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San Diego biotech news from BioSpace, Xconomy, PR Newswire, Marketwired and other sources, click on headlines to read the full story.

BioNano Genomics Raises $53 Million

November 19, 2014 – 4:01 pm | Edit Post

San Diego company sells genome mapping instruments that go beyond sequence.

Imagenetix, Inc. Reports September 30, 2014 Results

November 19, 2014 – 2:15 pm | Edit Post

SAN DIEGO, Nov. 19, 2014 /PRNewswire/ – Imagenetix, Inc. (OTCBB:IAGX) announced today results for the period ended September 30, 2014, the first reporting period subsequent to its emergence from a Chapter 11 proceeding under the U.S. Bankruptcy Code. Net sales were $164,000 and net income was $130,000 for the shortened period of September 17, 2014 through September 30, 2014.  Earnings per share were $0.00.  Due to the adoption of “Fresh Start Reporting” as a result of the bankruptcy proceeding, there are no comparisons reflected for previous periods. 

Commenting on the results of the period, William P. Spencer, President of Imagenetix, stated, “I am delighted that we are now moving forward.  The successful results obtained from the reorganization and the ability to reflect profitability already reflect an increase in shareholder value and a positive future direction.  We have emerged successfully from Chapter 11 as a profitable, stronger company with a much healthier balance sheet and much of our debt satisfied or substantially reduced.”

About Imagenetix

Imagenetix, based in San Diego, California, is an innovator of scientifically tested, natural-based, proprietary, bioceutical products developed to enhance human health on a global basis.  Imagenetix develops and formulates proprietary over-the-counter topical creams, skincare products and nutritional supplements to be marketed globally through multiple channels of distribution.  In addition, the company develops patentable compounds for entering into licensing agreements with pharmaceutical partners.  

Certain matters in this news release are forward-looking statements which are subject to risks and uncertainties that could cause actual results to vary materially from those projected.  Such risks and uncertainties include, but are not limited to, adverse fluctuations in future operating results due to a number of economic, competitive, and other factors, including, among other things, the size and timing of customer contracts, new or increased competition, changes in market demand, and seasonality of purchases of the company’s products and services.  Additional information with respect to these and other factors, which could materially affect the company and its operations, are included in the company’s SEC filings.

Contact

Imagenetix Investor Relations

William P. Spencer

(858)385-2797

Chief Executive Officer

Imagenetix, Inc.

Tel: (858) 674-8455

 

Imagenetix, Inc.

 Condensed Consolidated Statement of Income

(Unaudited)

Period Ended

September 30,

2014

Net sales

Product sales

$

315

Licenses and royalties

163,991

  Total net sales

164,306

Cost of sales

3,031

Gross profit

161,275

Operating expenses:

General and administrative

3,656

Payroll expense

21,292

Consulting expense

6,403

Operating expenses 

31,351

Operating income 

129,924

Other income (expense):

Other income

-

Income before income taxes

129,924

Income tax expense 

-

Net income 

$

129,924

Basic net income per share

$

0.00

Fully diluted net income per share

$

0.00

Basic weighted average common shares outstanding

28,272,955

Fully diluted weighted average common shares outstanding

29,350,386

 

Imagenetix, Inc.

 Condensed Consolidated Balance Sheets

 September 30,

 September 16,

2014

2014

(Unaudited)

(Unaudited)

ASSETS 

Current assets:

Cash 

$

255,545

$

1,493,709

Accounts receivable, net

324,793

160,802

Inventories, net

75,474

48,740

Prepaid expenses and other current assets

23,899

23,899

Total current assets

679,711

1,727,150

Property and equipment, net 

25,487

25,487

Goodwill on fresh start from bankruptcy

8,205,597

8,205,597

Other assets 

22,969

23,166

Long-term deferred tax assets

-

-

Total Assets

$

8,933,764

$

9,981,400

LIABILITIES AND STOCKHOLDERS’ EQUITY  

Current liabilities:

Secured note payable   

$

-

$

726,250

Accounts payable

137,078

277,638

Accrued liabilities

84,163

244,913

Customer deposits

8,250

8,250

Total current liabilities

229,491

1,257,051

Long term claims payable

2,250,000

2,400,000

Stockholders’ equity  

Preferred stock, $.001 par value; 5,000,000 shares

  authorized: none outstanding

-

-

Common stock, $.001 par value; 50,000,000 shares

  authorized: 28,272,955 issued and outstanding at 

  September 30, 2014 and September 16, 2014, respectively

28,272

28,272

Capital in excess of par value

6,296,077

6,296,077

Retained earnings

129,924

-

Total stockholders’ equity 

6,454,273

6,324,349

Total Liabilities and Stockholders’ Equity

$

8,933,764

$

9,981,400

SOURCE Imagenetix, Inc.

Imagenetix, Inc. Reports September 30, 2014 Results

November 19, 2014 – 2:15 pm | Edit Post

SAN DIEGO, Nov. 19, 2014 /PRNewswire/ – Imagenetix, Inc. (OTCBB:IAGX) announced today results for the period ended September 30, 2014, the first reporting period subsequent to its emergence from a Chapter 11 proceeding under the U.S. Bankruptcy Code. Net sales were $164,000 and net income was $130,000 for the shortened period of September 17, 2014 through September 30, 2014.  Earnings per share were $0.00.  Due to the adoption of “Fresh Start Reporting” as a result of the bankruptcy proceeding, there are no comparisons reflected for previous periods. 

Commenting on the results of the period, William P. Spencer, President of Imagenetix, stated, “I am delighted that we are now moving forward.  The successful results obtained from the reorganization and the ability to reflect profitability already reflect an increase in shareholder value and a positive future direction.  We have emerged successfully from Chapter 11 as a profitable, stronger company with a much healthier balance sheet and much of our debt satisfied or substantially reduced.”

About Imagenetix

Imagenetix, based in San Diego, California, is an innovator of scientifically tested, natural-based, proprietary, bioceutical products developed to enhance human health on a global basis.  Imagenetix develops and formulates proprietary over-the-counter topical creams, skincare products and nutritional supplements to be marketed globally through multiple channels of distribution.  In addition, the company develops patentable compounds for entering into licensing agreements with pharmaceutical partners.  

Certain matters in this news release are forward-looking statements which are subject to risks and uncertainties that could cause actual results to vary materially from those projected.  Such risks and uncertainties include, but are not limited to, adverse fluctuations in future operating results due to a number of economic, competitive, and other factors, including, among other things, the size and timing of customer contracts, new or increased competition, changes in market demand, and seasonality of purchases of the company’s products and services.  Additional information with respect to these and other factors, which could materially affect the company and its operations, are included in the company’s SEC filings.

Contact

Imagenetix Investor Relations

William P. Spencer

(858)385-2797

Chief Executive Officer

Imagenetix, Inc.

Tel: (858) 674-8455

 

Imagenetix, Inc.

 Condensed Consolidated Statement of Income

(Unaudited)

Period Ended

September 30,

2014

Net sales

Product sales

$

315

Licenses and royalties

163,991

  Total net sales

164,306

Cost of sales

3,031

Gross profit

161,275

Operating expenses:

General and administrative

3,656

Payroll expense

21,292

Consulting expense

6,403

Operating expenses 

31,351

Operating income 

129,924

Other income (expense):

Other income

-

Income before income taxes

129,924

Income tax expense 

-

Net income 

$

129,924

Basic net income per share

$

0.00

Fully diluted net income per share

$

0.00

Basic weighted average common shares outstanding

28,272,955

Fully diluted weighted average common shares outstanding

29,350,386

 

Imagenetix, Inc.

 Condensed Consolidated Balance Sheets

 September 30,

 September 16,

2014

2014

(Unaudited)

(Unaudited)

ASSETS 

Current assets:

Cash 

$

255,545

$

1,493,709

Accounts receivable, net

324,793

160,802

Inventories, net

75,474

48,740

Prepaid expenses and other current assets

23,899

23,899

Total current assets

679,711

1,727,150

Property and equipment, net 

25,487

25,487

Goodwill on fresh start from bankruptcy

8,205,597

8,205,597

Other assets 

22,969

23,166

Long-term deferred tax assets

-

-

Total Assets

$

8,933,764

$

9,981,400

LIABILITIES AND STOCKHOLDERS’ EQUITY  

Current liabilities:

Secured note payable   

$

-

$

726,250

Accounts payable

137,078

277,638

Accrued liabilities

84,163

244,913

Customer deposits

8,250

8,250

Total current liabilities

229,491

1,257,051

Long term claims payable

2,250,000

2,400,000

Stockholders’ equity  

Preferred stock, $.001 par value; 5,000,000 shares

  authorized: none outstanding

-

-

Common stock, $.001 par value; 50,000,000 shares

  authorized: 28,272,955 issued and outstanding at 

  September 30, 2014 and September 16, 2014, respectively

28,272

28,272

Capital in excess of par value

6,296,077

6,296,077

Retained earnings

129,924

-

Total stockholders’ equity 

6,454,273

6,324,349

Total Liabilities and Stockholders’ Equity

$

8,933,764

$

9,981,400

SOURCE Imagenetix, Inc.

Imagenetix, Inc. Reports September 30, 2014 Results

November 19, 2014 – 2:15 pm | Edit Post

SAN DIEGO, Nov. 19, 2014 /PRNewswire/ – Imagenetix, Inc. (OTCBB:IAGX) announced today results for the period ended September 30, 2014, the first reporting period subsequent to its emergence from a Chapter 11 proceeding under the U.S. Bankruptcy Code. Net sales were $164,000 and net income was $130,000 for the shortened period of September 17, 2014 through September 30, 2014.  Earnings per share were $0.00.  Due to the adoption of “Fresh Start Reporting” as a result of the bankruptcy proceeding, there are no comparisons reflected for previous periods. 

Commenting on the results of the period, William P. Spencer, President of Imagenetix, stated, “I am delighted that we are now moving forward.  The successful results obtained from the reorganization and the ability to reflect profitability already reflect an increase in shareholder value and a positive future direction.  We have emerged successfully from Chapter 11 as a profitable, stronger company with a much healthier balance sheet and much of our debt satisfied or substantially reduced.”

About Imagenetix

Imagenetix, based in San Diego, California, is an innovator of scientifically tested, natural-based, proprietary, bioceutical products developed to enhance human health on a global basis.  Imagenetix develops and formulates proprietary over-the-counter topical creams, skincare products and nutritional supplements to be marketed globally through multiple channels of distribution.  In addition, the company develops patentable compounds for entering into licensing agreements with pharmaceutical partners.  

Certain matters in this news release are forward-looking statements which are subject to risks and uncertainties that could cause actual results to vary materially from those projected.  Such risks and uncertainties include, but are not limited to, adverse fluctuations in future operating results due to a number of economic, competitive, and other factors, including, among other things, the size and timing of customer contracts, new or increased competition, changes in market demand, and seasonality of purchases of the company’s products and services.  Additional information with respect to these and other factors, which could materially affect the company and its operations, are included in the company’s SEC filings.

Contact

Imagenetix Investor Relations

William P. Spencer

(858)385-2797

Chief Executive Officer

Imagenetix, Inc.

Tel: (858) 674-8455

 

Imagenetix, Inc.

 Condensed Consolidated Statement of Income

(Unaudited)

Period Ended

September 30,

2014

Net sales

Product sales

$

315

Licenses and royalties

163,991

  Total net sales

164,306

Cost of sales

3,031

Gross profit

161,275

Operating expenses:

General and administrative

3,656

Payroll expense

21,292

Consulting expense

6,403

Operating expenses 

31,351

Operating income 

129,924

Other income (expense):

Other income

-

Income before income taxes

129,924

Income tax expense 

-

Net income 

$

129,924

Basic net income per share

$

0.00

Fully diluted net income per share

$

0.00

Basic weighted average common shares outstanding

28,272,955

Fully diluted weighted average common shares outstanding

29,350,386

 

Imagenetix, Inc.

 Condensed Consolidated Balance Sheets

 September 30,

 September 16,

2014

2014

(Unaudited)

(Unaudited)

ASSETS 

Current assets:

Cash 

$

255,545

$

1,493,709

Accounts receivable, net

324,793

160,802

Inventories, net

75,474

48,740

Prepaid expenses and other current assets

23,899

23,899

Total current assets

679,711

1,727,150

Property and equipment, net 

25,487

25,487

Goodwill on fresh start from bankruptcy

8,205,597

8,205,597

Other assets 

22,969

23,166

Long-term deferred tax assets

-

-

Total Assets

$

8,933,764

$

9,981,400

LIABILITIES AND STOCKHOLDERS’ EQUITY  

Current liabilities:

Secured note payable   

$

-

$

726,250

Accounts payable

137,078

277,638

Accrued liabilities

84,163

244,913

Customer deposits

8,250

8,250

Total current liabilities

229,491

1,257,051

Long term claims payable

2,250,000

2,400,000

Stockholders’ equity  

Preferred stock, $.001 par value; 5,000,000 shares

  authorized: none outstanding

-

-

Common stock, $.001 par value; 50,000,000 shares

  authorized: 28,272,955 issued and outstanding at 

  September 30, 2014 and September 16, 2014, respectively

28,272

28,272

Capital in excess of par value

6,296,077

6,296,077

Retained earnings

129,924

-

Total stockholders’ equity 

6,454,273

6,324,349

Total Liabilities and Stockholders’ Equity

$

8,933,764

$

9,981,400

SOURCE Imagenetix, Inc.

MabVax Therapeutics And Memorial Sloan-Kettering Cancer Center Report on Potential Use of Dual-Labeled Antibody To Detect and Guide Surgical Removal of Pancreatic Cancer

November 19, 2014 – 12:00 pm | Edit Post

SAN DIEGO, Nov. 19, 2014 /PRNewswire/ — MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX) a clinical stage oncology drug development company in conjunction with the Department of Radiology at Memorial Sloan-Kettering Cancer Center (MSKCC) presented results on the use of MabVax’s lead antibody development candidate, HuMab 5B1, as the targeting vehicle carrying two different imaging agents intended to significantly improve the imaging of pancreatic tumors and facilitate more effective cancer resections.  The results were presented at the World Molecular Imaging Congress in Seoul, South Korea by Jacob Houghton, Ph.D. and Jason Lewis, Ph.D. of MSKCC.  The HuMab 5B1 antibody was conjugated individually to a near-infrared fluorescent agent (NIRF) for optical imaging and desferrioxamine (DFO), a chelate used to radiolabel with Zirconium-89 (89Zr) for PET imaging. Each singly labeled construct performed well in illuminating the targeted tumors. Additionally, a dual-labeled construct was prepared to incorporate the advantages of both modalities into a single construct. The dual-labeled HuMab 5B1 yielded high-resolution PET images of the targeted cancer and its metastases prior to resection while the fluorescent label significantly enhanced the imaging of the tumor and definition of tumor margins during resection in multiple murine models of pancreatic cancer.   The imaging agent developed in this study showed exceptional potential as a tool to aid in the diagnosis, staging, and resection of pancreatic cancer.

J. David Hansen, President and CEO of the Company, stated, “With five-year survival rates in pancreatic cancer of only 5% and more than half of all patients initially diagnosed already having metastatic disease, the difficulties in identifying distant metastases that often go undetected as well as problems defining tumor margins during resection are both major concerns that affect outcomes for pancreatic cancer patients.  This study showed favorable results for the dual labeled antibody in detecting human pancreatic cancer cells in the animal model.” 

This study was conducted using human pancreatic cancer cell lines implanted orthotopically into the pancreas of mice.  Both the PET and NIRF imaging revealed high uptake in the cancer cells that increased over time. Negligible background signal was observed.  After serial PET images were completed, image-guided removal of the implanted tumors was facilitated by the fluorescent label bound to the antibody.

Recently MabVax nominated its HuMab 5B1 antibody as a clinical candidate for the diagnosis and treatment of pancreatic and colon cancer.  The fully human antibody, recovered from patients undergoing cancer vaccine treatment at Memorial Sloan-Kettering Cancer Center, has entered GMP manufacturing to produce clinical trial supplies for a planned Phase 1 program to begin in the second half of 2015. The development plan calls for dual Phase 1 clinical trials.   One program will be aimed at demonstrating the utility of the radiolabeled antibody as a novel PET imaging agent for the diagnosis and management of pancreatic cancer.  The second program will determine the safety and potential utility of the full-length antibody as a treatment for the same cancer.  The dual-labeled antibody will be considered as a follow-on development program to enhance the initial PET only imaging product.

About HuMab 5B1

The HuMab 5B1 has demonstrated high specificity, affinity, and lack of cross-reactivity with similar antigens.  The antibody has also shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon, and small cell lung cancer.  Ongoing toxicology results continue to demonstrate an acceptable profile in acute and repeat dose studies in animals.  The antibody, when radiolabeled to create a novel PET imaging agent, has demonstrated high image resolution of tumors in established animal models.  The company believes that the HuMab 5B1 antibody met all of the Company’s criteria for moving the product forward as a clinical development candidate.

About MabVax

MabVax Therapeutics Holdings, Inc. is a clinical stage biotechnology company focused on the development of vaccine and antibody based therapies to address unmet medical needs in the treatment of cancer.  MabVax has discovered a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers with the Company’s proprietary vaccines. MabVax has the exclusive license to the therapeutic vaccines from Memorial Sloan Kettering Cancer Center.  MabVax has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof of concept Phase II multi-center clinical trials, and a vaccine targeting neuroblastoma ready for Phase II clinical development.

Additional information about the Company is available at www.mabvax.com.

Forward Looking Statements

This press release contains “forward-looking statements” regarding matters that are not historical facts, including statements relating to the Company’s development pipeline and stock symbol.  We have no assurance that all of the product development pipeline will be fully developed by the Company.   Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements.  Words such as “anticipates,” “plans,” “expects,” “intends,” “will,” “potential,” “hope” and similar expressions are intended to identify forward-looking statements.  These forward-looking statements are based upon current expectations of the Company and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties.  Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release relating to the Company may be found in the Company’s periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled “Risk Factors” in its annual report on Form 10-K for the fiscal year ended December 31, 2013 and in the Proxy Statement dated July 25, 2014, as amended and supplemented from time to time and in our quarterly report on Form 10-Q for June 30, 2014.  The parties do not undertake any obligation to update forward-looking statements contained in this press release.
SOURCE MabVax Therapeutics Holdings, Inc.

MabVax Therapeutics And Memorial Sloan-Kettering Cancer Center Report on Potential Use of Dual-Labeled Antibody To Detect and Guide Surgical Removal of Pancreatic Cancer

November 19, 2014 – 12:00 pm | Edit Post

SAN DIEGO, Nov. 19, 2014 /PRNewswire/ — MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX) a clinical stage oncology drug development company in conjunction with the Department of Radiology at Memorial Sloan-Kettering Cancer Center (MSKCC) presented results on the use of MabVax’s lead antibody development candidate, HuMab 5B1, as the targeting vehicle carrying two different imaging agents intended to significantly improve the imaging of pancreatic tumors and facilitate more effective cancer resections.  The results were presented at the World Molecular Imaging Congress in Seoul, South Korea by Jacob Houghton, Ph.D. and Jason Lewis, Ph.D. of MSKCC.  The HuMab 5B1 antibody was conjugated individually to a near-infrared fluorescent agent (NIRF) for optical imaging and desferrioxamine (DFO), a chelate used to radiolabel with Zirconium-89 (89Zr) for PET imaging. Each singly labeled construct performed well in illuminating the targeted tumors. Additionally, a dual-labeled construct was prepared to incorporate the advantages of both modalities into a single construct. The dual-labeled HuMab 5B1 yielded high-resolution PET images of the targeted cancer and its metastases prior to resection while the fluorescent label significantly enhanced the imaging of the tumor and definition of tumor margins during resection in multiple murine models of pancreatic cancer.   The imaging agent developed in this study showed exceptional potential as a tool to aid in the diagnosis, staging, and resection of pancreatic cancer.

J. David Hansen, President and CEO of the Company, stated, “With five-year survival rates in pancreatic cancer of only 5% and more than half of all patients initially diagnosed already having metastatic disease, the difficulties in identifying distant metastases that often go undetected as well as problems defining tumor margins during resection are both major concerns that affect outcomes for pancreatic cancer patients.  This study showed favorable results for the dual labeled antibody in detecting human pancreatic cancer cells in the animal model.” 

This study was conducted using human pancreatic cancer cell lines implanted orthotopically into the pancreas of mice.  Both the PET and NIRF imaging revealed high uptake in the cancer cells that increased over time. Negligible background signal was observed.  After serial PET images were completed, image-guided removal of the implanted tumors was facilitated by the fluorescent label bound to the antibody.

Recently MabVax nominated its HuMab 5B1 antibody as a clinical candidate for the diagnosis and treatment of pancreatic and colon cancer.  The fully human antibody, recovered from patients undergoing cancer vaccine treatment at Memorial Sloan-Kettering Cancer Center, has entered GMP manufacturing to produce clinical trial supplies for a planned Phase 1 program to begin in the second half of 2015. The development plan calls for dual Phase 1 clinical trials.   One program will be aimed at demonstrating the utility of the radiolabeled antibody as a novel PET imaging agent for the diagnosis and management of pancreatic cancer.  The second program will determine the safety and potential utility of the full-length antibody as a treatment for the same cancer.  The dual-labeled antibody will be considered as a follow-on development program to enhance the initial PET only imaging product.

About HuMab 5B1

The HuMab 5B1 has demonstrated high specificity, affinity, and lack of cross-reactivity with similar antigens.  The antibody has also shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon, and small cell lung cancer.  Ongoing toxicology results continue to demonstrate an acceptable profile in acute and repeat dose studies in animals.  The antibody, when radiolabeled to create a novel PET imaging agent, has demonstrated high image resolution of tumors in established animal models.  The company believes that the HuMab 5B1 antibody met all of the Company’s criteria for moving the product forward as a clinical development candidate.

About MabVax

MabVax Therapeutics Holdings, Inc. is a clinical stage biotechnology company focused on the development of vaccine and antibody based therapies to address unmet medical needs in the treatment of cancer.  MabVax has discovered a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers with the Company’s proprietary vaccines. MabVax has the exclusive license to the therapeutic vaccines from Memorial Sloan Kettering Cancer Center.  MabVax has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof of concept Phase II multi-center clinical trials, and a vaccine targeting neuroblastoma ready for Phase II clinical development.

Additional information about the Company is available at www.mabvax.com.

Forward Looking Statements

This press release contains “forward-looking statements” regarding matters that are not historical facts, including statements relating to the Company’s development pipeline and stock symbol.  We have no assurance that all of the product development pipeline will be fully developed by the Company.   Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements.  Words such as “anticipates,” “plans,” “expects,” “intends,” “will,” “potential,” “hope” and similar expressions are intended to identify forward-looking statements.  These forward-looking statements are based upon current expectations of the Company and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties.  Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release relating to the Company may be found in the Company’s periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled “Risk Factors” in its annual report on Form 10-K for the fiscal year ended December 31, 2013 and in the Proxy Statement dated July 25, 2014, as amended and supplemented from time to time and in our quarterly report on Form 10-Q for June 30, 2014.  The parties do not undertake any obligation to update forward-looking statements contained in this press release.
SOURCE MabVax Therapeutics Holdings, Inc.

MabVax Therapeutics And Memorial Sloan-Kettering Cancer Center Report on Potential Use of Dual-Labeled Antibody To Detect and Guide Surgical Removal of Pancreatic Cancer

November 19, 2014 – 12:00 pm | Edit Post

SAN DIEGO, Nov. 19, 2014 /PRNewswire/ — MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX) a clinical stage oncology drug development company in conjunction with the Department of Radiology at Memorial Sloan-Kettering Cancer Center (MSKCC) presented results on the use of MabVax’s lead antibody development candidate, HuMab 5B1, as the targeting vehicle carrying two different imaging agents intended to significantly improve the imaging of pancreatic tumors and facilitate more effective cancer resections.  The results were presented at the World Molecular Imaging Congress in Seoul, South Korea by Jacob Houghton, Ph.D. and Jason Lewis, Ph.D. of MSKCC.  The HuMab 5B1 antibody was conjugated individually to a near-infrared fluorescent agent (NIRF) for optical imaging and desferrioxamine (DFO), a chelate used to radiolabel with Zirconium-89 (89Zr) for PET imaging. Each singly labeled construct performed well in illuminating the targeted tumors. Additionally, a dual-labeled construct was prepared to incorporate the advantages of both modalities into a single construct. The dual-labeled HuMab 5B1 yielded high-resolution PET images of the targeted cancer and its metastases prior to resection while the fluorescent label significantly enhanced the imaging of the tumor and definition of tumor margins during resection in multiple murine models of pancreatic cancer.   The imaging agent developed in this study showed exceptional potential as a tool to aid in the diagnosis, staging, and resection of pancreatic cancer.

J. David Hansen, President and CEO of the Company, stated, “With five-year survival rates in pancreatic cancer of only 5% and more than half of all patients initially diagnosed already having metastatic disease, the difficulties in identifying distant metastases that often go undetected as well as problems defining tumor margins during resection are both major concerns that affect outcomes for pancreatic cancer patients.  This study showed favorable results for the dual labeled antibody in detecting human pancreatic cancer cells in the animal model.” 

This study was conducted using human pancreatic cancer cell lines implanted orthotopically into the pancreas of mice.  Both the PET and NIRF imaging revealed high uptake in the cancer cells that increased over time. Negligible background signal was observed.  After serial PET images were completed, image-guided removal of the implanted tumors was facilitated by the fluorescent label bound to the antibody.

Recently MabVax nominated its HuMab 5B1 antibody as a clinical candidate for the diagnosis and treatment of pancreatic and colon cancer.  The fully human antibody, recovered from patients undergoing cancer vaccine treatment at Memorial Sloan-Kettering Cancer Center, has entered GMP manufacturing to produce clinical trial supplies for a planned Phase 1 program to begin in the second half of 2015. The development plan calls for dual Phase 1 clinical trials.   One program will be aimed at demonstrating the utility of the radiolabeled antibody as a novel PET imaging agent for the diagnosis and management of pancreatic cancer.  The second program will determine the safety and potential utility of the full-length antibody as a treatment for the same cancer.  The dual-labeled antibody will be considered as a follow-on development program to enhance the initial PET only imaging product.

About HuMab 5B1

The HuMab 5B1 has demonstrated high specificity, affinity, and lack of cross-reactivity with similar antigens.  The antibody has also shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon, and small cell lung cancer.  Ongoing toxicology results continue to demonstrate an acceptable profile in acute and repeat dose studies in animals.  The antibody, when radiolabeled to create a novel PET imaging agent, has demonstrated high image resolution of tumors in established animal models.  The company believes that the HuMab 5B1 antibody met all of the Company’s criteria for moving the product forward as a clinical development candidate.

About MabVax

MabVax Therapeutics Holdings, Inc. is a clinical stage biotechnology company focused on the development of vaccine and antibody based therapies to address unmet medical needs in the treatment of cancer.  MabVax has discovered a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers with the Company’s proprietary vaccines. MabVax has the exclusive license to the therapeutic vaccines from Memorial Sloan Kettering Cancer Center.  MabVax has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof of concept Phase II multi-center clinical trials, and a vaccine targeting neuroblastoma ready for Phase II clinical development.

Additional information about the Company is available at www.mabvax.com.

Forward Looking Statements

This press release contains “forward-looking statements” regarding matters that are not historical facts, including statements relating to the Company’s development pipeline and stock symbol.  We have no assurance that all of the product development pipeline will be fully developed by the Company.   Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements.  Words such as “anticipates,” “plans,” “expects,” “intends,” “will,” “potential,” “hope” and similar expressions are intended to identify forward-looking statements.  These forward-looking statements are based upon current expectations of the Company and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties.  Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release relating to the Company may be found in the Company’s periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled “Risk Factors” in its annual report on Form 10-K for the fiscal year ended December 31, 2013 and in the Proxy Statement dated July 25, 2014, as amended and supplemented from time to time and in our quarterly report on Form 10-Q for June 30, 2014.  The parties do not undertake any obligation to update forward-looking statements contained in this press release.
SOURCE MabVax Therapeutics Holdings, Inc.

Of Mice, Not Men

November 19, 2014 – 11:47 am | Edit Post

Researchers at the University of California, San Diego School of Medicine and Ludwig Cancer Research, with colleagues across the country and world, have discovered that a significant number of mouse genes do not in fact behave like their human counterparts, suggesting science will need to rethink at least some roles of the lab mouse as a model organism.

Of Mice, Not Men

November 19, 2014 – 11:47 am | Edit Post

Researchers at the University of California, San Diego School of Medicine and Ludwig Cancer Research, with colleagues across the country and world, have discovered that a significant number of mouse genes do not in fact behave like their human counterparts, suggesting science will need to rethink at least some roles of the lab mouse as a model organism.

Using geometry to design new drugs

November 19, 2014 – 7:16 am | Edit Post

Using cyclic peptides to block the EphA4 receptor as therapy for ALS and neurodegenerative diseases