Heat Biologics, a firm founded in 2008 to develop an off-the-shelf allogeneic immunotherapy technology based on heat-shock proteins, is taking its place in biotech's bustling initial public offering (IPO) queue.

The Chapel Hill, N.C.-based firm, which filed confidentially late last year as an emerging growth company under the Jumpstart Our Business Startups Act, recently disclosed a price range of $10 to $12 per share for 2.3 million shares, which would raise about $25.3 million at midpoint pricing.

The company increased the number of shares from the 1.7 million previously anticipated. Net proceeds from the IPO are expected to total about $22.5 million – $26 million if underwriters Aegis Capital and Cantor Fitzgerald & Co. exercise their overallotment option of 340,909 additional shares – and will be used to support clinical and regulatory activities, including Phase II studies of lead program, HS-110, in non-small-cell lung cancer (NSCLC).

Heat's technology, dubbed ImPACT (Immune Pan Antigen Cytotoxic Therapy), emerged from the laboratory of Eckhard Podack, a professor of microbiology and immunology at the University of Miami, Miller School of Medicine. It's based on heat-shock protein (HSP) gp96, a chaperone protein that has been shown to mobilize and activate killer T cells to fight cancer. (See BioWorld Today, July 15, 2011.)

A folding protein, HSP gp96 normally is attached to cells via the KDEL sequence. During necrosis, the cells release HSP gp96, along with any other HSPs being folded at the time, to create an immune response. Heat's approach involves severing the attachment between HSP gp96 and the cells, enabling gp96 to continuously secrete from cells to generate that immune response.

HS-110 was developed using a lung cancer cell line, which, after being irradiated to prevent the cancer from replicating, was then genetically modified to secrete gp96. Once injected into the NSCLC patient, the immunotherapy is designed to generate a pan antigen immune response.

In early clinical testing in 18 NSCLC patients, HS-110 demonstrated an immune response in those with advanced disease. In 11 of 15 patients (73 percent) who completed the first course of therapy, there was a twofold or greater increase in CD8 cells secreting interferon gamma, and those patients also showed an estimated median survival of 16.5 months. That compares to the 4.5-month median survival for the four patients who were immune nonresponders.

The median survival rate at one year was 44 percent with HS-110 vs. 5.5 percent based on published data.

Heat submitted an investigational new drug application (IND) for Phase II testing of HS-110. About $8.4 million of the IPO proceeds will support work in NSCLC.

About $1 million will be used for Phase I studies testing the second product, HS-410, in bladder cancer. Heat intends to submit an IND for a Phase I/II study to test the product, which comprises a bladder cancer cell line that, like HS-110, has been modified to secrete antigens bound to gp96. The planned trial is expected to enroll about 93 patients, starting in the third quarter, with high-risk, superficial bladder cancer who have completed surgical resection and six weekly intravesical bacillus Calmet-Guerin immunotherapy installations.

The study will evaluate safety, tolerability, immune response and preliminary clinical activity.

Beyond those programs, Heat also has plans to test HS-110 in combination with other lung cancer treatments. It also has preclinical programs targeting breast and ovarian cancers.

As of March 30, Heat had about $4.9 million in cash and equivalents. To date, the company has relied largely on grant funding to support its work, with the National Institutes of Health (NIH) awarding more than $14 million to ImPACT inventor Podack.

In addition to cancer, the technology also has application in viral diseases. The NIH is funding a program in HIV, testing an immunotherapy candidate for prophylaxis and therapeutic use in nonhuman primates.

Upon pricing, Heat would trade on Nasdaq under the ticker "HTBX," and would have about 5.9 million shares – 6.2 million shares with full overallotments – outstanding.

In other financings news:

• Anavex Life Sciences Corp., of New York, said it closed a $2.6 million private placement financing and conversion of liabilities and an agreement with institutional investor Lincoln Park Capital Fund LLC for a funding commitment of up to $10 million with an initial investment of $100,000. The private placement priced units – each comprising one common share and one share purchase warrant – at 40 cents apiece. R.F. Lafferty & Co. Inc. served as placement agent. Under terms of the $10 million common stock purchase agreement, Lincoln Park Capital initially purchase 250,000 shares for $100,000. After the SEC has declared effective the firms' registration statement, Anavex has the right, at its discretion over a three-year period, to sell up to an additional $9.9 million of common stock to Lincoln Park Capital. Proceeds will be used to advance clinical trials of Anavex 2-73, a drug candidate for Alzheimer's disease, and for general corporate purposes. Anavex also appointed Christopher U. Missling CEO. Shares of Anavex (OTCBB:AVXL) closed Monday at 58 cents, down 3 cents.

• Biodelivery Sciences International Inc., of Raleigh, N.C., said it secured a $20 million senior secured loan from an affiliate of Midcap Financial LLC. The proceeds strengthen the firm's cash position as it moves toward submission of a new drug application for Bunavail in opioid dependence and the completion of two Phase III trials for BEMA Buprenorphine for chronic pain.

• Glythera Ltd., of Newcastle, UK, said it achieved a number of technical and commercial milestones, resulting in the release of a second tranche of funding totaling £700,000 (US$1 million) from the IP Group and its managed fund, the Finance for Business North East Technology Fund. Glythera, which develops next-generation therapeutics using advanced glycosylation technologies, received an initial investment of £600,000 in April 2012. A third tranche of funding will be made available once further technological progress has been made.

• Paladin Labs Inc., of Montreal, and Bioniche Life Sciences Inc., of Belleville, Ontario, said they closed the various agreements associated with a strategic collaboration to refinance and increase Bioniche's debt, provide new equity and enter the first licensing deal for Bioniche's Phase III bladder cancer product, Urocidin. The closing of the deals resulted in the issuance of a further $5 million in debt financing to Bioniche from Paladin. As partial consideration for entering the amended loan transaction, Bioniche granted Paladin warrants to acquire common shares.

• Prosensa Holding NV, of Leiden, the Netherlands, closed its initial public offering of 6.9 million shares priced at $13 apiece, including an additional 900,000 shares purchased as overallotment options. Proceeds will fund the company's work in Duchenne's muscular dystrophy (DMD), including its current DMD development portfolio, early stage DMD discovery work and DMD support projects, as well as other non-DMD projects and for working capital and general corporate purposes. (See BioWorld Today, July 1, 2013.)