On October 15, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, reported that the Company will present the final results of its DRIIV-1 Phase 1 study of AsiDNA, the Company’s first-in-class DDR inhibitor, in a poster session on October 27, 2019, during the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston (Press release, Onxeo, OCT 15, 2019, View Source [SID1234542263]).

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Olivier de Beaumont, Medical Director of Onxeo, commented: "DRIIV-1 demonstrated AsiDNA’s favorable safety profile and validated its mechanism of action in patients’ tumor cells through the activation of its biological targets. Most importantly, the optimal active dose of AsiDNA of 600 mg was determined and is currently being utilized in our ongoing DRIIV-1b study, which is evaluating AsiDNA in combination with chemotherapy. DRIIV-1 was the foundation of our clinical development strategy for AsiDNA via intravenous administration and we look forward to presenting and discussing the compelling results of this important study, as well as reviewing our anticipated next steps, with the international oncology community."

The poster, titled "Phase I dose escalation study evaluating the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of AsiDNA, a first-in-class DNA Repair Inhibitor, administered intravenously (IV) in patients with advanced solid tumors," will be presented by Professor Christophe Le Tourneau, principal investigator of the study and Head of the Department of Drug Development and Innovation at the Curie Institute (Paris, France).

Session Title Clinical Trials

Session Date Sunday, October 27

Session Start Time 12:30

Session End Time 16:00

Location Hall D, Hynes Convention Center

Permanent Abstract Number A076

The primary objective of this open label, dose escalation study, was to establish dose-limiting toxicities and identify the maximum tolerated dose of AsiDNA administered intravenously (IV). Other objectives included evaluating the product candidate’s safety profile, pharmacokinetic and pharmacodynamic parameters and preliminary efficacy data. Twenty-two patients with advanced solid tumors having failed previous anticancer therapies received a loading dose of AsiDNA for three consecutive days, followed by a one-hour IV-infusion once per week in 21 day cycles. In each subsequent cycle, AsiDNA was given weekly and administered until disease progression, unacceptable toxicity or patient’s decision.

Biological activity was evidenced by the increase of gH2AX and pHSP90, two intratumoral biomarkers of DNA-PK, one of the DDR proteins targeted by AsiDNA. The product candidate’s favorable safety profile was confirmed, with 90% of all product-related adverse events being non-specific grade 1 and 2 events. The maximum tolerated dose was not reached. The 600 mg dose has been identified as the optimal biological dose for further development due to the favorable safety and pharmacokinetic profile, as well as robust target engagement, demonstrated at this dosage level. Disease stabilization was achieved in two patients with advanced colorectal cancer.

On October 15, 2019 Portola Pharmaceuticals, Inc. (NASDAQ: PTLA) reported that it will host a webcast and conference call to discuss the Company’s financial results for the quarter ended September 30, 2019, and provide a general business overview, on Tuesday, November 5, 2019, at 4:30 p.m. ET (1:30 p.m. PT) (Press release, Portola Pharmaceuticals, OCT 15, 2019, View Source [SID1234542282]).

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Conference Call Details
The live conference call on Tuesday, November 5, 2019, at 4:30 p.m. ET, can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765) 507-2588 internationally and using the passcode 2980632. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.

On October 15, 2019, Seelos Corporation ("STI"), a wholly-owned subsidiary of Seelos Therapeutics, Inc. ("Seelos"), and Phoenixus AG f/k/a Vyera Pharmaceuticals AG ("Vyera"), reported that it entered into an amendment (the "Amendment") to the Asset Purchase Agreement by and between STI and Vyera, dated March 6, 2018 (the "Initial Agreement"), as amended by a first amendment thereto entered into on May 18, 2018 (the "First Amendment"), and a second amendment thereto entered into on December 31, 2018 (the "Second Amendment" and the Initial Agreement, as amended by the First Amendment and the Second Amendment, the "Purchase Agreement") (Filing, 8-K, Apricus Biosciences, OCT 15, 2019, View Source [SID1234542378]). Pursuant to the Initial Purchase Agreement, STI acquired the assets (the "Vyera Assets") and liabilities (the "Vyera Assumed Liabilities") of Vyera related to a product candidate currently referred to as SLS-002 (intranasal ketamine). Pursuant to the Purchase Agreement, STI agreed that if it received regulatory approval to commence a Phase III clinical trial for SLS-002 and no third party had alleged any claim of conflict, infringement, invalidity or other violation of any rights of others with regard to the Vyera Assets, STI would commence a Phase III clinical trial for SLS-002 by June 30, 2020 (the "Phase III Obligation"), and if STI failed to do so, the Purchase Agreement would terminate immediately and become null and void and all of the Vyera Assets and the Vyera Assumed Liabilities would automatically be returned to Vyera. The Purchase Agreement further provided that as partial consideration for the Vyera Assets, STI agreed to make to Vyera certain one-time, non-refundable milestone payments, including a $3.5 million cash payment upon dosing of the first patient in a Phase III clinical trial for SLS-002 (the "Dosing Milestone").

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Pursuant to the Amendment, STI remains obligated to use its commercially reasonable efforts to seek regulatory approval in the United States for and commercialize SLS-002. However, the Amendment eliminates the Phase III Obligation. In addition, in replacement of STI’s obligation to pay the Dosing Milestone, STI agreed pursuant to the Amendment to (i) issue Vyera in January 2020 that number of registered shares of Seelos common stock equal to $2,250,000 divided by a 30-day volume weighted average price of the common stock calculated prior to such issuance date and (ii) make cash payments to Vyera in the amounts of $750,000, $750,000, $1 million and $1 million in October 2019, early January 2020, early April 2020 and early July 2020, respectively (each, a "Payment Obligation"). In event STI fails to timely meet a Payment Obligation (subject to a cure period), Vyera has the right to require that all of the Vyera Assets and the Vyera Assumed Liabilities be returned by STI to Vyera.

On October 15, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a first-in-human Phase 1/2a study of AFM24 (Press release, Affimed, OCT 15, 2019, View Source [SID1234542265]). The initial goal of the study is to determine the maximum tolerated dose and recommended Phase 2 dose of AFM24, as well as to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with advanced cancers known to express the epidermal growth factor receptor, EGFR. The second part of the study will evaluate the preliminary efficacy of AFM24 in patients with select solid tumor subtypes.

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Affimed also announced that the FDA has cleared an IND application for a Phase 1 study to evaluate a stable complex of AFM13, its lead innate cell engager, pre-mixed with cord blood-derived allogeneic NK cells (cbNK cells) as an investigational treatment for patients with relapsed/refractory CD30-positive lymphoid malignancies. In addition, the registration-directed study of AFM13 as monotherapy in relapsed/refractory peripheral T cell lymphoma (pTCL), where patients have very few treatment options, is on track to initiate this year.

AFM24: Potential to Address Current Treatment Limitations in Solid Tumors
"Our goal at Affimed is to develop medicines that activate the innate immune system, the body’s first line of defense, as a powerful way to treat patients living with cancer," said Dr. Adi Hoess, Chief Executive Officer of Affimed. "The IND filing is an important step toward the development of AFM24, our innate cell engager designed to target EGFR-expressing cancers, including those with resistance to existing EGFR-targeted therapies."

AFM24, a tetravalent, bispecific EGFR- and CD16A-binding innate cell engager from Affimed’s fit-for-purpose ROCK platform, is designed to address limitations associated with other EGFR-targeted therapies, such as toxicities or resistance, by using a new mechanism of action to target EGFR-expressing solid tumors through activation of innate immunity rather than inhibition of EGFR-mediated signal transduction.

AFM24 has the potential to provide meaningful benefit to patients with certain mutations that cannot be addressed by existing EGFR-targeted therapies. According to internal market research, leading clinical experts across multiple cancer indications see a tremendous need for novel immuno-oncology approaches for the treatment of solid tumors. Preclinical data showed AFM24’s ability to bridge NK cells and macrophages to EGFR-expressing tumor cell lines and induce cell lysis through antibody-dependent cellular cytotoxicity (ADCC), independent of RAS mutational status, and antibody-dependent cellular phagocytosis (ADCP). In addition, AFM24 enhanced tumor infiltration of NK cells and elicited dose-dependent anti-tumor efficacy in in vivo tumor models. Treatment of cynomolgus monkeys with AFM24 showed a favorable safety profile, even when the animals were treated at high dose levels, demonstrating AFM24’s potential to have lower toxicities in humans compared to other EGFR-targeted therapeutics.

AFM13: Lead Innate Cell Engager, Targeting CD30-positive Lymphomas
"We also continue to progress our lead innate cell engager, AFM13," said Dr. Hoess. "The clearance of the IND for AFM13 pre-mixed with cord blood-derived NK cells is a significant milestone in our overall clinical development plan. The planned clinical study will investigate the potential for adoptive cellular therapy together with our AFM13 innate cell engager to overcome a patient’s dysfunctional immune system to treat cancer."

AFM13 binds to CD16A on NK cells with high affinity, which enables the formation of a stable complex of AFM13 and cbNK cells that results in pre-mixed AFM13 with cbNK cells. This will be investigated in CD30-positive lymphoma patients and the study will be conducted by The University of Texas MD Anderson Cancer Center (MDACC) as an investigator-sponsored study. It builds upon encouraging in vitro and in vivo data that showed a significant enhancement of antitumor activity of pre-mixed AFM13 with cbNK cells versus cbNK cells alone.

Enrollment is ongoing for a Phase 1b/2a study of AFM13 led by Columbia University, with 13 patients now recruited. Previously reported data from this investigator-sponsored translational study in patients with relapsed/refractory CD30-positive lymphoma with cutaneous manifestation confirmed single-agent activity of AFM13, with an objective response rate of 50% (5 out of 10 patients). Patients who responded showed increased infiltration of NK cells, as well as NK cell-mediated killing in the patients’ tumors. These encouraging data supported Affimed’s rationale to study AFM13 in patients with relapsed/refractory CD30-positive pTCL and the registration-directed Phase 2 study of AFM13 is on track to enroll patients this quarter.

On October 15, 2019 Heska Corporation (NASDAQ: HSKA – News; "Heska" or the "Company"), a provider of advanced veterinary diagnostic and specialty products, reported its third quarter 2019 financial performance in a press release on Tuesday, November 5, 2019 before the market opens, and to host an earnings call to discuss the results at 9 a.m. MT / 11 a.m. ET on the same day (Press release, Heska, OCT 15, 2019, View Source [SID1234542284]).

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To access the conference call:

From within the United States, please dial 1-866-548-4713
From outside of the United States, please dial 1-323-794-2093
Reference Conference ID: 3413443

The earnings call will be webcast live from the Company’s website at View Source

A telephonic replay will be available beginning at 2 p.m. ET November 5 and will continue through 11:59 p.m. ET on Tuesday, November 19, 2019. The webcast will be archived on www.heska.com for 90 days.

To access the replay:

From within the United States, please dial 1-844-512-2921
From outside the United States, please dial 1-412-317-6671
Reference Replay Pin Number: 3413443