On February 5, 2018 Yuhan Corporation (KRX:000100.KS) (Yuhan) and Sorrento Therapeutics, Inc. (Nasdaq:SRNE) (Sorrento) reported that the South Korean Ministry of Food and Drug Safety (MFDS) has approved ImmuneOncia Therapeutics’ (51% Yuhan/49% Sorrento joint venture formed in March 2016) IND for the initiation of clinical trials for Sorrento-discovered anti-PD-L1 monoclonal antibody STI-A1015 (IMC-001), which is exclusively licensed to ImmuneOncia for select regional markets by Sorrento (Press release, ImmuneOncia Therapeutics, FEB 5, 2018, View Source [SID1234531898]).

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Yuhan had initially contributed more than $10M to the formation of ImmuneOncia and towards the development of IMC-001, with a commitment of additional funding for clinical development of IMC-001. Sorrento contributed its antibody STI-A1015 (IMC-001) and two other antibodies, as well as cGMP manufacturing and regulatory expertise support for the data submission package for the IND.

The clinical Phase 1 studies will enroll patients suffering from solid tumors at two clinical sites in South Korea, namely, Seoul National University Hospital (SNUH) and Samsung Medical Center (SMC).

"We are proud to announce the acceptance of the IND by MFDS for our anti-PD-L1 antibody IMC-001. Throughout the IND-enabling activities, our team has worked collaboratively with our Sorrento colleagues to generate a high-quality submission package that was very well received by MFDS", said Dr. Kwang Ho Cheong, CEO of ImmuneOncia Therapeutics.

"Yuhan is proud of this outstanding achievement by Dr. Cheong and the ImmuneOncia team. Together with our friends and partners from Sorrento, we created ImmuneOncia to develop important immunotherapies for cancer patients in South Korea and worldwide. Through our investment in ImmuneOncia, Yuhan has become a true biopharmaceutical company. We look forward to the future success of IMC-001 and the other antibody programs in ImmuneOncia’s pipeline", said Mr. Jung Hee Lee, CEO and President of Yuhan Corporation.

"We are very pleased with the progress made by our joint venture in the past year. We believe this is additional validation of our antibody technology as well as our in-house cGMP antibody manufacturing and development capabilities. Notably, Sorrento has retained the rights for STI-A1015 (IMC-001) in many major markets, including the EU, Japan and the US, and we intend to leverage ImmuneOncia’s clinical work to support our clinical development in these territories where we retain rights to STI-A1015 (IMC-001). We also think the success of ImmuneOncia further highlights our ability to create shareholder value through productive strategic partnerships," added Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics.

ImmuneOncia is exploring being publicly-listed on the South Korea Stock Exchange (KSEX) in 2019, which could result in additional sources of non-dilutive capital for Sorrento.

About IMC-001 (PD-L1 monoclonal antibody)

IMC-001 is a fully human anti-PD-L1 monoclonal antibody (mAb) immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, then suppressing the inhibition of PD-1/PDL1 signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting Natural Killer (NK) cells and other effector cells against the tumor potentially further strengthening the anti-tumor effect of the antibody

On February 5, 2018 H3 Biomedicine Inc., a clinical stage biopharmaceutical company specializing in the discovery and development of next generation cancer medicines using its data science and precision chemistry product engine, reported that company management will present an overview of the company at the 2018 BIO CEO & Investor Conference on Monday, February 12, 2018, at 9:45 a.m. EST at the New York Marriott Marquis in New York (Press release, H3 Biomedicine, FEB 5, 2018, View Source [SID1234523723]).

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On February 5, 2018 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reportd that it will be announcing its final results for the year ended December 31, 2017 on Monday, March 12, 2018 at 7:00 am Greenwich Mean Time (GMT) (Press release, Hutchison China MediTech, FEB 5, 2018, View Source [SID1234523724]).

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An analyst presentation will be held at 9:00 am GMT (5:00 pm Hong Kong Time) on the same day at Citigate Dewe Rogerson, 3 London Wall Buildings, London, EC2M 5SY, UK, which will be webcast via the company website at www.chi-med.com/investors/event-information/. The presentation will be available to download before the analyst presentation begins.

For North America based analysts and investors, Chi-Med will also host a conference call with Q&A at 9:00 am Eastern Daylight Time (1:00 pm GMT).

Details of the analyst presentation and conference call dial-in will be provided in the financial results announcement. A replay will also be available on the website shortly after each event.

On February 4, 2018 ADC BIO reported the development of a revolutionary, ‘downstream bio-conjugation’ method that will present a new paradigm in Antibody Drug Conjugate (ADC) development and manufacturing (Press release, ADC BIO, FEB 4, 2018, View Source [SID1234526749]). In contrast to the existing approaches – which undertake bio-conjugation after both the mAb and cytotoxic have been manufactured – this new approach moves the conjugation step into the later stages of the downstream processing (DSP), with conjugation and antibody purification carried out concurrently.

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"The major benefit, and the reason this approach will prove so disruptive, is that it will save several months of manufacturing time and up to 25% of the overall costs. But it will require much of the industry, with its current ingrained manufacturing methods, to re-evaluate exactly how it structures the supply chain that often uses three CMOs," commented Charlie Johnson, CEO of ADC Bio.

Using this ‘downstream bio-conjugation’ approach, potentially means less time at the antibody manufacturer (i.e. less time in traditional downstream processing), with the remaining downstream processing and conjugation service both transferring to the bio-conjugation CMO. The result is a refined, simpler and much more efficient system – saving up to three months of development time and resources plus creating large cost savings.

Under the Company’s new process, the starting point for the conjugation will no longer be post-creation of purified antibodies and will instead begin with antibody supernatants. This persuasive approach forgoes the need for extensive chromatographic purification techniques to deliver purified antibody.

The Company’s groundbreaking production technique – yet to be formally named – would also remove the need for expensive Protein A resins, instead replacing them with capture resins that are at the heart of the Company’s core ‘Lock-Release’ technology. In ADC manufacturing, the Protein A capture step is the most costly in downstream processing, delivering semi-purified antibody. Now, starting from antibody supernatant, ADC Bio’s unique approach will see their patented ‘Lock-Release’ technology facilitate both the antibody capture step and subsequent conjugation to the ADC payload – essentially replacing the Protein A resin and assembling the ADC in an efficient manner. The subsequent viral inactivation, removal and polishing will then occur post-conjugation.

The benefits of eliminating the need for proteinaceous A & G resins extends beyond substantial cost savings. Incidental leaching of these proteins from their purification media increases the impurities in a biopharmaceutical drug product – all of which have to be removed in subsequent chromatography polishing steps before an antibody can be used for any therapeutic application. Moreover, Protein A is known to cause immunogenic responses in humans and has proven toxic in a number of clinical studies – thus its removal is mandatory.

On February 2, 2018 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it will host a webcast and conference call on Friday, February 9, 2018, at 4:30 p.m. EST to discuss its financial results for the fiscal 2018 first quarter ended December 31, 2017 (Press release, Arrowhead Pharmaceuticals, FEB 2, 2018, View Source [SID1234523702]).

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 4788374.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 4788374.