On September 14, 2020 Merck, a leading science and technology company, reported more than 30 abstracts will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 from September 19-21 (Press release, Merck & Co, SEP 14, 2020, View Source [SID1234565057]). The abstracts span the Company’s clinical program in oncology across several innovative modalities and mechanisms that have the potential to advance treatment across a range of tumor types including biliary tract, lung and urothelial (bladder) cancers.

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"Our oncology ambition is to discover innovative therapies with transformative results. The data being presented in urothelial cancer demonstrate this approach in action, where we are seeing promising results for a new first-line maintenance therapeutic option with BAVENCIO in this form of cancer," said Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck. "In addition, long-term follow-up data in advanced lung cancer from two of our in-house developed mechanisms—our oral MET inhibitor, tepotinib, and our first-in-class bifunctional fusion protein immunotherapy targeting TGF-β/PD-L1, bintrafusp alfa—continue to show sustained impact in one of the leading causes of cancer mortality."

Key data highlights at ESMO (Free ESMO Whitepaper)

Avelumab (BAVENCIO)

Phase III JAVELIN Bladder 100 (Presentations #699O; 704MO; 745P). Primary results from the JAVELIN Bladder 100 study demonstrated an overall survival (OS) benefit for BAVENCIO vs. best supportive care in the first-line maintenance treatment of advanced urothelial carcinoma, making BAVENCIO the first and only immunotherapy to significantly prolong OS in this setting. Three new abstracts from the JAVELIN Bladder 100 study will be presented at ESMO (Free ESMO Whitepaper):

An oral presentation during the Proffered Paper 1 – GU, non-prostate session scheduled on September 19, 2020 at 5:28pm–5:40pm CEST/11:28am-11:40am EDT, will highlight associations between clinical outcomes and exploratory biomarkers (Presentation #699O)
Two other abstracts provide more information on prespecified subgroup analyses, as well as patient-reported outcomes.
Phase III JAVELIN Head and Neck 100 (Presentation #910O). Primary results from this Phase III study will be presented. The study is a demonstration of our commitment to develop options for patients with squamous cell carcinoma of the head and neck, and the results increase understanding in the field of the role of immunotherapy.

Tepotinib
Phase II VISION (Presentations: #1283P; 1286P; 1347P). Three posters from the largest study in patients with non-small cell lung cancer (NSCLC) harboring METex14 skipping treated with tepotinib—an oral, once-daily, highly-selective MET inhibitor. Data presented will highlight:

Durable clinical activity that has been consistent across clinically relevant subgroups both in treatment-naïve and in previously treated patients as well as in patients with brain metastases as assessed by liquid biopsy or tissue biopsy (Poster #1283P)
Health-related quality of life (HRQOL) has shown to be maintained, with clinically meaningful delays in the time to deterioration of cough, dyspnea, and chest pain (Poster #1286P)
A safety profile consisting of mostly mild-to-moderate adverse events with few treatment discontinuations.
INSIGHT 2 (NSCLC): The INSIGHT 2 study assessing the combination of osimertinib and tepotinib in patients with EGFR-mutant NSCLC that has developed resistance to first-line osimertinib treatment due to MET amplification is ongoing and actively recruiting patients (Poster #1415TiP).

Bintrafusp alfa (M7824)

Data from the INTR@PID clinical trial program for first-in-class bintrafusp alfa, an investigational bifunctional fusion protein, targeting both TGF-β and PD-L1 pathways, shows promising and durable responses across multiple tumor types including NSCLC and biliary tract cancer (BTC) with a manageable safety profile in Phase I expansion cohorts.

Two long-term follow-up studies assessing efficacy and safety from the INTR@PID clinical trial program will be presented as posters at ESMO (Free ESMO Whitepaper) 2020:

INTR@PID Solid Tumor 001 three-year long-term follow-up for 2L treatment of NSCLC (Poster #1272P)
INTR@PID Solid Tumor 008 28-month long-term follow-up in patients with pretreated biliary tract cancer (Poster #73P)
In addition, preliminary analysis will be presented in a mini-oral presentation (#616MO) from a trial conducted by the National Cancer Institute (NCI), the Quick Efficacy Seeking Trial (QuEST), investigating a triple combination therapy (BN-brachyury [BVax] + bintrafusp alfa + N-803) in castration-resistant prostate cancer. Available on demand from September 18 at ESMO (Free ESMO Whitepaper).org.

Cetuximab (ERBITUX) (Presentations: #397O; 402MO; 511P; 960P; 922P)

For the Company’s first biology-driven leader ERBITUX, a number of investigator-sponsored studies (ISS), including in combination with BAVENCIO (avelumab), continue to demonstrate its steady role across the continuum of care in metastatic colorectal cancer, and backbone of treatment of squamous cell carcinoma of the head and neck. Data demonstrating the role of ERBITUX as a promising combination partner include an oral presentation investigating avelumab plus cetuximab in pre-treated RAS wild type metastatic colorectal cancer patients as re-challenge strategy: the Phase II CAVE (cetuximab-avelumab) mCRC study. This will be presented during the Proffered Paper GI – colorectal session scheduled on September 19, 2:49pm-3:01pm CEST/8:49am-9:01am EDT (Presentation #397O)

*BAVENCIO is under clinical investigation for the first-line maintenance treatment of advanced UC and not yet approved in any markets outside of the US.

†Tepotinib is the International Nonproprietary Name (INN) for the MET kinase inhibitor MSC2156119J. Tepotinib is currently under clinical investigation in NSCLC and not yet approved in any markets outside of Japan.

‡Bintrafusp alfa is currently under clinical investigation and not approved for any use anywhere in the world.

About BAVENCIO (avelumab)

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.10-12 In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications

The European Commission has authorized the use of BAVENCIO in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). In September 2017, the European Commission granted conditional marketing authorization for BAVENCIO as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).

In the US, BAVENCIO (avelumab) is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Additionally, the US Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

BAVENCIO is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC)

The special warnings and precautions for use for BAVENCIO monotherapy include infusion-related reactions, as well as immune-related adverse reactions that include pneumonitis and hepatitis (including fatal cases), colitis, pancreatitis (including fatal cases), myocarditis (including fatal cases), endocrinopathies, nephritis and renal dysfunction, and other immune-related adverse reactions. The special warnings and precautions for use for BAVENCIO in combination with axitinib include hepatotoxicity.

The SmPC list of the most common adverse reactions with BAVENCIO monotherapy in patients with solid tumors includes fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, weight decreased and vomiting. The list of most common adverse reactions with BAVENCIO in combination with axitinib includes diarrhea, hypertension, fatigue, nausea, dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia.

About Tepotinib

Tepotinib is an oral MET inhibitor that is designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations. Discovered and developed in-house at Merck, it has been designed to have a highly selective mechanism of action, with the potential to improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations. In March 2020, tepotinib became the first oral MET inhibitor indicated for the treatment of advanced NSCLC harboring MET gene alterations to receive a regulatory approval globally, with the Japanese Ministry of Health, Labour and Welfare (MHLW) approval for the treatment of patients with unresectable, advanced or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations whose disease progressed following platinum-based cancer therapy. Tepotinib is also being investigated in the Phase II INSIGHT 2 study in combination with osimertinib in MET amplified, advanced or metastatic NSCLC harboring activating EGFR mutations that has progressed following first-line treatment with osimertinib.

About Bintrafusp Alfa

Bintrafusp alfa (M7824), discovered in-house at Merck and currently in clinical development through a strategic alliance with GSK, is a potential first-in-class investigational bifunctional fusion protein designed to simultaneously block two immunosuppressive pathways, TGF-β and PD-L1, within the tumor microenvironment. This bifunctional approach is thought to control tumor growth by potentially restoring and enhancing anti-tumor responses. In preclinical studies, bintrafusp alfa has demonstrated antitumor activity both as monotherapy and in combination with chemotherapy. Based on its mechanism of action, bintrafusp alfa offers a potential targeted approach to addressing the underlying pathophysiology of difficult-to-treat cancers.

About ERBITUX (cetuximab)

ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells (antibody-dependent cell-mediated cytotoxicity [ADCC]).

ERBITUX has already obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.

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On September 13, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) and Immunomedics (Nasdaq: IMMU) reported that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Immunomedics for $88.00 per share in cash (Press release, Gilead Sciences, SEP 13, 2020, View Source [SID1234565056]). The transaction, which values Immunomedics at approximately $21 billion, was unanimously approved by both the Gilead and Immunomedics Boards of Directors and is anticipated to close during the fourth quarter of 2020.

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The agreement will provide Gilead with TrodelvyTM (sacituzumab govitecan-hziy), a first-in-class Trop-2 directed antibody-drug conjugate (ADC) that was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in April for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Immunomedics plans to submit a supplemental Biologics License Application (BLA) to support full approval of Trodelvy in the United States in the fourth quarter of 2020. Immunomedics is also on track to file for regulatory approval in Europe in the first half of 2021.

In the Phase 3 ASCENT study, which was halted early due to efficacy based on the unanimous recommendation of the independent Data Safety Monitoring Committee, Trodelvy significantly improved progression-free survival (PFS) and overall survival (OS) in previously treated patients with advanced mTNBC. Detailed results from this study are expected to be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020.

Beyond mTNBC, Trodelvy is also being studied in an ongoing Phase 3 trial in third line HR+/HER2- breast cancer and a registrational Phase 2 study in bladder cancer. Additional ongoing studies are evaluating the potential of Trodelvy as a treatment for non-small cell lung cancer and other solid tumor types. Trodelvy is being studied as both a monotherapy and in combination with checkpoint inhibitors and other non-immuno-oncology products by Immunomedics and independent investigators. Additional clinical data for Trodelvy in bladder cancer and other solid tumors will also be presented at ESMO (Free ESMO Whitepaper) this coming week.

"This acquisition represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio. Trodelvy is an approved, transformational medicine for a form of cancer that is particularly challenging to treat. We will now continue to explore its potential to treat many other types of cancer, both as a monotherapy and in combination with other treatments," said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. "We look forward to welcoming the talented Immunomedics team to Gilead so we can continue to advance this important new medicine for the benefit of patients with cancer worldwide."

"We are very pleased that Gilead recognized the value of Trodelvy – both for the important role it has already begun to play for patients with metastatic triple-negative breast cancer and for its potential to help many other patients with cancer in the future," said Behzad Aghazadeh, PhD, Executive Chairman of Immunomedics. "We are excited for the opportunities ahead of us as we join with Gilead to advance our shared mission in defeating cancer. By working with Gilead, we have the opportunity to accelerate our progress and improve care for patients in need of new therapies."

Compelling Strategic Benefits

Rapidly Expanding Trodelvy’s Benefit for Patients Globally: After closing Gilead intends to initiate numerous additional mid- and late-stage studies in the near term to determine which patients will benefit from Trodelvy as both a monotherapy or in combination with other products. Gilead brings commercial, medical, regulatory and manufacturing expertise, which will help rapidly advance Trodelvy through development and reach additional patients. Gilead will also bring to Immunomedics an established infrastructure and operations in Europe and Japan to support the launch of Trodelvy in those regions, pending approval. After closing, Gilead will retain global rights to Trodelvy outside of greater China, South Korea and certain Southeast Asian countries.
Trodelvy is Foundational to Gilead’s Oncology Franchise: Trodelvy will bring to Gilead a cornerstone product that broadens and deepens the company’s solid tumor pipeline, building on current marketed products and late-stage clinical candidates for patients with hematological malignancies at Kite and Gilead, including Yescarta, Tecartus and magrolimab.

Trodelvy is approved as a third-line treatment for mTNBC and has shown promise for earlier stages of the disease. TNBC represents approximately 15 to 20 percent of all breast cancer cases and is generally considered the most aggressive form of breast cancer. HR+/HER2- breast cancer accounts for more than 70 percent of all breast cancers.
Accelerates Gilead’s Revenue and EPS Growth: Trodelvy was launched in May of 2020 and has significant commercial potential in mTNBC and other solid tumors. In addition to immediately accelerating Gilead’s revenue growth, the acquisition of Immunomedics is expected to be neutral to accretive to Gilead’s non-GAAP EPS in 2023 and significantly accretive thereafter.
Transaction Terms and Financing

Under the terms of the merger agreement, a wholly-owned subsidiary of Gilead will promptly commence a tender offer to acquire all of the outstanding shares of Immunomedics’ common stock. The $88.00 per share acquisition price represents a 108 percent premium to Immunomedics’ closing price on September 11, 2020. Following successful completion of the tender offer, Gilead will acquire all remaining shares not tendered in the offer through a second step merger at the same price as the tender offer.

The consummation of the tender offer is subject to various conditions, including a minimum tender of at least a majority of outstanding Immunomedics shares, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.

The tender offer is not subject to a financing condition and will be funded through approximately $15 billion in cash on hand, as well as approximately $6 billion in newly issued debt. Gilead expects to retain an investment grade credit rating following this transaction and this agreement does not alter Gilead’s stated capital allocation strategy or its commitment to maintain and grow its dividend over time.

Lazard and Morgan Stanley & Co. LLC are acting as financial advisors to Gilead. Centerview Partners LLC and BofA Securities are acting as financial advisors to Immunomedics. Cowen & Company, LLC also provided advice to Immunomedics. Davis Polk & Wardwell LLP is serving as legal counsel to Gilead and Watchell, Lipton, Rosen & Katz is serving as legal counsel to Immunomedics.

Conference Call

At 5:00 p.m. Eastern Time today, Gilead’s management will host a conference call and a simultaneous webcast to discuss the transaction. A live webcast of the call can be accessed at Gilead’s Investors page at View Source Please connect to the website at least 15 minutes prior to the start of the call to allow adequate time for any software download that may be required. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 5776009 to access the call.

Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, September 15, 2020. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID 5776009. The webcast will be archived on www.gilead.com for one year.

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a Trop-2 directed antibody-drug conjugate indicated for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. To learn more about TRODELVYTM (sacituzumab govitecan-hziy), please visit View Source

Trodelvy carries a black box warning for severe neutropenia and severe diarrhea. The most common adverse reactions occurring in 25 or more percent of patients included nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash and abdominal pain. The most common Grade 3 or 4 adverse events occurring in more than 5 percent of patients were neutropenia, white blood cell count decreased, anemia, hypophosphatemia, diarrhea, fatigue, nausea and vomiting. Two percent of patients discontinued treatment due to adverse events. There were no deaths related to treatment and no severe cases of neuropathy or interstitial lung disease. See trodelvy.com for additional U.S. important safety information and full Prescribing Information, including Boxed Warning.

On September 12, 2020, Seattle Genetics, Inc. (the "Company") reported that it entered into a license and collaboration agreement (the "Collaboration Agreement") with Merck Sharp & Dohme Corp. ("MSDC"), a subsidiary of Merck & Co., Inc., effective September 13, 2020 (Filing, 8-K, Seattle Genetics, SEP 12, 2020, View Source [SID1234565063]). Pursuant to the Collaboration Agreement, the Company and MSDC agreed to jointly develop and commercialize, on a worldwide basis, the Company’s product candidate, ladiratuzumab vedotin. Ladiratuzumab vedotin is an antibody-drug conjugate that is currently being evaluated in phase 1 and phase 2 clinical trials both as monotherapy and in combination with other agents (including Keytruda (pembrolizumab)) for patients with metastatic breast cancer and select solid tumors with high LIV-1 expression.

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Pursuant to the Collaboration Agreement, the Company granted to MSDC co-exclusive (with the Company) worldwide development and commercialization licenses for ladiratuzumab vedotin and other LIV-1-targeting ADCs (the "Licensed Product"). In addition to an upfront cash payment of $600 million, the Company will be eligible to receive up to $850 million in milestone payments upon the initiation of certain clinical trials and regulatory approval in certain major markets and up to an additional $1.75 billion in milestone payments upon the achievement of specified annual sales thresholds of the Licensed Product. Globally, the Company will be responsible for 50% of future costs to develop and commercialize the Licensed Product and receive 50% of the profits.

The companies would jointly develop the Licensed Product. The Company would lead regulatory and distribution activities, and record sales, in the United States and Canada. MSDC would lead regulatory activities in Europe, and the Company would lead distribution activities and record sales in Europe. The Company and MSDC would co-commercialize the Licensed Product in the United States and Europe. MSDC would lead regulatory, promotion and distribution activities, and would record sales, in countries outside of the United States, Canada and Europe.

The Collaboration Agreement will remain in effect, unless earlier terminated, until the Licensed Product is no longer being developed or commercialized under the Collaboration Agreement. The Collaboration Agreement also contains customary provisions for termination by MSDC for convenience, and by either party, including in the event of breach of the Collaboration Agreement, subject to cure, or upon a challenge of such party’s licensed patents or upon the other party’s bankruptcy, subject, in each case, to customary reversion rights.

Stock Purchase Agreement

On September 12, 2020 and effective September 13, 2020, in connection with entry into the Collaboration Agreement, the Company entered into a stock purchase agreement (the "Purchase Agreement") with MSDC pursuant to which the Company agreed to issue and sell, and MSDC agreed to purchase, 5,000,000 newly-issued shares of the Company’s common stock (the "Shares"), at a purchase price of $200 per share, for an aggregate purchase price of $1.0 billion, pursuant to the terms and conditions thereof. Pursuant to the Purchase Agreement and subject to certain conditions and limitations, the Company agreed to file certain registration statements with the Securities and Exchange Commission (the "SEC"), upon demand by MSDC not sooner than 18 months following the closing of the transactions contemplated by the Purchase Agreement, to register the resale of the Shares by MSDC, and MSDC agreed that, excluding specified extraordinary matters, it will vote the Shares in accordance with the recommendations of the Company’s board of directors at any meeting of the Company’s stockholders until such time as MSDC, together with its affiliates, beneficially owns less than 1% of the Company’s outstanding common stock.

The closing of the purchase and the sale of the Shares is subject to the satisfaction or waiver of certain customary closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act").

The foregoing is only a brief description of the Collaboration Agreement and the Purchase Agreement (together, the "Agreements"), does not purport to be complete and is qualified in its entirety by reference to the full text of such Agreements, which the Company intends to file as exhibits to its Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 to be filed with the SEC. In addition, the Agreements contain customary representations, warranties and covenants by the Company, indemnification obligations of the parties and other obligations of the

parties. The representations, warranties and covenants contained in the Agreements are made only for purposes of such Agreements and are made as of specific dates; are solely for the benefit of the parties; may be subject to qualifications and limitations agreed upon by the parties in connection with negotiating the terms of the Agreements, including being qualified by confidential disclosures made for the purpose of allocating contractual risk between the parties, instead of establishing matters as facts; and may be subject to standards of materiality and knowledge applicable to the contracting parties that differ from those applicable to investors generally. Investors should not rely on the representations, warranties and covenants or any description thereof as characterizations of the actual state of facts or condition of the Company.

On September 11, 2020 Harbour BioMed (HBM), a global, clinical-stage, innovative biopharmaceutical company reported a strategic partnership agreement with Hualan Genetic Engineering Co., Ltd (Hualan Genetic) to develop HBM’sHBM’s three proprietary innovative monoclonal and bispecific antibodies (Press release, Harbour BioMed, SEP 11, 2020, View Source [SID1234565054]).

Under the terms of the agreement, Hualan Genetic will be responsible for preclinical and process development in exchange for exclusive rights for the development, manufacturing, and commercialization of these innovative antibody drugs in Greater China (Mainland China, Hong Kong, Taiwan and Macau). HBM will retain the rights for advancing the clinical development and commercialization in rest of the world. Both parties will collaborate on clinical developments and drug manufacturing. HBM will receive an upfront payment of USD 8.75M and royalties based on sales in Greater China.

Using its proprietary H2L2 and HCAb fully human transgenic mouse platforms, HBM has developed a series of novel antibody candidates against oncology and immunological diseases. Many of these candidates have already progressed to preclinical and clinical stages. HBM has developed an immune cell engager platform HBICE, and one product of this collaboration with Hualan Genetic is HBICE bispecific antibody.

Hualan Genetic has been dedicated to R&D and the production of monoclonal antibodies, recombinant human coagulation factors, recombinant hormone drugs. To date, the company has 19 recombinant protein products under development and 7 monoclonal antibody products that received approval for the clinical trial, among which several are under Phase III clinical study. Hualan Genetic is a novel biopharmaceutical company specializing in R & D, production and sales with product indications covering a dozen major diseases, including breast cancer, melanoma, lung cancer, colorectal cancer,

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On September 11, 2020 Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), a global biopharmaceutical company, reported that the U.S Food and Drug Administration (FDA) has granted Orphan Drug Designation for GLR2007, for the treatment of malignant glioma (Press release, Gan and Lee Pharmaceuticals, SEP 11, 2020, View Source;lee-has-been-granted-orphan-drug-designation-by-the-us-fda-301128483.html [SID1234565045]). GLR2007 is a cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor that Gan & Lee is developing for the treatment of advanced solid tumors. Glioma is a broad term describing neuroepithelial tumors originating from glial cells of the central nervous system, including astrocytic tumors such as glioblastomas (GBM).

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GBM is one of the most aggressive primary brain tumors and has median survival of 12 to 15 months, despite advances in surgery, chemotherapy, and radiation therapy1. "There is significant unmet medical need in this patient population, and this orphan drug designation represents an important milestone in the Gan & Lee clinical development program investigating GLR2007," Michelle Mazuranic, Head of Medical Affairs, EU/US, Gan & Lee.

The FDA’s Orphan Drug Designation program grants orphan status to compounds intended to treat rare disorders that impact less than 200,000 people in the U.S annually 2. The designation provides certain benefits to the drug developer including 7 years of market exclusivity upon FDA approval, prescription drug user fee waiver and tax credits for qualified clinical trials 3. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining market approval. The Gan & Lee GLR2007 Phase 1 clinical trial (NCT04444427) is currently enrolling patients to establish the safety, tolerability, and optimal dosing strategy of GLR2007 in patients with advanced solid tumors. "Receiving Orphan Drug Designation for GLR2007 is a positive step forward in the development of this clinical program," Kai Du, CEO of Gan & Lee Pharmaceuticals, Chairman of Gan & Lee USA Corporation.