On November 8, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that new data from Cohort 2 of the ongoing Phase 2 lifileucel metastatic melanoma study (C-144-01) were presented Friday, Nov. 8, 2019, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting in National Harbor, Maryland (Abstract P865) (Press release, Iovance Biotherapeutics, NOV 8, 2019, View Source [SID1234550799]).

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Highlights from the poster presentation include:

An objective response rate (ORR) of 35 percent as assessed by IRC as compared to 36 percent as assessed by investigator
Median DOR was not reached as assessed by either IRC (range: 1.6+ to 21.2+ months) or investigator (range: 2.2 to 21.2+ months) at 11.3 months median follow up. In addition, based on the most recent data cut from the study, median DOR was not reached as assessed by investigator at 12.8 months of median study follow-up.
An overall concordance rate of 89.4 percent between investigator assessment and IRC assessment (n=66)
"We are pleased to see continued evidence of durability with lifileucel therapy as patients are evaluated with longer term follow-up," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "In addition, concordance between IRC assessment and investigator reported results is highly favorable in this metastatic disease setting as compared with the published literature. These results continue to show that lifileucel offers a potential therapeutic option for the metastatic melanoma patients enrolled in this study. We continue to enroll patients in the pivotal cohort of the study, Cohort 4, which is expected to serve as the basis for an expected Biologics License Application (BLA) submission for lifileucel in late 2020."

Cohort 2 in the ongoing C-144-01 study includes consecutively dosed post-PD-1 patients with Stage IIIC/IV unresectable melanoma who also have received BRAF/MEK therapy if clinically indicated. In this study, patients had experienced a mean of 3.3 lines of prior therapy including anti-PD1 blocking antibody, and the patients had a high baseline tumor burden. The adverse event profile of lifileucel treatment in the C-144-01 study continued to be consistent with the underlying advanced disease and the profile of the lymphodepletion and IL-2 regimens.

On November 8, 2019 Affimed N.V. ("Affimed" or the "Company") (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported the pricing of its previously announced public offering of 12,000,000 of its common shares at a public offering price of $2.50 per common share (Press release, Affimed, NOV 8, 2019, View Source [SID1234550798]). In addition, Affimed has granted the underwriters a 30-day option to purchase up to an additional 1,800,000 common shares at the public offering price less underwriting discounts. After deducting the underwriting discounts, the net proceeds of the public offering are expected to be approximately $28.2 million. The offering is expected to close on or about November 13, 2019, subject to customary closing conditions.

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Jefferies LLC and SVB Leerink LLC are acting as joint book-running managers and SunTrust Robinson Humphrey, Inc. and Laidlaw & Company (UK) Ltd. as co-managers of the offering. A shelf registration statement relating to these securities filed with the Securities and Exchange Commission (the "SEC") was declared effective by the SEC on November 7, 2018. The offering will be made only by means of a prospectus and prospectus supplement. A preliminary prospectus supplement and accompanying prospectus related to the offering have been filed with the SEC and are available at the SEC’s website located at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. Copies of the final prospectus supplement and accompanying prospectus related to the offering may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by email at [email protected], or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On November 8, 2019 BioInvent International AB (publ) (OMXS: BINV) reported it will make a poster presentation with preclinical data on BI-1206 at the annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in Orlando, Florida held December 7-10 (Press release, BioInvent, NOV 8, 2019, View Source [SID1234550797]).

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The abstract, published here, highlights a preclinical study of BI-1206 in an ibrutinib-venetoclax dual resistant PDX model derived from a doubly-resistant mantle cell lymphoma (MCL) patient. Single agent BI-1206 had potent anti-MCL activity in the FcγRIIb-expressing MCL PDX model to overcome ibrutinib-venetoclax dual resistance.

FcγRIIb was further shown to be highly expressed in 27/27 primary patient MCL samples examined. Along with previously published data demonstrating an important role for FcγRIIB in resistance to rituximab-based cancer immunotherapy, and BI-1206 in boosting rituximab efficacy and overcoming rituximab-resistance, these data indicate the significant potential of BI-1206 to address a significant unmet need in MCL and hematologic malignancy.

BioInvent CEO Martin Welschof said: "These pre-clinical data indicate a broad and clinically important role of FcγRIIb in mantle cell lymphoma, and highlight the potential of BI-1206 to help overcome resistance in this indication. This further reinforces our belief that FcγRIIb will become a key element for treating hematological and solid malignancies, and the potential of BI-1206 to play an important role in combating these diseases."

BI-1206, one of BioInvent’s proprietary anti-FcyRIIB antibodies and its lead compound, is currently being investigated in clinical trials in non-Hodgkin lymphoma, chronic lymphocytic leukemia and solid tumors.

Details of the poster:

Title: BI-1206, a Monoclonal Antibody Against FcyRIIIb, Showed Superior Anti-Tumor Activity in an Ibrutinib-Venetoclax Dual Resistant PDX Model in Mantle Cell Lymphoma

Session Name: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents: Poster II

Time: Sunday, December 8, 2019, 6:00 – 8:00 PM

Location: Orange County Convention Center, Hall B

On November 8, 2019 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that the underwriters of its previously announced global offering of ordinary shares (including in the form of American Depositary Shares (ADSs)) have exercised their option to purchase 600,000 additional ADSs in full on the same terms and conditions as the global offering (Press release, argenx, NOV 8, 2019, View Source [SID1234550788]). This option exercise brings the anticipated total gross proceeds from the global offering to approximately $557 million (approximately €502 million) from the sale of an aggregate of 4,600,000 ordinary shares (including in the form of ADSs).

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Morgan Stanley, Cowen, BofA Securities and Evercore acted as joint bookrunning managers for the offering. Kempen acted as lead manager for the offering and Wolfe Capital Markets and Advisory acted as co-manager.

The closing of the global offering, including with respect to the ADSs subject to the option, is expected to occur on November 12, 2019, subject to customary closing conditions. On this timing, due to a public holiday in the United States, November 12, 2019 would count as T+2 settlement in the United States and a T+3 settlement for investors that purchase ordinary shares traded on Euronext Brussels.

The securities were offered pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement relating to the securities was filed with the SEC on November 6, 2019 and a final prospectus supplement relating to the securities will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the global offering may be obtained for free from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, New York 10014, United States, Attention: Prospectus Department; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

On November 8, 2019 Oxford BioDynamics Plc (AIM: OBD), a biotechnology company focused on the discovery and development of epigenetic biomarkers for the pharmaceutical and biotechnology industry, reported that data yielded by application of its 3D genome architecture technology platform, EpiSwitch, will be presented at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 34th Annual Meeting (Press release, Oxford Biodynamics, NOV 8, 2019, View Source [SID1234550787]). The poster presentations indicate that the biomarkers identified by EpiSwitch, using blood samples from patients treated with immune checkpoint inhibitors, provide information that can be used to understand various disease states and has the potential to shed light on the impact of treatment to improve clinical outcomes. The posters were co-authored with collaborating scientists from EMD Serono (the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada), Pfizer, Oxford BioDynamics and the Mayo Clinic.

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In the studies, researchers profiled patients with non-small cell lung cancer (NSCLC) or melanoma treated with avelumab (an anti-PD-L1 antibody), pembrolizumab (an anti-PD-1 antibody), or pembrolizumab in combination with a non-platinum chemotherapeutic agent, and generated models to differentiate responders from non-responders using machine learning methods. All computational analyses for identification of classification models was performed by Oxford BioDynamics.

The findings are being presented as part of the following two posters:

(P142) "Development and Validation of Baseline Predictive Biomarkers for Response to Avelumab in second-line (2L) non-small cell lung cancer (NSCLC)"*
(P143) "Development and Validation of Baseline Predictive Biomarkers for Response to Immuno-Checkpoint Treatments in the context of Multi-Line and Multi-Therapy Cohorts using EpiSwitch Epigenetic Profiling"
Findings from both posters indicate that the chromosome conformation signatures identified retrospectively by EpiSwitch represent strong systemic cellular network deregulations associated with differences in clinical phenotypes and outcomes. Full results are being submitted for publication.

"These findings show that immuno-oncology biomarker development with EpiSwitch yielded robust exclusion of non-responders across indications and combinations, provided asset-specific classifiers with high PPV, and may enable IO drug development programs to advance with smaller patient cohorts," said Alexandre Akoulitchev, Director and Chief Scientific Officer of Oxford BioDynamics. "While this initial single-arm study design doesn’t permit differentiation between the prognostic and predictive values of the EpiSwitch classifiers, the rationale for a blinded, comparator arm test is compelling. The ability to stratify patients based on their genomic architecture to reduce the risk, cost and time to market for therapeutic development programmes would be a game changer in immuno-oncology."

The EpiSwitch research was funded by Merck KGaA, Darmstadt, Germany, as part of an alliance with Pfizer.

*Avelumab is not approved for the treatment of non-small cell lung cancer or melanoma.

About EpiSwitch

EpiSwitch is a novel epigenetic-based technology platform that supports precision medicine initiatives including: prediction of response to therapy, patient prognosis, disease diagnosis & subtyping and residual disease monitoring. The result of robust, validated, award-winning technology and methodology, EpiSwitch stratifies patients based on their genomic architecture to reduce the risk, cost and time to market for therapeutic development programmes, provide significant insights into disease mechanisms and help personalize therapeutics to ensure better outcomes. To learn more about EpiSwitch, please visit View Source