Immuno-Oncology Summit

On September 28, 2021 ImmunoPrecise (IPA) reported that it will be exhibiting at the Immuno-Oncology Summit in Boston on October 4-6, 2021 (Press release, ImmunoPrecise Antibodies, SEP 28, 2021, View Source [SID1234590389]). The event is being held at the Westin Copley Place and virtually. Visit booth 22 and learn how IPA can accelerate your immuno-oncology programs.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The Immuno-Oncology Summit focuses on the latest in applied research and provides comprehensive and in-depth coverage across all modalities and stages in the pipelines. The event brings together an international group of thought leaders and decision-makers from both industry and academia to discuss the latest developments in immuno-oncology

Labcorp to Announce Third Quarter Financial Results on October 28, 2021

On September 28, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported that it will release its financial results for the third quarter of 2021 before the market opens on Thursday, October 28, 2021 (Press release, LabCorp, SEP 28, 2021, View Source [SID1234590388]). The company will host a conference call and webcast beginning at 9 a.m. ET that day to discuss the results. The earnings release and accompanying financial information will be posted on the Labcorp Investor Relations website.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Interested parties can access the conference call by dialing 1-877-898-8036 within the U.S. and Canada, or 1-720-634-2811 internationally, using the conference ID 4893731. In addition, a real-time webcast of the conference call will be available on the Labcorp Investor Relations website.

An audio replay of the conference call will be available from 1 p.m. ET on October 28, 2021, until 11:30 p.m. ET on November 11, 2021, by dialing 1-855-859-2056 within the U.S. and Canada, or 1-404-537-3406 internationally, using the conference ID 4893731. The webcast of the conference call will be archived and accessible through October 14, 2022, on the Labcorp Investor Relations website.

NANOBIOTIX Announces Red Journal Publication of Preclinical Data Showing Radioenhancer NBTXR3 May “Reprogram” the Tumor Microenvironment to Overcome Anti-PD-1 Resistance and Evoke Abscopal Effect

On September 28, 2021 NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanophysics-based approaches to expand treatment possibilities for patients with cancer, reported the publication of preclinical findings with the University of Texas MD Anderson Cancer Center (MD Anderson) in the International Journal of Radiation Oncology, Biology, Physics (Red Journal) (Press release, Nanobiotix, SEP 28, 2021, View Source [SID1234590387]). These data support the further exploration of potential first-in-class, solid tumor-agnostic, therapeutic combination-agnostic radioenhancer NBTXR3 as a new therapeutic option seeking to induce significant tumor cell death when activated by radiotherapy, prime immune response, and overcome resistance to anti-PD-1.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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View the full publication here: View Source(21)00860-9/fulltext

"Patients across the oncology landscape are in urgent need of innovation that can make a difference," said Laurent Levy, co-founder and chief executive officer of Nanobiotix. "We are proud to collaborate with MD Anderson as we seek to validate the broadly applicable, local and systemic potential benefits of NBTXR3. The Red Journal provides a critical platform for the advancement of radiation oncology, and we believe this publication represents an important contribution to the academic and medical research communities as we seek to expand treatment possibilities for millions of patients with cancer."

Background

Immune checkpoint inhibitors (ICIs) such as anti-PD-1 have shown tremendous promise for the treatment of some patients with metastatic tumors. Oncologists have hypothesized the possibility of combining ICIs with radiotherapy (RT) to control the irradiated tumor and turn those tumors into a "self-vaccine" that could improve systemic control of distant metastases as well. To date, however, most patients with cancer have shown resistance to anti-PD-1, limiting the effect of this combination.

This preclinical mouse model study conducted in collaboration between MD Anderson and Nanobiotix hypothesized that NBTXR3 could "reprogram" the tumor microenvironment in local and distant tumors, overcoming resistance to anti-PD-1 when activated by radiotherapy (RT) in mouse models of metastatic lung cancer.

Key Findings on the Triple Combination of NBTXR3 plus Radiotherapy plus Anti-PD-1 in the Mouse Model

NBTXR3 improved tumor treatment in both anti-PD-1 sensitive and resistant models
NBTXR3 promoted the activities of several antitumor immune pathways
NBTXR3 increased cell death in irradiated tumor and facilitated immune response in unirradiated tumors
NBTXR3 delayed the growth of targeted and distant tumors, improved survival rates, and reduced spontaneous metastases
Conclusion

This study supports further exploration of the triple combination of NBTXR3 plus RT plus anti-PD-1 as a new therapeutic option for the treatment of both primary and metastatic lung cancer, and the potential of this combination to achieve the promise of transforming irradiated tumors into "self-vaccines." These results could support significance for the radioenhancer’s clinical application, as the strong activation of an effective immune response in anti-PD-1 resistant tumors may expand treatment possibilities for the majority of patients who do not respond to anti-PD-1 therapy.

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy; and a phase III global registrational study is planned to launch in 2021. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the planned phase III study.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company-sponsored phase I clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with world class partners to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

The Board of Directors Approves the Half-Yearly Financial Report at 30 June 2021 (Price sensitive) – Courtesy English Translation

On September 28, 2021 Philogen S.p.A. (the "Company" or "Philogen") and, together with its Swiss subsidiary Philochem AG, (the "Group"), reported that which met today under the chairmanship of Dr. Duccio Neri, approved the condensed interim consolidated financial statements as of June 30, 2021 (Press release, Philogen, SEP 28, 2021, View Source [SID1234590386]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Dario Neri, CEO of Philogen, commented on the results for the year and the evolution of the business: "On March 3, 2021, we completed the process of listing Philogen on the Mercato Telematico Azionario organized and managed by Borsa Italiana S.p.A.. The transaction provided the Group with the financial resources necessary to execute its business plan. The results for the first half of 2021 continue to reflect the Group’s change in strategy, already initiated in 2019, to focus primarily on the clinical development of its two most advanced proprietary products: Nidlegy and Fibromun. Development is proceeding according to the anticipated plans described in the prospectus.

We expect to complete patient enrollment in the European Phase III clinical trial of Nidlegy in melanoma by mid-2022. With respect to the two European clinical trials of Fibromun in newly diagnosed and second recurrence sarcoma, completion of recruitment of the respective patients is expected by the end of 2023."

CONSOLIDATED FINANCIAL STATEMENTS AT 30 JUNE 2021 The Group’s total Revenues at 30 June 2021 amount to € 1,952 thousand and consist of:
(i) Revenues from contracts with customers amounting to € 1,548 thousand, and
(ii) Other income amounting to € 404 thousand. Compared to the same period of the previous year, there is a percentage decrease of 22.5% which reflects the change in strategy, already initiated in 2019, which has led the Group to focus mainly on the clinical development of the most advanced proprietary products (Nidlegy and Fibromun) while continuing the development activities under the existing contracts. The change shows a decrease in revenues from contracts with customers of approximately Euro 760 thousand mainly due to the completion of some contracts during 2020. Operating costs, amounting to € 10,059 thousand, show an increase of approximately 23.2% compared to the period ended 30 June 2020. The change is mainly attributable to the extraordinary costs incurred in the first six months of 2021 related to the IPO process and partly to the operational and governance structure the company is setting up to execute its business plan. EBITDA decreased by 43.6% compared to June 30, 2020, as a result of the above. Amortisation and depreciation, amounting to € 753 thousand, are in line with the previous period (€ 706 thousand at 30 June 2020). Main Office: Loc. Bellaria, 35-53018 Sovicille (SI), Italy e-mail: [email protected] – website: www.philogen.com ________________________________________________________________________________________________________________________ PRESS RELEASE 2 EBIT, calculated as the difference between EBITDA and depreciation and amortisation, showed a negative balance of €8,860 thousand, a decrease of 39.5% compared to the period ended 30 June 2020, as a result of the reduction in EBITDA described above. In the period ended June 30, 2021, net financial management showed a positive balance of € 586 thousand compared to a negative balance of € 1,628 thousand in the same period of the previous year. The change is mainly due to the fair value of the portfolio which for most of the year 2020 reflected the negative trend of the financial markets related to the effects of the Covid-19 pandemic. It should be noted that the company holds a portfolio of financial investments fed by liquidity in excess of current cash requirements.

As a result of the above, the loss for the period increased by approximately 2.7% compared to the period ended 30 June 2020. The Group closed the first half of 2021 with liquidity of Euro 113,242 thousand compared to Euro 61,943 thousand at 31 December 2020 and a net financial position at 30 June 2021 of Euro 96,077 thousand compared to a net financial position of Euro 44,238 thousand at 31 December 2020 and 104.668 thousand at 31 March 2021, showing an overall percentage increase of more than 100%, as a result of the capital raised during the IPO, amounting to Euro 65,404 thousand, net of commissions paid to the consortium for the institutional placement and costs related to the issue of new shares of approximately Euro 3,635 thousand. Between Q1 and Q2 2021 the net financial position decreased by approximately 8%. Cash and cash equivalents fell from €122,414 thousand at 31 March 2021 to €113,242 thousand at 30 June 2021, a decrease of approximately €9,172 thousand.

This change was due mainly due to
(i) capital expenditure on the construction of the new GMP plant at Rosia (Siena) of approximately €2.877 thousand,
(ii) extraordinary costs related to the IPO process of approximately Euro 1,078 thousand,
(iii) costs for ordinary operations of approximately Euro 5,427 thousand,
(iv) proceeds from ongoing research and development contracts of approximately Euro 105 thousand, and
(v) the net fair value of the securities portfolio of approximately Euro 106 thousand. Current and non-current financial indebtedness decreased from €17,746 thousand at 31 March 2021 to €17,165 thousand at 30 June 2021, a decrease of approximately 3% relative to the progress of the existing amortisation plans. It should be noted that the financial indebtedness of approximately Euro 11,851 thousand is represented by the notional debt relating to the lease contracts for the buildings of the three company sites, represented according to international accounting standards (IFRS 16). The remaining amount relates to the outstanding loan taken out to finance the expansion of the Rosia (Siena) production site. This loan requires compliance with commercial and financial covenants, the breach of which does not necessitate repayment of the loan but results in a 0.50% increase in the interest rate.

MAIN EVENTS OCCURRING AFTER THE PERIOD ENDED 30 JUNE 2021 As of July 20, 2021, the director Dr. Sergio Dompé, through the company Dompé Holding S.r.l., by virtue of the confidence placed in the Company’s possibilities and capabilities, purchased 185,831 Philogen shares on the market. On August 30, the lock-up commitment on the part of the former shareholders of Palio Ordinarie S.p.A., which was merged by incorporation into Philogen with effect from January 2021, came to an end. The lock-up agreement entered into between the companies participating in the merger had as its objective the stabilization of Philogen’s ordinary shares, prohibiting their transfer for a period of 180 days from the start of trading. At the end of this period on August 30, the shares became freely transferable. In addition, also on August 30 (180 days from the start of trading) the lock-up commitment on the part of Philogen’s other minority shareholders (Palio Speciali S.r.l., MRS S.r.l. and Mathias Winter) came to an end. FORESEEABLE EVOLUTION OF OPERATIONS During the first half of 2021, the patient enrollment rate, which had declined slightly in 2020, increased again. In addition to the general variable trend of the patient enrollment rate from year to year and the improvement of the situation related to the COVID-19 pandemic, this increase could be related to the opening of new clinical centers. In order to further accelerate recruitment, the Group intends to open new centers in several European and non-European countries for the various ongoing studies conducted with its proprietary drugs. Main Office: Loc. Bellaria, 35-53018 Sovicille (SI), Italy e-mail: [email protected] – website: www.philogen.com ________________________________________________________________________________________________________________________ PRESS RELEASE 3 As is known, the Group is committed to developing its contractual activities as well as strengthening its internal research and development activities. It also maintains numerous contacts with other potential industrial partners in order to develop its business and seek new opportunistic scientific collaboration agreements. Despite the emergency situation due to COVID-19, the Group has continued its research and development activities on a constant basis. The continuation of the health emergency in the second half of 2021 and the consequent measures, including regulatory measures, that have become necessary and may still become necessary to combat the emergency could have a negative impact on the above activities, slowing them down in part.

OTHER SIGNIFICANT RESOLUTIONS OF THE BOARD OF DIRECTORS Approval of the regulations for the Stock Grant 2024-2026 Incentive Plan, reserved for Group employees and implementation of the Plan With reference to the "Stock Grant Plan 2024-2026", reserved for Group employees, adopted by the Company’s Shareholders’ Meeting on May 31, 2021, the Board of Directors, on the proposal of the Appointments and Remuneration Committee, approved the regulations for this Plan. Pursuant to art. 84-bis of the Issuers’ Regulation adopted by Consob with resolution no. 11971/1999 and subsequent amendments, it is also announced that the Board of Directors implemented the Plan, in particular by identifying the beneficiaries and defining the performance objectives and related targets, and by allocating a total of 145,000 units. The communication table drawn up in compliance with the indications contained in Scheme 7 of Annex 3A and table no. 1 provided for by paragraph 4.24 of Annex 3A, Scheme 7, of the Issuers’ Regulations, which gives an account of the state of execution of the Plan, is attached. The features of the 2024-2026 Stock Grant Plan are explained in the information document available and available on the Company’s website. Assignment of performance objectives and definition of targets within the so-called management by objectives (MBO) incentive plan for executive directors. The Board of Directors, on the proposal of the Appointments and Remuneration Committee, with reference to the so-called management by objectives ("MBO") monetary incentive plan, of which the executive directors are beneficiaries from 1 April 2021, assigned the performance objectives and defined the targets to which the maximum monetary remuneration is associated

Sorrento to Participate in the Benzinga Healthcare Small Cap Conference on September 30th

On September 28, 2021 Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento") reported that Dr. Henry Ji, Chairman and CEO, will be participating in the Benzinga Healthcare Small Cap Conference (Press release, Sorrento Therapeutics, SEP 28, 2021, View Source [SID1234590384]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Dr. Ji will be providing company updates at 11:30 AM ET as well as participating in a panel discussion at 12:35 PM EDT.

The link below will allow participants to watch the presentation and panel live. Free registration is required for the event.

View Source