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NOXXON Announces a Capital Increase of €0.5 Million Through a Private Placement of Shares

On January 14, 2020 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that following discussions with investors it has received commitments for an investment of €0.5 million through a private placement (Press release, NOXXON, JAN 14, 2020, View Source [SID1234553182]).

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"We are pleased with the ongoing support of the investment community, in particular the long-term investors from Europe and the US who continue to support NOXXON’s strategy and also invested in the capital increases last year. This investment provides additional capital for the company and allows us to advance the Phase 1/2 trial of NOX-A12 in combination with radiotherapy as a 1st line treatment in brain cancer patients, which is one of the key clinical goals for NOXXON. As with the previous private placement, for which we have attracted long-term equity investors, there are no warrants or other option-like instruments attached to this financing," said Aram Mangasarian, CEO of NOXXON.

The price agreed with investors of €0.51 per share represents a 26% discount on the average closing price of the shares over the seven trading days from December 31, 2019, to January 9, 2020. As such, it is anticipated that 980,389 new shares will be issued in the context of this financing. Closing and settlement of this transaction is expected within the next seven days.

A2A Pharmaceuticals Inc. Today Announced a Multi-target Co-development Agreement With Daewoong Pharmaceutical for AI-enhanced Oncology Drug Discovery

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.

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."

XBiotech Commences Tender Offer to Purchase up to $420,000,000 of its Shares

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.

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).

NantKwest and ImmunityBio Announce Complete Response in Metastatic Pancreatic Cancer in the First Patient to Receive PD-L1 Tumor-Targeted Natural Killer Cells (PD-L1.t-haNK) Combined with N-803 IL-15 Fusion Protein

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.

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."

PharmaMar announces the initiation of a study of lurbinectedin in combination with immunotherapy

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.

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.