Gearing up to start an international Phase III study of its lead program in brain cancer, privately held Antisense Pharma GmbH brought in an additional €27 million (US$38 million) in venture capital.
That funding comes from MIG Funds 5, the fifth VC fund of German firm MIG Verwaltungs AG, which previously invested in the company's $18 million round closed in November 2005.
MIG funding primarily goes to medium-sized companies that are not publicly listed. In a press release, the VC said that its hefty investment in Antisense Pharma stems, in part, from the company's promising data on AP 12009, a TGF-beta 2-inhibitor in development for anaplastic astrocytoma and other cancers.
As the company's name suggests, AP 12009 is an antisense drug - specifically, a phosphorothioate oligonucleotide - and is designed to down-regulate the production of transforming growth factor-beta 2, a polypeptide growth factor linked to tumor progression.
It's that target, Antisense Pharma has said, that separates AP 12009 from high-profile antisense failures, such as Carlsbad, Calif.-based Isis Pharmaceuticals Inc.'s ICAM-1 inhibitor Alicaforsen and PKC-alpha inhibitor Affinitak, which missed in Crohn's disease and non-small-cell lung cancer, respectively, and Genta Inc.'s Genasense (oblimersen sodium), a Bcl-2 inhibitor that failed in multiple myeloma and was rejected by the FDA for use in chronic lymphocytic leukemia and melanoma. (See Clinic Roundup, page 2.)
Isis has since moved on to second-generation antisense drugs, and Berkeley Heights, N.J.-based Genta continues to hold out hope for Genasense, having recently appealed an FDA non-approvable letter in CLL and initiated a new, biomarker-specific Phase III study in melanoma.
Antisense Pharma hopes it will avoid the earlier antisense pitfalls by going after TGF-beta 2, a target believed to regulate several mechanisms for tumor growth, including immunosuppression, invasion, migration, proliferation and angiogenesis.
To date, AP 12009 has shown promise against several cancer types. In the lead indication of recurrent anaplastic astrocytoma, a form of high-grade glioma, the drug resulted in a steadily increasing tumor response rate over 14 months compared to responses from standard chemotherapy treatment, which resulted in a transient peak at six months that was not sustainable and had decreased to zero at 14 months.
Interim data from the 134-patient Phase IIb trial, which was presented in June at the American Society of Clinical Oncology meeting in Chicago, also showed that 67 percent of patients in the AP 12009 group were still alive vs. 42 percent of the control group.
The company is getting ready for a large Phase III study, to start next year in recurrent or refractory anaplastic astrocytoma. Representatives of the Regensburg, Germany-based firm could not be reached for further comment, but said in a press release that the latest funding is expected to support AP 12009 development to the market.
Following anaplastic astrocytoma, AP 12009 is being explored in earlier studies in pancreatic cancer, melanoma and colorectal cancer, with promising results to date.
In other financings news:
• Access Pharmaceuticals Inc., of Dallas, secured agreements for a $19.5 million recapitalization, which includes $9.5 million in a private financing led by SCO Capital Partners and Perceptive Life Sciences. In addition, SCO Capital Partners, Oracle Partner and certain affiliates agreed to exchange $10 million principal amount of senior debt into Series A convertible preferred stock. Access said the new funding will support its clinical program of ProLindac, a DACH platinum prodrug that has shown activity in solid tumors and is in Phase II development. Rodman & Renshaw LLC acted as the exclusive placement agent. Shares of Access (OTC BB:ACCP) fell 51 cents, or 14 percent, Thursday to close at $3.14.
• Diamyd Medical, of Stockholm, Sweden, increased its investments in Meriden, Conn.-based Protein Sciences Corp. with another $1 million in the form of a convertible note. Diamyd previously invested $3 million, which was converted into Protein Sciences common stock, and now represents Protein Sciences second largest shareholder. Protein Sciences is manufacturing the active compound (GAD65) to be used in several upcoming studies, including Phase III studies with the Diamyd therapeutic vaccine for diabetes.
• MiddleBrook Pharmaceuticals Inc., of Germantown, Md., is raising up to $10 million in cash through an agreement with Deerfield Management, a health care investment firm and one of MiddleBrook's largest shareholders. The company immediately will receive $7.5 million, with the additional $2.5 million to become available, if necessary, upon FDA approval of Amoxicillin Pulsys in pharyngitis/tonsillitis. Under the terms, MiddleBrook sold certain assets relating to its cephalexin business, excluding cephalexin Pulsys, to Deerfield for $7.5 million. The firm will continue operating the existing cephalexin business, with a 20 percent royalty to Deerfield, which declines to a single-digit royalty as the agreement matures. In addition, MiddleBrook granted Deerfield a six-year warrant to buy 3 million shares of company stock priced at $1.38 each. The company is continuing to explore strategic alternatives, such as a possible sale, partnership or merger, and said that process might extend beyond Amoxicillin Pulsys' Jan. 23 PDUFA date. Shares of MiddleBrook (NASDAQ:MBRK) closed at $1.30 Thursday, down 8 cents.