On February 7, 2020 Adaptimmune Therapeutics plc ("Adaptimmune") (Nasdaq: ADAP), a leader in T-cell therapy to treat cancer, reported that the underwriters of its previously announced public offering of 21,000,000 American Depositary Shares ("ADSs"), which initially closed on January 24, 2020, have exercised in full their option to purchase an additional 3,150,000 of its ADSs at a price to the public of $4.00 per ADS, raising additional net proceeds of approximately $11.7 million, after deducting underwriting discounts and commissions and estimated offering expenses (Press release, Adaptimmune, FEB 7, 2020, View Source [SID1234554027]). The option exercise closed on February 7, 2020.

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After giving effect to the option exercise, Adaptimmune sold a total of 24,150,000 ADSs in connection with the offering, generating net proceeds of approximately $89.8 million, after deducting the underwriting discount and other offering expenses payable by Adaptimmune. Adaptimmune intends to use the net proceeds from this offering to advance the development of its immunotherapies into and through clinical trials as well as for other general corporate purposes.

Cowen acted as sole book-running manager for the offering and Roth Capital Partners acted as co-manager for the offering.

A shelf registration statement on Form S-3 relating to the public offering of the ADSs described above was declared effective by the Securities and Exchange Commission ("SEC") on September 10, 2019. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to these securities may also be obtained by sending a request to: 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.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

For readers in the European Economic Area

In any EEA Member State, this communication is only addressed to and directed at qualified investors in that Member State within the meaning of the Prospectus Regulation. The term "Prospectus Regulation" means Regulation (EU) 2017/1129.

For readers in the United Kingdom

This communication, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of s21 Financial Services and Markets Act 2000 as amended) in connection with the securities which are the subject of the offering described in this press release or otherwise, is being directed only at (i) persons who are outside the United Kingdom; (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) (Investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); (iii) certain high net worth companies and persons who fall within Article 49(2)(a) to (d) (High net worth companies, unincorporated associations etc) of the Order; and/or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as "relevant persons"). The ADSs are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such ADSs will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this communication or any of its contents.

On February 7, 2020 AbbVie (NYSE:ABBV) reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, AbbVie, FEB 7, 2020, View Source [SID1234554026]).

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"Our strong performance this quarter completes another excellent year for AbbVie," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "The launches of Skyrizi and Rinvoq are going extremely well, and we are entering 2020 with substantial momentum. We also look forward to completing the planned Allergan acquisition in the first quarter."

Fourth-Quarter Results

Worldwide net revenues were $8.704 billion, an increase of 4.8 percent on a reported basis, or 5.3 percent operationally. Excluding the unfavorable impact of international HUMIRA net revenues due to biosimilar competition, fourth-quarter net revenues grew 11.0 percent operationally.
U.S. HUMIRA net revenues were $3.969 billion, an increase of 9.8 percent. Internationally, HUMIRA net revenues were $948 million, a decrease of 27.3 percent on a reported basis, or 25.4 percent operationally, due to biosimilar competition. Global HUMIRA net revenues of $4.917 billion were flat on a reported basis and increased 0.5 percent operationally.
Global IMBRUVICA net revenues were $1.296 billion, an increase of 28.9 percent, with U.S. net revenues of $1.073 billion and international profit sharing of $223 million. Global VENCLEXTA net revenues were $251 million. Global net revenues from the hematologic oncology portfolio were $1.547 billion, an increase of 37.0 percent on a reported basis, or 37.2 percent operationally.
Global SKYRIZI net revenues were $216 million and global RINVOQ net revenues were $33 million.
On a GAAP basis, the gross margin ratio in the fourth quarter was 77.0 percent. The adjusted gross margin ratio was 81.6 percent.
On a GAAP basis, selling, general and administrative expense was 22.4 percent of net revenues. The adjusted SG&A expense was 21.6 percent of net revenues.
On a GAAP basis, research and development expense was 17.7 percent of net revenues. The adjusted R&D expense was 15.3 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.
On a GAAP basis, the operating margin in the fourth quarter was 45.5 percent. The adjusted operating margin was 44.6 percent.
On a GAAP basis, net interest expense was $455 million. The adjusted net interest expense was $282 million.
On a GAAP basis, the tax rate in the quarter was 8.9 percent. The adjusted tax rate was 8.8 percent.
Diluted EPS in the fourth quarter was $1.88 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.21.
Note: "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net revenues at the prior year’s foreign exchange rates.

Recent Events

AbbVie and Allergan announced that Allergan has entered into definitive agreements to divest brazikumab and Zenpep in conjunction with the ongoing regulatory approval process for AbbVie’s acquisition of Allergan. AstraZeneca will acquire brazikumab, an investigational IL-23 inhibitor in Phase 2b/3 development for Crohn’s Disease and in Phase 2 development for ulcerative colitis, including global development and commercial rights. Nestle will acquire and take full operational ownership of Zenpep, a treatment for exocrine pancreatic insufficiency, as well as Viokace, another pancreatic enzyme preparation, as part of the transaction. The closings of the divestitures of brazikumab and Zenpep are contingent upon receipt of U.S. Federal Trade Commission and European Commission (EC) approval, closing of AbbVie’s pending acquisition of Allergan and the satisfaction of other customary closing conditions. AbbVie and Allergan continue to expect to close the pending transaction in the first quarter of 2020.
AbbVie announced regulatory approvals for RINVOQ (upadacitinib) for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA). The approvals from the EC and the Japanese Ministry of Health, Labour and Welfare are based on results from the SELECT Phase 3 program, one of the largest registrational Phase 3 programs in RA, with approximately 4,400 patients evaluated across five studies.
AbbVie announced positive top-line data from the Phase 3 SELECT-PsA 1 study, the second of two registration-enabling trials evaluating RINVOQ in psoriatic arthritis (PsA). In this study, both doses of RINVOQ (15 mg and 30 mg, once daily) met the primary endpoint of ACR20 at week 12 versus placebo in adult patients with active PsA who have responded inadequately or are intolerant to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs). RINVOQ also demonstrated significant improvements in signs and symptoms of the disease across a variety of endpoints compared to placebo. Both doses of RINVOQ also significantly inhibited radiographic progression at week 24 compared to placebo. The 30 mg dose of RINVOQ achieved superiority to adalimumab in terms of ACR20 response at week 12, whereas both doses achieved non-inferiority vs. adalimumab. The safety profile of RINVOQ was consistent with previously reported results across indications, with no new safety risks detected. Detailed data from both pivotal studies will be presented at an upcoming medical meeting and AbbVie expects to submit our regulatory applications for RINVOQ in PsA in the second quarter of this year.
AbbVie announced positive data from a head-to-head Phase 3 study evaluating SKYRIZI (risankizumab) compared to Cosentyx in adult patients with moderate to severe plaque psoriasis. In the study, SKYRIZI met both primary endpoints and all ranked secondary endpoints, demonstrating higher rates of skin clearance compared to Cosentyx. SKYRIZI met the primary endpoint of superiority with at least a 90 percent improvement from baseline in the Psoriasis Area and Severity Index (PASI 90) at week 52. Of patients treated with SKYRIZI, 87 percent achieved PASI 90 compared to 57 percent of Cosentyx-treated patients at 52 weeks. At week 16, SKYRIZI met the other primary endpoint of non-inferiority to Cosentyx, with 74 percent of SKYRIZI patients achieving PASI 90 compared to 66 percent of Cosentyx patients. SKYRIZI also showed superiority compared to Cosentyx for all ranked secondary endpoints, including PASI 100, and PASI 75, as well as a static Physician Global Assessment score of clear or almost clear at week 52. The safety profile of SKYRIZI was consistent with that observed in previously reported studies, with no new safety signals observed through week 52. SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
At the American College of Rheumatology (ACR)/Association for Rheumatology Health Professionals (ARHP) Annual Meeting, AbbVie presented data for RINVOQ, HUMIRA (adalimumab) and SKYRIZI, with 38 abstracts presented across multiple rheumatic conditions, including RA, ankylosing spondylitis (AS) and PsA. Included in the presentations were new data from the Phase 2/3 SELECT-AXIS 1 trial in which twice as many adult patients with active AS treated with RINVOQ achieved the primary endpoint of Assessment of SpondyloArthritis International Society (ASAS) 40 response at week 14 versus placebo. The safety profile of RINVOQ was consistent with that of previous studies in rheumatoid arthritis, with no new safety risks detected. AbbVie also presented long-term data from the SELECT Phase 3 program further evaluating efficacy and safety across measures with RINVOQ, even without methotrexate, in patients with moderate to severe RA.
AbbVie announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for VENCLYXTO (venetoclax) in combination with obinutuzumab for the treatment of patients with chronic lymphocytic leukemia (CLL) who were previously untreated. The CHMP positive opinion is based on results from the Phase 3 CLL14 clinical trial, which showed that patients who completed one year of treatment with VENCLYXTO plus obinutuzumab had prolonged progression-free survival (PFS) and higher rates of minimal residual disease (MRD) negativity compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil. This represents the third positive CHMP opinion for VENCLYXTO and if approved by the EC, VENCLYXTO plus obinutuzumab would be the first chemotherapy-free, oral combination regimen given with a fixed duration for patients with previously-untreated CLL. Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
AbbVie announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IMBRUVICA (ibrutinib) in combination with rituximab for the first-line treatment of younger patients (70 years old or younger) with CLL or small lymphocytic lymphoma (SLL). The application is being reviewed under the FDA’s Real-Time Oncology Review pilot program and is based on results from the Phase 3 E1912 study, which showed significantly improved PFS and overall survival (OS) in patients treated with IMBRUVICA plus rituximab compared to those treated with fludarabine, cyclophosphamide and rituximab (FCR). Safety data were consistent with the known safety profile of IMBRUVICA and if approved, the milestone will mark the 11th FDA approval for IMBRUVICA across six distinct disease areas. IMBRUVICA is jointly developed and commercialized with Janssen Biotech, Inc.
At the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (ASH) (Free ASH Whitepaper), AbbVie presented data from more than 40 abstracts, including 18 oral presentations, featuring the latest scientific progress from its Hematologic Oncology programs. Key data presentations included new data from the Phase 2 CAPTIVATE study evaluating IMBRUVICA plus VENCLEXTA (venetoclax) in previously untreated patients with CLL; new data from the Phase 3 E1912 study evaluating IMBRUVICA plus rituximab versus FCR in front-line CLL, results of a 7.5-year pooled analysis for IMBRUVICA monotherapy showing earlier treatment extended PFS and increased the likelihood of a complete response in patients with relapsed/refractory mantle cell lymphoma; updated data from the Phase 3 MURANO trial four-year analysis demonstrating PFS and OS benefits with VENCLEXTA plus rituximab in patients with relapsed/refractory CLL; and results from a Phase 2 study of navitoclax in combination with ruxolitinib showing clinically meaningful spleen responses, reductions in allelic burden and improvements in total symptom score, as well as improvements in bone marrow fibrosis.
AbbVie announced that the CHMP of the EMA has recommended a change to the marketing authorization for MAVIRET (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection. If approved by the EC, MAVIRET will be the only pan-genotypic 8-week treatment option for treatment-naïve, chronic HCV patients, without cirrhosis or with compensated cirrhosis. The positive recommendation is supported by data from the Phase 3b EXPEDITION-8 study, which showed that with 8 weeks of MAVIRET, an overall 98 percent patients achieved a sustained virologic response 12 weeks after treatment (SVR12), and for patients with GT3, the SVR12 rate was over 95%. A final EC decision is expected in 2020.
AbbVie and Harpoon Therapeutics, Inc., a clinical-stage immunotherapy company developing a novel class of T cell engagers targeting both solid tumors and hematologic malignancies, announced an exclusive worldwide option and license transaction for HPN217, Harpoon’s B cell maturation antigen (BCMA)-targeting Tri-specific T cell Activating Construct (TriTAC), and an expansion of their existing discovery collaboration for up to six additional targets. These agreements build upon the discovery collaboration established by the two companies in October 2017 and are expected to advance and broaden the use of Harpoon’s proprietary TriTAC platform. The collaboration broadens AbbVie’s oncology research platform to expand the development of potentially life-changing treatments for patients.
AbbVie announced a collaboration with Scripps Research to develop new therapies for a range of diseases, including in the therapeutic areas of oncology, immunology, neurology and fibrosis. Under the terms of the license agreement, Scripps Research will continue to conduct pre-clinical research and development activities and, in some cases, Phase 1 clinical trials with AbbVie having an exclusive option to further develop and commercialize. The collaboration broadens AbbVie’s research platform to expand the development of potentially life-changing treatments for patients.
The Chinese health authorities have requested supply of Aluvia (lopinavir/ritonavir) as part of the government’s broader efforts to address the coronavirus crisis in China. In response to this request, AbbVie has confirmed a donation of Aluvia as an experimental option to support this growing public health crisis.
Full-Year 2020 Outlook

AbbVie is issuing its standalone GAAP diluted EPS guidance for the full-year 2020 of $7.66 to $7.76, representing growth of 46.0 percent at the midpoint. AbbVie expects to deliver standalone adjusted diluted EPS for the full-year 2020 of $9.61 to $9.71, representing growth of 8.1 percent at the midpoint. The company’s standalone 2020 adjusted diluted EPS guidance excludes $1.95 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.

AbbVie expects standalone revenue growth approaching 8.0 percent on an operational basis.

Statements Required by the Irish Takeover Rules

The directors of AbbVie accept responsibility for the information contained in this announcement. To the best of the knowledge and belief of the directors of AbbVie (who have taken all reasonable care to ensure that such is the case), the information contained in this announcement is in accordance with the facts and does not omit anything likely to affect the import of such information.

Any holder of 1% or more of any class of relevant securities of AbbVie Inc. may have disclosure obligations under Rule 8.3 of the Irish Takeover Panel Act, 1997, Takeover Rules 2013.

On February 7, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that additional data will be presented from a cohort of Chinese patients in the Phase III IMbrave150 study that evaluated Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as a treatment for people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy (Press release, Hoffmann-La Roche, FEB 7, 2020, View Source [SID1234554001]).

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Data from 194 Chinese patients who took part in the IMbrave150 study were consistent with the global results, that showed a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) compared with standard-of-care sorafenib.

Among Chinese patients, Tecentriq in combination with Avastin reduced the risk of death (OS) by 56% (hazard ratio [HR]=0.44; 95% CI: 0.25–0.76) and reduced the risk of disease worsening or death (PFS) by 40% (HR=0.60; 95% CI: 0.40–0.90), compared with sorafenib. Tecentriq and Avastin were generally well-tolerated with manageable toxicities, and the safety profile was consistent with the known safety profiles of the individual medicines and with the underlying disease.

"Almost half of all cases of hepatocellular carcinoma globally are found in China, so it is extremely encouraging that Chinese patients treated with Tecentriq and Avastin had substantially longer survival outcomes, as compared with the current standard of care in China", said Levi Garraway, M.D., Ph.D, Roche’s Chief Medical Officer and Head of Global Product Development. "We are working closely with the China National Medical Products Administration (NMPA), who recently accepted our supplemental Biologics License Application (sBLA) for the combination, along with global health authorities in the hope of bringing this treatment option to patients as soon as possible."

These data will be presented in the plenary session entitled ‘Round table focus on HCC and transplantation’ at the Liver Cancer Summit 2020, on 8 February at 08:00 am CET.

Every year, more than 750,000 people worldwide are diagnosed with HCC, the most common form of liver cancer – with the majority of cases in Asia and almost half of all cases in China. Elsewhere, incidence of liver cancer is on the rise across Europe and the US, with the number of liver cancer cases in the US more than tripling since 1980.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMbrave150 study
IMbrave150 is a global Phase III, multicentre, open-label study of 501 people with unresectable HCC who have not received prior systemic therapy. People were randomised 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Of 194 Chinese patients (137 from the IMbrave150 global study and 57 from a China extension cohort), 133 were randomised to receive Tecentriq and Avastin and 61 to sorafenib. Tecentriq was administered intravenously (IV), 1200 mg on day 1 of each 21-day cycle, and Avastin was administered IV, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib was administered by mouth, 400 mg twice per day, on days 1–21 of each 21-day cycle. People received the combination or the control arm treatment until unacceptable toxicity or loss of clinical benefit, as determined by the investigator. The co-primary endpoints were OS and PFS by independent review facility (IRF) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1). Additional study endpoints included overall response rate (ORR), PFS and duration of response (DoR), as measured by RECIST v1.1 (investigator-assessed [INV] and IRF) and HCC mRECIST (IRF), as well as patient-reported outcomes (including time to deterioration of patient-reported quality of life), safety and pharmacokinetics.

Key efficacy endpoint results for OS and PFS (co-primary endpoints) in Chinese patients are shown below:

Tecentriq + Avastin (n=133) Sorafenib
(n=61)
Median OS, months
(95% CI) NE
(13.5–NE) 11.4
(6.7–NE)
OS, HR (95% CI) 0.44
(0.25–0.76)
Median PFS, months
(95% CI) 5.7
(4.2–8.3) 3.2
(2.6–4.8)
PFS, HR (95% CI) 0.60
(0.40–0.90)
NE, not estimable; median follow-up 7.2 months (Tecentriq and Avastin) and 5.6 months (sorafenib); PFS measured as per IRF RECIST v1.1. No formal statistical testing was conducted in the Chinese subpopulation.

Grade 3–4 adverse events (AEs) occurred in 59% of people receiving Tecentriq and Avastin and 47% of people receiving sorafenib. Grade 5 AEs occurred in 2% and 3% of people, respectively.

Key efficacy endpoint results for OS and PFS (co-primary endpoints) for the global population are shown below:

Tecentriq + Avastin (n=336) Sorafenib
(n=165)
Median OS (months)
(95% CI) NE 13.2
(10.4–NE)
OS, HR (95% CI) 0.58 (0.42-0.79)
Log rank p-value 0.0006
Median PFS (months)
(95% CI) 6.8
(5.7–8.3) 4.3
(4.0–5.6)
PFS, HR (95% CI) 0.59 (0.47–0.76)
Log rank p-value <0.0001
NE, not estimable; median follow-up 8.6 months; PFS measured as per IRF RECIST v1.1.
Grade 3–4 adverse events (AEs) occurred in 57% of people receiving Tecentriq and Avastin and 55% of people receiving sorafenib. Grade 5 AEs occurred in 5% and 6% of people, respectively.

About hepatocellular carcinoma
HCC is an aggressive cancer with limited treatment options and is a major cause of cancer deaths worldwide.[1] Every year, more than 750,000 people worldwide are diagnosed with HCC,[1],[2] with the majority of cases in Asia and almost half of all cases in China.[2],[3] In the US, the number of liver cancer cases have more than tripled since 1980 and HCC represents the fastest-rising cause of cancer-related death, while in Europe, liver cancer is also on the rise.[4–6] HCC develops predominantly in people with cirrhosis due to chronic hepatitis (B or C) or alcohol consumption, and typically presents at an advanced stage.[1] The prognosis for unresectable HCC remains poor, with few systemic therapeutic options and a 1-year survival rate of less than 50% following diagnosis.[7]

About the Tecentriq and Avastin combination
There is a strong scientific rationale to support the use of Tecentriq plus Avastin in combination. The Tecentriq and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers. Avastin, in addition to its established anti-angiogenic effects, may further enhance Tecentriq’s ability to restore anti-cancer immunity, by inhibiting vascular endothelial growth factor (VEGF)-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasise).

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

On February 7, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has entered into an agreement with National Cancer Center Japan to support an investigator-initiated clinical study based on the patient-requested therapy system (Press release, Chugai, FEB 7, 2020, View Source [SID1234554000]).

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The clinical research program titled "the prospective trial of patient-proposed healthcare services with multiple targeted agent based on the result of gene profiling by multigene panel test" is led by National Cancer Center Hospital as a coordinating secretariat. The study aims to examine new therapeutic opportunities for patients with genetic alterations identified with comprehensive genomic profiling tests who have no treatment options available including approved drugs or clinical trials by utilizing the patient-requested therapy system. Advocating the objectives of the clinical study, Chugai will provide drugs in the study.

"The recent insurance coverage for the genomic analysis using next-generation sequencing (NGS) technology enabled allow us to select optimized cancer treatment for each patient. However, some patients cannot receive molecularly matched therapy due to lack of approved drugs even if gene alteration has been identified. We are very pleased that our products will help offer such patients therapeutic opportunities," said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. "Chugai will continue striving to promote advanced personalized healthcare to realize the optimal treatment for each patient as a leading company in oncology."

On February 6, 2020 Zetagen Therapeutics, Inc., a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported the close of $5.34M Series A funding round (Press release, Zetagen Therapeutics, FEB 6, 2020, View Source [SID1234643690]). The financing will accelerate the growth of the Company’s ongoing clinical programs for ZetaMet (Zeta-BC-003), a synthetic, small-molecule, inductive biologic being developed to target and resolve metastatic lesions while inhibiting future tumor growth.

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"We are extremely pleased to have reached such an important milestone in Zetagen’s advancement as a biopharmaceutical company, " said Joe C. Loy, CEO of Zetagen Therapeutics, Inc. "This funding is paramount to accelerating our clinical programs around ZetaMet (Zeta-BC-003) by adding the necessary scientific infrastructure that will allow us to prepare for future human clinical trials."

ZetaMet (Zeta-BC-003) is a novel molecular pathway paired with a proprietary, drug-eluting implant technology. The novel therapy is designed to resolve tumor growth, inhibit pain, and regenerate bone. Zetagen exclusively licensed the platform technology from the State University of New York in 2016.