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¡´Opdivo pk. Nexavar phase 3 (·m1½u¥ÎÃÄ)---Oct 2018 complete (NCT 02576509)

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mOS= 19.5¤ëLenvima : 16.3¤ëNexavar(p>0.05)

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mOS= 10.4¤ëLenvima : 8.2¤ëNexavar(p>0.05)

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TTP¥­§¡´_µo= 8.9¤ëLenvima : 3.7¤ëNexavar(p<0.00001)

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aspartate aminotransferase¤W¤É5%:8%,

diarrhea4%:4%

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¡´ Lenvima+Keytruda¥Î¦bRCC(renal cell carcinoma)¤@½uªvÀø2018/01/09¦³®³¨ìFDAªºbreakthrough therapy

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1. Japan (June 2017)

2. United States and Europe (July 2017)

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Our research indicates that there are several players with mid/late-stage clinical candidates that are likely to enter the market in the coming decade; examples include Agios Pharmaceuticals, Celgene, Polaris Group, Bio-Cancer Treatment International, BERG Health, Cornerstone Pharmaceuticals, Taiho Pharmaceutical, Novartis and 3-V Biosciences.

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Dear all,

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¡´¥_·¥¬PªºÄvª§¹ï¤âNewlink¦³·s®ø®§¡÷´N¬O2018¦~·|Àu¥ý¦bIndoximod+Keytruda or Indoximod+Opdivo¤W¡I

Jan 8, 2018

NewLink Genetics Outlines 2018 Business Priorities to Support Phase 3 Pivotal Trial of Indoximod Plus PD-1 Inhibitors

NewLink Genetics updates financial and clinical guidance

AMES, Iowa, Jan. 08, 2018 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (NASDAQ:NLNK) today announced Indigo301, the name of its upcoming Phase 3 trial of indoximod plus PD-1 inhibitors for patients with advanced melanoma, and outlined 2018 business priorities to support this trial. In addition, the company updated clinical and financial guidance and provided preliminary unaudited financial information for year-end 2017.

¡´Newlinkªº¦Ñ¤j·|¦b01/11 36th JP Morgan¤W³ø§i¡I

These updates were made in conjunction with the 36th Annual JP Morgan Healthcare Conference that begins today in San Francisco. NewLink Genetics¡¦ Chairman and Chief Executive Officer, Charles J. Link, Jr., M.D., will discuss the Company¡¦s continued execution of its corporate strategy and 2018 priorities as part of a live presentation on Thursday, January 11, 2018, at 11:00 AM PT/2:00 PM ET. The slide presentation with updated guidance has been posted on the Company¡¦s website and may be found here. The oral presentation will be webcast and available on the NewLink Genetics website under the Investors & Media tab under Events & Presentations.

¡´Indoximod+Keytruda or Indoximod+Opdivo phase 3¬Omelanoma¡A©M¬P¬PÃö«Y¤£¤j¡I

Indigo301 is a randomized Phase 3 study of indoximod or placebo plus KEYTRUDA® (pembrolizumab) or OPDIVO® (nivolumab) for patients with unresectable or metastatic melanoma. The choice of PD-1 inhibitors will be at the physician¡¦s discretion, mirroring the general clinical setting. The study will consist of a planned 624 patients enrolled at approximately 100 sites in multiple countries and will include co-primary endpoints of Progression-Free Survival (PFS) and Overall Survival (OS), with a secondary endpoint of Objective Response Rate (ORR).

¡´¦ý¬O¡A¯ØŦÀù´N©M¬P¬P¬ÛÃö¤F¡IIndoximod+Imfinzi (AstraZeneca)ªºPhase 2 RCT·|¦b1H2018±Ò°Ê¡I

¡´¯ØŦÀùindoximod + gem/nab-paclitaxelªºPhase 2µ²ªG¤]±N¦b1H2018¤½§G¡I

NewLink has focused its business priorities on the execution of Indigo301 for patients with advanced melanoma, said Dr. Link. We will also initiate a randomized Phase 2 trial in collaboration with AstraZeneca for patients with metastatic pancreatic cancer, and we anticipate clinical data from additional development programs.

To expedite the enrollment of Indigo301, NewLink Genetics has expanded the planned number of trial sites both within and outside of the US and plans several clinical recruitment initiatives to engage with the oncology community with the goal to enroll the majority of patients in 2018. As a result of these clinical planning efforts, NewLink Genetics is accordingly updating its guidance for clinical trials as follows:

Clinical Guidance and Milestones

• Enroll the majority of Indigo301 trial by the end of 2018

• Phase 2 results for indoximod + PD-1 blockade in advanced melanoma expected in 2018

• Phase 2 results for indoximod + gem/nab-paclitaxel in pancreatic cancer expected 1H 2018

• Phase 2 randomized AstraZeneca collaboration in pancreatic cancer to initiate 1H 2018

¡´­È±o´Á«ÝNewlink¯ØŦÀùindoximod + gem/nab-paclitaxelªºPhase 2µ²ªG¡Aª¾¤vª¾©¼¡I¦n®a¦b

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¡´­è­èªº·s»D¡G¥@¬É«e20¤j(¥@¬É³Ì¤jªº¯Ø®q¯ÀÃÄ°Ó)ªº¤¦³Á¤jÃÄ°ÓNovo nordisk¡A±ý¨Ö¤ñ§Q®ÉÃÄ°ÓAblynx¡A¦]¬°¦ûNovo nordisk²Ä¤G¾P°âÃBªº¦å²G¯e¯f¥ÎÃÄ¡A¦b¤W­Ó¤ëRocheªºHemlibra phase 3¼Æ¾Ú¤½§G«á¡ANovo nordisk¦p¨~¨ë¦b­I¡A¥²¶·¨³³t¨ÖÁÊ¡A¥iÅý¨ä¦å²G¯e¯f¥ÎÃħG§½§ó§¹¾ãªºAblynx¡A±µ¤U¨Ó¤~¥i¥H©MRoche§Ü¿Å¡I

¡´2017/12/07Novo nordisk²Ä¤@¦¸³Û»ù¨CªÑ26.75¼Ú¤¸(·¸»ù60%)¨ÖAblynx (2017/12/06 AblynxªÑ»ù19.12)¡A2017/12/14 Ablynx Â_µM©Úµ´¡I

¡´2017/12/22Novo nordisk­×§ï»ù®æ¦Ü¨CªÑ30.50¼Ú¤¸(·¸»ù66%[2018/01/05 3­Ó¤ë§¡»ù18.39¼Ú]¡A¥]§t¨CªÑ28¼Ú¤¸¤Î´Á«Ý»ù­ÈÅvCVR[AblynxªºSTEADY trial Phase 2§¹¦¨¥I0.5¼Ú, ALX-0171 Phase 3§¹¦¨¥I2.0¼Ú]2.5¼Ú¤¸)¨ÖAblynx (2017/12/06 AblynxªÑ»ù19.12)¡A2017/12/23 Ablynx ¦A¦¸Â_µM©Úµ´¡I

¡´2018/01/05 Novo nordiskªºCEO§iª¾AblynxªºCEO¡A·Q­n¦n¦n²á¤@²á¡A¨ÌµM³Q©Úµ´¡I

Following this, Lars Fruergaard Jørgensen, chief executive efficer of Novo Nordisk, spoke to Edwin Moses, chief executive officer of Ablynx on 5 January 2018 to reiterate Novo Nordisk¡¦s commitment to the transaction and to encourage Ablynx to meet with Novo Nordisk in order to have a discussion around key value drivers. Unfortunately, this offer was again refused by the Board of Directors of Ablynx.

¡´¦Ñ´­Ä±±o«Ü¦³½ìªº¬O¡A­ì¨Ó³Q©Úµ´³o»ò¦h¦¸«á¡A¶R¤è·|µo·s»D½Z¡A§â´£®×ªº²Ó¸`¤½¶}¡I¨ÖÁʪº±ø¥ó¤º®e©M²Ä¤G¦¸³Û»ù¨CªÑ30.50¼Ú¤¸(Á`¦@26E¼Ú ©Î 31EÁâ)¤@¼Ë¡A¨Ã¨S¦³¼W¥[¡A·N«ä¬O­n¹GAblynxªÑªF¦V¤½¥q¬IÀ£¶Ü¡H(¦pªG¤j¦h¼ÆAblynxªºªÑªF³£»{¬°¦Eºâªº¸Ü)

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08 Jan 2018 06:30 CET

Novo Nordisk has proposed to acquire Ablynx for up to EUR 30.50 per share in cash, consisting of EUR 28.00 upfront and EUR 2.50 in Contingent Value Rights

• Proposal consists of upfront cash consideration of EUR 28.00 per share and one Contingent Value Right (¡¦CVR¡¦) with total potential cash payments over time of up to EUR 2.50 per share

• Opportunity to combine Ablynx¡¦s lead asset caplacizumab for the treatment of the rare bleeding disorder acquired Thrombotic Thrombocytopenic Purpura (aTTP) with Novo Nordisk¡¦s existing haematology franchise and extensive worldwide resources

• Novo Nordisk intends to keep Ablynx as a global antibody centre-of-excellence within Novo Nordisk, with Ablynx¡¦s Ghent site to become an important part of Novo Nordisk¡¦s R&D organisation

• All-cash transaction of approximately EUR 2.6 billion[1] represents a substantial premium of up to 66% over Ablynx¡¦s 3 month Volume Weighted Average Price (VWAP) of EUR 18.39

• CVR structure provides Ablynx¡¦s shareholders with potential to receive a specific cash return related to upcoming events concerning vobarilizumab and ALX-0171

• Novo Nordisk encourages Ablynx¡¦s Board of Directors to engage in a negotiated transaction for the benefit of all stakeholders

¡´¾Ç¨ìªºÁÙ¦³³o­Ó¦rContingent Value Right (¡¦CVR¡¦)¡÷´Á«Ý»ù­ÈÅv¡I

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Celgene Corporation Enters Into Global Strategic Immuno-Oncology Collaboration with BeiGene to Advance PD-1 Inhibitor Program for Solid Tumor Cancers

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• Collaboration maximizes potential for best-in-class PD-1-based immuno-oncology combinations in solid tumors by leveraging BGB-A317¡¦s differentiated profile and Celgene¡¦s novel pipeline assets and global oncology expertise

• BeiGene to acquire Celgene¡¦s commercial operations in China and exclusive license to Celgene¡¦s China cancer commercial portfolio (ABRAXANE®, REVLIMID®, VIDAZA®)

• BeiGene to receive $263 million in upfront license fees and $150 million equity investment

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I saw the sun begin to dim

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Blow cold

A man learns who is there for him

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If all was lost

Is more I gain

Cause it led me back...

To you

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I drank champagne with kings and queens

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The pitfalls of the man I became

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For years and years

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The crazy speed of always needing more

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I remember who all this was for

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And from now on

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From now on

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