On September 2, 2021 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that two oral presentations will be highlighted at the ESMO (Free ESMO Whitepaper) 2021 Virtual Congress (Press release, Innate Pharma, SEP 2, 2021, View Source [SID1234587147]).

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AstraZeneca will present a late-breaker abstract on the COAST Phase 2 trial, highlighting progression-free survival (PFS) results for novel durvalumab combinations with potential new medicines, including Innate’s monalizumab, and oleclumab, an anti-CD73 monoclonal antibody, in unresectable, Stage III non-small cell lung cancer (NSCLC). Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

In addition, Innate will present pre-clinical data from its next-generation, proprietary, multi-specific NK cell engager platform known as ANKETTM (Antibody-based NK cell Engager Therapeutics).

"We’re pleased with the continued progress of monalizumab, particularly in a combination trial with durvalumab in unresectable, Stage III non-small cell lung cancer," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "Furthermore, the pre-clinical ANKETTM data at ESMO (Free ESMO Whitepaper) validates the importance of NK cell science and its role in the next wave of immunotherapy, while serving as the scientific engine to further advance our clinical pipeline. We look forward to seeing both oral presentations at ESMO (Free ESMO Whitepaper)."

Presentation details

Monalizumab:

Title: COAST: an open-label, randomised, phase 2 platform study of durvalumab alone or in combination with novel agents in patients with locally advanced, unresectable, Stage III NSCLC
Date and time: September 17, 2021, at 2:20 p.m. CEST
Presentation number: LBA42

Alexandre Martinez-Marti (Barcelona, Spain) will deliver the presentation.

ANKET:

Title: Harnessing innate immunity in cancer therapies: the example of Natural Killer Cell Engagers
Date and time: September 18, 2021 at 1:30 p.m. CEST
Presentation number: 1O

Professor Eric Vivier, DVM, Chief Scientific Officer of Innate Pharma, will deliver the presentation.

About Monalizumab:

Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Monalizumab may reestablish a broad anti-tumor response mediated by NK and T cells, and may enhance the cytotoxic potential of other therapeutic antibodies1.

AstraZeneca obtained full oncology rights to monalizumab in October 2018 through a co-development and commercialization agreement initiated in 2015. The ongoing development for monalizumab is focused on investigating monalizumab in various combination strategies in different malignancies.

About COAST Trial:

COAST is a Phase 2, multi-arm, randomised trial investigating durvalumab alone or in combination with either monalizumab, an anti-NKG2A monoclonal antibody, or oleclumab, an anti-CD73 monoclonal antibody, in 189 patients with locally advanced, unresectable Stage III NSCLC who had not progressed after concurrent CRT.

COAST is being conducted by AstraZeneca in 82 centers across nine countries in North America, Europe and Asia. The primary endpoint of the trial is overall response rate (ORR) as a measure of anti-tumor activity. Secondary endpoints include safety, duration of response, overall survival and PFS.

About ANKETTM:

ANKETTM (Antibody-based NK cell Engager Therapeutics) is Innate Pharma’s proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer. The Company’s latest innovation, its tetra-specific ANKET molecule, is the first NK cell engager technology to engage activating receptors (NKp46 and CD16), a tumor antigen and a cytokine (IL-2v) via a single molecule. This leverages the advantages of harnessing NK cell effector functions against cancer cells and also provides proliferation and activation signals targeted to NK cells.

In preclinical studies, Innate’s tri-2 and tetra-specific technology has demonstrated potent NK cell activation, cytotoxicity and efficient control of tumor growth in preclinical models. This versatile fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

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