On June 24, 2019 NantKwest Inc. (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and other diseases, reported that the company’s PD-L1 t-haNK investigational new drug application (IND) has cleared FDA review and the program has now transitioned to a first-in-human clinical trial in patients with locally advanced or metastatic solid cancers (Press release, NantKwest, JUN 24, 2019, https://ir.nantkwest.com/news-releases/news-release-details/nantkwest-launches-first-class-first-human-phase-i-clinical?field_nir_news_date_value[min]=2019 [SID1234537231]).

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Programmed death-ligand 1 (PD-L1) is a transmembrane protein that plays a major role in suppressing the immune system in many cancer patients. The binding of PD-L1 to the inhibitory checkpoint molecule PD-1 establishes an inhibitory signal that reduces the proliferation of antigen-specific T-cells while also reducing apoptosis in suppressive regulatory T cells (Tregs) that further inhibits immune responses.

NantKwest’s PD-L1 t-haNK cell therapy is a novel, NK cell-based immuno-oncology therapy that includes a PD-L1 based Chimeric Antigen Receptor (CAR) engineered into the company’s proprietary haNK NK cell, which also includes the high affinity variant of the CD16 receptor (V158 FcγRIIIa) to mediate antibody dependent cellular cytotoxicity (ADCC). Together, the use of this targeted, bi-specific, next generation PD-L1 t-haNK therapy has been shown in preclinical studies to significantly enhance cancer cell killing and improve overall response rates.

"In just a few short weeks since announcing the FDA clearance of our first bi-specific, engineered NK cell therapy clinical trial using a CD19 t-haNK targeting patients in lymphoma, we are now pleased to announce that the FDA has authorized the company to go forward with our second bi-specific NK cell therapy clinical trial using a PD-L1 t-haNK targeting patients with solid tumors," commented Dr. Patrick Soon-Shiong, Chairman and CEO of NantKwest. Dr. Soon-Shiong continued, "We plan to synergistically combine a wide range of immunotherapy molecules with our proprietary, multi-targeted, off-the-shelf NK cell therapy, in this case, a PD-L1 t-haNK to explore the unique therapeutic potential of integrating both the innate and adaptive immune systems to achieve durable complete remissions. Based on the FDA clearance, we look to rapidly transition this program to a Phase I human clinical trial designed to assess the safety, tolerability and efficacy of PD-L1 t-haNK cell therapy in patients with solid tumors. Upon completion of this safety phase, NantKwest intends to combine this PD-L1 t-haNK cell therapy with other immunomodulatory agents including NabFc-N803, a IL15 cytokine super agonist and Adenovirus/ yeast vectors delivering tumor associated and neoantigens, as part of an integrative, combination therapy designed to further enhance the therapeutic effectiveness of this novel NK cell-based therapeutic intervention, which we describe as our NANT Cancer Memory Vaccine."

PD-L1 t-haNK

NantKwest’s PD-L1 t-haNK cell therapy is designed to provide precise tumor-cell specificity through the use of a CAR construct that utilizes a PD-L1-specific scFv (single chain antibody fragment) engineered into the company’s proprietary haNK NK cell that includes the high affinity variant of the CD16 receptor (V158 FcγRIIIa) to mediate antibody dependent cellular cytotoxicity (ADCC). In preclinical studies, cytotoxicity of these GMP-grade, cryopreserved PD-L1 t-haNK cells were comprehensively evaluated against a panel of cancer cell lines with different levels of PD-L1 expression in vitro and in vivo, with these studies showing increased activity and selective cytotoxicity toward a wide range of PD-L1-expressing tumor cells.

To better inform routine patient care, these clinical trials will incorporate a state-of-the-art, biomarker analysis, including GPS Cancer, which is an integrated, multi-omics, whole genome, transcriptomic platform, provided by NantHealth, an affiliated company. These comprehensive molecular analysis tools are designed to provide critical information to the clinical study team regarding the unique molecular alterations associated with the patient’s cancer and response rates, potentially enhancing patient management.

Additional information regarding the PD-L1 t-haNK clinical study can be found at www.nantkwest.com or www.clinicaltrials.gov/.

On June 24, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported the presentation of data updates on two clinical studies at the 15th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland (Press release, Affimed, JUN 24, 2019, View Source [SID1234537230]).

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The data from an oral and a poster presentation featured Affimed’s lead innate cell engager AFM13, a first-in-class tetravalent, bispecific antibody derived from the ROCK platform that is being developed to treat CD30-positive lymphomas. AFM13 specifically binds to CD30 on tumor cells and to CD16A on innate immune cells, such as NK cells and macrophages.

"The results of the completed Phase 1b study of AFM13 in combination with pembrolizumab in Hodgkin lymphoma and of Columbia University’s study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous presentation substantiate the potential of AFM13 to make a difference in the lives of patients with limited to no treatment options," said Dr. Leila Alland, Affimed’s Chief Medical Officer. "We look forward to advancing our innate cell engagers in future clinical studies, including our registration-directed study of AFM13 in relapsed and refractory peripheral T cell lymphoma and transformed mycosis fungoides."

Final clinical results from a Phase 1b combination study of AFM13 and pembrolizumab in patients with relapsed or refractory Hodgkin lymphoma (Abstract #128, oral presentation)
Final results from a completed Phase 1b dose escalation study of AFM13 in combination with pembrolizumab (Keytruda) in patients with relapsed or refractory Hodgkin lymphoma (HL; NCT02665650) were presented during an oral session by Dr. Stephen M. Ansell, Professor of Medicine at Mayo Clinic Rochester, MN and Chair of Faculty Development and Recruitment, Division of Hematology, Department of Internal Medicine, and International Coordinating Principal Investigator of the study. Overall, the combination of AFM13 and pembrolizumab was well tolerated, with no new or worsening safety signals compared to known safety profiles of each agent alone. At the highest treated dose, the objective response rate (ORR) of 88% (by both independent and investigator assessments) and the complete response (CR) rates of 42% and 46% by investigator and independent assessments, respectively, compared favorably to the historical data of monotherapy pembrolizumab in a similar patient population, with the CR rates approximately double that of pembrolizumab. The estimated progression-free survival (PFS) was 78% and 45% at 6 and 12 months, respectively. Response rates were high amongst the subgroup of patients who were primary refractory to brentuximab vedotin (BV), with 11 of the 13 patients achieving an objective response (ORR 85%, 46% CR rate). A deepening of responses was reported over time in multiple patients, and patients previously transplant-ineligible transitioned to transplant after achieving an objective response with the combination of AFM13 and pembrolizumab.

"Despite advances in the treatment of patients with Hodgkin lymphoma, there remains a need for new treatment options for patients who have failed multiple lines of treatment," commented Dr. Ansell. "I am encouraged by the results achieved in this study, which showed that the combination of AFM13 and pembrolizumab is well-tolerated and achieved high and deep response rates even in patients who were refractory to brentuximab vedotin."

Updated clinical and immunological data from a Phase 1b/2a study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous presentation (Abstract #259, poster presentation)
New data from an AFM13 Phase 1b/2a study in patients with relapsed or refractory CD30-positive lymphoma with cutaneous presentation (NCT03192202) were presented by Dr. Ahmed Sawas, Assistant Professor of Medicine at the Columbia University College of Physicians and Surgeons and the New York-Presbyterian Hospital, and Principal Investigator of the study. In this study, AFM13 was well tolerated and resulted in a high ORR of 50% (1 CR and 4 PRs) including therapeutic activity post-BV failure. This included 2 of 5 responses in the subset of patients with transformed mycosis fungoides (T-MF), a particularly hard-to-treat disease.

Analysis of tumor biopsies showed increased numbers of NK cells both before and during treatment with AFM13 amongst the patients responding to therapy. This was also associated with markers of NK cell-mediated tumor cell killing. In the peripheral blood, NK cell activation markers were observed amongst the responders, and there were associated decreases in total numbers of circulating NK cells and regulatory T cells.

Overall, the data support the potential of AFM13 as a novel immuno-therapeutic to treat CD30-expressing lymphomas. A registration-directed Phase 2 international multicenter study of AFM13 in refractory peripheral T cell lymphoma (PTCL) and T-MF is planned.

On June 24, 2019 Amplia Therapeutics (ASX: ATX) is reported the appointment of Dr John Lambert as Chief Executive Officer (Press release, Amplia Therapeutics, JUN 24, 2019, View Source;[email protected] [SID1234537229]). Long serving former CEO, Mr Simon Wilkinson, will remain on the Company’s Board as a non-executive director.

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Based in Melbourne, Dr Lambert has worked in drug discovery and development for over 20 years. His previous roles have included senior management positions at Biota Holdings Limited and Medicines Development for Global Health. His experience spans the full drug development lifecycle from early discovery, intellectual property protection, licensing, product development, and regulatory approval. John has been Amplia’s Operations Manager since August 2018 and has been directing all aspects of the Company’s clinical enabling work since that time.

"The appointment of Dr Lambert as Chief Executive is another important step in the transformation of Amplia" said Chairman Dr Warwick Tong. "John’s experience and enthusiasm make him the ideal candidate to deliver the near and medium term clinical development milestones we have set for the Company".

The Board of Amplia acknowledges the hard work and dedication of outgoing CEO Simon Wilkinson. "Mr Wilkinson has been a great champion for our Company for many years and we are especially pleased that he will be continuing as a director to ensure a smooth transition for Dr Lambert" said Dr Tong.

Dr Lambert commented "I am delighted to take up the Chief Executive role at Amplia Therapeutics. I’m particularly excited to be working alongside a Board with so much industry experience and I am looking forward to working with them to deliver on our objectives and drive value for our shareholders."

For Further Information
Dr Warwick Tong, Chairman
+61 450 296 930
www.ampliatx.com
Details of Dr Lambert’s remuneration as CEO follow.

On June 24, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), reported it will effect a one-for-twelve reverse stock split of its issued and outstanding common stock (Press release, Xenetic Biosciences, JUN 24, 2019, View Source [SID1234537228]). Pursuant to the Certificate of Change filed with the Secretary of State of the State of Nevada, the reverse stock split will be effective at 12:01 a.m., Eastern Time, on June 25, 2019. Xenetic expects that upon the opening of trading on June 25, 2019, its common stock will trade on the Nasdaq Capital Market on a split-adjusted basis under the current trading symbol "XBIO" and the new CUSIP number 984015 503.

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No fractional shares will be issued as a result of the reverse stock split. Any fractional shares that would result from the reverse stock split will be rounded up to the nearest whole share.

Stockholders of record are not required to send in their current stock certificates or evidence of book-entry or other electronic positions for exchange. Following the effectiveness of the reverse stock split, each stock certificate and book-entry or other electronic position representing issued and outstanding shares of Xenetic’s common stock will be automatically adjusted. Those stockholders holding common stock in "street name" will receive instructions from their brokers if they need to take any action in connection with the reverse stock split. Stockholders should direct any questions concerning the reverse stock split to their broker or Xenetic’s transfer agent and registrar, Empire Stock Transfer, Inc., at [email protected].

On June 24, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that it will release its financial results for the second quarter of 2019 before the market opens on Wednesday, July 24, 2019, and will hold a conference call on the same day at 8:30 a.m. EDT (Press release, Thermo Fisher Scientific, JUN 24, 2019, View Source [SID1234537227]).

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During the call, the company will discuss its financial performance, as well as future expectations. To listen, call (877) 273-7122 within the U.S. or (647) 689-5496 outside the U.S. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com. The earnings press release and related information can be found in that section of our website under "Financial Results." A replay of the call will be available under "Webcasts and Presentations" through Friday, August 9, 2019.