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On October 30, 2017 Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to MM-121, its investigational drug candidate, for the treatment of heregulin positive non-small cell lung cancer (Press release, Merrimack, OCT 30, 2017, View Source [SID1234521289]). MM-121 (seribantumab) is a fully human monoclonal antibody designed to block tumor survival signals and enhance the anti-tumor effect of combination therapies by targeting the cell surface receptor HER3 (ErbB3) in patients with high expression of the biomarker heregulin.

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“This is an important regulatory step forward for the clinical development of MM-121 in non-small cell lung cancer and we are pleased to have access to additional support from the FDA in this indication,” said Sergio Santillana, M.D., MSc, Chief Medical Officer. “Merrimack is dedicated to designing and developing novel precision therapeutics that shape treatment strategies for patients, and our randomized Phase 2 clinical trial of MM-121 in heregulin positive non-small cell lung cancer is well underway. We look forward to expanding the development of MM-121 to a biomarker-selected population of breast cancer patients later this year.”

The FDA’s orphan drug designation is granted to drugs and biologics intended to treat rare diseases or conditions with a prevalence of fewer than 200,000 people in the U.S. This designation includes eligibility for a seven-year period of marketing exclusivity for MM-121 upon approval, as well as other development assistance and financial incentives.

MM-121 is currently being evaluated in the SHERLOC study, a global randomized Phase 2 study that will assess progression-free survival of MM-121 in combination with docetaxel versus docetaxel alone. The study is enrolling patients with heregulin positive non-small cell adenocarcinoma of the lung who have progressed after a platinum-containing regimen and may have received anti PD-1 or anti-PD-L1 therapy. Top-line data for the SHERLOC study are expected in the second half of 2018.

In addition, Merrimack will be evaluating MM-121 in the SHERBOC trial, a global randomized Phase 2, double-blind, placebo-controlled clinical study of MM-121 added to standard of care in patients with heregulin positive, hormone receptor positive, HER2 negative metastatic breast cancer. The first patient is expected to be dosed in the SHERBOC study by the end of 2017.

About MM-121

MM-121, also known as seribantumab, is Merrimack’s wholly owned, fully human anti-HER3 (ErbB3) monoclonal antibody that targets phenotypically distinct heregulin positive cancer cells within solid tumors. Heregulin positive cancer cells are characterized by their ability to escape the effects of targeted, cytotoxic and anti-endocrine therapies and potentially contribute to rapid clinical progression in patients whose tumor cells test positive for heregulin as detected by RNA-ISH. When used in the combination setting, seribantumab is designed to block the heregulin/HER3 signaling axis to make tumor cells more sensitive to the effects of the combination therapy.

On October 30, 2017 Novartis reported, that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100% of the share capital of AAA subject to certain conditions (Press release, Novartis, OCT 30, 2017, View Source [SID1234521290]). Advanced Accelerator Applications (NASDAQ:AAAP) is a radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicines including Lutathera (177Lu-DOTATATE), a first-in-class RLT product for neuroendocrine tumors (NETs). Radiopharmaceuticals, such as Lutathera, are unique medicinal formulations containing radioisotopes which are used clinically for both diagnosis and therapy. The transaction would strengthen Novartis’ oncology presence with both near-term product launches as well as a new technology platform with potential applications across a number of oncology early development programs.

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“Novartis has a strong legacy in the development and commercialization of medicines for neuroendocrine tumors where significant unmet need remains for patients,” said Bruno Strigini, CEO, Novartis Oncology. “With Lutathera we can build on this legacy by expanding the global reach of this novel, differentiated treatment approach and work to maximize Advanced Accelerator Applications broader RLT pipeline and an exciting technology platform.”

Lutathera was approved in Europe in September 2017 for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutathera is under review in the U.S. with a Prescription Drug User Fee Act (PDUFA) date of January 26, 2018.

The efficacy and safety of Lutathera were established in the pivotal Phase III trial known as NETTER-1. The primary endpoint of the study was progression free survival with secondary endpoints including objective response rates, overall survival, safety and tolerability. The study met its primary endpoint with Lutathera achieving statistically significant and clinically meaningful 79% reduction in risk of disease progression or death compared to the control therapy (hazard ratio 0.21, 95% confidence interval: 0.13-0.33, p<0.0001). At the time of study publication in the New England Journal of Medicine (January 2017), median PFS in the control arm was 8.4 months and had not yet been reached in the Lutathera arm.

In addition to Lutathera, AAA brings a broad set of skills in developing, manufacturing and commercializing radiopharmaceuticals, including the companion diagnostics for Lutathera (NETSPOT and SomaKit TOC(TM)). AAA had sales of EUR 109 million in 2016.

Transaction Details
Under the terms of the memorandum of understanding, which has been approved by AAA’s Board of Directors, Novartis will make a cash offer of USD 41 per ordinary share of AAA and USD 82 per American Depositary Share (each representing 2 ordinary shares of AAA) subject to certain conditions. This offer values AAA’s equity at USD 3.9 billion.

The transaction to acquire AAA is planned to be fully funded through external short- and long-term debt.

Novartis will commence a tender offer upon completion of works council consultation and AAA’s Board of Directors recommending the tender offer to AAA shareholders. The senior management and Directors of AAA have, in their capacity as shareholders of AAA, undertaken to tender their shares into the proposed tender offer. The transaction is additionally subject to (i) the valid tender pursuant to the tender offer of ordinary shares (including ordinary shares in the form of American Depositary Shares) of AAA representing at least 80% of the outstanding ordinary shares on a fully diluted basis and (ii) receipt of customary transactional regulatory approvals and other customary closing conditions.

Transaction Terms
The tender offer will be implemented in accordance with the terms and conditions of the binding memorandum of understanding between Novartis and Advanced Accelerator Applications. In addition to the offer terms, the memorandum of understanding contains representations, warranties and undertakings by Novartis and Advanced Accelerator Applications typical in similar transactions. The memorandum of understanding may be terminated by Novartis or Advanced Accelerator Applications under certain circumstances prior to the commencement or completion of the tender offer, including, for example, a material breach by either party of the terms and conditions of the memorandum of understanding prior to the commencement of the tender offer, the Board of Directors of AAA not issuing their positive recommendation following successful completion of the works council consultation, or amending its recommendation in a manner adverse to Novartis, non-receipt of customary transactional regulatory approvals and certain other circumstances. The parties have further agreed on certain expense reimbursement and termination fees payable by AAA to Novartis under certain circumstances, including, if the Board of Directors of AAA determines not to issue a positive recommendation following completion of the works council consultation or subsequently changes or withdraws its recommendation.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “planned,” “to strengthen,” “to acquire,” “would,” “under review,” “potential,” “intends,” “pipeline,” “can,” “work to,” “will,” or similar expressions, or by express or implied discussions regarding the potential outcome of the tender offer for Advanced Accelerator Applications to be commenced by Novartis, and the potential impact on Novartis of the proposed acquisition, including express or implied discussions regarding potential future sales or earnings of Novartis, and any potential strategic benefits, synergies or opportunities expected as a result of the proposed acquisition; and regarding potential marketing approvals, new indications or labeling for the potential, investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward looking statements. There can be no guarantee that the proposed acquisition described in this press release will be completed, or that it will be completed as currently proposed, or at any particular time. Neither can there be any guarantee that Novartis will achieve any particular future financial results as a result of the proposed acquisition, or that Novartis will be able to realize any of potential strategic benefits, synergies or opportunities as a result of the proposed acquisition. Nor can there be any guarantee that the potential, investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations could be affected by, among other things: regulatory actions or delays or government regulation generally, including potential regulatory actions or delays relating to the completion of the potential acquisition described in this release, as well as potential regulatory actions or delays with respect to the development of the products described in this release; the potential that the strategic benefits, synergies or opportunities expected from the proposed acquisition may not be realized or may take longer to realize than expected; the uncertainties inherent in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection; safety, quality or manufacturing issues; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; the particular prescribing preferences of physicians and patients; uncertainties regarding actual or potential legal proceedings, including, among others, potential legal proceedings with respect to the proposed acquisition; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

Lutathera and Netspot are registered trademarks of Advanced Accelerator Applications.

Additional Information
This press release is neither an offer to purchase nor a solicitation of an offer to sell securities. The tender offer for the outstanding ordinary shares and American Depositary Shares of Advanced Accelerator Applications (the “Company”) described in this press release has not commenced. At the time the tender offer is commenced, Novartis and an indirect wholly owned subsidiary of Novartis (“Purchaser”) will file, or will cause to be filed, a Schedule TO Tender Offer Statement with the U.S. Securities and Exchange Commission (the “SEC”) and the Company will file a Schedule 14D-9 Solicitation/Recommendation Statement with the SEC, in each case with respect to the tender offer. The Schedule TO Tender Offer Statement (including an offer to purchase, a related letter of transmittal and other offer documents) and the Schedule 14D-9 Solicitation/Recommendation Statement will contain important information that should be read carefully before any decision is made with respect to the tender offer. Those materials and all other documents filed by, or caused to be filed by, Novartis and Purchaser with the SEC will be available at no charge on the SEC’s website at www.sec.gov (link is external). The Schedule TO Tender Offer Statement and related materials may be obtained for free under the “Investors – Financial Data” section of Novartis website at View Source The Schedule 14D-9 Solicitation/Recommendation Statement and such other documents may be obtained for free from the Company under the “Investor Relations” section of the Company’s website at View Source

New data show that switching patients with Crohn’s disease (CD) to INFLECTRA (infliximab CT-P13) from REMICADE (infliximab) led to comparable efficacy, safety and tolerability to treatment with REMICADE over a 24 week period (Press release, Pfizer, OCT 30, 2017, View Source [SID1234521318]). The full 54-week results of the randomized controlled trial comparing INFLECTRA and REMICADE in biologic-naïve patients with active CD support the long-term effectiveness of treatment with INFLECTRA.1 The results also show that INFLECTRA was well-tolerated, with a similar safety profile to REMICADE.1 Pfizer Inc. (NYSE:PFE) and Celltrion Healthcare jointly announced the secondary outcomes from the phase III trial of INFLECTRA in CD at the 25th United European Gastroenterology (UEG) Week.

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*INFLECTRA is marketed as INFLECTRA (infliximab-dyyb) in the United States (U.S.) and under other brand names in some countries. In the EU, INFLECTRA is marketed as INFLECTRA (infliximab CT-P13)
**REMICADE is a U.S. registered trademark of Janssen Biotech, Inc.

"The data announced today show that 24 weeks (six months) after switching from REMICADE to the Infliximab biosimilar CT-P13, patients with Crohn’s disease continue to experience similar efficacy, safety and tolerability compared to staying on REMICADE," said Stephen B Hanauer, M.D., Professor of Medicine-Gastroenterology and Hepatology, Feinberg School of Medicine, Northwestern University, US. "These data support previous findings which demonstrate the importance of CT-P13 as a treatment option for patients with Crohn’s disease, providing healthcare professionals further confidence when stable patients switch to CT-P13 from REMICADE."

"These new data add to the considerable body of evidence, including real-world studies and the NOR-SWITCH trial, for the switching of stable patients to INFLECTRA," said Sam Azoulay, M.D., Senior Vice President, Chief Medical Officer, Pfizer Essential Health. "Today’s announcement further highlights Pfizer’s commitment to biosimilars and provides additional evidence supporting use of INFLECTRA in Crohn’s disease."

The study previously reported its primary endpoint at six weeks, demonstrating non-inferiority of INFLECTRA compared to REMICADE in the treatment of CD.2

More than 50 real-world studies in IBD have been conducted with INFLECTRA, evaluating over 7,500 IBD patients in real-world settings.2,3,4,5,6,7,8,9,10,11,12,13,14 There is an important and growing body of evidence for the switching of stable REMICADE patients to INFLECTRA. Clinical studies supporting this switch include NOR-SWITCH,15 BIO-SWITCH,16 PROSIT-BIO3 and now CT-P13 3.4.1,2,17 For example, the NOR-SWITCH study published earlier this year showed that switching from REMICADE to INFLECTRA was not inferior to continued treatment with REMICADE when measured across all adult indications.15

About the trial

This is a randomized, double-blind, parallel-group, phase III study conducted over 54 weeks in 220 patients with active CD to compare overall safety and efficacy between INFLECTRA and REMICADE as determined by the Crohn’s Disease Activity Index (CDAI)-70 response rates†.1 The primary endpoint of the 54 week study was collected at week 6 to demonstrate that INFLECTRA is non-inferior to REMICADE in the treatment of CD.2 From Week 30, patients on REMICADE were randomized to either continue on the same treatment or switch to INFLECTRA while patients on INFLECTRA were randomized to either continue on the same treatment or switch to REMICADE.1 Final study results were collected at 54-weeks.1

The pre-specified secondary endpoints reported today include CDAI-70 response rates after week 6, clinical remission,[1] Short Inflammatory Bowel Disease Questionnaire (SIBDQ)[2] results, and safety endpoints including adverse events and immunogenicity. While not powered to draw definitive conclusions, these new data add to the body of evidence supporting use of INFLECTRA in the Crohn’s Disease indication, including switch to INFLECTRA from REMICADE.1 Comparable efficacy, as measured by CDAI-70 response and clinical remission after week 6 was observed, and these response rates were maintained and observed to be similar in all study arms at week 54.1 One-year data including adverse drug reactions, serious adverse events and infections were observed to be similar among all treatment groups.1 There were no clinically meaningful differences in immunogenicity results throughout the study period among treatment groups up to week 54.1

† CDAI: Crohn’s Disease Activity Index, a recognised measure for the evaluation of disease activity. A response to treatment is measured as a decrease of 70 points or greater (CDAI-70).
[1] Clinical remission: decrease in CDAI >150 points
[2] Short Inflammatory Bowel Disease Questionnaire, a health-related quality of life tool measuring physical, social, and emotional status, and has been predominantly used in trials for Crohn’s disease.

ABOUT INFLECTRA: IMPORTANT SAFETY INFORMATION AND INDICATIONS FROM THE U.S. PRESCRIBING INFORMATION

Only your doctor can recommend a course of treatment after checking your health condition. INFLECTRA (infliximab-dyyb) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with INFLECTRA.

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking infliximab products and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including INFLECTRA, the chances of getting lymphoma or other cancers may increase.

You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take INFLECTRA?

You should let your doctor know if you have or ever had any of the following:

Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start INFLECTRA.
Lived in a region where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
Infections that keep coming back, diabetes, or an immune system problem.
Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
Heart failure or any heart condition. Many people with heart failure should not take INFLECTRA.
Hepatitis B virus (HBV) infection or think you may be a carrier of HBV. Your doctor will test you for HBV.
Nervous system disorders (like multiple sclerosis or Guillain-Barré syndrome).
Also tell your doctor if you:

Use the medicines Kineret (anakinra), Orencia (abatacept), or Actemra (tocilizumab) or other medicines called biologics used to treat the same problems as INFLECTRA.
Are pregnant, plan to become pregnant, are breast-feeding, or have a baby and were using INFLECTRA during your pregnancy. Tell your baby’s doctor about your INFLECTRA use. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death.
Recently received or are scheduled to receive a vaccine. Adults and children taking INFLECTRA should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer) while taking INFLECTRA.
What should I watch for and talk to my doctor about before or while taking INFLECTRA?

The following serious (sometimes fatal) side effects have been reported in people taking INFLECTRA.

You should tell your doctor right away if you have any of the signs listed below:

Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red, or painful skin or any open sores. INFLECTRA can make you more likely to get an infection or make any infection that you have worse.
Lymphoma or any other cancers in adults and children.
Skin cancer—any changes in or growths on your skin.
Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash, and/or joint pain.
Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
Blood disorders—fever that doesn’t go away, bruising, bleeding, or severe paleness.
Nervous system disorders—numbness, weakness, tingling, changes in your vision, or seizures.
Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun.
Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.
The more common side effects with infliximab products are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing, and stomach pain.

INFLECTRA is a prescription medication used to treat:

Crohn’s Disease

Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven’t responded well to other therapies
Paediatric Crohn’s Disease

Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active Crohn’s disease who haven’t responded well to other therapies
Ulcerative Colitis

Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who haven’t responded well to other therapies
Rheumatoid Arthritis

Can reduce signs and symptoms, help stop further joint damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis, in combination with methotrexate
Ankylosing Spondylitis

Can reduce signs and symptoms in patients with active ankylosing spondylitis
Psoriatic Arthritis

Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in patients with psoriatic arthritis
Plaque Psoriasis

Approved for the treatment of adult patients with chronic severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if INFLECTRA is appropriate considering other available therapies
Please see full Prescribing Information for INFLECTRA (infliximab-dyyb).

On October 30, 2018 Xynomic Pharma, a clinical stage US oncology drug development company, reported that it has acquired exclusive global rights to develop, manufacture and commercialize BI 882370, a 2nd-generation RAF inhibitor, from Boehringer Ingelheim, a top-20 global pharmaceutical company (Press release, Xynomic Pharmaceuticals, OCT 30, 2017, View Source [SID1234527683]). Under the terms of the agreement Xynomic will pay upfront, milestone and royalty payments up to approximately $502 million.

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BI 882370 is a potent and selective RAF inhibitor uniquely binding to the DFG-out conformation, whereas marketed BRAF inhibitors occupy the DFG-in conformation. BI 882370 inhibited proliferation of BRAFmut melanoma cell lines with 100x higher potency (EC50 1 – 10 nM) than vemurafenib (VEM), a marketed BRAF inhibitor.

In the colorectal cancer (CRC) animal models, BI 882370 was superior to VEM in both the Colo-205V600V/E model and HT-29V600V/E model. BI 882370 in combination with cetuximab induced tumor regressions in the less sensitive HT-29 model.

In melanoma’s G-361V600V/E model, BI 882370 was superior to VEM, marketed BRAF inhibitor dabrafenib (DAB), marketed MEK inhibitor trametinib (TRA) and DAB-TRA combination. In a second melanoma model A375V600E in which tumors developed resistance to VEM, the TRA-BI 882370 combination demonstrated superior efficacy over TRA-DAB combination.

There were no relevant findings in exploratory toxicology studies at exposures delivering efficacy superior to VEM, DAB and TRA.

"BI 882370, with an impressive efficacy and safety profile demonstrated in animal models, is well positioned to become a best-in-class 2nd-generation Pan-RAF inhibitor for the treatment of B-RAF mutant cancers including CRC and melanoma. We are honored to partner with BI, a global leader in oncology, and will move this asset into clinical testing expeditiously," said Y. Mark Xu, Chairman, CEO and President of Xynomic.

RAF inhibitors have attracted resurged and strong interest in oncology. Compared to 1st-generation, BI 882370 may provide an improved therapeutic window, enabling more pronounced and longer-lasting pathway suppression and thus resulting in improved efficacy.

Xynomic’s pipeline also includes Abexinostat, a potentially best-in-class HDAC inhibitor entering global pivotal Ph 3 trials against Non-Hodgkin’s lymphoma and renal cell carcinoma.