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OncoSec Announces Closing of First Tranche of $15 Million At Market Investment from Alpha Holdings, Inc.

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.

AstraZeneca presents advances in improving treatment options for ovarian and lung cancer patients at ESMO 2018

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]).

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

Roche to present new positive data from its broad cancer immunotherapy programme and across a wide range of cancers at the European Society for Medical Oncology (ESMO) 2018 Congress

On October 9, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new results from a number of studies across its industry leading oncology portfolio of approved and investigational medicines will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, taking place from 19-23 October, in Munich, Germany (Press release, Hoffmann-La Roche, OCT 9, 2018, View Source [SID1234529810]). These data include positive Phase III results from Roche’s cancer immunotherapy development programme across multiple tumour types, positive Alecensa (alectinib) data from the Phase III ALESIA study and new pivotal data for entrectinib, a tumour-agnostic investigational medicine that targets NTRK gene fusion-positive solid tumours.

"We look forward to presenting the first positive Phase III study of a cancer immunotherapy combination in breast cancer, which showed encouraging results for Tecentriq plus nab-paclitaxel in people with metastatic triple-negative breast cancer, specifically in the PD-L1-positive population," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We will also share new data from our pivotal analysis of entrectinib for people with NTRK gene fusion-positive solid tumours, an example of our continued commitment to developing next-generation personalised treatments."

An audio webcast for analysts and investors to discuss key data presented on the Roche Group’s oncology portfolio and pipeline during the ESMO (Free ESMO Whitepaper) 2018 Congress in Munich, will be held on Monday 22 October 2018 from 6:00 – 7:15 pm CEST. Further details are available here.

Follow Roche on Twitter via @Roche and keep up to date with ESMO (Free ESMO Whitepaper) 2018 Congress news and updates by using the hashtag #ESMO18.

Key Presentations
Breast cancer:
Primary results will be presented from the positive, Phase III, randomised IMpassion130 study investigating Tecentriq (atezolizumab) plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) as an initial (first-line) treatment for people with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC), an aggressive type of the disease which currently has limited treatment options. Abstract LBA1_PR (Presidential Symposium 1) Saturday, 20 October, 16:30 -16:45 CEST: Hall A2 – Room 18

As reported earlier this year by Roche, the combination of Tecentriq plus chemotherapy (nab-paclitaxel) significantly reduced the risk of disease worsening or death (progression-free survival, PFS) in the intention-to-treat and the PD-L1-positive populations, and showed an encouraging overall survival (OS) improvement at this interim analysis in people whose disease expresses the PD-L1 protein, a subgroup determined by PD-L1 biomarker testing.

Data from the IMpassion130 study will also be featured as part of ESMO (Free ESMO Whitepaper)’s press programme on Saturday, 20 October.

Tumour-agnostic:
Pivotal data from the positive Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA trials will be presented on entrectinib (RXDX-101) for the treatment of people with NTRK gene fusion-positive solid tumours. Abstract LBA17 (oral) – Sunday, 21 October, 11:24 – 11:36 CEST: Hall B3 – Room 22

Molecular profiling and next-generation sequencing will play a critical role in identifying people most likely to benefit from entrectinib. Roche is combining comprehensive genomic profiling with precision medicines, like entrectinib, in order to offer patients more personalised healthcare solutions.

Entrectinib has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA); Priority Medicines (PRIME) designation by the European Medicines Agency (EMA); and Sakigake Designation by the Japan Ministry of Health, Labour and Welfare for the treatment of NTRK gene fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or have no acceptable standard therapies.

Lung cancer:
Key data to be presented at ESMO (Free ESMO Whitepaper) cover advances from Roche’s lung cancer programme, including a combination approach using the cancer immunotherapy Tecentriq with targeted therapies and a range of different chemotherapies.

OS and PFS data will be presented for the first time from the positive Phase III IMpower130 study, a multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and nab-paclitaxel) versus chemotherapy (carboplatin and nab-paclitaxel) alone for advanced non-squamous non-small cell lung cancer (NSCLC). Abstract LBA53 (oral) – Monday, 22 October, 09:15 – 09:30 CEST: Hall A1 – Room 17

PFS data will also be presented for the first time from the positive Phase III ALESIA study, a randomised, multicentre, open-label study evaluating the efficacy and safety of Alecensa versus crizotinib in Asian patients with treatment-naive anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. Abstract LBA10 (Presidential Symposium 3) – Monday, 22 October, 17:30-17:45 CEST: Hall A2 – Room 18

Liver cancer:
Updated data will be presented from a Phase Ib study assessing the safety and clinical activity of the combination of Tecentriq and Avastin as treatment for patients with unresectable or advanced hepatocellular carcinoma (HCC). HCC is an aggressive cancer with limited treatment options and a major cause of cancer deaths worldwide. Earlier this summer the US FDA granted BTD for Tecentriq in combination with Avastin as an initial (first-line) treatment for people with advanced or metastatic HCC. Data at ESMO (Free ESMO Whitepaper) include longer follow-up and data from patients with hepatitis B virus, a major driver of the disease. Abstract LBA26 (oral) – Sunday, 21 October, 11:54 – 12:09 CEST: Hall A1 – Room17

Overview of key data featuring Roche medicines at ESMO (Free ESMO Whitepaper) 2018

About Roche in Oncology
Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast.

The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa (alectinib); Avastin (bevacizumab); Cotellic (cobimetinib); Erivedge (vismodegib); Gazyva/Gazyvaro (obinutuzumab); Herceptin (trastuzumab); Kadcyla (trastuzumab emtansine); MabThera/Rituxan (rituximab); Perjeta (pertuzumab); Tarceva (erlotinib); Tecentriq (atezolizumab); Venclexta/Venclyxto (venetoclax); Xeloda (capecitabine); Zelboraf (vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies

Strong showing for Oncology Drug Developers Among Fierce 15 Award Winners

On October 2nd, 2018 Fierce Biotech disclosed the 15 selected companies for the Fierce 15 Award. This prestigious award has come to symbolize novelty and being at the forefront of biotechnology development among privately held businesses. The winners of this award are aiming at breakthroughs and big things, not at being ‘me-too’.

Since 2010 1stOncology has included the Fierce 15 award in a set of attractive benchmarking parameters to identify and analyze the pipeline of movers and shakers in cancer drug development. Year after year oncology keeps coming back as a dominating therapeutic area among the Fierce 15 awardees and 2018 is no different!
In fact, no less than eleven out of the fifteen 2018 Fierce 15 companies are active in cancer drug development. Three of the companies, Beam Therapeutics, Gossamer Bio and Quentis Therapeutics were all founded in 2018, with another three companies formed in 2017, see table below. Compass Therapeutics is this year oldest recipient founded in 2013.

Fierce pointed to the fact that this years winners have been notable in their success in already raising serious funding. In total they have raised $1.36 billion in funding rounds and capital commitments with four over $100 million and most others between $40 million and $60 million. Notable too was that all eleven of the oncology companies were based out of the US, whereas in previous years the field has been more global.

Our 1stOncology clients can review detailed pipeline analysis of each these Fierce 15 companies via our special analyst report available in the platform. For all others, we are happy to offer a free online demo here, so you can see the actionable information that 1stOncology provides.

List of Oncology Associated Companies Among this Year Recipients of the Fierce 15 Award:

Navidea Biopharmaceuticals to Present at the 2018 BIO Investor Forum

On October 8, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that its Chief Executive Officer, Jed Latkin, will present a corporate overview of the Company at the 2018 BIO Investor Forum, being held October 17-18, 2018 in San Francisco, California (Press release, Navidea Biopharmaceuticals, OCT 8, 2018, View Source [SID1234530337]).

Conference Presentation Details:

Where: The Westin St. Francis Hotel, San Francisco, California
When: Thursday, October 18, 2018 at 11:15AM PDT
Room: Elizabethan C
Conference Website:
View Source

To schedule a meeting, investors can submit meeting requests through the conference one-on-one partnering system.