On November 13, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that it will hold a call with investors on Friday, November 13 at 8:20 a.m. ET to provide deep dive analysis of preliminary clinical efficacy results of its U.S. phase 1 clinical trial (NCT03934814) evaluating lemzoparlimab (also known as TJC4) for the treatment of relapsed or refractory solid tumors (Press release, I-Mab Biopharma, NOV 13, 2020, View Source [SID1234570923]). The results are being presented this week at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The purpose of the call is to provide an expanded analysis of the clinical efficacy signal from the U.S. phase 1 clinical trial, which is not previously discussed.

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Please click here to access the meeting presentation.

I-Mab Conference Call and Webcast Information

Investors and analysts are invited to join the conference call on November 13 at 8:20 a.m. ET using the following dial-in information:

A live webcast and an archived replay of the conference call can be accessed on the Company’s investor relations website at View Source

A telephone replay will be available approximately two hours after the conclusion of the call by dialing +1 855-452-5696 (U.S.), +61 2 8199-0299 (International), 400-632-2162 (Mainland China), or 800-963-117 (Hong Kong). The conference ID number for the replay is 4556519. The replay will be available through November 20, 2020.

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting minimal untoward effect on red blood cells, thus avoiding severe anemia.

Lemzoparlimab’s hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of the phase 1 clinical trial have provided further, clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda for the treatment of solid tumors and with Rituxan for the treatment of patients with lymphoma in the U.S., in addition to an ongoing clinical trial with patients with AML/MDS in China.

In September 2020, I-Mab and AbbVie entered into a global strategic partnership to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China. The collaboration is subject to certain pre-closing conditions.

On November 13, 2020 Selvita (WSE: SLV), one of the largest preclinical contract research organizations in Europe, reported its Q3 2020 estimated financial results and provided a corporate update (Press release, Selvita, NOV 13, 2020, View Source;utm_medium=rss&utm_campaign=selvita-reports-strong-financial-results-for-q3-2020 [SID1234570922]).

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For the nine months ended September 30, 2020, Selvita reports consolidated revenues of EUR 23.7 million, up by 44% on a year-on-year basis. The EBITDA result reached EUR 5.7 million, compared to EUR 3.8 million the corresponding period last year. The backlog** for 2020, as of November 10, amounts to EUR 30.3 million and indicates an increase of 38%, as compared to the value reported a year ago.

The Company consistently strengthens its position on the global market, especially among the U.S. customer base, considered the world’s largest biotechnology market.

Commercial revenues in the Services Segment increased in YTD Q3 2020 period to EUR 19.1 million, showing a 45% increase, as compared to EUR 13.6 million in the corresponding period last year. The EBITDA result of the Services Segment amounted to EUR 4.9 million, indicating a 24% profitability level.

The Company’s net profit in the first three quarters of the year amounted to EUR 3.3 million, compared to EUR 1.9 million for a corresponding period last year.

– The first three quarters of 2020 were a very intensive period for Selvita. During that time, we announced a new development strategy for 2020-2023, and subsequently successfully raised EUR 20 million from the issue of C series shares for the planned investments. Despite the COVID-19 pandemic, we are systematically strengthening our competitive position on the global market. We not only increased employment but also invested in the state-of-the-art equipment, building solid foundations for further organic growth – comments Dariusz Kurdas, Chief Financial Officer at Selvita.

Selvita plans to continue its dynamic development in the coming years. One of the goals as outlined in the strategy is the creation of the Selvita Research Centre to secure a proprietary research space. Selvita has already made the first steps towards executing this goal and signed a contract in August 2020, purchasing a plot of land in the neighborhood of its current laboratories. The Company also received from the Polish Ministry of Development Funds and Regional Policy a grant application recommendation to finance the Selvita Research Centre’s construction. This grant provides Selvita with over EUR 9 million of non-dilutive financing. The project’s total value amounts to EUR 32 million (including the amount of VAT), and is anticipated to be finalized within next three years.

The presented data are estimates, and their calculations have been made in accordance with the current best knowledge of the Company. The Selvita Management Board has decided to postpone the publication of the final financial results for the first three quarters of 2020, which will be published on November 24, 2020.

On November 13, 2020 Immunophotonics, Inc. reported the first patient treated in the phase 1b/2a clinical trial examining IP-001 in thermally ablated solid tumors (Press release, Immunophotonics, NOV 13, 2020, View Source [SID1234570921]). The trial, conducted in collaboration with the Swiss Group for Clinical Cancer Research (SAKK), will assess the safety, tolerability and anti-tumor activity of IP-001 administered intratumorally following tumor ablation.

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"The initiation of this clinical trial marks a significant milestone for Immunophotonics. The trial will serve as a foundation in demonstrating the potential of IP-001 to ignite the immune system, transforming a routine tumor ablation into a systemic immunotherapy," said Lu Alleruzzo, CEO of Immunophotonics. "IP-001 is the first of what is expected to be many novel agents and combinations that we bring into clinical development to help patients suffering from cancer."

Prof. Markus Jörger, M.D., Ph.D., Coordinating Investigator of the trial commented, "IP-001 combines the promise of modern immunotherapy with the trend towards intratumoral treatment. SAKK is excited to bring this novel treatment to patients in desperate need for new innovative treatment options."

Following the phase 1b all-comer portion of the trial, Immunophotonics intends to evaluate the safety and efficacy of IP-001, in conjunction with tumor ablation, in phase 2 cohorts of patients with specific types of cancer.

On November 13, 2020 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported that it will be announcing its results for the third quarter 2020 on Tuesday 17 November 2020 (Press release, BerGenBio, NOV 13, 2020, View Source [SID1234570916]). A webcast presentation by BerGenBio’s senior management team will take place at 10:00 am CET.

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The live webcast link will be available at www.bergenbio.com in the Investors/Financial Reports section. A recording will be available shortly after the webcast has finished.

The third quarter report and presentation will be available on the Company’s website in the Investors/Financial Reports section from 7:00 am CET the same day.

On November 13, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Roche’s Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) utilizing ENHANZE, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer (Press release, Halozyme, NOV 13, 2020, View Source [SID1234570914]). Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European Commission in the near future.

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"We are delighted that Phesgo, the first combination of two established monoclonal antibodies with our ENHANZE technology, administered in just 5-8 minutes, is one step closer to becoming available for patients with HER-2 positive breast cancer in the EU," said Dr. Helen Torley, president and chief executive officer.

Phesgo can be administered in approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose1. This is compared to approximately 150 minutes for a sequential infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines2,3.

The recommendation from the CHMP is based on results from the pivotal phase III FeDeriCa study, which met its primary endpoint, with Phesgo showing non-inferior levels of Perjeta in the blood during a given dosing interval (Ctrough), when compared to IV administration of Perjeta. The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus Herceptin and chemotherapy, and no new safety signals were identified, including no meaningful difference in cardiac toxicity. The most common adverse events in both arms were alopecia, nausea, diarrhea and anemia1,4.

The U.S. Food and Drug Administration recently expedited the approval of Phesgo for the treatment of early and metastatic HER2-positive breast cancer. Based on the decision of the treating physician and the preference of the patient, it can be administered by a healthcare professional in a treatment center or in a patient’s home.

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.