On August 10, 2018 Artios Pharma Limited (Artios), a leading DNA Damage Response (DDR) company developing innovative treatments for cancer, reported the completion of a $84 million (£65 million) Series B financing following high interest from investors (Press release, Artios Pharma, AUG 10, 2018, View Source [SID1234529507]).

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The financing, which was significantly oversubscribed, was led by Andera Partners (formerly EdRIP) and LSP (Life Sciences Partners), with participation by additional new investors Pfizer Ventures and Novartis Venture Fund (NVF). Artios’ existing shareholders Arix Bioscience, SV Health Investors, M Ventures, IP Group plc and AbbVie Ventures also participated in the fundraise.

Commenting on today’s announcement, Raphael Wisniewski, Partner of Andera Partners, said: "We believe Artios’ DDR programmes have the potential to bring real impact to cancer patients. DDR is an exciting field of biology, which has been clinically validated by the first generation PARP inhibitors currently on the market. The new funds will allow Artios to advance its portfolio of first-in-class, small molecule DDR programmes including its lead programme targeting DNA polymerase theta (Polθ), through clinical proof of concept trials. We are delighted to work with the management team in building a world class DDR targeted oncology company."

Dr Rene Kuijten, Managing Partner of LSP, commented: "Artios represents a unique opportunity to deliver a truly world class biotech company. LSP has worked with Artios’ team before at KuDOS (successfully sold to AstraZeneca) which developed olaparib, the first approved PARP inhibitor and used in ovarian and breast cancer, creating a billion dollar market. We are very excited to support this proven management team once again as it seeks to build on its leading position in the DDR field by advancing its programmes into clinical development."

Niall Martin, Chief Executive Officer of Artios, added: "We are delighted to welcome Andera Partners, LSP, Pfizer Ventures and Novartis Venture Fund to Artios and I would like to thank our existing investors for their continued support, which will help us develop and deliver our exciting DDR targeted therapies to cancer patients. This investor syndicate creates a very strong and committed shareholder base with a track record of supporting successful next generation companies. The oversubscribed Series B fundraise is a strong endorsement of our world-leading development pipeline and reflects the opportunity for DDR to yield new breakthrough oncology products."

Artios is actively developing a pipeline of highly promising first-in-class DDR therapies identified from a global network of leading researchers in the DDR field, including through Cancer Research UK. The inhibition of novel DNA repair targets like Polθ, in tumours where DNA damage response factors have been lost or down regulated, will lead to cancer cells being selectively killed without harming normal cells. This creates an opportunity for such products to be used both in monotherapy and in combination with existing and future cancer therapies.

In conjunction with the Series B financing, Raphael Wisniewski from Andera Partners, Rene Kuijten from LSP and Barbara Dalton from Pfizer Ventures, will join the Board of Artios as directors and Florian Muellershausen from NVF will join as an observer. This financing follows a $36 million Series A fundraise that was completed in September 2016.

On August 10, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, reported that abstracts from its LOXO-292 and larotrectinib programs have been accepted for presentation at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer to be held September 23-26, 2018, in Toronto, Canada (Press release, Loxo Oncology, AUG 10, 2018, View Source [SID1234528661]).

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The LOXO-292 oral presentation will provide an updated analysis of patients with RET fusion non-small cell lung cancer (NSCLC) enrolled in the dose escalation cohorts of the ongoing LIBERTTO-001 Phase 1/2 clinical trial. The larotrectinib poster will provide an analysis of patients with TRK fusion NSCLC enrolled to the larotrectinib clinical program.

The schedule for the presentations is as follows:

LOXO-292 Oral Presentation Session Date & Time: September 25, 2018, 3:15-4:45 p.m. ET
Title: Clinical Activity of LOXO-292, a Highly Selective RET Inhibitor, in Patients with RET Fusion+ Non-Small Cell Lung Cancer
Abstract Number: 13922
Session Title: Novel Therapies in MET, RET and BRAF
Presenter: Geoffrey R. Oxnard, M.D.

Larotrectinib Poster Presentation Session Date & Time: September 24, 2018, 9:45 a.m.-6:00 p.m. ET
Title: Rapid, Robust and Durable Responses to Larotrectinib in Patients with TRK Fusion Non-Small Cell Lung Cancer
Abstract Number: 14528
Session Title: Targeted Therapy
Presenter: Anna F. Farago, M.D., Ph.D.

About LOXO-292
LOXO-292 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 is currently being studied in the global LIBRETTO-001 Phase 1/2 trial. For additional information about the LOXO-292 clinical trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

About RET-Altered Cancers
Genomic alterations in the RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary and other thyroid cancers, and a subset of other cancers. Activating RET point mutations account for approximately 60% of medullary thyroid cancer (MTC). Both RET fusion cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET.

About Larotrectinib
Larotrectinib is an oral and highly selective investigational tropomyosin receptor kinase (TRK) inhibitor in clinical development for the treatment of patients with cancers that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In clinical trials, larotrectinib demonstrated anti-tumor activity in patients with tumors harboring NTRK gene fusions, regardless of patient age or tumor type. In an analysis of 55 RECIST-evaluable adult and pediatric patients with NTRK gene fusions, larotrectinib demonstrated a 75 percent centrally-assessed confirmed overall response rate (ORR) and an 80 percent investigator-assessed confirmed ORR, across many different types of solid tumors. The majority of all adverse events were grade 1 or 2.

Larotrectinib has been granted Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation by the U.S. FDA.

In November 2017, Loxo Oncology and Bayer entered into an exclusive global collaboration for the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor. Bayer and Loxo Oncology are jointly developing the two products with Loxo Oncology leading the ongoing clinical studies as well as the filing in the U.S., and Bayer leading ex-U.S. regulatory activities and worldwide commercial activities. In the U.S., Loxo Oncology and Bayer will co-promote the products.

For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com/trk-trials.

About TRK Fusion Cancer
TRK fusion cancer occurs when a neurotrophic tyrosine receptor kinase (NTRK) gene fuses with another unrelated gene, producing an altered tropomyosin receptor kinase (TRK) protein. The altered protein, or TRK fusion protein, is constantly active, triggering a permanent signal cascade. These proteins become the primary driver of the spread and growth of tumors in patients with TRK fusion cancer. TRK fusion cancer is not limited to certain types of cells or tissues and can occur in any part of the body. NTRK gene fusions occur in various adult and pediatric solid tumors with varying prevalence, including appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, GIST, infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer, and various sarcomas.

Only sensitive and specific tests can reliably detect TRK fusion cancer. Next-generation sequencing (NGS) can provide a comprehensive view of genomic alterations across a large number of genes. Fluorescence in situ hybridization (FISH) can also be used to test for TRK fusion cancer, and immunohistochemistry (IHC) can be used to detect the presence of TRK protein.

On August 10, 2018 Omeros Corporation (NASDAQ: OMER), reported that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the 2018 Wedbush PacGrow Healthcare Conference in New York next week (Press release, Omeros, AUG 10, 2018, View Source;p=RssLanding&cat=news&id=2363283 [SID1234528663]). The presentation is scheduled for Tuesday, August 14, 2018 at 2:30 p.m. EDT.

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The presentation will be webcast. The live and archived webcasts can be accessed on the "Events" page of the company’s website at www.omeros.com.

On August 10, 2018 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the second quarter ended June 30, 2018 and a business update (Press release, Adamis Pharmaceuticals, AUG 10, 2018, View Source [SID1234528712]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "Recently, we have announced several significant achievements for our company. The Sandoz partnership for the commercialization and distribution of Symjepi in the U.S. will likely prove to be the most transformative for the Company. Under the agreement, Sandoz will take responsibility for sales and marketing. We believe the financial terms of the agreement could provide for a meaningful recurring revenue to Adamis. We have also expanded our pipeline with our sublingual tadalafil (Cialis) product candidate, which is in development."

Dr. Carlo added, "The successful underwritten public offering of common stock has provided the necessary resources to advance our pipeline. We were fortunate to have had multiple fundamental health care funds lead that offering. These recent advancements have put Adamis in a strong position for growth."

Company Highlights and Product Updates

Some of the company’s product updates and accomplishments since the beginning of the second quarter of 2018 include the following:

Symjepi (epinephrine) Injection 0.30mg – The company entered into a commercialization and distribution agreement with Sandoz, a division of Novartis, to market and sell Symjepi in the U.S. Key terms include: Sandoz to pay a supply price to Adamis for product, Adamis 50% profit split and Sandoz right of first negotiation for territories outside the U.S.;
APC-8000 (sublingual tadalafil) – The company is developing a new fast-dissolving sublingual tablet containing tadalafil (Cialis) and intends to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) with the goal of filing a New Drug Application (NDA) before year-end;
APC-6000 (naloxone) – We continue to advance our naloxone product candidate for opioid overdose, and plan to file an NDA with the FDA before year-end. This is our second product using our FDA-approved injection device;
APC-1000 (beclomethasone) – The FDA cleared Adamis to begin Phase 3 pivotal studies with our beclomethasone metered dose inhaler and we are planning to begin patient recruitment in Q4;
APC-4000 (fluticasone) – Fluticasone will be our first product candidate using our patented dry powder inhaler device platform purchased from 3M. We continue to work on proof of concept studies with the objective of demonstrating proper dosing of the steroid;
Balance sheet – We strengthened our cash position with an underwritten equity offering that raised net proceeds of approximately $37.6 million.
Second Quarter Financial Results

Revenues were approximately $3.9 million and $3.8 million for the three months ended June 30, 2018 and 2017, respectively. The increase in revenues for the three months ended June 30, 2018 compared to the comparable period of 2017 reflected an increase in sales of USC’s compounded and non-compounded pharmaceutical formulations resulting in part from price increases and marketing personnel efforts.

Net loss from operations for the three months ending June 30, 2018 and 2017, respectively, was approximately $9.7 million and $4.9 million. The increase in net loss primarily resulted from an increase in both selling, general and administrative ("SG&A") expenses and research and development ("R&D") expenses.

SG&A expenses for the three months ended June 30, 2018 and 2017 were approximately $6.4 million and $5.7 million, respectively. The increase was primarily due to adding personnel, increases in compensation and benefits expense, as well as, increases in the cost of maintaining licenses, registrations and intellectual property.

R&D expenses were approximately $4.8 million and $1.2 million for the three months ended June 30, 2018 and 2017, respectively. The increase was the result of the expense of advancing several late-stage candidates in our product pipeline.

At June 30, 2018, the Company had cash and cash equivalents of $4.4 million. On August 6, 2018, the Company announced the closing of an underwritten public offering resulting in net proceeds of approximately $37.6 million.

Future Milestones for 2018

Commercial launch of Symjepi (epinephrine) Injection 0.3mg in the U.S. – timing of launch and commercial strategy will be at Sandoz’s sole discretion;
FDA approval of lower dose Symjepi (epinephrine) Injection 0.15mg;
Announcement of ex-U.S. strategy for Symjepi;
Filing an NDA for naloxone injection;
Filing an NDA for the sublingual tadalafil (Cialis) tablet;
Commencement of Phase 3 studies for beclomethasone in asthmatics;
Growing net revenue of outsourcing facility (U.S. Compounding) by 30% over 2017.

On August 10, 2018 -Celltrion, Inc. (KRX:068270) reported is set to launch global Phase 3 clinical trial for its bevacizumab biosimilar ‘CT-P16’ for the treatment of cancer (Press release, Celltrion, AUG 10, 2018, View Source [SID1234528713]).

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Celltrion successfully completed Phase 1 clinical study on the safety and pharmacokinetic assessment of CT-P16 in June 2018. Further, it recently submitted its Clinical Trial Application for Phase 3 clinical study to the National Authority of Medicines and Health Products, I.P. (Infarmed) of Portugal.

Beginning with Portugal, Celltrion is set to conduct Phase 3 clinical trial for CT-P16 in about 150 sites in some 20 nations across Europe, Asia and South America.

Meanwhile, Roche’s Avastin, the originator of CT-P16, is a therapeutic anti-cancer drug for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, and glioblastoma. It last year recorded global sales of about USD 6.7 billion1, making it blockbuster medicine.

"We are successfully conducting the clinical trial for the bevacizumab biosimilar ‘CT-P16’ as planned. We will secure the competitiveness for CT-P16 compared with its competitive biosimilars." says an official of Celltrion.

1 Source: Roche Financial Report 2017