On January 9, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported a regulatory update regarding its TELLOMAK Phase II trial, evaluating the efficacy and safety of lacutamab (IPH4102) in patients with advanced T-cell lymphomas (Press release, Innate Pharma, JAN 9, 2020, View Source [SID1234552893]). The Company has been in ongoing discussions with regulatory authorities regarding Good Manufacturing Practice (GMP) deficiencies at the Company’s manufacturing subcontractor site that manages the fill and finish operations of the lacutamab clinical vials. Based on these discussions, on December 13, 2019, the Company decided to suspend enrollment of new patients in the TELLOMAK trial, except in Italy where the clinical trial has been suspended.

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The Company has received the following new regulatory feedback:

The US Food and Drug Administration (FDA) has placed the TELLOMAK trial on partial clinical hold. Currently enrolled patients can continue treatment in the trial due to the high degree of unmet medical need, once patients are re-consented. However, no new patients can enroll in the trial until a new GMP-certified batch is available.
UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has agreed for the trial to continue as planned with current available supply.
To note, the Company is awaiting final feedback from the National Agency for the Safety of Medicines and Health Products in France (ANSM).

The FDA did not cite any safety issues related to the trial medication. This is consistent with the review conducted by the Independent Data Monitoring Committee (IDMC), which concluded there were no new, unexpected safety issues related to lacutamab, and the product appeared to be well-tolerated among current patients enrolled in the trial. In addition, the IDMC determined it would be acceptable to continue recruiting additional patients in the TELLOMAK trial, if agreed by regulatory agencies.

The Company is working to transfer the lacutamab fill and finish manufacturing to another contract manufacturing organization (CMO). At this stage, it anticipates that a new clinical GMP-certified batch should be available in the second half of 2020.

At this point in time, the Company maintains its partial clinical hold guidance globally as it obtains more information from additional regulatory authorities. The Company will provide a further update in due course.

About the GMP Deficiency:
This situation is related to GMP deficiencies put forward by the Company’s manufacturing subcontractor, Rentschler Fill Solutions GmbH or "RFS" (now known as Impletio Wirkstoffabfüllung GmbH). RFS was granted a Good Manufacturing Practice (GMP) certificate by the Austrian regulatory agency in August 2018, which was further confirmed in October 2019 after two on-site inspections. In November, RFS unilaterally withdrew the Certificate of Conformity of batches they have produced, including the lacutamab batch currently used in the TELLOMAK trial. RFS also filed for bankruptcy.

The Company’s utmost priority is to ensure patient safety. An extensive internal and third-party analysis concluded that there was no evidence that the integrity of the product was questioned.

On January 9, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the Company entered into a global licensing agreement with Verastem Oncology (Nasdaq: VSTM) regarding CKI27 (CH5126766), an investigational anticancer agent under development by Chugai for solid tumors (Press release, Chugai, JAN 9, 2020, View Source [SID1234552891]).

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Phase I studies mainly initiated by investigators are ongoing in solid tumors including non-small cell lung cancer, ovarian cancer and colorectal cancer to investigate CKI27 both as monotherapy and combination therapy with other anticancer agents.

Under this agreement, Chugai will grant Verastem an exclusive worldwide license to manufacture, develop and commercialize CKI27. In return for the license, Chugai will receive an upfront fee of USD three million. If the compound is successfully launched as an approved pharmaceutical product, Chugai will also receive royalty payments from Verastem.

"We are delighted to have concluded a worldwide license agreement of CKI27 with Verastem, an expert in oncology" said Dr. Hisafumi Okabe, Chugai’s Executive Vice President, General Manager of Translational Research Division. "We hope the development of CKI27 by Verastem will accelerate in order to deliver a new treatment option to cancer patients as soon as possible."

On January 8, 2020 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, and Daewoong Pharmaceutical Co. Ltd., (KSX: 069620), a leading Korean pharmaceutical company, reported that they have agreed to establish a joint venture in South Korea, and to enter a collaboration and license agreement for the joint venture to develop the next generation of cell and gene therapies incorporating Affimer proteins to enhance the immune-modulatory effects (Press release, Avacta, JAN 8, 2020, View Source [SID1234612389]).

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Mesenchymal stem cells (MSCs) are promising agents for the treatment of autoimmune and inflammatory diseases. The joint venture will develop a new class of MSCs that are primed to produce Affimer proteins, which are designed to enhance the immune-modulatory effect when administered to patients, by reducing inflammatory or autoimmune responses.

Daewoong will provide the joint venture with access to its proprietary technology for generating allogeneic MSCs from a single donor to treat a large number of patients. This proprietary technology facilitates developing cell therapies as "off-the-shelf" products.

Avacta will develop Affimer proteins against several undisclosed targets which will be transferred to the joint venture to be incorporated into MSCs. The resulting engineered MSCs will have broad ranging therapeutic utility, depending on the Affimer proteins’ intended therapeutic purposes.

Avacta’s research and development costs will be fully covered by the joint venture and Avacta retains the rights to commercialise the Affimer proteins outside of the field of cell therapies. Avacta’s shareholding in the joint venture is 45% with Daewoong holding 55%, and the joint venture will be operationally managed by Seng-ho Jeon, CEO of Daewoong, with a Board composed of representatives of both Avacta (Alastair Smith, CEO and Matthew Vincent, VP Business Development and Strategy) and Daewoong.

"Our partnership reinforces the shared vision of both companies to design the next level of treatment paradigm, and to open up a new horizon in immunotherapeutic strategies", said Seng-ho Jeon. "This innovative collaboration will deliver invaluable synergy and lead to new solutions with the potential to transform patients’ lives."

"We are very excited to establish the joint venture with Daewoong, a world-class partner, combining our powerful Affimer platform with MSCs to develop breakthrough medicines targeting immune-mediated diseases", said Dr Alastair Smith, CEO of Avacta. "Affimer proteins have the potential to selectively modulate signalling pathways in inflammatory diseases in order to reduce the aberrant immune response occurring in those tissues, as well as positively impacting tissue regenerative pathways meant to repair and restore normal function to the affected tissues. We look forward to working closely with the Daewoong team to advance these promising therapeutics, and get them to the patients who need them."

On January 8, 2020 NexImmune, a clinical-stage biopharmaceutical company developing novel immune-therapeutics based on a proprietary Artificial Immune Modulation (AIM) nanotechnology platform, reported that industry veterans Han Myint, MD, and John Trainer, MBA, have been appointed as the Company’s Chief Medical Officer and Chief Financial Officer, respectively (Press release, NexImmune, JAN 8, 2020, View Source [SID1234554873]).

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Dr. Myint commented, "I am very excited to join NexImmune at such a time where I can leverage my professional experience to oversee the Company’s first two clinical trials for NEXI-001 and NEXI-002 in patients with relapsed forms of Acute Myeloid Leukemia (AML) and Multiple Myeloma, respectively. The Company has developed a novel technology that direcects endogenous T cells against multiple tumor antigen targets. For patients suffering from a variety of cancers, I believe this approach has the potential to deliver potent anti-tumor activity while minimizing potential off-target toxicities, and I am looking forward to working with team to make this a reality for these patients."

Trainer commented, "The tremendous potential of the NexImmune AIM platform in multiple types of cancer and other disease areas is a significant growth opportunity. Scaling up and financing this growth through additional capital raises, partnerships and a potential IPO will be a top priority. I’m excited to be a part of the NexImmune team as we push forward on our mission to help patients."

Dr. Myint most recently served as the Vice President of Global Medical Affairs – Myeloid Diseases at Celgene. While in that role, he led the Global Franchise Team – Myeloid, and worked very closely with cross-functional teams representing commercial, market access, regulatory, translational and clinical functions to create a cohesive global disease strategy for all development stage compounds in the Myeloid disease pipeline including AML, Myelodysplastic Syndrome (MDS), Myelofibrosis and Thalassemia. Prior to his six year tenure at Celgene, Dr. Myint practiced academic hematology at multiple prestigious institutions, including Rush University in Chicago, and became a Fellow at the Royal College of Physicians and Royal College of Pathologists in London, England. He has expertise and clinical experience in hematological malignancies and stem cell transplantation. Additionally, Dr. Myint built a FACT-accredited and Center of Excellence-Designated Transplant Program at the University of Colorado, Denver, while becoming a fellow of the American College of Physicians.

Trainer most recently served as Vice President and Head of Partnering & Strategy for MedImmune, the biologics-focused R&D unit of AstraZeneca. There, he led all in-licensing, out-licensing and collaboration work for MedImmune including such transactions as the spin-out of Viela Bio (which raised a $250m Series A). Trainer was also responsible for working with partners such as Johns Hopkins University and the NIH to help develop promising new companies and technologies. Previous to that role, Trainer was Vice President, Corporate Development for AstraZeneca and the commercial leader for AstraZeneca’s Infection, Neuroscience and Gastrointestinal group globally, as well as holding a variety of financial, transactional and commercial roles at MedImmune. He received his MBA from Harvard Business School and his undergraduate degree from Harvard College.

Scott Carmer, President and CEO of NexImmune, commented on the additions to the Company’s Executive Leadership Team, "I am thrilled to have both Han and John join our team. Individually, each is a highly respected and accomplished industry leader. Together, their combined experience, expertise and leadership will be a strong complement to those of our existing executive team. As we initiate our first clinical trials in 1Q2020, NexImmune is now poised to exploit the full potential of our unique technology platform for the benefit of patients in need."

On January 8, 2020 Almirall, S.A. (ALM) has reported the execution of an option agreement to acquire Bioniz Therapeutics, Inc. a clinical stage biopharmaceutical company based in Irvine, California, which develops first-in-class peptide treatments that selectively inhibit multiple cytokines to treat immuno-inflammatory diseases and T-cell malignancies (Press release, Almirall, JAN 8, 2020, View Source;articleId=4224566&id=4224567 [SID1234553266]). If Almirall exercises the option, it will also enter into a broader research agreement with Bioniz NewCo, using its multiple cytokine inhibitor platform with the objective to deliver at least 3 IND-approved candidates.

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Through this collaboration, Almirall executes its strategy to develop and expand its R&D pipeline with new treatment modalities with the objective to address highly underserved diseases within oncodermatology and immunodermatology.

Under the terms of the agreement, Almirall will strengthen its medical dermatology pipeline. If Almirall opts-in, Almirall will have access to a clinical stage asset in development for several indications and will start a research collaboration to expand the early stage pipeline:

BNZ-1, a novel multicytokine inhibitor in development for: i) refractory Cutaneous T-cell Lymphoma (CTCL), an orphan disease with high unmet medical need and ii) alopecia areata, an autoimmune hair disorder with no approved treatments.
Research collaboration using Bioniz multiple cytokine inhibitor platform technology with the objective to deliver at least 3 IND-approved candidates.
During the option collaboration period, Bioniz will complete the current ongoing phase 1/2 clinical trial in CTCL and the parties will collaborate to define the future CTCL development activities. After opting-in, Bioniz will spin off other assets than BNZ-1 as well as the proprietary platform technology to a NewCo. and Almirall will continue with the development of BNZ-1.

Under the terms of the agreement, Almirall will make an initial payment of $15 MM to Bioniz in exchange for an option to acquire all Bioniz outstanding shares. Following the availability of phase 1/2 results in CTCL, certain human biomarkers laboratory data and the official FDA End of Phase 2 meeting minutes, Almirall will have 60 days to exercise its option. If Almirall elects to exercise its option, the company will pay an option exercise fee of $47 MM in different instalments in the following years. Almirall will make additional payments upon the achievement of certain development, regulatory and commercial milestones.

Bhushan Hardas, MD, MBA, Almirall’s Chief Scientific Officer, commented that "this agreement is a big step forward for us in our objective of becoming a leader in Onco-dermatology and Immuno-dermatology. With Bioniz Therapeutics Inc. combined with our long experience and understanding in the area of dermatology, we will be able to identify new avenues with the potential to develop the right therapies for patients with high unmet needs".

Nazli Azimi, Founder and Chief Executive Officer of Bioniz Therapeutics, Inc. stated "we are delighted to enter into this agreement with Almirall, a global leader in medical dermatology who shares our vision of building an Immuno-dermatology franchise for BNZ-01. This partnership gives prominence to our leadership position in the discovery and development of first-in-class multi-cytokine inhibitor peptides to treat immuno-inflammatory diseases and cancer."

About BNZ-01

Bioniz’s lead development candidate, BNZ-01, is a PEGylated peptide that functions as a selective inhibitor of cytokines IL-2, IL-9, and IL-15. Bioniz Therapeutics is developing BNZ-01 for the treatment of CTCL and autoimmune diseases (Alopecia Areata). BNZ-01 has been evaluated in Ph1 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) and is currently being evaluated in a Phase 1/2a study in CTCL patients and ready to start a Phase 2 PoC study in Alopecia Areata.