On December 12, 2018 Generex Biotechnology Corporation (OTCQB:GNBT) reported that the FDA had reviewed the company’s investigational new drug (IND) application and given notification that the study can proceed (Press release, Generex, DEC 12, 2018, View Source [SID1234532037]). The study: A Phase II Clinical Trial of Pembrolizumab (Keytruda) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer, is sponsored by Generex and conducted under a collaboration agreement with Merck and a clinical trial agreement with the NSABP Foundation, Inc. (NSABP).

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The combination study builds on previous clinical studies of both AE37 and Keytruda. AE37, a cancer vaccine, was the subject of a 300 patient prospective, randomized and single-blinded Phase II study in patients with breast cancer. That study showed a strong trend toward reduced relapses,particularly in patients with triple negative breast cancer. Keytruda also has shown encouraging results in patients with triple negative breast cancer when used as monotherapy. The complementary mechanisms of action of the two drugs suggest the combination may have the potential to be better than either alone.

AE37 is unique among therapeutic cancer vaccines in that it ensures specific activation of CD4+ T helper cells, which are critical in generating an effective immune response. Its improved immunological potency, along with an excellent safety profile, offers particular advantages for combination studies. In addition to the Phase II study in breast cancer patients, AE37 also has been tested in a Phase I study in prostate cancer patients. AE37 treated patients have consistently displayed a robust, long-lasting and specific response to the vaccine.

Liesha Emens, M.D., Ph.D., Principal Investigator for the study and Professor of Medicine at the University of Pittsburgh Medical Center commented: "So far, metastatic triple negative breast cancer patients treated upfront with immunotherapy benefit clinically from immune checkpoint immunotherapy only if their tumors contain PDL1+ cells. Increasing the number of patients with immune-activated tumors should bring the benefit of immunotherapy to even more patients. This Phase II trial will test whether the AE37 vaccine may trigger immunity in triple negative breast cancer patients, priming them for clinical benefit from immune checkpoint blockade."

Eric von Hofe, President of NuGenerex-ImmunoOncology commented: "We are gratified to see this important trial moving forward. While we have tested AE37 in breast and prostate cancer patients, there is good rationale for inclusion of AE37 in the treatment regimen of a variety of additional cancer types of high unmet need. Gastric, colon, ovarian and bladder cancers all express the same tumor target expressed in breast and prostate cancer that AE37 activates the immune system to recognize."

About AE37

AE37 is an investigational therapeutic cancer vaccine being developed to treat certain types of breast cancer. It is a combination of portions of two proteins that together stimulate the immune system to fight cancer cells.

Up to 80 percent of breast cancers express some level of a protein called HER2. While treatments exist to target HER2 in breast cancer patients with the highest level of HER2 expression (roughly 25%), the majority of patients who have lower levels of expression have more limited treatment options. AE37 consists of a protein derived from the HER2 protein combined with a portion of the MHC class II associated invariant chain which has been termed Ii-Key.

AE37 does not directly target HER2, but rather acts as a vaccine to activate the immune system to recognize the HER2 protein, which is expressed on cancer cells as foreign. AE37 ensures activation of CD4-positive lymphocytes, immune cells that are important in stimulating both the antibody response (antibodies against HER2) and cellular responses directed against the HER2 protein in breast cancer cells. The Ii-Key peptide is coupled with the HER2 protein to ensure a more robust and long-lasting response.

On December 12, 2018 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that it has commenced an underwritten public offering of its common shares (Press release, VBI Vaccines, DEC 12, 2018, View Source [SID1234532101]). VBI also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of common shares offered in the public offering. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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BMO Capital Markets, Canaccord Genuity LLC, and Oppenheimer & Co. Inc. are acting as joint book-runners for the underwritten public offering.

VBI intends to use the net proceeds from the offering to progress its research and development programs, which include, among other things, funding the continued clinical development of Sci-B-Vac, including the ongoing Phase 3 clinical program in the United States, Europe and Canada; the Phase 1/2a clinical study of the therapeutic vaccine candidate, VBI-1901, for glioblastoma (GBM); the prophylactic vaccine candidate, VBI-1501, for cytomegalovirus (CMV); and the immuno-therapeutic candidate, VBI-2601, for hepatitis B. The net proceeds will also be used for general corporate purposes, including working capital and capital expenditures.

A shelf registration statement relating to the common shares was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on June 8, 2017. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement (when available) and accompanying prospectus may be obtained from BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036 or by e-mail at [email protected], or from Canaccord Genuity LLC, Attention: Equity Syndicate Department 99 High Street, 12th Floor, Boston, MA 02110 or by e-mail at [email protected], or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004 or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

The securities will not be offered or sold, directly or indirectly, in Canada or to any resident of Canada.

On December 12, 2018 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported that Aron Knickerbocker, Chief Executive Officer, will present at the 37th Annual J.P. Morgan Healthcare Conference, Wednesday, January 9, 2019 at 2:00 pm PT (Press release, Five Prime Therapeutics, DEC 12, 2018, View Source [SID1234532039]).

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The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at View Source Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.

On December 11, 2018 Black Diamond Therapeutics, a biotechnology company developing a new type of precision medicine for cancer, reported that $20 million Series A financing exclusively from founding investor Versant Ventures (Press release, Black Diamond Therapeutics, DEC 11, 2018, View Source [SID1234532909]). Black Diamond is the first company launched out of Ridgeline, Versant’s Discovery Engine based in Basel, Switzerland, and has a unique platform capable of prosecuting allosteric mutant oncogenes.

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Oncogenes are activated by kinase domain mutations or by allosteric mutations. While kinase domain mutations have been successfully drugged with selective inhibitors and are standard of care in many malignancies, allosteric mutations represent an undrugged and unexplored space.

During its stealth stage, Black Diamond built and established proof of concept for its MAP (mutation, allostery and pharmacology) platform to uncover, discover and target allosteric mutant oncogenes. While Black Diamond founders David Epstein, Ph.D., and Elizabeth Buck, Ph.D., constructed and optimized the platform, parallel efforts by the Ridgeline team involved translational work to create leads, validate the resulting targets and bring forward drug candidates.

"The fundamental discovery underlying Black Diamond is there are whole sets of oncogenic lesions outside the ATP binding site that are activated by common mechanisms and are inhibited by a single class of our drugs," said Black Diamond CEO Dr. Epstein. "Our platform generates single molecules able to treat entire baskets of mutations that otherwise would have been deemed unactionable."

Dr. Epstein has extensive experience developing precision medicine cancer therapies. He previously was CSO of OSI Pharmaceuticals (acquired by Astellas Pharma), where he and Dr. Buck led research and translational science on a variety of novel agents including erlotinib, a small molecule inhibitor of epidermal growth factor receptor approved to treat non-small cell lung cancer and pancreatic cancer.

"As a new company in an important field of novel cancer medicines, Black Diamond is a premier example of Versant’s three key differentiating features – a focus on breakthrough innovation, geographic reach and company creation capabilities," said Alex Mayweg, Ph.D., a partner at Versant and a member of Black Diamond’s board. "We are very pleased to support a company that has an exceptionally powerful platform able to fuel its growth and pipeline for the foreseeable future."

To further progress and build out its breakthrough precision medicine platform, Black Diamond is finalizing a financing with additional investors that is expected to be announced in 2019. Proceeds will allow Black Diamond to advance two to three existing development candidates into the clinic in the next 24 months, and to bolster its platform’s ability to rapidly identify precision medicines for mutant cancers intractable to standard care.

MAP: a unique platform

Black Diamond’s industry-leading MAP platform identifies and drugs allosteric mutant disease targets. MAP involves mining a proprietary algorithm for allosteric oncogenes, validating their oncogenicity, elucidating the precise mechanism by which a given oncogene is allosterically activated, and designing drugs specific for these groups of allosteric mutations.

As genomic profiling and sequencing of cancer patients is becoming standard, MAP can pinpoint new druggable mutation baskets from the thousands of lesions identified across genes and patients, and can create high-impact precision medicines. Some of the allosteric mutation baskets represent 2-15% of patients in a given tumor tissue or across tumor sites.

MAP has generated a pipeline of five programs, including three that have progressed compounds through lead optimization or into IND-enabling studies. The fourth and fifth programs are in lead identification.

Black Diamond’s first two disclosed programs are targeting groups of EGFR and HER2 allosteric mutants.

The company also will use a portion of its Series A round to establish operations in Toronto, thus gaining access to the city’s deep pool of computing talent. Black Diamond expects this computational center of excellence will enable machine learning-based target discovery of new allosteric mutants that complements the existing MAP platform.

On December 11, 2018 Northwest Biotherapeutics (OTCQB: NWBO) — ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancer, reported that it has entered into agreements with a large multi-national corporation for a package transaction involving the Company’s property located near Cambridge, UK. Pursuant to these agreements, (Press release, Northwest Biotherapeutics, DEC 11, 2018, View Source [SID1234532024])

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•The Company will sell most of its UK property to the multi-national corporation.

•The Company will receive £37.5 million (approximately $47.3 million) cash payment at closing.

•The Company will retain ownership of 17 acres of the property, which are excluded from the sale and which the Company believes will have substantial additional value in the future.

•The Company will retain a lease-back of the approximately 87,000 square foot manufacturing facility which the Company has been developing on the site, along with substantial adjacent areas, for up to 40 years on favorable terms.

The cash purchase price to be paid for the sale of most of the UK property will provide approximately $47.3 million of non-dilutive gross proceeds. Transaction expenses for broker and legal fees are expected to total about £1.3 million. The Company plans to use the transaction proceeds for Company obligations and operations.

The Company acquired the property for approximately £18 million. The Company’s subsequent investments into the property have been focused on the 87,000 square foot manufacturing facility, including refurbishments, structural improvements, extension of an additional level of interior space, and buildout of initial clean-room manufacturing suites. The Company will retain the value and use of these investments through the favorable lease-back of this manufacturing facility. The Company also retains the freedom to make further alterations, additions and improvements.

The lease-back of the manufacturing facility will initially be for 20 years, with a renewal for a second 20 years on the same terms at the Company’s option. The rent is determined by valuing the entire manufacturing facility as a warehouse. No rent is payable for the first year. Starting in year two, the rent is approximately £5.76 per square foot per year, with limited adjustments once every five years.

The lease includes substantial adjacent areas, including for surface parking of 600 vehicles and for equipment, plant and facilities that support or are related to operations in the manufacturing facility. The Company believes that, with internal buildout of further manufacturing suites inside this facility, it will potentially be capable of supporting production of DCVax products for up to 10,000 patients per year.

The property and the manufacturing facility are situated in the heart of the "Golden Triangle" of leading academic centers and rapidly developing R&D centers, from which the Company can draw the technical personnel needed for its operations. The property and manufacturing facility are also situated on or near major transportation arteries, including nearby Stanstead Airport, the major air shipping hub.

"Now that the data from our Phase 3 clinical trial of DCVax-L have further matured and provided a further encouraging picture of patient survival, and we are ready to move forward with the months of work related to completion of the trial, we are very pleased to have a new war chest of funding for this work," commented Linda Powers, CEO of NWBio. "We are also looking forward to proceeding with further DCVax-Direct trials."

"We are especially pleased to obtain this funding on a non-dilutive basis, and to seamlessly continue our activities with the UK manufacturing facility under the favorable lease-back."