On February 15, 2021 Elicio Therapeutics, a private biotechnology company developing a pipeline of potent immunotherapies based on its proprietary lymph node targeting technology, reported Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer, will co-lead a workshop, "Improving Efficacy and Solid Tumor Infiltration with Combination Strategies," at the upcoming CAR-TCR Digital Summit Europe, February 16 – 18, 2021 (Press release, Elicio Therapeutics, FEB 15, 2021, View Source [SID1234575073]).

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The Elicio Amphiphile platform enables precise targeting and delivery of immunogens directly to the lymphatic system, orchestrating the immune response, to significantly amplify and enhance the body’s own system of defenses to defeat cancer and stop its recurrence. When combined with CAR-T therapy, AMP-CAR-T amplifiersspecifically designed to bind to the CAR receptor are presented on the cell surface of immune cells in the lymph nodes. CAR-T cells passing through the lymph nodes en route to the tumor see these AMP-CAR-T amplifiers on the surface of specialized antigen presenting cells (APCs), which then deliver potent activating signals to T cells to coordinate their expansion, development of anti-tumor functions, and mobilization against tumors.

"Through published studies in mice, Amphiphile activation of the chimeric antigen receptor when CAR-T cells entered the native micro-environment of lymph nodes, enhanced treatment of multiple solid tumors," said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. "We have seen that this combination approach enhances trafficking, infiltration and persistence. Such potent amplification of the engineered T cell immune responses were critical, enabling prolonged survival and durable cures in solid tumor models where CAR-T alone had no effect."

At the summit Dr. Haqq will discuss:

Activation of CAR-T cells with Amphiphiles delivered to the lymph nodes to induce massive CAR-T expansion.
Lymph node activation to improve CAR-T function.
Ten-fold improvement in CAR-T trafficking into the solid tumors.
Durable complete responses observed for solid tumors across cancer types.
Persistence of CAR-T cells enabling rejection of additional cancer cells in rechallenge experiments that used doses lethal to untreated mice.
Induction of antigen spreading using the Amphiphile technology to recruit antitumor T cells to participate in a broad tumor attack.
Elicio is developing the AMP-CAR-T platform for combination with CAR-T cell therapies in a variety of settings including those targeting CD19, BCMA, and several solid tumor indications.

On February 15, 2021 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the Company’s Scientific Advisory Board member, internationally recognized cancer expert and Prof. of Human Anatomy and Embryology, Juan Marchal M.D., Ph.D., at the University of Granada, Spain, believes that recent favorable results studying the effects of proenzymes on cancer represents renewed hope for sufferers and predicts an excellent clinical impact as a novel treatment approach (Press release, Propanc, FEB 15, 2021, View Source [SID1234575074]). Recent results from the Company’s Proenzymes Optimization Project 1 ("POP1") Joint Research and Drug Discovery Program showing treatment with pancreatic proenzymes has been shown to decrease the expression of genes related to oncogenesis and metastasis, thus implying it is selectively directed towards inhibiting the spread of cancer. This is particularly significant, since the incidence of metastasis greatly reduces the life expectancy of cancer patients. Furthermore, results indicate that pancreatic proenzymes prepare the body to face the fight against cancer, by reducing the creation of pre-metastatic tumor niches.

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In the field of experimental oncology, Prof. Marchal is leading the implementation of different therapeutic strategies directed against cancer stem cells, based on novel synthetic and naturally derived drugs, or a tumor specific suicide gene therapy strategy. He has multiple research partnerships within industry, including through the MEDINA Foundation, sponsored by Merck Sharpe and Dohme (MSD) in partnership with the regional government of Andalusia, Spain, and GENYO, the new Pfizer-University of Granada-Junta de Andalucía Center for Genomics and Oncological Research (GENYO) in Spain.

"Among the projects for the formulation and detection of anti-cancer factors we are carrying out in our laboratory, the study of the effects of pancreatic proenzymes is one of the most exciting. This research is the result of over a decade long collaboration between my research group and Propanc, led by my colleague, Prof. Macarena Perán (Ph.D.), which I am also very involved with," said Prof. Marchal. "I am delighted to continue collaborating closely with Propanc. We are looking at the possibility of implementing Phase II clinical studies on patients with pancreatic and ovarian cancers in Spain, after a Phase I, First-In-Human (FIH) study is completed in Australia. We recently discussed the project with reputable oncologists and they confirmed their interest in participating. Searching for new cancer treatments to achieve a definitive cure for cancer patients is my motivation."

"We continue to work with oncology experts like Profs. Marchal and Perán, and the scientific observations we have made regarding the effects of proezyme therapy as an effective cancer treatment are convincing," said Dr. Julian Kenyon M.B.Ch.B., M.D., Propanc’s Chief Scientific Officer. "Since I first commenced my physician sponsored clinical research into proenzyme therapy nearly fifteen years ago, many of my initial observations have been proven scientifically, which leads me to conclude that proenzymes can prevent and treat metastatic cancer from solid tumors, which is the main cause of patient death for sufferers. I am very excited to see what our therapy can do for cancer patients in future clinical studies."

The POP1 program is designed to produce a further enhanced clinical compound to the Company’s lead product candidate, PRP, which is entering clinical stage. The objective is to produce large quantities of trypsinogen and chymotrypsinogen for commercial use that exhibits minimal variation between lots and without sourcing the proenzymes from animals. Propanc is undertaking the challenging research project in collaboration with the Universities of Jaén and Granada, led by research scientists Mr. Aitor González M.Sc. and Ms. Belen Toledo M.Sc., supported by Profs. Perán and Marchal, representing the Universities, and Dr. Kenyon.

On February 15, 2021 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported the enrollment and first week of treatment of the first patient in the third, high dose cohort of the Phase 1/2 clinical trial (Press release, NOXXON, FEB 15, 2021, View Source [SID1234575075]). The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients who would not benefit clinically from treatment with standard chemotherapy.

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Once the newly enrolled patient in the third cohort has received a four-week treatment of NOX-A12 and radiotherapy, the Data Safety Monitoring Board will convene to determine whether it is safe to recruit the remaining two patients into the cohort.

"As we enter the last cohort of the dose escalation trial and obtain sufficient data, we will soon be in a position to determine the recommended dose for our next randomized, controlled brain cancer trial which will compare NOX-A12 combined with radiotherapy to standard of care. We then plan to recruit additional patients to broaden the safety and efficacy data-set. The additional data will provide a comprehensive basis for discussions with EU and US regulators concerning plans for our next trial, which is planned to be registrational," commented Aram Mangasarian, CEO of NOXXON. "Recruitment into the current trial continues in our six study centers, three of which were added in October 2020 in order to mitigate the challenges faced by hospital staff as a result of the COVID-19 pandemic. Six months of data from the second and third cohorts of patients should be available at end-Q2 2021 and end-Q3 2021, respectively," he concluded.

On February 15, 2021 OSE Immunotherapeutics reported that the Company has signed a loan agreement of up to €25 million with the European Investment Bank (EIB) (Press release, OSE Immunotherapeutics, FEB 15, 2021, View Source [SID1234646986]).

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The loan facility of up to €25 million is divided into three tranchesincluding two tranches of €10 million each and a third tranche of €5 million.

The first €10 million tranche, unconditional and which OSE will request payment before the end of May 2021, will help expand the clinical development of Tedopi in combination with a checkpoint inhibitor in additional cancer indications. This first tranche will also support the entry into Phase 1/2 of OSE279, OSE’s proprietary anti-PD-1 antibody, in a niche oncology indication. This development of OSE279 will allow OSE Immunotherapeutics to have its own proprietary anti-PD-1 antibody and leverage it across OSE’s product portfolio in combination with other drug candidates. Moreover, OSE-279 is the key anti-PD-1 backbone component of the bifunctional checkpoint inhibitor BiCKI platform, targeting PD-1 and other innovative targets, paired with novel immunotherapy targets.

The remaining two tranches of €10 and €5 million, available upon achievement of specific clinical milestones, are planned to be used to accelerate the clinical development of the Company’s other programs, in particular CD28 antagonist FR104 and new anti-ChemR23 agonist OSE-230.

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, comments: "We are very grateful for EIB’s support, a major financial European institution, as the Company is at an inflection point of its growth. The first €10 million tranche allows OSE to extend its financial visibility to Q2 2022. This new flexible funding tool will help expand and accelerate the development of our clinical stage portfolio and explore new therapeutic indications with strong medical need, reinforcing OSE’s status as a key global player in immunotherapy."

Ambroise Fayolle, Vice-President of the EIB, explains: "The EIB is pleased to announce its support of OSE, a biotech combining a high level of research and innovation, highly qualified collaborators and cutting-edge expertise in the field of monoclonal and bispecific antibodies. The portfolio of products under development in various therapeutic areas such as immuno-oncology, autoimmune diseases and a vaccine project against SARS-CoV-2, means that OSE Immunotherapeutics is a potential major player in the health sector. This project is fully in line with the mandate set for the EIB by its shareholders – the EU Member States – to support innovation across Europe".

This loan will carry a fixed interest of 5% per year paid annually, with a maturity of five years (each drawdown is treated separately in terms of maturity). The repayment of each tranche will therefore be made at the end of a period of five years after the date of disbursement of the said tranche.

The loan agreement is supplemented by an agreement to issue warrants to the EIB for the first two tranches of the financing, in particular 850,000 warrants for the first tranche to be issued when drawn. 550,000 additional warrants could be issued if the second tranche of €10 million is drawn by OSE Immunotherapeutics.

Each warrant will give the right to subscribe to one ordinary share of OSE Immunotherapeutics at the subscription price of €0.01 and at the exercise price calculated on the basis of the volume-weighted average of the 3 trading days preceding the pricing (which will take place at the end of May 2021), with a discount of 2.5%.

The warrants will be exercisable for a period of 12 years.
Subject to certain customary exceptions, the warrants will only be exercisable after a five-year period starting from the drawdown of the relevant tranche, thus limiting the impact in terms of dilution and volatility in the coming years.

The warrant agreement includes an exercise parity adjustment clause which could apply, under certain conditions, in case of capital increase. The EIB will be granted with the possibility, under certain conditions, to request OSE Immunotherapeutics to buy back its warrants for a maximum amount of €15 million and, beyond that amount, to find a buyer and pay interests on the price of the remaining warrants

On February 15, 2021 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Medpace, FEB 15, 2021, View Source [SID1234575076]).

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Fourth Quarter and Full Year 2020 Financial Results

Revenue for the three months ended December 31, 2020 increased 13.0% to $259.7 million, compared to $229.9 million for the comparable prior-year period. Revenue for the year ended December 31, 2020 increased 7.5% to $925.9 million, compared to $861.0 million for the year ended December 31, 2019. On a constant currency organic basis, revenue for the fourth quarter of 2020 increased 12.2% compared to the fourth quarter of 2019 and increased 7.3% for the year ended December 31, 2020 compared to the year ended December 31, 2019.

Backlog as of December 31, 2020 grew 20.1% to $1.5 billion from $1.3 billion as of December 31, 2019. Net new business awards were $358.6 million, representing a net book-to-bill ratio of 1.38x for the fourth quarter of 2020, as compared to $281.1 million for the comparable prior-year period. For the year ended December 31, 2020, net new business awards were $1,175.0 million, representing a net book-to-bill ratio of 1.27x, compared to $1,094.4 million for the year ended December 31, 2019. The Company calculates the net book-to-bill ratio by dividing net new business awards by revenue.

For the fourth quarter of 2020, total direct costs were $176.8 million, compared to total direct costs of $167.2 million in the fourth quarter of 2019. For the full year 2020, total direct costs were $647.2 million, compared to $615.3 million in the full year 2019. Selling, general and administrative (SG&A) expenses were $22.4 million in the fourth quarter of 2020, compared to SG&A expenses of $21.3 million in the fourth quarter of 2019. For the full year 2020, SG&A expenses were $92.2 million, compared to $95.2 million for the full year 2019.

GAAP net income for the fourth quarter of 2020 was $50.9 million, or $1.35 per diluted share, versus GAAP net income of $29.8 million, or $0.78 per diluted share, for the fourth quarter of 2019. This resulted in a net income margin of 19.6% and 13.0% for the fourth quarter of 2020 and 2019, respectively. GAAP net income for the full year 2020 was $145.4 million, or $3.84 per diluted share, versus GAAP net income of $100.4 million, or $2.67 per diluted share, for the full year 2019. This resulted in a net income margin of 15.7% and 11.7% for the full year 2020 and 2019, respectively.

EBITDA for the fourth quarter of 2020 increased 46.3% to $60.2 million, or 23.2% of revenue, compared to $41.1 million, or 17.9% of revenue, for the comparable prior-year period. EBITDA for the full year 2020 increased 25.5% to $187.8 million, or 20.3% of revenue compared to $149.6 million, or 17.4% of revenue, for the prior year. On a constant currency basis, EBITDA for the fourth quarter of 2020 increased 46.4% from the fourth quarter of 2019 and increased 24.6% for the full year 2020 compared to the full year 2019.

A reconciliation of the Company’s non-GAAP financial measures, including EBITDA and EBITDA margin to the corresponding GAAP measures is provided below.

Balance Sheet and Liquidity

The Company’s Cash and cash equivalents were $277.8 million at December 31, 2020, and the Company generated $105.5 million in cash flow from operating activities during the fourth quarter of 2020. During the fourth quarter of 2020, the Company repurchased approximately 0.41 million shares at an average price of $115.42 per share for a total of $47.4 million. The Company had $102.6 million remaining under its authorized share repurchase program at the end of the quarter.

Financial Guidance

The Company forecasts 2021 revenue in the range of $1.075 billion to $1.175 billion, representing growth of 16.1% to 26.9% over 2020 revenue of $925.9 million. GAAP net income for full year 2021 is forecasted in the range of $154.5 million to $170.5 million. Additionally, full year 2021 EBITDA is expected in the range of $205.0 million to $225.0 million. Based on forecasted 2021 revenue of $1.075 billion to $1.175 billion and GAAP net income of $154.5 million to $170.5 million, diluted earnings per share (GAAP) is forecasted in the range of $4.08 to $4.50. This guidance assumes a full year 2021 tax rate of 15.0% to 16.0% and does not reflect the potential impact of any share repurchases the Company may make pursuant to the share repurchase program.

Conference Call Details

Medpace will host a conference call at 9:00 a.m. ET, Tuesday, February 16, 2021, to discuss its fourth quarter 2020 results.

To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 9646903.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

A recording of the call will be available until Tuesday, February 23, 2021. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 9646903.