On November 9, 2020 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported new data on BT-001, a novel oncolytic vaccinia virus armed with a Treg-depleting human recombinant anti-CTLA4 antibody and GM-CSF to target the tumor microenvironment, in the SITC (Free SITC Whitepaper) abstract "BT-001, an oncolytic vaccinia virus armed with a Tregdepleting human recombinant anti-CTLA4 antibody and GM-CSF to target the tumor microenvironment" (Abstract number: 594) (Press release, Transgene, NOV 9, 2020, View Source [SID1234570396]).

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The poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting outlines BT-001’s unique multifunctional properties combining potent oncolytic activities with the production of high intra-tumoral concentrations of an anti-CTLA4 antibody and GM-CSF, with very low systemic exposure. It is shown that the murine surrogate mBT-001 has demonstrated outstanding antitumoral activity in several syngeneic tumor models inducing long-lasting antitumoral immune responses and abscopal effects. It concludes that BT-001 has potential for broad single agent activity-including in poorly responsive immune excluded cancers, and that selective tumor-localized delivery of anti-CTLA4 may allow for a better tolerated, sustained and more effective combination therapy with antibodies targeting the PD-1/PDL1 axis.

The poster will be available in the Virtual Poster Hall November 11-14, 2020, 9:00 a.m.-5:00 p.m. EST (3:00 – 11:00 p.m. CET). The presenting authors will answer questions on Thursday, November 12 from 4:50 to 5:20 p.m. EST (10:50 – 11:20 p.m. CET) and Saturday, November 14 from 1:00 to 1:30 p.m. EST (7:00 – 7:30 p.m. CET).

BT-001 is being co-developed by BioInvent and Transgene. It was generated using Transgene’s Invir.IO platform and its patented large-capacity VVcopTK-RR-oncolytic virus, which has been engineered to encode both a Treg-depleting anti-CTLA4 antibody generated by BioInvent’s proprietary n-CoDeR /F.I.R.S.T platforms, and the cytokine GM-CSF. BT-001 is expected to enter Phase I clinical development before the end of 2020. "BT-001 offers exciting potential for the treatment of cancer thanks to its unique, multiple mechanisms of action. It has been designed to combine multiple anti-cancer properties including killing of cancer cells and the production of an anti-CTLA4 antibody and GM-CSF directly at the site of the tumor, while also generating an immune response against tumor cells," said Martin Welschof, CEO of BioInvent.

Philippe Archinard, PhD, Chairman and CEO of Transgene, said: "BT-001 has induced long-lasting antitumoral immune responses and abscopal effects in tumor models, and this activity is further enhanced by a combination with anti-PD-1 treatment. We look forward to further investigating this oncolytic virus in a Phase I trial which is still expected to start before the end of the year."

On November 9, 2020 Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported that pre-clinical research results focusing on its PD1-41BB switch receptor technology in a poster to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Annual Meeting (SITC 2020) being held virtually on 9-14 November 2020 (Press release, MediGene, NOV 9, 2020, View Source [SID1234570395]). The poster # 614 will be available in the Virtual Poster Hall from 11-14 November 2020 from 9:00 am – 5:00 pm EST (3:00 pm – 11:00 pm CET), Q&A sessions will be held on Thursday, 12 November 2020, 4:50 pm – 5:20 pm EST (10:50 pm – 11:20 pm CET) and on Saturday, 14 November 2020, 1:00 pm – 1:30 pm EST (7:00 pm – 7:30 pm CET).

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The poster # 614 entitled, "Co-stimulation via PD1-41BB chimeric switch receptor enhances function of TCR-T cells in an immune-suppressive milieu and under chronic antigen stimulation", describes 2- and 3-dimensional in vitro tumor cell culture models representing the harsh conditions encountered by T cells in solid tumors including low nutrients and high levels of immunosuppressive soluble factors. T cell receptor-modified T cells (TCR-Ts) which also express Medigene’s PD1-41BB switch receptor have the ability to overcome the inhibitory tumor microenvironment and repeatedly kill tumor cells in multiple challenges. The PD1-41BB expressing TCR-T cells show a higher level of metabolic fitness enabling them to persist and proliferate much more effectively despite the normally negative factors produced by tumor cells.

Further research including in vivo studies and safety evaluations will be conducted towards eventual clinical trials of PD1-41BB-expressing TCR-T cells in the therapeutic treatment of solid tumors.

Prof. Dolores Schendel, Chief Executive Officer and Chief Scientific Officer of Medigene: "In preclinical studies we have shown that our PD1-41BB switch receptor significantly enhances the functionality of TCR-Ts in a hostile solid tumor microenvironment. Enabling our TCR-Ts to function with greater activity in the solid tumor setting, which normally shuts T cells down, should give our TCR-Ts the ability to persist longer and hopefully bring about durable therapeutic responses in the clinic."

The poster will be available at www.medigene.com/technologies/abstracts from 11 November 2020, 9:00 am EST (3:00 pm CET).

On November 9, 2020 Aptevo Therapeutics Inc. ("Aptevo") (NASDAQ:APVO), a biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR bispecific technology platform, reported that it will present two new posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Virtual Annual Meeting, to be held from Monday, November 9, 2020 to Saturday, November 14, 2020 (Press release, Aptevo Therapeutics, NOV 9, 2020, View Source [SID1234570394]).

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The posters will provide updates on APVO603, which is wholly owned by Aptevo Therapeutics, and the phase 1-ready ALG.APV-527 developed in partnership with Alligator Bioscience.

The abstracts and the accompanying posters will be available in the Virtual Poster Hall to registered attendees from 8:00 am EST on Monday, November 9, until the Virtual Poster Hall closes on December 31, 2020 on the SITC (Free SITC Whitepaper) abstract website. Details will also be posted on the Aptevo Therapeutics website.

Title: APVO603: Dual-targeting of 4-1BB and OX40 with an ADAPTIR bispecific antibody enhances anti-tumor responses to solid tumors

Summary: The data to be presented will highlight preclinical in vivo anti-tumor activity showing that APVO603 significantly reduces tumor burden in a murine bladder cancer model. APVO603 is shown to synergistically enhance CD4, CD8 T-cell and NK cells’ cytotoxic potential when compared to either 4-1BB or OX40 monospecific antibodies alone or in combination. This was demonstrated in multiple in vitro studies showing increased effector cell proliferation, cytokine secretion, granzyme expression and tumor lysis. Lead cell clone has been identified, CMC activities have been initiated and pre-IND studies have begun. Current Preclinical and CMC activities support advancing the APVO603 program towards clinical development for the treatment of multiple solid tumors.

Details of the Oral Presentation:
During Session 208 (Bispecific Antibodies in Cancer Immunotherapy) on Thursday, November 12th at 4 p.m. EST there will be a pre-recorded presentation covering the APVO603 program followed by a live question and answer period.

Details of the Poster Presentation:
Live question and answer sessions will occur for the APVO603 poster (Number 633) on Wednesday, November 11th from 5:15-5:45 p.m. EST and Friday, November 13th from 4:40-5:10 p.m. EST.

Title: ALG.APV-527: Potent tumor-directed T cell activation and in vivo tumor inhibition induced by a 4-1BB x 5T4 ADAPTIR bispecific antibody

Summary: The poster will present preclinical data demonstrating that ALG.APV-527 has a favorable safety profile with no indication of systemic immune activation or liver toxicity in NHP or murine models. ALG.APV-527 induces robust in vitro killing of tumors that is dependent on 5T4 engagement. In vivo, ALG.APV-527 augmented anti-tumor responses and promoted tumor-specific memory. Clinical development is planned for ALG.APV-527 and CTA documents are prepared for filing of a phase 1 clinical trial in the European Union for treatment of solid tumors expressing 5T4 such as non-small cell lung cancer, mesothelioma and head and neck cancer.

Details of the Poster Presentation:
Live question and answer sessions will occur for the ALG.APV-527 poster (Number 851) on Wednesday, November 11th from 5:15-5:45 p.m. EST and Friday, November 13th from 4:40-5:10 p.m. EST.

On November 9, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that Jeff Goater, its chief executive officer, and Robert Ross, M.D., its chief medical officer, will participate in a fireside chat at the upcoming Cowen 4th Annual IO Next Summit on Friday, November 13, 2020 at 10:45 a.m. ET (Press release, Surface Oncology, NOV 9, 2020, https://investors.surfaceoncology.com/news-releases/news-release-details/surface-oncology-present-cowen-io-next-summit [SID1234570388]). The discussion will focus on Surface’s lead programs, SRF617 (targeting CD39) and SRF388 (targeting IL-27).

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The live audio and subsequent archived webcasts of the fireside chat will be accessible from the events page of the Company’s investor relations website, investors.surfaceoncology.com/news-events/events.

On November 9, 2020 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the third quarter ended September 30, 2020 and provided a business update (Press release, Adamis Pharmaceuticals, NOV 9, 2020, View Source [SID1234570387]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated,

"We are excited to have US WorldMeds in full control of our SYMJEPI product now that the transition from Sandoz has been completed. We expect to see the full impact of this transition going forward and I expect 2021 to be the breakout year for this product. We and our commercial partner eagerly await the FDA’s decision on our ZIMHI NDA which has a target PDUFA date of November 15th. We remain very excited about the remainder of this year and beyond."

Product Updates

SYMJEPI (epinephrine) Injection

On July 1, 2020, Adamis’ new commercial partner, USWM began promoting SYMJEPI (epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection 0.15mg products through its field sales force in the U.S. USWM expects to focus its sales efforts on the high-prescribing allergists, pediatricians, and primary care physicians. The transition of sales and distribution from Sandoz to USWM was completed on October 31, 2020 and now USWM is fully responsible for sales and distribution of SYMJEPI.

The company’s Australian partner, Emerge Health, which was acquired by Chiesi Farmaceutica in June, continues to work through the regulatory process with the Therapeutic Goods Administration (TGA) in Australia and the company expects a decision from the TGA sometime in the first half of 2021.

ZIMHI (naloxone) Injection

The FDA has provided a target action date (PDUFA) of November 15, 2020 with respect to the company’s resubmitted New Drug Application (NDA) relating to ZIMHI. The company continues to work with its commercial partner, as USWM prepares for the commercial launch of ZIMHI.

Tempol

Since licensing this product, the company has made some progress on the development of Tempol. Unfortunately, few therapies have been successful so far for the treatment of COVID-19. In preliminary results from a study in collaboration with Stanford University, Tempol inhibits the release of multiple cytokines from activated immune cells of COVID-19 patients. This new data now provides the additional scientific rationale needed to conduct clinical studies in early COVID-19 patients with Tempol. We are currently identifying sites that could conduct this trial. With the additional data from this study, the company continues to explore its options for government and other forms of funding to potentially support additional testing of Tempol.

Discussions with various groups continue to evolve on the funding and design of a large clinical study to examine the effects of Tempol for the treatment of radiation induced dermatitis. One of these groups, which was previously under the direction Dr. Stephen Hahn (current FDA commissioner), conducted successful clinical studies of Tempol for the treatment of radiation induced alopecia.

Drug Outsourcing Facility

Year to date, sterile and non-sterile revenues from the company’s wholly owned drug outsourcing facility, US Compounding (USC), were adversely affected by slowing demand due to the COVID-19 outbreak. Revenues decreased by approximately 21% for the nine months ended September 30, 2020, compared to the same period in the prior year.

Third Quarter Financial Results

Revenues were approximately $4.3 million and $5.9 million for the three months ended September 30, 2020 and 2019, respectively. This decrease in revenues of approximately 27% year over year was primarily due to the COVID-19 pandemic which has adversely affected revenues from sales of USC products, in part due to reductions or cancellations of outpatient or elective surgeries and other medical procedures and reductions in office visits to physicians’ offices, healthcare facilities or clinics by patients, and the resulting decreased demand by USC’s customers for certain of USC’s products.

Selling, general and administrative expenses for the three months ended September 30, 2020 and 2019 were approximately $5.8 million and $5.3 million, respectively.

Research and development expenses were approximately $1.7 million and $3.3 million for the three months ended September 30, 2020 and 2019, respectively. The decrease was primarily due to completing work on ZIMHI and a decrease in development costs of our other product candidates.

Cash and equivalents at the end of the third quarter was approximately $12.4 million. This amount includes proceeds from an equity offering completed in September which provided net proceeds of approximately $10.7 million.

Targeted Milestones

●FDA approval and U.S. commercial launch of ZIMHI;
●Apply for government and other forms of funding for Tempol trial in COVID-19 patients; and
●Ex-US partnerships for SYMJEPI and ZIMHI.

Conference Call

Adamis will host a conference call and live webcast on Monday, November 9, 2020 at 2:00 pm Pacific Time to discuss its financial and operating results for the third quarter of 2020 as well as provide an update on business developments and activities.

US Dial-in (Toll Free): 1-855-327-6838

TOLL/International Dial-in: 1-604-235-2082

Conference ID: 10011804

Webcast: View Source

In addition, a telephone playback of the call will be available after approximately 5:00 pm PT on November 9, 2020. To listen to the replay, call toll free 1-844-512-2921 within the United States or 1-412-317-6671 when calling internationally (toll). Please use the replay PIN number 10011804.