On January 14, 2020 A2A Pharmaceuticals Inc. (A2A) reported an agreement to design and co-develop oncology drug candidates with Daewoong Pharmaceutical Co., Ltd. (Daewoong), a major pharmaceutical company in South Korea, using its proprietary AI-enabled drug discovery platform SCULPT (Press release, A2A Pharmaceuticals, JAN 14, 2020, View Source [SID1234553181]). The companies will collaborate on up to three oncology drug targets to accelerate Daewoong’s efforts to develop innovative oncology treatments through open collaboration.

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Under this collaboration, A2A will use its computational drug discovery platform to design new compound structures, which will be synthesized and evaluated by Daewoong. Both parties will actively cooperate in preclinical optimization and selection of lead candidates to enter the clinic.

A2A will receive upfront and preclinical milestones for each discovery target under the agreement, and could receive clinical and commercialization milestones, and royalties. A2A will have the option to develop compounds from the collaboration that Daewoong decides not to pursue.

"A2A’s technology has demonstrated success going after difficult-to-drug targets in diseases with high unmet needs for patients", said A2A CEO, Dr. Sotirios Stergiopoulos. He added "We’re excited to embark on this collaborative journey with Daewoong, combining our strengths to bring high quality drugs to the patients who need them faster."

With this partnership, Daewoong expects to expand its portfolio in oncology, while also to secure a successful case of AI-based drug development, which has been emerging as a recent pharmaceutical industry trend. There is justified precedent, because compared to traditional new drug development processes, A2A’s proprietary SCULPT platform will generate higher quality new drug candidates while greatly reducing the time and cost of development.

"Even though it is still in its very early stages, the development of new AI-based drugs is rising globally" said Sengho Jeon, CEO of Daewoong, "This open-collaboration between Daewoong’s strong expertise in new drug development and A2A’s SCULPT platform technology will significantly enhance the competitiveness of Daewoong in the oncology market."

On January 14, 2020 XBiotech Inc. (NASDAQ: XBIT) ("XBiotech") reported that it commenced a "modified Dutch auction" tender offer to purchase up to $420,000,000 of its common shares, or such lesser number of common shares as are properly tendered and not properly withdrawn, at a price not less than $30.00 nor greater than $33.00 per common share, to the seller in cash, less any applicable withholding taxes and without interest (the "Offer") (Press release, XBiotech, JAN 14, 2020, View Source [SID1234553180]). The Offer is made upon the terms and subject to the conditions described in the offer to purchase and in the related letter of transmittal. The closing price of XBiotech’s common shares on the NASDAQ Global Select Market on January 13, 2020, the last full trading day before the commencement of the Offer, was $18.62 per share. The Offer is scheduled to expire at 5:00 p.m., New York City time, on February 12, 2020, unless the Offer is extended.

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XBiotech believes that the Offer represents an efficient mechanism to provide XBiotech’s stockholders with the opportunity to tender all or a portion of their stock and thereby receive a return of some or all of their investment in XBiotech if they so elect. The Offer provides stockholders with an opportunity to obtain liquidity with respect to all or a portion of their stock without the potential disruption to XBiotech’s stock price.

The Offer is not contingent upon obtaining any financing. However, the Offer is subject to a number of other terms and conditions, which are described in detail in the offer to purchase. Specific instructions and a complete explanation of the terms and conditions of the Offer will be contained in the offer to purchase, the letter of transmittal and the related materials, which will be mailed to stockholders of record shortly after commencement of the Offer.

None of XBiotech, the members of its Board of Directors (including the Independent Committee who authorized the Offer), the information agent or the depositary makes any recommendation as to whether any stockholder should participate or refrain from participating in the Offer or as to the price or prices at which stockholders may choose to tender their shares in the Offer.

D.F. King & Co., Inc. will serve as information agent for the Offer. Stockholders with questions, or who would like to receive additional copies of the Offer documents may call D.F. King at (212) 269-5550 (banks and brokers) or (866) 856-3065 (all others).

On January 14, 2020 NantKwest Inc., (Nasdaq: NK), a clinical-stage natural killer cell-based therapeutics company, reported results from their Phase 1 trial investigating a novel, first-in-human immunotherapy consisting of NantKwest’s off-the-shelf, PD-L1 tumor-targeted NK cells (NCT04050709) (Press release, NantKwest, JAN 14, 2020, https://ir.nantkwest.com/news-releases/news-release-details/nantkwest-and-immunitybio-announce-complete-response-metastatic?field_nir_news_date_value[min]= [SID1234553179]). In addition, NantKwest and ImmunityBio, Inc., a privately held immunotherapy company, reported on a compassionate use expanded access IND combining the PD-L1-targeted NK cell with ImmunityBio’s IL-15 fusion protein (N-803) in a patient with metastatic pancreatic cancer who had relapsed after prior standard of care therapy.

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The findings on the Phase 1 safety and early signals of efficacy were reported by Patrick Soon-Shiong, M.D., Chairman and CEO of NantKwest, at the J.P. Morgan Healthcare Conference in San Francisco.

"We hypothesize that a common treatment protocol that harnesses both the natural-killer cell and the T cells could be effective in treating cancer across multiple tumor types. This has been supported by the early signals of safety and efficacy in Phase 1 and 2 studies of NantKwest’s natural killer cells in advanced cancers. We recently reported at the 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference (SITC) (Free SITC Whitepaper) complete responses in third-line Merkel cell carcinoma and fourth-line head and neck cancers when haNK CD-16 NK cells combined with Pfizer’s PD-L1 antibody, Avelumab, and with ImmunityBio’s N-803, an IL-15 superagonist were administered," said Dr. Soon-Shiong. "Most recently we reported complete responses using combination therapies which included haNK, Avelumab and N-803 in Triple Negative Breast Cancer. Durable complete responses were observed in these patients who had failed all standards of care therapy for breast cancer. The results were presented at the 2019 San Antonio Breast Cancer Symposium (SABCS) in December 2019."

"The evolution of the next generation NK in our platform was now to enable haNK cells to target tumors by expressing PD-L1 CAR (chimeric antigen receptor) on the surface of haNK NK cells. These PD-L1.taNK NK cells have the properties of targeting PD-L1 on tumors, without the need of an additional PD-L1 checkpoint, Avelumab."

The FDA authorized the first-in-human safety studies of PD-L1.t-haNK (Quilt 3.064; NCT04050709) at doses of two billion cells administered bi-weekly as outpatients. No dose limiting or treatment-related events were noted in patients treated to date in this first dosing cohort. The study is now enrolling the dose cohort of four billion cells per infusion.

PD-L1.t-haNK Combined with N-803 IL-15 Protein for Treatment of Metastatic Pancreatic Cancer

An expanded access regimen incorporating N-803 with PD-L1.t-haNK was authorized to treat a patient with metastatic pancreatic cancer who had failed standard of care, based on the safety and efficacy data of the Phase 1 trial in 11 patients with metastatic pancreatic cancer who had received haNK and N-803. After five infusions of PD-L1.t-haNK and N-803, the patient’s tumor metastasis resolved completely per CT/Pet scan and the complete response has been confirmed by a repeat CT/Pet scan. Patient continues to receive ongoing treatment.

"We are extremely pleased that the FDA granted us this expanded IND authorization to initiate this novel immunotherapy treatment enabling the cross-talk of the innate natural killer system with the adaptive T cell," said Dr. Soon-Shiong. "Achieving complete response in metastatic pancreatic cancer and durable, complete responses in metastatic TNBC patients that have failed all current standards of care is a promising finding which may further validate our approach to orchestrate both the innate and adaptive immune system," continued Soon-Shiong. "Pancreatic cancer and TNBC are highly aggressive cancers with limited treatment options. These results are important, proof-of-concept supporting our hypothesis that comprehensively activating the immune responses of the NK, T and Dendritic cells, the ‘triangle offense’, would induce immunogenic cell death leading to durable responses, even among this challenging patient population. Based on these encouraging findings, we plan to initiate clinical trials to confirm efficacy in second-line metastatic pancreatic cancer and third-line Triple Negative Breast cancer."

On January 14, 2020 PharmaMar (MSE:PHM) has reported the start of a Phase I-II clinical trial in Spain to determine the recommended dose and efficacy of lurbinectedin in combination with atezolizumab (Roche) in patients with advanced SCLC whose disease has progressed following previous platinum-based chemotherapy (Press release, PharmaMar, JAN 14, 2020, View Source [SID1234553178]). The first patient has already been enrolled.

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This is a prospective, open-label, multi-center study which will include two parts: a Phase I study with primary objective to determine the Recommended Dose (RD) of the lurbinectedin-atezolizumab combination, followed by a Phase II, single-arm study, with an expansion cohort of patients treated at the RD, this being determined during the Phase I part. The primary endpoint of the Phase II part is to evaluate the efficacy of the combination in terms of Overall Response Rate (ORR). Secondary objectives include Duration of Response (DoR), Progression-Free Survival (PFS) and Overall Survival (OS), in addition to the safety profile and tolerability of the combination.

Lurbinectedin has shown in pre-clinical studies that its mechanism of action induces cell death, reinstates and enhances systemic anticancer immune responses, resulting in a long-term immunological memory effect, underlining the potency of lurbinectedin combination with immunotherapy.

According to Dr. Luis Paz-Ares, Head of the Oncology Department at the 12 de Octubre University Hospital in Madrid and principal investigator of the study, "the efficacy demonstrated by lurbinectedin as a single agent in the Phase II Basket trial and the results seen in preclinical combinations with immunotherapy make us optimistic about the start of this new trial, with which we hope to provide a new treatment option for patients with small-cell lung cancer".

SCLC is a very aggressive cancer that is usually diagnosed with advanced, often metastatic disease, limiting the role of traditional approaches and posing a worse prognosis when compared to other lung cancers. About 14% of lung cancers are 2 Small Cell1, with about 30,000 new cases in the United States alone each year2. This tumor is strongly associated with smoking, which is a major public health problem.

On January 14, 2020 Perrigo Company plc (NYSE: PRGO) (TASE: PRGO) Chief Executive Officer and President Murray S. Kessler reported that it will highlight the progress of the Company’s transformation into a consumer self-care company and discuss certain financial metrics for recently completed periods later at the 38th Annual J.P. Morgan Healthcare Conference (Press release, Perrigo Company, JAN 14, 2020, View Source [SID1234553176]).

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The presentation will cover the major initiatives completed in year one of the transformation including efforts to reconfigure the company’s product portfolio, deliver on its base plans, create repeatable platforms for growth, drive organizational effectiveness and capabilities, increase productivity, allocate capital and deliver consistent and sustainable results in-line with consumer-packaged goods peers.

Kessler commented, "We are pleased to see the business responding to our transformation efforts. While we have only completed the first year of our 2 to 3-year transformation journey, the revenue growth we have seen in the second half indicates that we are on the right track. The third quarter was strong. The fourth quarter was outstanding. All business segments delivered stellar fourth quarter net sales results with strong organic growth. The Consumer Self-Care Americas segment achieved reported net sales growth of more than 15% in the quarter versus prior year, with adjusted organic net sales(1) higher by 11%, led by strong performances in both the OTC and infant nutrition businesses. Fourth quarter reported net sales in the Consumer Self-Care International segment increased 8%, with 4% adjusted organic net sales growth. Rx had a nice quarter as well, growing fourth quarter reported net sales by 3% versus last year. Second half results support our belief that the company will exceed its long-term revenue target of 3% growth in the coming year."

Preliminary Unaudited Fiscal Year 2019 Net Sales Results
Benefiting from a strong fourth quarter, consolidated reported net sales for fiscal 2019 were $4.8 billion for the full year, an increase of 2% compared to the prior year. Excluding the impact of currency, adjusted net sales(2) increased 6%. Adjusted organic net sales were up 3%.

Worldwide Consumer reported net sales were approximately $3.9 billion, an increase of 2% compared to the prior year. Excluding the impact of currency, adjusted net sales increased 6%. Adjusted organic net sales were up 2%.

Consumer Self-Care Americas segment reported net sales were approximately $2.5 billion, an increase of approximately 3% compared to the prior year. Excluding the impact of currency, adjusted net sales increased 7%. Adjusted organic net sales were up more than 2%.

Consumer Self-Care International segment reported net sales were approximately $1.4 billion, a decrease of 1% compared to the prior year. Excluding the impact of currency, adjusted net sales increased 5%. Adjusted organic net sales were up 2%.

Rx segment reported net sales were approximately $970 million for the full year, an increase of 5% compared to the prior year.

The Company currently intends to release its fourth quarter and full year 2019 financial results in the fourth week of February 2020.

Mr. Kessler’s presentation is scheduled for today at 4:30 PM EST. Interested parties can access the presentation webcast at View Source

See attached Appendix for reconciliation of adjusted (non-GAAP) to reported (GAAP) financial measures.

(1) Adjusted organic net sales growth excludes the 2019 acquisition of Ranir, the exited animal health and infant foods businesses in both periods, the voluntary global market withdrawal of ranitidine in the third quarter 2019, and the impact of currency.

(2) Adjusted net sales growth excludes the exited animal health and infant foods businesses in both periods, the voluntary global market withdrawal of ranitidine in the third quarter 2019, and the impact of currency.