On November 11, 2020 ron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron Therapeutics, will present at the following virtual investor conferences (Press release, Heron Therapeutics, NOV 11, 2020, View Source [SID1234570601]):

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Stifel 2020 Virtual Healthcare Conference: Tuesday, November 17, 2020 at 3:20 pm ET
Jefferies Virtual London Healthcare Conference: Thursday, November 19, 2020 at 1:30 pm GMT
3rd Annual Evercore ISI HealthCONx Conference: Tuesday, December 1, 2020 at 4:20 pm ET
A live webcast of each presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of each presentation will be archived on the site for 60 days.

On November 11, 2020 Xencor (NASDAQ: XNCR), MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) and Incyte (NASDAQ: INCY) reported a clinical collaboration to investigate the combination of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), first-line DLBCL, and relapsed or refractory follicular lymphoma (FL) (Press release, Incyte, NOV 11, 2020, View Source [SID1234570600]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

‟Xencor is pleased to partner with MorphoSys and Incyte to advance the development of plamotamab, our CD20 x CD3 XmAb bispecific antibody that has demonstrated encouraging clinical activity as a monotherapy in non-Hodgkin lymphoma," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. " Plamotamab, which redirects T cells to tumors, and tafasitamab, a CD19-directed XmAb antibody, combine powerful and distinct immune pathways, and this collaboration is designed to enable us to generate new clinical insights and accelerate development timelines for patients who may need additional therapeutic options. It builds upon many years of partnership between Xencor and MorphoSys following MorphoSys’ in-licensing of tafasitamab in 2010."

‟Tafasitamab in combination with lenalidomide is an important new relapsed/refractory DLBCL treatment option for appropriate patients in the United States today, and its mechanism of action, efficacy and safety profile make it an attractive combination partner," said Jean-Paul Kress, M.D., chief executive officer of MorphoSys. " We believe that tafasitamab as a backbone can add value to new combinations such as with CD20 x CD3 bispecifics, and we are excited about this collaboration with Xencor and Incyte aiming to help more patients in areas of unmet need."

‟This collaboration has the potential to advance patient care and Incyte is proud to join Xencor and MorphoSys in evaluating this new combination approach for these serious cancers," said Hervé Hoppenot, chief executive officer of Incyte.

Xencor’s plamotamab is a tumor-targeted bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3). Tafasitamab is MorphoSys’ CD19-directed antibody which was recently approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Under the terms of the agreement, the companies plan to initiate a Phase 1/2 study evaluating the combination of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory DLBCL. Additionally, the companies are planning to evaluate the combination in relapsed or refractory FL and first-line DLBCL in multiple Phase 1b studies. MorphoSys and Incyte will provide tafasitamab for the studies, which will be sponsored and funded by Xencor and are planned to be conducted in North America, Europe and Asia-Pacific.

The collaboration is effective immediately upon the execution of the agreement.

About Plamotamab (XmAb13676)

Plamotamab (XmAb13676) is a tumor-targeted bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3), which is currently in a Phase 1 clinical study for the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). An XmAb Bispecific Fc domain serves as the scaffold for these two antigen binding domains and confers long circulating half-life, stability and ease of manufacture on plamotamab. CD20 is highly expressed on B-cell tumors, including NHL and CLL. Engagement of CD3 by plamotamab activates T cells for highly potent and targeted killing of CD20-expressing tumor cells.

About Tafasitamab

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi is a registered trademark of MorphoSys AG.
mAb is a registered trademark of Xencor, Inc.

On November 11, 2020 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, reported financial results for the quarter ended September 30, 2020 (Press release, Ascendis Pharma, NOV 11, 2020, View Source [SID1234570599]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"As Ascendis progresses toward closing out 2020, I am proud that we are on track or ahead of schedule for all 2020 corporate goals and to achieve Vision 3×3, moving us one step closer to becoming a fully integrated, global biopharmaceutical company," said Jan Mikkelsen, President and CEO. "As a company, we are driven by our core values to achieve our long-term strategic Vision 3×3, using the power of the TransCon technology. We push ourselves to continually deliver not only in endocrinology but also in oncology and to bring these products to patients as efficiently and safely as possible."

Corporate Highlights & Progress

TransCon hGH (lonapegsomatropin)
○ Submitted MAA to the EMA, which has now validated the application.
○ Filed a Clinical Trial Notification with the Pharmaceuticals and Medical Devices Agency in Japan to initiate the company’s phase 3 riGHt Trial of lonapegsomatropin for the treatment of pediatric GHD.
○ Announced the U.S. Food and Drug Administration (FDA) accepted the company’s Biologics License Application and set a PDUFA date for June 25, 2021.
TransCon PTH
○ Submitted regulatory filings to enable initiation of European and Canadian sites for phase 3 PaTHway Trial.
○ Received orphan designation by the European Commission (EC) for the treatment of hypoparathyroidism (HP).
○ Submitted an amendment to its IND with FDA for the PaTHway phase 3 clinical trial evaluating the safety, tolerability and efficacy of TransCon PTH in adults with HP.
○ Announced preliminary six-month results from the open-label extension portion of PaTH Forward, a global phase 2 trial evaluating the safety, tolerability and efficacy of TransCon PTH in adult subjects with HP. The preliminary results support potential use of TransCon PTH as a hormone replacement therapy for HP and demonstrated normalization of quality of life.
TransCon CNP
○ In collaboration with VISEN Pharmaceuticals, filed an IND application to initiate the phase 2 ACcomplisH China Trial.
○ Received orphan designation by the EC.
Oncology
○ On track for filing IND or similar for TransCon TLR7/8 Agonist by year-end. TransCon TLR7/8 Agonist is a long-acting prodrug of resiquimod. Administered as an intratumoral injection, TransCon TLR7/8 Agonist is designed to provide sustained release of unmodified resiquimod directly to the tumor.
Announced Mark A. Bach, M.D., Ph.D., as Senior Vice President of Clinical Development and Medical Affairs for Endocrinology Rare Diseases. Dr. Bach has 30 years of experience in clinical research and development.
Ended the third quarter 2020 with cash, cash equivalents and marketable securities totaling €957.5 million.
Third Quarter 2020 Financial Results

For the third quarter, Ascendis Pharma reported a net loss of €121.7 million, or €2.31 per share (basic and diluted) compared to a net loss of €25.1 million, or €0.53 per share (basic and diluted) for the same period in 2019.

Revenue for the third quarter was €2.8 million compared to €2.2 million in the same quarter of 2019. The increase was due to a higher sale of clinical supply and services to VISEN, partly offset by a lower amount of license revenue being recognized.

Research and development (R&D) costs for the third quarter were €64.1 million compared to €46.3 million during the same period in 2019. Higher R&D costs in 2020 reflect an increase in personnel-related costs, expansion of R&D facilities and the continued progress in development of the company’s product candidates.

Selling, general and administrative (SG&A) expenses for the third quarter were €17.5 million compared to €10.0 million during the same period in 2019. The increase is primarily due to additional personnel-related costs, higher IT and other infrastructure costs and continued build of the company’s commercial capabilities.

As of September 30, 2020, Ascendis Pharma had cash, cash equivalents and marketable securities totaling €957.5 million compared to €471.6 million as of June 30, 2020. As of September 30, 2020, Ascendis Pharma had 53,416,091 ordinary shares outstanding.

Conference Call and Webcast information

Ascendis Pharma will host a conference call and webcast today at 4:30 p.m. Eastern Time (ET) to discuss its third quarter 2020 financial results. Details include:

A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

On November 11, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody technology platform, reported that Sean McCarthy, D.Phil., president, chief executive officer, and chairman, will participate in the following virtual healthcare conferences in November (Press release, CytomX Therapeutics, NOV 11, 2020, View Source [SID1234570597]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Jefferies Virtual London Healthcare Conference
Date: Wednesday, November 18, 2020
Presentation Time: 10:15a.m. ET

32nd Annual Piper Sandler Virtual Healthcare Conference
Date: Monday, November 30, 2020
Presentation Time: November 23, 2020 at 10:00 a.m. ET. The fireside chat will be available for on-demand viewing before the conference.

Webcasts from both conferences will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. An archived replay will be available for 90 days following the events.

On November 11, 2020 Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported that it plans to offer and sell, subject to market and other conditions, 5,000,000 shares of its common stock in an underwritten public offering (Press release, Five Prime Therapeutics, NOV 11, 2020, View Source [SID1234570596]). In connection with the offering, Five Prime intends to grant the underwriters in the offering a 30-day option to purchase up to an additional 750,000 shares of common stock offered in the public offering.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Five Prime plans to use the net proceeds of the offering, together with other available funds, to fund ongoing clinical development of bemarituzumab and FPT155, to advance FPA157 through preclinical and into clinical development, to advance its late-stage research programs and for working capital and general corporate purposes.

Cowen and SVB Leerink are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as co-manager for the offering.

The shares of common stock are being offered pursuant to a "shelf" registration statement previously filed with and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 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 e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities 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. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus, which are a part of the effective registration statement.