On October 9, 2018 Immune Pharmaceuticals, Inc. (OTCQB: IMNP) ("Immune" or the "Company"), a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases, reported that it has entered into a Securities Purchase Agreement with an institutional investor pursuant to which it has sold $5.5 million in principal amount of Senior Secured Redeemable Convertible Debentures (the "Debentures") for $2 million in cash, and a $3 million promissory note to be funded upon the earlier of the effectiveness of a registration statement covering the resale of the shares issuable or conversion of the Debentures (Press release, Immune Pharmaceuticals, OCT 9, 2018, View Source [SID1234530276]).

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Tony Fiorino MD, PhD, Immune’s interim Chief Executive Officer, said "This financing gives us the means to continue the recent forward momentum we have achieved with bertilimumab, with the goal of building what we believe will be substantial additional value. We expect the proceeds from this transaction to fund our operations into the second quarter of 2019. Over that time, we expect to achieve previously disclosed milestones that include the release of additional results from the BP-01 study, obtaining important regulatory feedback, advancing our new manufacturing process and unblinding the ulcerative colitis study, which has now completed recruiting subjects."

Dr. Fiorino went on to say, "I accepted the role of interim Chief Executive Officer because I believe that bertilimumab is a strategically attractive asset, and this funding provides us with runway to pursue that option. Given the challenging financing environment faced by the company, we have decided to accelerate our plan to seek a development partner for bertilimumab. We will initiate the bertilimumab partnering process this quarter, rather than waiting to complete these important milestones prior to formally launching a process."

The Debentures bear compounded interest at a rate of 10% per annum, subject to adjustment as specified in the Debentures, and mature five years from the issuance date. The debt is convertible into shares of Immune common stock at a conversion price of $0.075 per share, subject to certain adjustments in the event of future financings. The Company also issued to the investor 50 million three-year warrants exercisable at $0.10 per share, also subject to adjustment in the event of future financings. The Debentures are secured by the Company’s assets, other than those associated with Ceplene (histamine dihydrochloride).

The Company does not currently have sufficient common shares authorized if the Debentures are converted in full and the Warrants are exercised, and plans to call a special meeting of stockholders within 90 days to obtain approval for an increase in the authorized common stock to enable us to satisfy those obligations.

In connection with this financing, the holders of the Company’s Original Issue Discount Convertible Debentures agreed to waive the outstanding event of default resulting from the suspension of the trading of the Company’s common stock on the Nasdaq Capital Market (other than the required increase in the principal amount of the OID Debentures) and to amend the OID Debentures to enable the Company to consummate the financing, in exchange for an aggregate amendment fee of $49,220.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor will there be any sale of these securities in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction.

On October 9, 2018 Veracyte, Inc. (Nasdaq: VCYT) reported that new interim data from a three-year, "real world," prospective clinical utility study show that use of the Percepta Bronchial Genomic Classifier to evaluate patients with potentially cancerous lung nodules reduced invasive procedures during 12 months of patient follow-up (Press release, Veracyte, OCT 9, 2018, View Source [SID1234530238]). The early findings were presented in an oral session at CHEST 2018, the annual meeting of the American College of Chest Physicians, being held October 6-10 in San Antonio, Texas.

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The ongoing 40-site registry trial aims to measure the impact of the Percepta test on lung nodule management in "real world" clinical practice and to monitor clinical outcomes of patients managed with the test. Reviewing results from the first 258 evaluable patients, researchers found that patients who had a negative Percepta result following an inconclusive bronchoscopy had lower rates of subsequent invasive procedures at all evaluation time points (immediately post-test, 3 months, 6 months and 12 months), compared to physicians’ plans for these patients prior to Percepta testing. At 12 months of follow-up, researchers observed a 20 percent relative reduction in invasive procedures as compared to physicians’ initial plans.

The findings also showed that Percepta classifier results changed how physicians managed patients with lung nodules. The researchers found that patients with negative Percepta test results were significantly less likely to undergo invasive procedures at all time points over the 12-month post-test period, as compared to patients with positive genomic test results.

"Physicians often use bronchoscopy to evaluate potentially cancerous lung nodules, but the results from this procedure are often inconclusive, which can lead to unnecessary, invasive follow-up procedures for a diagnosis," said Giulia C. Kennedy, Ph.D., chief scientific and medical officer at Veracyte. "These early data show that use of the Percepta test following an inconclusive bronchoscopy result can reduce the number of unnecessary procedures and that this trend is durable over 12 months of follow-up."

The Percepta classifier uses proprietary "field of injury"-based technology to detect genomic changes associated with lung cancer in the main lung airway of current and former smokers. Percepta detects these genomic changes to determine the likelihood that a nodule is cancerous without the need to sample the nodule directly. Clinical validation data published in The New England Journal of Medicine demonstrated the Percepta test’s high accuracy in identifying patients at low risk of lung cancer (negative predictive value of 91 percent), suggesting that these patients may safely avoid further invasive procedures.

"These new data reinforce the value that the Percepta classifier brings to lung cancer diagnosis by reducing, over the long term, the number of invasive procedures among patients being evaluated for suspicious lung nodules," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "We believe these findings support physicians’ use of the Percepta classifier as a complement to diagnostic bronchoscopy and look forward to sharing future findings from our ongoing registry trial."

The Percepta multicenter registry study has enrolled over 655 patients who were former or current smokers without prior active cancer and who were deemed eligible for bronchoscopy following identification of a pulmonary lesion on CT scan. Physicians captured a bronchial brushing at the time of the bronchoscopy to enable genomic diagnostic evaluation by the Percepta classifier if the bronchoscopy result was inconclusive.

Lung cancer is the leading cause of cancer-related deaths in the United States, killing over 154,000 Americans each year, according to the American Cancer Society. Early detection and diagnosis can significantly improve survival, but currently very few lung cancer cases (just 16 percent) are diagnosed at an early stage when the disease is most treatable. The identification of a lung nodule or lesion on a CT scan – either through screening or incidentally – is often the first sign that an individual may have lung cancer. Determining whether lung nodules or lesions identified on CT scans – either through screening or incidentally – are cancerous is often difficult, which can lead to patients undergoing invasive, risky and expensive procedures that are frequently unnecessary.

About Percepta

The Percepta Bronchial Genomic Classifier uses advanced genomic and machine learning technology to improve lung cancer diagnosis for patients while reducing the need for invasive procedures. The classifier is run when bronchoscopy results are inconclusive, and helps physicians determine which patients are at low or very low risk for cancer and may therefore be monitored with CT scans instead of undergoing further, invasive diagnostic procedures. The Percepta classifier uses proprietary "field of injury"-based technology to detect molecular changes in the main lung airway of current or former smokers. Percepta detects these genomic changes to determine the likelihood that a nodule is cancerous without the need to sample the nodule directly. The classifier’s performance has been validated in multiple, rigorous clinical studies, including clinical validation data published in The New England Journal of Medicine.

On October 9, 2018 Fresenius Kabi reported that it has reached a milestone on the road to approval for another biosimilar (Press release, Fresenius, OCT 9, 2018, View Source [SID1234530131]) . MSB11455, a biosimilar candidate for Neulasta (pegfilgrastim), has met its primary endpoints in the two pivotal clinical studies. For more information please see the website of Fresenius Kabi.

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On October 9, 2018 Dynavax Technologies Corporation (NASDAQ:DVAX) announced today that data will be presented from its ongoing Phase 1b/2 study investigating SD-101, Dynavax’s intratumoral TLR9 agonist, in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada) (Press release, Dynavax Technologies, OCT 9, 2018, View Source [SID1234530122]). Data will be presented in three individual sessions with data for advanced melanoma patients who are naïve to anti-PD-1 therapy being presented as a late-breaking abstract poster discussion, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, being held October 19-23, 2018 in Munich Germany.

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The details of the poster presentations and discussion sessions are as follows:

Phase Ib/II, open label, multicenter study of intratumoral SD-101 in combination with pembrolizumab in anti-PD-1 treatment naïve patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)

Poster Discussion Session: Head and Neck Cancers
Final Publication Number: 1050PD
Discussion Session Date/Time: Saturday, October 20, 2018, 3:00 PM – 4:15 PM CEST
Discussion Session Location: Hall B3 – Room 23, ICM München, Munich Germany
Poster Session Date/Time: Saturday, October 20, 9:00 AM CEST to Monday, October 22, 5:00 PM CEST
Poster Session Location: Hall B4 – ICM München, Munich Germany

Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced melanoma who are naïve to anti-PD-1 therapy

Poster Discussion Session: Melanoma and Other Skin Tumours
Final Publication Number: LBA45
Discussion Session Date/Time: Saturday, October 20, 2018, 2:45 PM – 4:05 PM CEST
Discussion Session Location: ICM – Room 14b, ICM München, Munich Germany
Poster Session Date/Time: Saturday, October 20, 2:45 PM CEST to Monday, October 22, 5:00 PM CEST
Poster Session Location: Hall B4 – ICM München, Munich Germany

Phase Ib/II study of the combination of SD-101 and pembrolizumab in patients with advanced melanoma who had progressive disease on or after prior anti-PD-1 therapy

Poster Session: Basic science, Endocrine tumours, Gastrointestinal tumours – colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Final Publication Number: 1265P
Poster Session Date/Time: Sunday, October 21, 12:45 PM – 1:45 PM CEST
Poster Session Location: Hall A3 – Poster Area Networking Hub, ICM München, Munich Germany

On October 9, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported that interim results of its ongoing Phase 1b study of navicixizumab in combination with paclitaxel in patients with platinum-resistant ovarian cancer will be presented in a poster presentation on October 20, 2018 at the European Society for Medical Oncology meeting to be held in Munich, Germany (Press release, OncoMed, OCT 9, 2018, View Source [SID1234530050]).

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Poster 951P/
Abstract 1389: A Phase 1b Study of Navicixizumab & Weekly Paclitaxel in Heavily Pre-Treated Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Date and Time: Saturday, October 20, 2018 from 12:30 pm to 1:30 pm CEST

Location: Hall A3 – Poster Area Networking Hub
About Navicixizumab
OncoMed’s anti-DLL4/VEGF bispecific antibody, navicixizumab, is designed to inhibit the function of both DLL4 and VEGF and thereby induce potent anti-tumor responses while mitigating certain angiogenic-related toxicities. Navicixizumab was developed utilizing OncoMed’s BiMAb bispecific platform technology, which enables the design of bispecific antibodies comparable to traditional monoclonal antibodies but possessing dual target-binding specificity. In preclinical studies, navicixizumab demonstrated robust in vivo anti-tumor efficacy across a range of solid tumor xenografts, including colon, ovarian, lung and pancreatic cancers, among others. Further, in preclinical studies dual inhibition of DLL4 and VEGF appeared to exhibit synergistic anti-tumor activity at doses where blockade of either target alone elicited sub-optimal activity. In a Phase 1a study with single-agent navicixizumab published in Investigational New Drugs, 19 of 66 patients with various types of refractory solid tumors had tumor shrinkage following treatment with navicixizumab. Notably, 3 of the 12 (25%) ovarian cancer patients treated in the trial achieved a partial response with single-agent navicixizumab therapy