreatic and bladder cancer.

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Summaries of the investigator presentations and key points made are as follows:

"Utilizing antibody fragments for same-day pre-targeted immunoPET imaging in preclinical pancreatic cancer" – Investigators demonstrated that the MabVax HuMab-5B1 antibody can be successfully produced as a smaller fragment called a F(ab’)2 and coupled to multiple imaging agents without impacting immunoreactivity. This smaller fragment was coupled with Zirconium and Copper-based PET imaging agents, and a commonly used fluorescence imaging agent. All three constructs produced promising results for rapid immunoPET or immunofluorescent imaging. The potential advantage of using a smaller fragment is that imaging results could be obtained more rapidly and perhaps within the same day, giving physicians more real-time information and providing increased convenience for patients. This work was led by Jacob Houghton, Ph.D. of the Department of Radiology at MSK.
"Bioorthogonal click chemistry for the development of 225 Ac-radioimmunoconjugates and its application to pretargeting" – Investigators demonstrated that the MabVax HuMab-5B1 antibody was successfully conjugated to the radioimmunotherapy agent 225Actinium without losing immunoreactivity. Actinium has received increased interest among investigators as a potential therapeutic modality because of its alpha particle radiation has a limited range in tissue of a few cell diameters and a greater energy release for selectively killing cancer cells. This work was led by Sophie Poty, Ph.D. from the Department of Radiology and the Molecular Pharmacology Program at MSK.

"Tumor-specific PET Imaging in a Bladder Cancer Model" – The investigators demonstrated that the 89Zirconium-labeled HuMab-5B1 labeled antibody can specifically bind to xenograft tumors of human bladder cancer in animal models, potentially leading to use as an immunoPET radiotracer. There is a large unmet medical need for new treatments for bladder cancer, with an estimated 76,900 new cases each year. MabVax’s 89Zirconium-labeled HuMab-5B1 antibody (MVT-2163) is now in a phase I clinical trial for evaluation as a PET imaging agent for pancreatic cancer targeting the CA19.9 epitope, which is expressed on one-third to one-half of bladder cancers. This work was led by Jeffrey Steckler and Jacob Houghton, Ph.D. of the Department of Radiology at MSK.
David Hansen, CEO of MabVax Therapeutics, said, "We are grateful to Jason S. Lewis, Ph.D. and his team for their continued pioneering work using the HuMab-5B1 platform. They are taking important steps in expanding the clinical utility of our HuMab-5B1 antibody, including (1) demonstrating that smaller fragments of our full-length antibody could provide significant advantages in speeding tumor imaging, (2) demonstrating the utility of our full length antibody with a new radioimmunotherapy approach, (3) helping MabVax to evaluate additional CA19-9 expressing cancers for which our antibody development program may have utility beyond our current focus on pancreatic cancer, and (4) completing investigations supporting our radioimmunotherapy product for which we plan to submit an Investigational New Drug Application later this year."

On September 26, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported it will present three new studies at the National Society of Genetic Counselors Annual Education Conference being held Sept. 28-Oct. 1, 2016 in Seattle, Washington (Press release, Myriad Genetics, SEP 26, 2016, View Source [SID:SID1234515405]).

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"We are excited to be co-sponsoring the 35th National Society of Genetic Counselors Annual Education Conference," said Susan Manley, L.C.G.C., M.B.A., vice president of Medical Services, Myriad Genetic Laboratories. "We’re looking forward to presenting important new scientific data, which will improve the practice of genetic counseling. We also are excited to host a patient advocacy event in conjunction with the Conference, which will help raise funds for important patient advocacy groups including Be the Difference Foundation, Hereditary Colon Cancer Foundation and Li-Fraumeni Syndrome Association."

Below is a list of the featured presentations at NSGC (#NSGC16):

Poster Presentations

Title: Average Age of Diagnosis of Ovarian Cancer for Women with Pathogenic Variants in BRIP1, RAD51C and RAD51D​.
Presenter: Susana San Roman.
Date: Friday, September 30, 2016: 11:30 am — 12:45 pm PT.
Poster: C-117.

Title: Ancestry-Based Cancer Risks Associated with APC I1307K​.
Presenter: Lavania Sharma.
Date: Friday, September 30, 2016: 11:30 am — 12:45 pm PT.
Poster: C-123.

Title: Psychosocial Outcomes of Identifying High or Moderate Risk Mutation Carriers by Hereditary Cancer Panel Testing.
Presenter: Julie Culver.
Date: Thursday, September 29, 2016: 5:45 pm — 7:00 pm PT.
Poster: B-71.
For more information about these presentations, including a complete list of abstracts and presentations, please visit the NSGC website at View Source