On January 28, 2019 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in a public offering (Press release, Cancer Genetics, JAN 28, 2019, View Source [SID1234533045]). 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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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The offering is being conducted as a "best efforts" offering and the placement agent is not obligated to purchase any securities.

Cancer Genetics intends to use the net proceeds from this offering to pay any amounts we are required to pay to our lenders, and if any proceeds remain available, to pay certain costs previously incurred by us in connection with our strategic initiatives and to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 5, 2017. A preliminary prospectus supplement describing the terms of the offering will be filed with the SEC and will form a part of the effective registration statement. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or 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 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.

On January 26, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported that in its lawsuit against Janssen Biotech and Genmab A/S, the United States (U.S.) District Court of Delaware, based on a hearing held November 27, 2018, has ruled in a Court Order on January 25, 2019, that the asserted claims of three MorphoSys patents with U.S. Patent Numbers 8,263,746, 9,200,061 and 9,758,590 are invalid (Press release, MorphoSys, JAN 26, 2019, View Source [SID1234532974]). The Court thus granted a motion for Summary Judgement of invalidity filed by Janssen Biotech and Genmab, A/S against the three patents held by MorphoSys. As a result of this decision, the jury trial scheduled for February 2019 to consider defendants’ alleged infringement and the validity of the MorphoSys patents will now not take place.

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MorphoSys’s management is disappointed with the decision and is considering all of its options. The company has the right to appeal this judgement to the Federal Circuit.

On April 4, 2016 MorphoSys had filed a lawsuit in the United States (U.S.) District Court of Delaware against Janssen Biotech, and Genmab, A/S for patent infringement of U.S. Patent Number 8,263,746. In 2017, a second and a third patent with US Patent Numbers 9,200,061 and 9,758,590 were added to the lawsuit. MorphoSys sought redress for infringement by Janssen’s and Genmab’s daratumumab, a CD38-directed monoclonal antibody for the treatment of multiple myeloma.

This court decision has no bearing upon the composition of matter patent protection for MorphoSys’s own CD38 antibody MOR202 and thus MorphoSys’s ability to develop MOR202 in various indications.

On January 26, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the U.S. District Court of Delaware has declared the three U.S. patents (Nos. 8,263,746, 9,200,061, and 9,758,590), asserted by MorphoSys AG against Genmab and Genmab’s collaboration partner Janssen Biotech, Inc. (Janssen) are invalid by summary judgment (Press release, Genmab, JAN 26, 2019, View Source [SID1234532904]). The patent infringement lawsuit was initiated by MorphoSys against Genmab and Janssen in April 2016 asserting that activities with DARZALEX (daratumumab) in the United States infringe its U.S. patents, and the case has been pending before the U.S. District Court of Delaware. The summary judgment order declared all three patents invalid due to lack of enablement. As a result of this decision, the jury trial scheduled for February 2019 will not take place. MorphoSys has the opportunity to appeal the district court decision to the U.S. Court of Appeals for the Federal Circuit (CAFC). In addition, during the case a further claim by Janssen and Genmab was included in the case that the three MorphoSys patents were unenforceable due to inequitable conduct by MorphoSys. That issue remains to be decided

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On January 25, 2019 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported, that the first stage of a Phase 2 study of its novel, targeted cancer immunotherapy candidate, BN-Brachyury in the treatment of advanced chordoma has completed recruitment of the planned 10 patients ahead of schedule (Press release, Bavarian Nordic, JAN 25, 2019, View Source [SID1234532899]).

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The multi-site trial, which holds the potential to serve as a registration trial, aims to determine if the combination of BN-Brachyury vaccine and the current standard of care, radiation therapy, results in a clinically meaningful objective response rate (ORR) within 12 months of radiation therapy, a timeframe during which historical controls show an ORR of less than 5% with radiation alone. Radiation has been shown to inflame the tumor, releasing cancer antigens. BN-Brachyury is designed to teach T cells to attack brachyury-expressing cells and kill the tumor cells.

As per the study design, the first 10 patients have now been enrolled, thus completing recruitment of stage 1 of the study. First results from this stage are expected to become available in the second half of 2019. If at least one objective response occurs in the first 10 patients, the study will advance into stage 2 with enrollment of additional 19 patients with an overall goal of 4 objective responses for all patients in the study for a successful outcome.

"We are excited about the great interest in our chordoma study, leading to a rapid enrollment of patients for the first part of the study," said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. "As there are no approved drugs for the treatment of chordoma, patients are truly limited in their options to control the disease, particularly in the advanced stage. We hope to demonstrate, that a targeted immunotherapy can improve the outcome for these patients and provide hope for a better life with cancer."

For more information on the trial, please visit: View Source

About chordoma
Chordoma is a rare cancer that universally overexpresses brachyury and occurs in the base of the skull and spine. There are approximately 1,000 new cases of chordoma diagnosed in the U.S. and E.U. annually, and 10,000 people living with the disease. Current treatments have resulted in limited success against chordoma, with a historical objective response rate of less than 5% with radiation alone.

About BN-Brachyury
Bavarian Nordic’s novel immuno-oncology candidate, BN-Brachyury, targets a key prognostic indicator of several common (e.g. colorectal, prostate, small cell lung, and triple negative breast cancer) and rare or orphan (e.g. chordoma, thyroid, neuroendocrine) cancers. Brachyury is a transcription factor that is believed to play a prominent role in the metastasis and progression of tumors. Expression of brachyury is highly correlated with metastatic disease, poor overall survival, multi-drug resistance, and decreased survival rates. BN-Brachyury utilizes a prime-boost vaccination regimen that has been optimized to include the gene for brachyury and other molecules known to increase immune activation. Patients will receive a primer of MVA-BN Brachyury followed by a booster doses of the recombinant fowlpox virus. A previous phase 1 trial demonstrated that MVA-BN-Brachyury could safely target brachyury and induce brachyury-specific T-cell immune responses.

BN-Brachyury has received orphan drug status from the FDA and may be eligible for Breakthrough Designation.

On January 25, 2019 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that two presentations highlighting the potential of Advaxis vectors to generate T cell responses to a large percentage of neoantigens and to promote antigen spreading and potentially slow progression of prostate cancer, were presented at the 2019 Keystone Symposia on Cancer Vaccines, held January 19-24 in Vancouver (Press release, Advaxis, JAN 25, 2019, View Source [SID1234532900]).

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The first presentation, "Neoantigen prioritization for use in a Listeria monocytogenes cancer vaccine" delivered by Brandon Coder, Ph.D., Associate Director Research & Development at Advaxis, shows the impact of CD8+ T cell responses generated to a large proportion of neoantigens, including those that were not immunogenic as peptide vaccines as well as large frameshift mutations (FSMs) that generated tumor-infiltrating lymphocytes that controlled tumor growth in preclinical CT-26 and MC-38 mouse models. The data presented support the potential of Advaxis vectors to be among the most efficient and effective at generating CD8+ T cell responses to neoantigens, including some that are not immunogenic by alternative methods of vaccination.

The second presentation, "Magnitude of anti-PSA T cell response is associated with antigen spreading and slowing in PSA and PAP velocity in ADXS-PSA treated mCRPC patients," was delivered by Robert G. Petit, Ph.D., Chief Scientific Officer and Executive Vice President of Advaxis. These data are from 13 patients treated in the ADXS-PSA monotherapy arm of Advaxis’ Phase 1/2 clinical trial of men with metastatic, castration-resistant prostate cancer (mCRPC). The presentation focused on the 56% of ADXS-PSA monotherapy patients (5/9) who exhibited a greater than three-fold increase above baseline in the magnitude of their PSA-specific T cell responses. All nine ADXS-PSA patients who received three or more treatments showed T cell responses against one or more prostate cancer antigens not included in ADXS-PSA, providing evidence of antigen spreading. Additionally, a greater magnitude of the PSA-specific T cell responses in ADXS-PSA-treated mCRPC patients was associated with more antigen spreading than those with a less than three-fold increase. Similarly, those patients with a greater than three-fold increase in PSA-specific T cells also exhibited a significant slowing in PSA and PAP velocities, which could support the potential for delaying progression and improving survival in larger studies. As previously reported, ADXS-PSA monotherapy showed a manageable safety profile with Grades 1–2 chills/rigors and fever in all patients and Grade 3 and Serious Adverse Events in five and two patients, respectively.

"These presentations highlight some of the potential benefits of the drug constructs from our proprietary Lm platform, namely the efficient generation of CD8+ T cell responses against neoantigens as well as the potential improvement of clinical endpoints due to the magnitude of these T cell responses and antigen spreading. The data directly support our ongoing investigations of the ADXS-NEO and ADXS-PSA constructs as well as future studies of the various drug constructs from our ADXS-HOT program," said Dr. Petit.