On May 12, 2020 Pillar Biosciences, an NGS clinical cancer diagnostics company, reported the closing of a $29.7 million Series C preferred stock financing (Press release, Pillar Biosciences, MAY 12, 2020, View Source [SID1234557626]). The financing will accelerate the expansion of Pillar’s in vitro diagnostic and research use only panels and advance Pillar’s global commercial outreach.

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Pillar’s flagship technology, SLIMamp target enrichment chemistry, enables automatable amplification of overlapping amplicons in a single tube from as little as 2.5ng DNA in less than 8 hours. Pillar’s complementary PiVAT bioinformatics platform enables variant calling down to 1% VAF for virtually every type of variant with minimal computing resources and processing time.

For precision medicine to become widely accessible, pathologists need streamlined NGS workflows that deliver timely results, especially for first line cancer therapies. Pillar Biosciences’s technology and products focus on providing pathologists with productive solutions so that precision medicine can become the norm.

Recently, a Pillar custom product received approval from New York State Department of Health. Pillar was also granted CE approval for its first in vitro diagnostic panel, the Pillar ONCO/Reveal Lung and Colon Cancer Assay, which guides the prescription of six different therapies simultaneously, reduces the need for repeat testing, and allows for treatment decisions in just 4 days.

Pillar Biosciences has made considerable progress towards ensuring global access to its suite of NGS panels and software. Pillar’s panels are compatible with Illumina, Ion Torrent, and MGI sequencing platforms. Pillar also recently secured distributors in Israel, Hong Kong, Macau, South Korea, and ASEAN countries.

"We are proud of what our customers have been able to accomplish with Pillar’s technology," said Dr. Gang Song, founder and CEO of Pillar Biosciences. "Now we are building IVD products that will be accessible to every pathologist, so that every cancer patient can get the right therapy the first time."

"We are a strong believer in using NGS tumor testing to make precision medicine the first line treatment," said Simone Song, Senior Partner of ORI Healthcare Fund, which invested in Pillar’s Series A round and also led the Series C round. "Pillar’s SLIMamp technology is fast, accurate, user friendly, and cost effective. We have confidence that Pillar will fulfill an unmet medical need and thus bring true benefits to cancer patients."

On May 12, 2020 Sanofi reported the Phase 3 IKEMA clinical trial evaluating Sarclisa (isatuximab) added to carfilzomib and dexamethasone met the primary endpoint at its first planned interim analysis, demonstrating significantly prolonged progression-free survival compared to standard of care carfilzomib and dexamethasone alone in patients with relapsed multiple myeloma (Press release, Sanofi, MAY 12, 2020, View Source [SID1234557569]). There were no new safety signals identified in this study.

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"When Sarclisa was added to standard-of-care treatment carfilzomib and dexamethasone in this phase 3 trial, results clearly demonstrated a significant reduction in risk of disease progression or death," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "This is the second positive phase 3 trial for Sarclisa, further supporting the potential our medicine has to improve outcomes for patients struggling with relapsed multiple myeloma."

Results will be submitted to an upcoming medical meeting and are anticipated to form the basis of regulatory submissions planned for later this year.

About the Trial

The randomized, multi-center, open label Phase 3 IKEMA clinical trial enrolled 302 patients with relapsed multiple myeloma across 69 centers spanning 16 countries. All study participants received one to three prior anti-myeloma therapies. During the trial, Sarclisa was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with carfilzomib twice weekly at the 20/56mg/m2 dose and dexamethasone at the standard dose for the duration of treatment. The primary endpoint of IKEMA is progression-free survival. Secondary endpoints include overall response rate, the rate of very good partial response or greater, minimal residual disease, complete response rate, overall survival and safety.

The use of Sarclisa in combination with carfilzomib and dexamethasone in relapsed multiple myeloma is investigational and has not been fully evaluated by any regulatory authority.

About Sarclisa

Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on multiple myeloma cells. It is designed to work through many mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of multiple myeloma cells, making it a potential target for antibody-based therapeutics such as Sarclisa.

Sarclisa is approved in the U.S. in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

Sarclisa has also received positive CHMP opinion in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. A final decision on the Marketing Authorisation Application for Sarclisa in the E.U. is expected in the coming months. The safety and efficacy of Sarclisa has not been fully evaluated by any regulatory authority outside of the U.S., Switzerland, Canada and Australia.

Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments for people with multiple myeloma. It is also under investigation for the treatment of other blood cancer types (hematologic malignancies) and solid tumors.

For more information on Sarclisa clinical trials please visit www.clinicaltrials.gov.

About Multiple Myeloma

Multiple myeloma is the second most common hematologic malignancy, with more than 138,000 new diagnoses of multiple myeloma worldwide yearly. Despite available treatments, multiple myeloma remains an incurable malignancy, and is associated with significant patient burden. Since multiple myeloma does not have a cure, most patients will relapse. Relapsed multiple myeloma is the term for when the cancer returns after treatment or a period of remission. Refractory multiple myeloma refers to when the cancer does not respond or no longer responds to therapy.

On May 13, 2020 Vaxart, Inc. ("Vaxart" or the "Company"), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, reported financial results for the first quarter ended March 31, 2020 and provided a corporate update (Press release, Aviragen Therapeutics, MAY 12, 2020, View Source [SID1234557595]).

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"In January we pivoted to COVID-19, and we are now on track to start a first Phase 1 study in the second half of this year with our oral tablet vaccine," said Wouter Latour, MD, chief executive officer of Vaxart, "We are developing a state-of-the-art gene-based vaccine utilizing our proprietary vector platform, and the lead candidate vaccines performed well in preclinical testing, generating very high levels of antibodies."

"For COVID-19, a key challenge will be to manufacture sufficient vaccine and efficiently vaccinate the millions at risk, and ultimately the entire population. Our vaccines are administered orally using a room temperature-stable tablet, an enormous logistical advantage over injectable vaccines in large vaccination campaigns. The bulk vaccine does not require sterile fill and finish, a significant bottleneck for injectable vaccines, but can be tableted very efficiently using high throughput industrial tableting equipment."

Corporate Highlights:

In preclinical testing, the Company’s lead vaccine candidates generated robust anti-SARS CoV-2 antibodies in all tested animals after both the first and second dose, with a clear boosting effect after the second dose. Antibody responses in all vaccinated groups were statistically significant (p<0.002), with median ELISA IgG antibody titers above 10,000 compared to a median titer of 1 in the untreated controls, a larger than 10,000 fold increase.

The manufacturing collaboration with Emergent BioSolutions is progressing well and, provided Vaxart elects to proceed, Emergent is on schedule to produce bulk cGMP vaccine in time for initiation of a Phase 1 clinical study during the second half of 2020.

The Universal Influenza vaccine collaboration with Janssen remains on schedule to provide results by mid-2020.

The Company continues to pursue strategic, financial and public-private partnerships to advance its development candidates, including its coronavirus vaccine candidates, norovirus and seasonal influenza vaccine programs.

Financial Results for the Three Months Ended March 31, 2020

Vaxart reported a net loss of $1.3 million for the first quarter of both 2020 and 2019. Net loss per share was $0.02 in 2020 compared to $0.18 in 2019 due to an increase in the number of shares outstanding.

Vaxart ended the quarter with cash and cash equivalents of $29.9 million compared to $13.5 million at December 31, 2019. The increase was primarily due to $9.2 million of net proceeds raised in a registered direct offering of common stock and warrants and $10.3 million from the exercise of common stock warrants, partially offset by $3.2 million of cash used in operations.

Revenue for the quarter was $2.9 million compared to $5.4 million in the first quarter of 2019. The $2.5 million decrease was principally due to the loss of royalty revenue of $0.7 million for Relenza following the expiration of the patent and a decrease of $1.9 million in royalty revenue for Inavir, partly due to higher sales in the three months ended December 31, 2019.

Research and development expenses were $1.5 million for the quarter compared to $3.8 million for the first quarter of 2019. The decrease was mainly due to a reduction in personnel costs after we ceased internal manufacturing as part of our December 2019 restructuring and a reduction in expenditure on our norovirus vaccine candidate.

General and administrative expenses were $2.0 million for the quarter, substantially unchanged from the first quarter of 2019.

On May 12, 2020 Amgen (NASDAQ:AMGN) reported that it will present at the Bank of America Merrill Lynch Virtual Global Healthcare Conference at 1:40 p.m. ET on Thursday, May 14 (Press release, Amgen, MAY 12, 2020, View Source [SID1234557627]). Peter H. Griffith, executive vice president and chief financial officer, and Murdo Gordon, executive vice president of Global Commercial Operations at Amgen will present.

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Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

On May 12, 2020 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH; Nasdaq: IPHA) reported its revenue and cash position for the three-month period ended March 31, 2020 (Press release, Innate Pharma, MAY 12, 2020, View Source [SID1234557570]).

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"During this quarter, we have maintained momentum with our pipeline as well as ensuring business continuity despite this challenging and unprecedented time," said Mondher Mahjoubi, Chief Executive Officer, Innate Pharma. "As an agile company with potential molecules in our pipeline that could make an impact in the fight against COVID-19, we have initiated the FORCE Phase II trial evaluating avdoralimab in COVID-19 patients with severe pneumonia with the goal of helping improve their prognosis. Additionally, we look forward to sharing new efficacy data on the Phase Ib/II monalizumab and cetuximab combination in IO-pretreated head and neck patients at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program. We are committed to executing across our pipeline programs and pursuing innovative therapies for high unmet patient populations."

First quarter of 2020 and recent pipeline highlights:

COVID-19 Impact:

As we navigate the COVID-19 pandemic, we are dedicated to supporting our patients, our employees and their families, and the communities where we live and work.

Currently, there is varying impact to our pipeline assets in relation to COVID-19, as outlined below. The COVID-19 pandemic could impair our ability to achieve our product development or commercialization objectives in the timeframes we had expected.

We are closely monitoring the rapidly evolving environment and will continue to provide relevant information on our COVID-19 web page as the situation evolves.

_________________________
iIncluding short term investments (€16.3 million) and non-current financial instruments (€33.9 million).

Lumoxiti, a first-in-Class marketed product in-licensed from AstraZeneca for the treatment of relapsed or refractory hairy cell leukemia:

In January, we announced that the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for Lumoxiti.
In March 2020, the Biologics License Application for Lumoxiti was transitioned from AstraZeneca (LSE/STO/NYSE: AZN) to Innate. The transition is on track to be completed in 2020.
Due to the COVID-19 pandemic, widespread restrictions and social distancing measures have limited opportunities for in-person marketing of Lumoxiti to oncology healthcare professionals and access to physicians causing interruptions of treatments for patients. As a result, the rate of new Lumoxiti patients has slowed which is expected to impact 2020 sales.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

At the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Conference, new efficacy data will be presented from a Phase II expansion cohort of IO-pretreated patients.
· ASCO (Free ASCO Whitepaper) abstract (Abstract #6516, Poster#177), entitled "Combination of Monalizumab and Cetuximab in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Cancer Previously Treated with Platinum-based Chemotherapy and PD-(L)1 Inhibitors."
The advancement of monalizumab in combination with cetuximab to a Phase III trial in IO-pretreated patients suffering from recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) is expected in 2020.
A controlled, randomized, study will explore monalizumab, amongst other treatment arms, to investigate the potential efficacy versus standard of care against COVID-19 in cancer patients with mild symptoms. This study is sponsored by Centre Léon Bérard, Lyon.
Lacutamab (IPH4102, anti-KIR3DL2 antibody):

In January, the French and UK regulatory agencies agreed the lacutamab TELLOMAK trial could resume recruitment in Sézary syndrome and mycosis fungoides patients. In all other geographies, no new patients may be enrolled in the trial until a new Good Manufacturing Practice (GMP)-certified batch is available. Currently enrolled patients can continue treatment in the trial except in Italy.
· New batches of drug product have been successfully manufactured. A new clinical GMP-certified batch is on track to be available in the second half of 2020.
· The Company is progressing PTCL in alternative clinical development pathways and therefore, has taken the decision to stop the PTCL cohort in the TELLOMAK study.
Due to slower clinical trial recruitment as a result of the regulatory status of TELLOMAK, compounded by the COVID-19 pandemic, potential delays in clinical development timelines may occur. The Company will provide an update in due time.
Avdoralimab (IPH5401, anti-C5aR antibody):

The first patient was dosed in a randomized, double-blind, placebo-controlled, FORCE clinical trial, evaluating the safety and efficacy of its anti-C5aR antibody, avdoralimab, in COVID-19 patients with severe pneumonia.
· The Phase II trial is supported by an exploratory translational study, EXPLORE, which suggests that patients who progress towards severe COVID-19 disease exhibit an increase of the C5a/C5aR pathway.
A controlled, randomized, study will explore avdoralimab, amongst other treatment arms, to investigate the potential efficacy versus standard of care against COVID-19 in cancer patients with pneumonia. This study is sponsored by Centre Léon Bérard, Lyon.
IPH5201 (anti-CD39 antibody), partnered with AstraZeneca:

In February 2020, the multicenter, open-label, dose-escalation Phase I trial started, which is evaluating IPH5201 as monotherapy or in combination with durvalumab (anti-PD-L1) with or without oleclumab (anti-CD73) in advanced solid tumors.
· The Phase I clinical trial evaluating IPH5201 in adult patients with advanced solid tumors has reactivated, following a temporary pause due to the COVID-19 pandemic.
Post-period events:

Following the dosing of the first patient on March 9, 2020 in the IPH5201 Phase I clinical trial, AstraZeneca made a $5.0 million milestone payment in April to Innate Pharma. In May, Innate made a €2.7 million milestone payment to Orega Biotech SAS pursuant to Innate’s exclusive licensing agreement.
Financial results:

Cash, cash equivalents and financial assets of the Company amounted to €206.9 million as of March 31, 2020. At the same date, financial liabilities amounted to €19.3 million.

During the first quarter of the year 2020 notably:

A $15.0m (€13.4m) milestone payment was made to AstraZeneca in January 2020 following the submission by AstraZeneca of the Marketing Authorization Access relating to the commercialization of Lumoxiti in Europe.

A €5.8m adverse variance in the fair value of our financial instruments was booked, resulting from the impact of the COVID-19 crisis on the financial markets.
Revenues for the first three-months of 2020 amounted to €19.3 million (€13.9 million for the same period in 2019). For the three-month period ended March 31, 2020, revenue from collaboration and licensing agreements mainly results from the spreading of the initial payments received under our agreements with AstraZeneca.