On October 3, 2019 Median Technologies (Paris:ALMDT) (ALMDT), The Imaging Phenomics Company, reported its results for the first half of 2019 (Press release, MEDIAN Technologies, OCT 3, 2019, View Source [SID1234540043]).

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The company’s Board of Directors met on October 1st and approved the consolidated financial statements for the first half of 2019.

With € 4 million in revenue, Median Technologies’ sales increased 19.5% compared to the first half of 2018. The company’s H1 revenue came solely from its iCRO business1.

During the first six months of 2019, Median Technologies continued to invest in the development of its imaging phenomics platform, iBiopsy and strengthened its AI and data science teams in order to cement its position as a leader in the field.

As Median started managing operations locally in China, the company’s iCRO Business Unit continued to expand, which resulted in a significant increase of Chinese orders throughout the half of the year. In Europe and the United States, new orders in the first half of 2019 exceeded the company’s expectations for the entire year. As of June 30, Median’s iCRO business unit was operationally at its break-even point.

Simplified financial statements (IFRS consolidated)

The company’s operating expenses dropped sharply compared to last year due to a 36% decrease in staff costs (€ -4.1 million as of June 30, 2019 vs. € -6.5 million as of June 30, 2018) and a 37% decrease in external costs (€ -3.5 million as of June 30, 2019 vs. € -5.6 million as of June 30, 2018).

As a result, the operating loss was cut by more than 50% to € -4.19 million. The company’s net result at the half-year mark went from € -9.0 million in 2018 to € -4.2 million in 2019.

As of June 30, 2019, Median had € 7.9 million in cash and cash equivalents, not including the Research Tax Credit payment (€1.6 million) which was received in July, and € 4.9 million in net equity. Net new orders reached € 11 million in the first half of the year bringing the company’s order backlog to € 30.7 million, up € 7 million compared to December 31, 2018. The extent of the order backlog makes Median confident about the company’s revenues for the second half of 2019 and 2020.

Latest developments and perspectives

During the third quarter of 2019, Median Technologies has continued negotiations for a € 35 million loan with the European Investment Bank (EIB), however the process was slowed down due to EIB logistical internal constrains. EIB and Median expect to finalize the agreement in Q4. Median expects the lending of the first tranche of € 15 million in the first half of 2020. Structured in three tranches, the loan will enable Median Technologies to boost investments in its imaging phenomics platform, iBiopsy, over the next few years. The ongoing negotiations for this loan were announced on May 15th.

Current trends point to the company’s positive results in the third quarter of 2019. Q3 results will be published shortly. Median’s iCRO business is expected to keep growing steadily worldwide. In the United States, two phase III contracts (totaling € 2 million) were signed in Q2, with one of the world’s top 3 pharmaceutical companies, a new customer for Median. These contracts have opened promising opportunities for Median in the US. The development of iBiopsy is progressing as planned, including an upcoming technology demonstrator at the annual convention of the RSNA (Radiological Society of North America) in early December.

"Our results for H1 have exceeded all expectations. We anticipate keeping up the momentum in the second half of the year," said Fredrik Brag, CEO and co-founder of Median.

Median informs its shareholders and the financial community at large that its financial statements for the first half of 2019 have been filed with the French market regulator and are now available on the company’s website.

On October 3, 2019 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported duvelisib (COPIKTRATM) has received orphan drug designation from the U.S. Food and Drug Administration for use in the treatment of T-Cell lymphoma (Press release, Verastem, OCT 3, 2019, View Source [SID1234540044]). The designation was created to encourage the development of drugs that may provide significant benefit to patients suffering from rare diseases.

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"Receiving orphan drug designation for T-Cell Lymphoma, in addition to the previously-granted Fast Track status, for Peripheral T-Cell lymphoma, marks another important regulatory milestone to bring COPIKTRA to patients who are faced with this aggressive type of disease with limited therapeutic options," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "We look forward to sharing the results of our Phase 2 PRIMO study and efficiently advancing our development program in this indication."

COPIKTRA is approved in the United States for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least 2 prior therapies and accelerated approval in follicular lymphoma (FL) after at least 2 prior systemic therapies. COPIKTRA is not currently approved for the treatment of T-cell lymphoma. The Company’s ongoing Phase 2 PRIMO study will provide guidance on a duvelisib monotherapy dosing regimen in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) and further characterize its efficacy and tolerability in this population.

In the U.S., under the Orphan Drug Act, the FDA’s Office of Orphan Products Development (OOPD) grants orphan drug status to a drug or biologic intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders, which is generally a disease that affects fewer than 200,000 individuals in the U.S. and that are expected to provide a significant therapeutic advantage over existing treatments. Orphan designation qualifies a company for benefits that apply across all stages of drug development, including an accelerated approval process, seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and a waiver of certain administrative fees.

About Peripheral T-Cell Lymphoma

Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma (NHL) that develops in mature white blood cells called "T cells" and "natural killer (NK) cells"1 which circulate with the lymphatic system.2 PTCL accounts for between 10-15% of all non-Hodgkin lymphomas (NHLs) and generally affects people aged 60 years and older.1 Although there are many different subtypes of peripheral T-cell lymphoma, they often present in a similar way, with widespread, enlarged, painless lymph nodes in the neck, armpit or groin.2 There is currently no established standard of care for patients with relapsed or refractory disease.1

SELECT IMPORTANT SAFETY INFORMATION

This does not include all information needed to use COPIKTRA (duvelisib) safety and effectively. See full Prescribing Information.

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS

See full Prescribing Information for complete boxed warning

Fatal and/or serious infections occurred in 31% (4% fatal) of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
Fatal and/or serious diarrhea or colitis occurred in 18% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
INDICATIONS AND USAGE

COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:

Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval based on overall response rate and continued approval may be contingent upon confirmatory trials
WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function.
Neutropenia: Monitor blood counts.
Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS

The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

To report Adverse Reactions, contact FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch and Verastem Oncology at 1-877-7RXVSTM (1-877-779-8786).

DRUG INTERACTIONS

CYP3A inducers: Avoid co-administration with strong CYP3A inducers.
CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed.

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.3,4,5 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.6 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

On October 3, 2019 AMN Healthcare Services, Inc. (NYSE: AMN), healthcare’s leader and innovator in workforce solutions and staffing services, reported that it has scheduled a conference call to discuss its third quarter 2019 financial results on Thursday, October 31, 2019 at 5:00 p.m. Eastern Time (Press release, AMN Healthcare Services, OCT 3, 2019, View Source [SID1234540062]). The same day, the Company also expects to issue an earnings news release after market close at approximately 4:15 p.m. Eastern Time.

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A live webcast of the call can be accessed through AMN Healthcare’s website at View Source Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Interested parties may participate live via telephone by dialing (800) 288-8960 in the U.S. or (612) 234-9960 for international callers. Following the conclusion of the call, a replay of the webcast will be available at the Company’s website. Alternatively, a telephonic replay of the call will be available beginning at 7:30 p.m. Eastern Time on October 31, 2019, and can be accessed until 11:59 p.m. Eastern Time on November 14, 2019 by calling (800) 475-6701 in the U.S. or (320) 365-3844 internationally, with access code 472944.

On October 2, 2019 Elicio Therapeutics, a next generation immuno-oncology company, reported that it has closed its $33 million Series B financing (Press release, Elicio Therapeutics, OCT 2, 2019, View Source [SID1234540027]). Proceeds from the financing will be used to advance Elicio’s pipeline of novel lymph node targeted immuno-therapies, including ELI-002, an Amphiphile mKRAS vaccine (AMP KRAS). ELI-002 targets all seven KRAS mutations that drive 99% of all mKRAS-driven cancers, estimated to be 25% of all human solid tumors.

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"We believe ELI-002 can become a universal mKRAS vaccine with the potential to treat and prevent disease recurrence for hundreds of thousands of patients with mKRAS-driven cancers, including pancreatic, colorectal and lung cancer," said Robert Connelly, CEO of Elicio. "This new funding is a strong endorsement of this program, the Amphiphile platform, and our progress."

Elicio has established an international investor base, including Clal Biotechnology Industries, Livzon Pharmaceutical Group and Efung Capital. "We are gratified to be able to expand our investor base and strengthen our balance sheet as we advance multiple Amphiphile immuno-therapies towards initial patient studies," Connelly said.

Elicio’s AMP KRAS vaccine ELI-002 has completed preclinical validation, IND-enabling GLP toxicology studies, GMP manufacturing, and a pre-IND meeting with the FDA and Elicio intends to begin an initial patient study in pancreatic cancer patients in the first half of 2020. These trials will be multi-site, randomized, controlled studies. Initial ELI-002 pancreatic cancer patient data is expected in the second half of 2020.

About the Amphiphile Platform
The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.

On October 2, 2019 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that data with the Company’s lead product candidate, RP1, will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in Washington, D.C. from November 6-10, 2019 (Press release, Replimune, OCT 2, 2019, View Source [SID1234540012]). The poster which will be presented on November 8, 2019 highlights results from the Phase 1 portion of the Phase 1/2 clinical trial of RP1 as a single agent and in combination with Opdivo (nivolumab) in patients with solid tumors.

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Details of Replimune’s poster presentation:

Abstract Title: Initial results of the phase 1 portion of an ongoing phase 1/2 study of RP1 as a single agent and in combination with nivolumab in patients with solid tumors

Poster #: P433

Date: Friday, November 8, 2019, 7:00 a.m. ET – 8:00 p.m. ET

Location: Gaylord National Hotel & Convention Center