On April 19, 2021 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases with significant unmet needs, reported the appointment of Martín Sebastian Olivo, M.D. as Chief Medical Officer, effective immediately (Press release, Protara Therapeutics, APR 19, 2021, View Source [SID1234578188]). Dr. Olivo brings to Protara more than 15 years of experience in oncology translational and clinical research and global drug development, most recently serving as Vice President, Breast Cancer Clinical Development Lead at Gilead Sciences, Inc. (formerly Immunomedics, Inc.).

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"We are very excited to welcome Dr. Olivo to our leadership team," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "The depth of his experience supporting the development and approval of oncology drug candidates is expected to be particularly instrumental as we continue to advance our lead product candidate, TARA-002, for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations."

"TARA-002 has strong potential to play a meaningful role in the treatment of NMIBC and potentially other cancers," said Dr. Olivo. "I look forward to working with this dynamic leadership team to advance transformative therapies for people with cancer and rare diseases of high unmet need."

Prior to joining Protara, Dr. Olivo served as Vice President, Breast Cancer Clinical Development Lead, at Gilead Sciences, Inc. (formerly Immunomedics, Inc.), a public biopharmaceutical company, from August 2018 to April 2021, where he led clinical development of a treatment for metastatic triple-negative breast cancer. Prior to joining Immunomedics, he served as Global Clinical Lead at Daiichi Sankyo Cancer Enterprise, a global pharmaceutical company, from July 2017 to July 2018, where he established a comprehensive clinical development plan for an early-stage oncology product candidate with applications in lung and breast cancer. From January 2011 to July 2017, Dr. Olivo served in several roles of increasing responsibility in the oncology business group at Eisai Inc., a pharmaceutical company, most recently serving as an International Project Team Leader.

Dr. Olivo received his M.D. from the University of Buenos Aires and his M.S. in Clinical and Pharmacological Research from Austral University in Buenos Aires. He completed his degree as a Clinical Oncologist at the University of Salvador. He has held various academic and clinical positions at the School of Medicine at the University of Buenos Aires, Hospital "Dr. Enrique Tornú" and the National Cancer Institute of Canada Clinical Trials Group.

On April 19, 2021 Zai Lab Limited ("Zai Lab" or the "Company") (NASDAQ:ZLAB, HKEX: 9688), an innovative commercial stage biopharmaceutical company, reported that it has commenced an underwritten public offering of $750,000,000 of American depositary shares ("ADSs"), each representing one ordinary share of the Company (Press release, Zai Laboratory, APR 19, 2021, View Source [SID1234578187]). All ADSs will be offered by Zai Lab. Zai Lab expects to grant the underwriters a 30-day option to purchase additional ADSs. Investors have an option to receive ordinary shares of the Company ("Shares") in lieu of ADSs in this offering only, and such option will not be available to purchasers of the additional ADSs.

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J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC, Citigroup Global Markets Inc., SVB Leerink LLC and Guggenheim Securities, LLC are acting as joint book-running managers for the ADS offering. J.P. Morgan Securities plc, Goldman Sachs (Asia) L.L.C., Jefferies Hong Kong Limited, Citigroup Global Markets Limited and Guggenheim Securities, LLC are acting as joint book-running managers in respect of any ordinary shares issued to investors electing to receive ordinary shares in lieu of ADSs. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

The offering will be made pursuant to a shelf registration statement on Form S-3ASR, which became automatically effective upon filing with the U.S. Securities and Exchange Commission ("SEC") on April 19, 2021. A preliminary prospectus supplement related to the proposed ADS offering is being filed with the SEC.

Copies of the registration statement on Form S-3ASR, the preliminary prospectus supplement and the accompanying prospectus may be obtained from: (i) J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, via telephone at 1-866-803-9204 or via email at [email protected], (ii) Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected], (iii) Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York 10022, or by telephone at 1-877-821-7388 or via email at [email protected], (iv) Citigroup Capital Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 1-800-831-9146 and (v) SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525 ex. 6105 or by email at [email protected].

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

On April 19, 2021 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company will release its financial results for the first quarter of 2021 after the market closes on Thursday, April 29, 2021 (Press release, MacroGenics, APR 19, 2021, View Source [SID1234578186]). MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, April 29, 2021 at 4:30 pm ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID# 5257004.

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The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On April 19, 2021 Incyte (Nasdaq:INCY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) reported the first patient has been dosed in the placebo-controlled Phase 3 inMIND study evaluating the efficacy and safety of tafasitamab or placebo in combination with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL) (Press release, Incyte, APR 19, 2021, View Source [SID1234578185]).

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"Despite improvements in treatment for patients with relapsed or refractory FL and MZL, there continues to be a significant medical need for additional therapies with improved outcomes," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. "We are pleased to have initiated the inMIND study as we seek meaningful, new options for patients with relapsed or refractory FL or MZL."

FL and MZL are the most common indolent, or slow growing, forms of B-Cell non-Hodgkin lymphomas (NHLs). FL and MZL account for approximately 20-25% and 7% of adult NHL cases, respectively.1 There are limited treatment options for the more than 17,000 new cases of relapsed or refractory FL treated every year in the United States, Europe and Japan.2

"We are looking forward to building on previous, exploratory data in FL, and the results seen with tafasitamab and lenalidomide in relapsed or refractory diffuse large B-cell lymphoma, to evaluate the potential benefit of adding tafasitamab to the current lenalidomide and rituximab combination regimen in patients with indolent lymphomas," said Mike Akimov, M.D., Ph.D., Head of Global Drug Development, MorphoSys.

On January 7, 2021, the U.S. Food and Drug Administration granted orphan drug designation to tafasitamab for the treatment of FL.

About inMIND

inMIND (NCT04680052), a global, double-blind, placebo-controlled, randomized Phase 3 study, is evaluating whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide alone as an add-on to rituximab in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study is expected to enroll over 600 adult (age ≥18 years) patients with relapsed or refractory FL or MZL.

The primary endpoint of the study is progression-free survival (PFS) in the FL population, and the key secondary endpoints are PFS and overall survival (OS) in the overall population as well as positron emission tomography complete response (PET-CR) at the end of treatment (EOT) in the FL population.

For more information about the study, please visit: View Source

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.

XmAb is a registered trademark of Xencor, Inc.

Important Safety Information

What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including:

Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.
The most common side effects of MONJUVI include:

Feeling tired or weak
Diarrhea
Cough
Fever
Swelling of lower legs or hands
Respiratory tract infection
Decreased appetite
These are not all the possible side effects of MONJUVI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

Have an active infection or have had one recently.
Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.
You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

On April 19, 2021 Amgen (NASDAQ:AMGN) reported that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for investigational bemarituzumab as first-line treatment for patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2 (HER2)-negative metastatic and locally advanced gastric and gastroesophageal (GEJ) adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin), based on an FDA-approved companion diagnostic assay showing at least 10% of tumor cells overexpressing FGFR2b (Press release, Amgen, APR 19, 2021, View Source [SID1234578184]).

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"The FIGHT trial is the first study to evaluate targeting the overexpression of FGFR2b in cancer. Bemarituzumab demonstrated clinically meaningful outcomes in key endpoints for patients with advanced gastric or gastroesophageal cancer as a frontline therapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Amgen looks forward to further investigating the role of FGFR2b and will continue to work with regulatory agencies on next steps to bring this potential first-in-class, frontline therapy to patients."

More than one million new gastric cancer cases are diagnosed annually, and gastric cancer is particularly prevalent in Asia.1,2 Approximately 80 to 85% of patients with advanced gastric and GEJ cancers are HER2-negative, and approximately 30% of these patients present with FGFR2b overexpression.3,4

Following sotorasib, bemarituzumab is the second asset in Amgen’s oncology portfolio to receive Breakthrough Therapy Designation in the past six months. A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that may demonstrate substantial improvement on a clinically significant endpoint over available medicines.5

The FIGHT trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone in patients with FGFR2b+, non-HER2 positive frontline advanced gastric or GEJ cancer. In the study, treatment with bemarituzumab plus chemotherapy demonstrated clinically significant and substantial improvements in the primary endpoint of progression-free survival (PFS) and secondary endpoint of overall survival (OS) in the patient population in which at least 10% of tumor cells overexpressed FGFR2b. Additional analysis showed a positive correlation between benefit and the prevalence of FGFR2b+ tumor cells, affirming both the importance of the FGFR2b target and the activity of bemarituzumab against this target. The Breakthrough Therapy Designation was granted based upon this subset of patients who showed at least 10% of tumor cells overexpressing FGFR2b.

Amgen acquired Five Prime Therapeutics on April 16, 2021. In addition to bemarituzumab, Five Prime’s pipeline complements Amgen’s efforts to bring innovative therapies to oncology patients.

About Bemarituzumab
Bemarituzumab (anti-FGFR2b) is a potential first-in-class investigational targeted antibody that is designed to block fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b. The company is also evaluating the potential for bemarituzumab in other cancers that overexpress FGFR2b.

Zai Lab (Shanghai) Co. Ltd. was granted an exclusive license to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology.