On September 2, 2021 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for inflammatory and fibrotic diseases with high unmet need, reported it has appointed Dale R. Pfost, PhD, as Chief Executive Officer (CEO) (Press release, Anchiano Therapeutics, SEP 2, 2021, View Source [SID1234587145]). Dr. Adi Mor, Company co-founder and current CEO, will continue in her role as Chief Scientific Officer (CSO) and remain as a member of the Board of Directors. The addition of Dr. Pfost, who brings more than 30 years of diverse experience as a life science senior executive, entrepreneur and venture investor, reflects a planned strategic expansion of the Chemomab senior management team. Dr. Pfost is expected to join the Company’s Board of Directors and subsequently become the company’s Chairman in 2022.

"The Board and I welcome Dale and thank Adi for her tremendous contributions as founding chief executive of Chemomab," said Stephen Squinto, PhD, Chairman of the Board at Chemomab and an Executive Partner at OrbiMed. "Adi built both the scientific and business platforms for Chemomab and she will continue to be instrumental in the development of our first-in-class therapeutic addressing a novel target for multiple inflammatory and fibrotic diseases, helping position the company for future success. We look forward to her continued contributions as we evolve and grow."

Dr. Pfost has served as CEO of six biotechnology companies, three of which became publicly traded with valuations exceeding two billion dollars. He has successfully completed dozens of financings, overseen numerous M&A transactions and served as a director at multiple public and private life science firms.

Dr. Squinto continued, "We are delighted that Dale is coming on board as CEO. He is a seasoned biotechnology industry veteran with deep relationships and a history of successfully building innovative companies through organic growth and strategic acquisitions. With two Phase 2 studies underway and a third poised to kick off in the coming months, Chemomab is making excellent progress on realizing its potential as a premier company addressing diseases with large unmet medical needs. We look forward to Dale’s astute leadership during the next stage of growth."

Dr. Pfost said, "Adi and the Chemomab team have built an impressive company based on a unique asset with multiple high value applications. They have demonstrated exceptional skill in undertaking translational work and establishing clinical programs, and we look forward to extending the company’s already strong network of scientific and clinical collaborators in the U.S. This is an exciting time to join, as the company is well-positioned for both continued progress with its current programs and for leveraging strategic growth opportunities."

Dr. Mor said, "We advanced our novel anti-CCL24 antibody from the lab to the clinic and executed a successful merger earlier in the year. Now is the right time to add to our leadership team as we expand our strategic scope and our geographic presence in the U.S. Dale has a terrific track record of successfully growing biotech companies and I welcome the opportunity to work with him to build on the strong foundation we have achieved to date."

Until it was acquired in May of this year, Dr. Pfost was Chairman and CEO of innovative drug discovery firm Lodo Therapeutics. Previously, he was the U.S.-based General Partner at London-based venture capital firm Advent Life Sciences and served as Executive Chairman of portfolio companies CN Creative and Vestagen Protective Technologies. He co-founded and was acting CEO of MicroBiome Therapeutics in the year leading up to its acquisition. Dr. Pfost also was founding CEO of Acuity Pharmaceuticals, which merged to form OPKO Health. He was the founding CEO of Oxford GlycoSciences and genomics pioneer Orchid BioSciences. Dr. Pfost was also CEO at anti-cancer company Receptor BioLogix, where he led its successful acquisition. His first company, which he started in graduate school, was acquired by SmithKline Beckman and produced the Biomek, still a leading laboratory automation system today. Dr. Pfost is the co-author of 10 scientific papers and an inventor on 10 patents. He earned a BS degree from the University of California Santa Barbara and a PhD in physics from Brown University.

Dr. Pfost’s appointment as CEO and member of the Board will become effective upon the approval of Chemomab shareholders, as is required for public companies based in Israel. A shareholder vote is expected in the fourth quarter of 2021. His expected appointment as Chairman in 2022 will also require shareholder approval.

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On September 2, 2021 Alligator Bioscience AB ("Alligator" or the "Company") reported that the Company, in order to enable further progress, will begin evaluating potential financing alternatives, which may include issuance of equity (Press release, Alligator Bioscience, SEP 2, 2021, View Source [SID1234587144]). Alligator’s board has appointed financial advisors and the Company has received support from certain of the Company’s largest shareholders for continued funding of the Company.

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To give Alligator’s new and experienced management team the right opportunities to develop the Company, the Board’s current assessment is that working capital will need to be strengthened in order to enable phase II studies for Mitazalimab, phase II preparations for ATOR-1017 as well as the development of other pipeline candidates and general corporate purposes. The Company will now continue dialogues with relevant stakeholders, evaluate its available funding alternatives, and revert to the market with more information in due course.

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 12:00 p.m. CEST on September 2, 2021.

On September 2, 2021 Alligator Bioscience AB (Nasdaq Stockholm: ATORX) and Scandion Oncology A/S (Nasdaq Stockholm: SCOL), reported the conclusion of their collaboration with a very positive outcome (Press release, Alligator Bioscience, SEP 2, 2021, View Source [SID1234587143]).

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The purpose of the collaboration was to explore the anti-tumor efficacy of the CD40 antibody mitazalimab in chemotherapy-resistant preclinical tumor models as an addition to chemotherapy (FOLFIRINOX) combined with SCO-101. The hypothesis that was tested was to see if SCO-101, as compared to saline control will revert chemotherapy resistance and thereby facilitate a strengthening of the anti-tumor effects of mitazalimab. After the final data has been evaluated, the joint feasibility study have reached all goals of the cooperation and the companies have now concluded the collaboration.

"The feasibility study supported our hypothesis and opens the door for harvesting the value of this successful study with larger players. Both Scandion Oncology and Alligator have limited resources and our joint intention was to support the hypothesis, which now has been achieved. We remain committed to further exploring the potential of SCO-101 in immuno-oncology," said Bo Rode Hansen, President and CEO of Scandion Oncology.

"We were pleased to see that the results strengthen and expand the preclinical efficacy data for mitazalimab by demonstrating synergy with FOLFIRINOX in tumors resistant to chemotherapy. We are committed to develop mitazalimab in hard-to-treat cancer, and this data is very valuable in continuing to assess the efficacy of mitazalimab as a combination therapy with FOLFIRINOX in pancreatic cancer in our OPTIMIZE-1 phase II study," said Søren Bregenholt, CEO of Alligator Bioscience.

As announced in June 2021, the combination of mitazalimab and FOLFIRINOX, in pre-clinical trials, demonstrated a strong anti-tumor response in FOLFIRINOX resistant cancer cells and indicated that the anti-tumor effect of SCO-101, mitazalimab and FOLFIRINOX is even more potent than mitazalimab and FOLFIRINOX. The data support the basic concept that SCO-101 in combination with chemotherapy and immuno-oncology is well tolerated and has a very potent anti-tumor effect in vivo on drug resistant cancer cells. The data further validate the potential of mitazalimab in combination with standard of care chemotherapy such as FOLFIRINOX.

On September 1, 2021 Polyphor and EnBiotix Inc., a privately held late clinical-stage rare disease company currently focused on products for rare, chronic respiratory diseases, reported that the companies have signed a merger agreement pursuant to which Polyphor acquires all of the outstanding capital stock of EnBiotix in exchange for shares of Polyphor common stock (Press release, Polyphor, SEP 1, 2021, View Source [SID1234639731]). The transaction is subject to a number of closing conditions, including approval by Polyphor and EnBiotix shareholders, satisfactory completion of due diligence and satisfactory assessment of tax consequences. Following closing, expected in Q4 2021, Polyphor will be renamed and is expected to trade under a new ticker symbol on the Swiss Stock Exchange.

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Assuming completion of the merger, the combined company’s initial pipeline will include:

– ColiFin(R) which EnBiotix has in-licensed from PARI Pharma GmbH, a global leader in nebulized therapies, for worldwide rights ex-Europe. Approved in Europe since 2010 as a front-line therapy for lung infections in cystic fibrosis (CF), ColiFin(R) has a proven safety, efficacy and commercial track record which the combined company will leverage towards the U.S. and global markets – and both within and outside the field of CF.

– Inhaled murepavadin, a novel class inhaled antibiotic specifically targeting P. aeruginosa, is being developed for the treatment of these infections in people with CF and is beginning Phase I development using eFlow(R) Technology nebulizer (PARI Pharma GmbH).

– EBX-002, a combination of amikacin (AMK) and a potentiator molecule for NTM infections which preclinical studies to date have shown potential for superior activity compared to ARYKACE(R).

– Polyphor’s new CXCR4 inhibitors focused on orphan, hematological malignancies.

The combined company plans to advance its pipeline through multiple clinical trials and strategic transactions to build a rare disease and oncology company, as follows:

– Initiation of a single Phase III trial of ColiFin(R) for the treatment of CF patients, upon completion of which the combined company plans to seek FDA approval in the US.

– Initiation of a Phase I trial of inhaled murepavadin for the treatment of CF patients.

– Additional oncology and non-oncology indications for balixafortide will be evaluated in collaboration with Fosun Pharma who owns China rights.

– Combined company aims to in-license or acquire other rare disease and oncology assets post-closing that will consolidate its position in these therapeutic areas.

"After an extensive and thorough review of a full range of strategic options for Polyphor, we are very pleased to announce the signing of a merger agreement with EnBiotix," said Kuno Sommer, chairman of the board of directors at Polyphor. "We believe the merged company’s strong pipeline and focus on rare diseases and oncology can provide substantial opportunities to benefit patients, in particular cystic fibrosis patients with two clinical stage programs."

"We are honored to merge with Polyphor to jointly expand our pipeline, shareholder base and management team in both the U.S. and Europe. As we continue to pursue a unique position as a rare disease and oncology company, this merger with Polyphor is truly strategic", said Jeffrey D. Wager, MD, Chairman & CEO of EnBiotix. "We believe the merged company will provide a powerful platform for pipeline and corporate development, and look forward to pursuing additional partnering opportunities as we seek to address the unmet needs of our target patient populations."

About the Proposed Merger

Pursuant to the merger agreement, Polyphor will offer to acquire all of the outstanding capital stock of EnBiotix in exchange for the issuance of newly issued shares of Polyphor common stock upon closing, subject to the satisfaction or waiver of customary closing conditions, including approval by Polyphor and EnBiotixs shareholders, satisfactory completion of due diligence and satisfactory assessment of tax consequences. Upon completion of the merger, former EnBiotix equity holders (including investors of the planned financing round) are expected to own approximately 74-77% of Polyphor’s common stock. Polyphor’s current shareholders are expected to own approximately 23-26 % of Polyphor’s issued common shares following the closing of the merger.

The transaction has been unanimously approved by the board of directors of both companies.

About Acquisition of Inhaled Murepavadin

Simultaneously, the companies have signed a definitive asset purchase agreement where EnBiotix acquires Polyphor’s inhaled murepavadin at an agreed valuation of USD 10 million in exchange for 2’599’655 of common shares of EnBiotix (15.4% fully diluted of EnBiotix). The closing of this agreement is expected in September 2021 and prior to the expected closing of the merger. In case Polyphor were to terminate the merger agreement following acceptance of a superior offer – a Polyphor option required under Swiss law -, EnBiotix has the option to reverse the sale.

Management and Organization

Upon completion of the merger, Jeffrey D. Wager, M.D., currently Chairman and CEO of EnBiotix, is expected to become Chairman of the Board of Directors and Chief Executive Officer of the combined company replacing the current CEO, Gökhan Batur, who will oversee the next steps until the closing of the merger. The board members and management team of the merged company will be announced at a later date.

Conference Call

Polyphor AG and EnBiotix Inc. Conference Call at 14.00 CET on September 3, 2021

On September 1, 2021 The Center for iPS Cell Research and Application, Kyoto University ("CiRA"; Headquarters: Sakyo-ku, Kyoto, Japan; Director: Shinya Yamanaka), KOTAI Biotechnologies, Inc. ("KOTAI"; Headquarters: Suita, Osaka, Japan; CEO, Kazuo Yamashita) and Thyas Co. Ltd. ("Thyas"; Headquarters: Sakyo-ku, Kyoto, Japan; CEO, Yasumichi Hitoshi) jointly reported that Thyas has joined joint research initiated by CiRA and KOTAI on personalized cancer immunotherapy using regenerated T cells1 derived from induced pluripotent stem (iPS) cells2 (Press release, Thyas , SEP 1, 2021, View Source [SID1234629214]).

The laboratory of Professor Shin Kaneko, CiRA,Department of Cell Growth and Differentiation, is conducting research on therapeutic regenerative T cells using iPS cells for cancer immune cell therapies. In these therapies, cytotoxic T cells3 that can attack cancer cells are isolated from cancer patients and reprogrammed into iPS cells. These patientsderived iPS cells (or allogeneic iPS cells transduced with these patients-derived TCR genes) are then used to produce large numbers of rejuvenated T cells with high anti-cancer function (see figure below). CiRA and KOTAI started the joint research in October, 2020 to establish more efficacious personalized cancer immune cell therapies using a surface antigens4 specifically expressed on anti-cancer cytotoxic T cells and immuno-informatics technologies possessed by KOTAI.

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Thyas is developing robust and standardized manufacturing methods to produce regenerated T cells for industrial use using the research achievements by Professor Kaneko. It has also been manufacturing the clinical-grade batches of regenerated T cell products for clinical studies. The inclusion of Thyas, well-experienced in the production of regenerated T cells, is expected to accelerate the clinical application of the joint research outcomes.

In this joint research, CiRA will isolate T cells from cancer tissue and conduct iPS cell induction, T cell redifferentiation, and functional evaluation, while KOTAI will provides information on the surface antigen for the T cell isolation and performs genetic analysis of the cells. Thyas will optimize the production of regenerated T cells for clinical trials. The first trials are scheduled to begin by 2025 and will be the world’s first iPSC-derived therapeutic cells equipped with personalized TCRs5.

By conducting this joint research, CiRA, KOTAI, and Thyas aim to establish personalized cancer immunotherapy using regenerated T cells and contribute to the further development and popularization of cancer immune cell therapy through the efforts toward clinical trials.

The Center for iPS Cell Research and Application (CiRA), Kyoto University : View Source
KOTAI Biotechnologies, Inc. : View Source
Thyas Co. Ltd.: View Source

(Note 1) T cells: A type of lymphocyte that acts in immunity by recognizing and eliminating infected cells and cancer cells. Each T cell responds to a specific antigen. There are various types of T cells, such as cytotoxic T cells, helper T cells and others.

(Note 2) iPS cells: Somatic cells, such as skin or blood cells are reprogrammed into the pluripotent state by introducing a few genes. iPS cells are a type of stem cell with almost indefinite capacity to multiply and can differentiate into almost any kind of cell in the body.

(Note 3) Cytotoxic T cells: A type of T cell. When antigen information is received from other immune cells, cytotoxic T cells attack the cells corresponding to the antigen.

(Note 4) Surface antigen: A substance on a cell surface recognized by an antibody.

(Note5) Thyas’ Regenerated T Cell Products
Thyas aims to start clinical trials of allogeneic iPS cell-derived regenerated T cell therapy targeting common antigens in 2023 as its first pipeline. Development of this personalized T cell therapy will be its second pipeline.