On October 9, 2018 Oblique Therapeutics, a biotech focused on new medicines for severe diseases with large unmet medical needs, reported that it will present new promising preclinical data for the drug candidate OT-1096 in triple-negative breast cancer (TNBC) at the largest oncology congress in Europe, the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), held 19-23 October in Munich, Germany (Press release, Oblique Therapeutics, OCT 9, 2018, View Source [SID1234529831]).

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The new data of the first-in-class anti-cancer agent OT-1096 shows promising preliminary results with improved tumor growth inhibition compared to pembrolizumab, one of the blockbuster drugs within immunooncology. The humanized TNBC PDX mouse-model, used in this study, allows for the growth of a breast cancer derived from a patient, in the presence of a human immune system. The results suggest that OT-1096 reduces tumor growth by two associated mechanisms; direct cancer cell killing activity by redox system modulation that, in turn, results in a beneficial immunomodulatory action through lowering of regulatory T-cells within the TIL* population as compared to controls. The results warrant further investigations of OT-1096 in TNBC and other aggressive cancers. Treatment with OT-1096 shows no safety or tolerability concerns.

"First of all, it is an honor to be recognized by ESMO (Free ESMO Whitepaper), and we are thrilled to exhibit our promising results for OT-1096 for the first time. Even more so, being part of changing the treatment landscape for cancer at this time is exciting for us: the 2018 Nobel Prize in Medicine was awarded for pioneering work in immunooncology and we see more and more traction and exciting results from novel immunomodulatory small molecules, such as ours, with the capacity to favorably change the immune system inside tumors ," said Prof. Owe Orwar, CEO at Oblique Therapeutics.

TNBC is an aggressive subtype of breast cancer associated with poor prognosis and limited treatment options, and new effective medicines are needed. Globally, two million people are diagnosed with breast cancer every year; of which 10-13 percent has TNBC.

Prof. Owe Orwar, CEO at Oblique Therapeutics, will present a poster (441P) with the title: "OT-1096, a first-in-class immunoactivating small molecule that targets the thioredoxin reductase/thioredoxin axis causes strong tumor growth inhibition by downregulating intratumoral Tregs in a humanized TNBC-PDX model" on Monday 22 October 2018 at 12:45-13:45. The abstract is available through esmo.org: View Source (search: 441P)

For more information, please contact:

Prof. Owe Orwar
CEO
Email: [email protected]

About OT-1096

OT-1096 is a next-generation first-in-class small molecule immunomodulator with anti-cancer activity. The initial clinical focus is on targeting advanced triple-negative breast cancer (TNBC) but the program will be extended to include other forms of metastatic and advanced cancer that fits to the mechanism of action of OT-1096.

On October 9, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, reported that it will present 54 abstracts, including eight oral presentations and three late breakers, to the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (ESMO 2018) Congress in Munich, Germany, 19-23 October (Press release, AstraZeneca, OCT 9, 2018, View Source [SID1234529815]).

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Data span several tumour types and include full results from the Phase III SOLO-1 ovarian cancer trial to be presented in the Presidential Symposium, along with new research on resistance mechanisms in metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). In addition, MedImmune Senior Vice President, Head of Oncology Innovative Medicines and Professor of Medicine and Medical Oncology at South-Paris University, Jean-Charles Soria, will be recognised for his outstanding contribution to medical oncology by receiving the 2018 ESMO (Free ESMO Whitepaper) Award.

Dave Fredrickson, Executive Vice President, Head of Oncology Business Unit, said: "Our diversified Oncology portfolio prioritises medicines with the potential to redefine the clinical practice of cancer treatment. We are working to deliver potentially curative approaches earlier in the treatment paradigm across a range of cancers. We are also exploring how to stay a step ahead of disease progression by understanding how tumours become resistant to treatment over time."

Detailed Lynparza data from the Phase III SOLO-1 trial in women with newly-diagnosed, advanced BRCA-mutated ovarian cancer

SOLO-1 is the only trial of a poly (ADP-ribose) polymerase (PARP) inhibitor, Lynparza, to demonstrate a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for women with newly-diagnosed, advanced BRCA-mutated ovarian cancer. Data from the trial by AstraZeneca and MSD, known as Merck in the US and Canada, will be featured in an ESMO (Free ESMO Whitepaper) Presidential Symposium (Presentation #LBA7_PRAbstract). In the 1st-line setting, only 20 percent of women have prolonged, relapse-free periods and are considered cured following surgery and chemotherapy, and 70 percent relapse within three years. These data will provide detailed PFS results for Lynparza, supporting the treatment goal of long-term remission in women with newly-diagnosed disease, where currently-available treatment options aimed at extending time to progression only offer modest improvements.

New understanding of acquired resistance mechanisms in lung cancer from the Phase III FLAURA trial

Preliminary data on acquired resistance mechanisms seen with 1st-line Tagrisso (osimertinib) use in the Phase III FLAURA trial (Presentation Number #LBA_5005) will be presented as a late-breaker, providing new insights into potential treatment strategies for patients with metastatic EGFR-mutated NSCLC.

Lung cancer Immuno-Oncology (IO): New insights from the Phase III PACIFIC trial

An oral presentation of subgroup analyses will explore the efficacy and safety of the PACIFIC regimen in unresectable, Stage III NSCLC evaluating differences in treatment and timing for chemoradiation therapy before Imfinzi (Abstract #1363O).

Early pipeline explores combinations in difficult-to-treat tumour types

Key presentations from AstraZeneca’s early stage pipeline include insight into novel DNA Damage Response (DDR)-IO combinations. A Phase I clinical and translational evaluation of the ATR inhibitor, AZD6738, in combination with Imfinzi in patients with lung or head and neck cancer will be featured as a poster discussion (Abstract #413PD).

Data from the early-stage IO pipeline, including updated results from the Phase Ib/II multi-indication SCORES trial of Imfinzi plus danvatirsen (AZD9150, STAT3) or AZD5069 (CXCR2), demonstrating the impact of targeting novel pathways, will also be presented (Abstract #1044O).

Additionally, new approaches to patient selection using different methods of detection of homologous recombination repair gene mutations will be highlighted in a Phase II trial of Lynparza plus abiraterone (Study 08) in metastatic castration-resistant prostate cancer (Abstract #97P).

Key AstraZeneca/MedImmune presentations at ESMO (Free ESMO Whitepaper) 2018:

Lead author

Abstract title

Presentation details

Ovarian cancer

Moore, K

Phase III SOLO1 trial: Maintenance olaparib following platinum-based chemotherapy in newly diagnosed patients (pts) with advanced stage ovarian cancer (OC) and a BRCA1/2 mutation (BRCAm)

Oral Presentation

Presidential Symposium 2

Sunday 21st October, 16:30-18:10

Presentation Time: 17:45-18:00

Location: Hall A2, Room 18

Abstract #LBA7_PR

Penson, RT

MEDIOLA: A Phase I/II trial of olaparib (PARP inhibitor) in combination with durvalumab (anti-PD-L1 antibody) in patients with advanced solid tumors – new ovarian cancer cohorts

Poster

Gynaecological cancers

Monday 22nd October, 12:45-13:45

Location: Hall A3

Abstract #448TiP

Colombo, N

BAROCCO: A randomized phase II study of weekly paclitaxel vs. cediranib-olaparib with continuous schedule vs. cediranib-olaparib with intermittent schedule in advanced platinum-resistant ovarian cancer

Poster

Gynaecological cancers

Saturday 20th October, 12:30-13:30

Location: Hall A3

Abstract #1002TiP

Lung Cancer

Ramalingam, S

Mechanisms of acquired resistance to first-line osimertinib: preliminary data from the phase III FLAURA study

Oral Presentation

NSCLC, metastatic

Friday 19th October, 16:00-17:30

Presentation Time: 16:00-16:12

Location: Hall A2, Room 18

Abstract #LBA50

Faivre-Finn, C

Efficacy and safety evaluation based on time from completion of radiotherapy to randomization with durvalumab or placebo in pts from PACIFIC

Oral Presentation​

Non-Metastatic NSCLC and Other Thoracic Malignancies

Sunday 21st October, 09:15-10:45

Presentation Time: 10:15-10:30

Location: Hall A1, Room 17
Abstract #1363O

Kowalski, D

ARCTIC: durvalumab + tremelimumab and durvalumab monotherapy vs SoC in ≥3L advanced NSCLC treatment

Oral Presentation ​

NSCLC, metastatic

Monday 22nd October, 09:15-11:00​

Presentation Time: 10:15-10:30

Location: Hall A1, Room 17​

Abstract #1378O

Bondarenko, I

Preliminary efficacy of durvalumab plus tremelimumab in platinum-refractory/resistant ED-SCLC from Arm A of the Phase II BALTIC study

Poster Discussion

Lung early

Sunday 21st October, 14:45-16:00

Discussion Time: 15:25-15:35

Location: ICM, Room 1

Abstract #1665PD

Early pipeline

Cohen, EW

Phase 1b/2 Study (SCORES) of Durvalumab (D) Plus AZD9150 or AZD5069 in Advanced Solid Malignancies and Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M-SCCHN): Updated Results

Oral Presentation

Head & Neck cancer
Monday 22nd October, 14:45-16:15

Presentation Time: 14:45-15:00

Location: ICM, Room 14b
Abstract #1044O

Krebs, MG

Phase I clinical and translational evaluation of AZD6738 in combination with durvalumab in patients (pts) with lung or head and neck carcinoma

Poster Discussion

Developmental therapeutics

Saturday 20th October, 15:00-16:15

Discussion Time: 15:00-15:20

Location: Hall B3, Room 22

Abstract #413PD

Carr, Thomas H

Multimodal detection of homologous recombination repair gene mutations (HRRm) in a Phase II trial of olaparib plus abiraterone in metastatic castrate resistant prostate cancer (mCRPC)

Poster

Biomarkers

Saturday 20th October, 12:30-13:30

Location: Hall A3

Abstract #97P

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 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, reported the closing of the first $8 million tranche of its $15 million investment from Alpha Holdings, Inc. (KOSDAQ: 117670) (Press release, OncoSec Medical, OCT 9, 2018, View Source [SID1234529816]). This value-focused, fundamental strategic investment is centered on the clinical development of OncoSec’s lead immunotherapy product candidate, TAVO (tavokinogene telseplasmid). TAVO enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with powerful immune-stimulating functions.

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Alpha Holdings is a leading Korean technology company engaged in the design, development, service and manufacture of system semiconductors, as well as the development of biotechnologies and thermal compound materials. Since 2002, Alpha Holdings has successfully carried out many projects as a major partner of Samsung Advanced Foundry Eco-system (SAFE) of Samsung Electronics. Alpha Holdings, a listed company in the KOSDAQ Market, was founded in 2002 and is headquartered in Seongnam, South Korea.

Under the terms of the agreement, Alpha Holdings has committed to purchase a total of $15 million worth of shares of common stock from OncoSec in two tranches at $1.50 per share. The two tranches are each subject to a six-month holding requirement from date of funding. As stated above, Alpha has funded the first tranche of $8 million. The closing of the second tranche is subject to the satisfaction of certain closing conditions. Further details of the transaction can be found in the Form 8-K filed by the Company describing the agreement.

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.