On October 5, 2020 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 antibody therapies, reported the expansion of AO-176’s clinical development into a Phase 1/2 chemotherapy combination trial for patients with select solid tumors (Press release, Arch Oncology, OCT 5, 2020, View Source;utm_medium=rss&utm_campaign=arch-oncology-advances-anti-cd47-antibody-ao-176-into-chemotherapy-combination-phase-1-2-trial-in-solid-tumors [SID1234568089]). AO-176 is an anti-CD47 antibody with a potential best-in-class profile that works by blocking the "don’t eat me" signal and also by directly killing tumor cells, with preferential binding to tumor versus normal cells.

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"With encouraging evidence of AO-176’s safety and anti-tumor activity as a single agent, we are expanding this trial to further evaluate this therapy in combination with chemotherapy in patients with select solid tumors," said Julie Hambleton, M.D., Interim President and Chief Executive Officer of Arch Oncology. "In the Phase 1 dose-escalation study, we established the recommended dose for Phase 2 development. In addition, we generated important clinical data on the safety and efficacy profile of AO-176 in patients with select solid tumors and we plan to submit these data to a medical meeting next year. With patient dosing underway with AO-176 in combination with chemotherapy, we are making significant progress developing AO-176 broadly for patients with solid tumors as well as hematologic malignancies."

Howard A. "Skip" Burris, III, M.D., President, Clinical Operations, Chief Medical Officer, and Principal Investigator, Sarah Cannon Research Institute, commented, "There is a growing body of preclinical and clinical data for AO-176, demonstrating this therapy’s highly-differentiated clinical profile among anti-CD47 therapeutics in development. As drugs against this target have demonstrated robust clinical activity, we are eager to assess this new combination treatment approach for patients with solid tumors who need better options for their disease."

This open-label, multi-center, dose-escalation Phase 1/2 trial is evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of AO-176 in combination with paclitaxel in patients with gastric, endometrial, and platinum-resistant ovarian cancers.

Across the United States, leading cancer treatment clinical trial sites are participating in this trial. For additional information, please visit www.clinicaltrials.gov using the trial identification number NCT03834948.

About AO-176

AO-176 is a humanized anti-CD47 IgG2 antibody with a potential best-in-class profile. AO-176 is highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class of innate checkpoint inhibitors. AO-176 works by blocking the "don’t eat me" signal, the standard mechanism of anti-CD47 antibodies. Beyond blocking this signal, AO-176 has additional mechanisms, including directly killing tumor cells and inducing DAMPs (Damage Associated Molecular Patterns), resulting in Immunogenic Cell Death. Importantly, AO-176 binds preferentially to tumor cells, instead of to normal cells, and binds even more potently to tumors in their acidic microenvironment (low pH). Publications and presentations on AO-176 can be found at our Pubs & Posters page.

AO-176 is being evaluated in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and multiple myeloma. In a Phase 1 trial in solid tumors, AO-176 demonstrated encouraging safety and evidence of anti-tumor activity when administered as a single agent. Additional information about these trials may be found at www.clinicaltrials.gov using the trial identification number NCT03834948 (solid tumors) or NCT04445701 (multiple myeloma).

On October 5, 2020 ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric and orphan drugs reported the inclusion of the first-in patient in a clinical study aimed at demonstrating the bioequivalence between Kimozo, the first pediatric formulation of temozolomide under clinical development, and Temodal capsule (Press release, ORPHELIA Pharma, OCT 5, 2020, View Source [SID1234568070]).

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Although not approved in this indication, temozolomide is an essential anticancer medicine recommended for use in treatment protocols of relapsed or refractory neuroblastoma, a condition that affects young children. However, the only oral formulations that are commercially available are in the form of capsules that are poorly adapted to children. Caretakers are thus compelled to open capsules and disperse the content into a soft food prior to administration to the child, which harbors several risks such as the uncertainty with regards to the delivered dose, the exposure of the caregiver to the cytotoxic drug and the instability of the drug in aqueous milieu. To overcome the risks this situation implies, Kimozo, a ready to use oral formulation has been specifically designed to address the needs of the pediatric population.

Kimozo has been developed in collaboration with Gustave Roussy, one of the leading cancer centers in Europe. The current clinical trial conducted by ORPHELIA Pharma aims at demonstrating, first for regulatory purposes, the bioequivalence between Kimozo and the Temodal capsules in adult patients having brain cancers, with additional clinical investigation to come in the pediatric population of interest.

"We have reached an important milestone for Kimozo with the clinical trial approval from competent authorities and the recruitment of a first patient", said Caroline Lemarchand, Chief Pharmaceutical Development Officer of ORPHELIA Pharma "We plan to enroll 30 patients by mid-2021 thanks to the support of the three neuro-oncology teams involved in the study: Professor Ducray of the Hospices Civils de Lyon (coordinating investigator), Professor Chinot of the Timone Hospital in Marseille and Dr Bronnimann of Saint-André Hospital in Bordeaux. "

"We are pleased to contribute to the development of this new pediatric formulation of temozolomide. A liquid form is unambiguously of interest for treating children.", underlines Pr. François Ducray. Hugues Bienaymé, General Manager of ORPHELIA Pharma further comments: "This first administration is a major milestone in the development of Kimozo. We are now preparing the opening of our second clinical trial, which will evaluate Kimozo in pediatric patients, by the end of the year ", he concludes.

About the Bioequivalence Study (NCT04467346)

The clinical trial entitled "Bioequivalence Study between temozolomide oral suspension (Ped-TMZ) and Temodal capsules" (NCT04467346) is an open label phase I study, randomized, crossover, 2-period study in 30 male/female patients with primary CNS malignancies. Patients will receive, under fasting conditions, 200 mg/m² of Temozolomide Oral Suspension (Ped-TMZ, the code name of Kimozo) or Temodal, as single oral administration in 2 different study periods depending on the randomization, with no wash out period between administrations. The primary objective is to evaluate the bioequivalence between Kimozo and Temodal capsules for oral administration. The secondary objectives are to define the pharmacokinetic parameters of Kimozo administration and to assess its buccal safety.

The clinical centers are Hospices Civils de Lyon, Bron, France ; CHU de Bordeaux, Bordeaux, France and Hôpital de la Timone (AP-HM), Marseille, France. The Study sponsor is ORPHELIA Pharma.

About Kimozo

Kimozo (also known as ORP-005 or Ped-TMZ) is a ready-to-use and taste-masked oral suspension of temozolomide that is currently under development to address children needs. Kimozo is an investigational medicinal product not yet approved for marketing anywhere in the world.

On October 2, 2020 Celex Oncology reported strong new data that confirms that its patent protected solution of combining a sodium channel blocker with a potassium channel opener produces an enhanced response in inhibiting metastatic invasion in cancer cells (Press release, CELEX Oncology, OCT 2, 2020, View Source [SID1234632186]). Today’s data also reinforces the Company’s earlier findings of inhibiting metastatic invasion by blocking voltagegated sodium channels.

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The company’s CEO and Professor Mustafa Djamgoz said "the new results are significant because they further underline and strengthen the potential of the new cancer treatment mechanism that we are developing in clinical trials".

The new data will make it possible to create a novel drug composition that will give the company’s drug candidates a prolonged patent life, and can benefit patients with a superior second-generation drug.

As reported earlier, the Celex mechanism appears to be present in in many (if not all) of the most commonly occurring cancer forms and as a result can offer a significant breakthrough in the treatment of major cancers. The Company’s CEO and Professor Mustafa Djamgoz adds "This means our treatment has the potential to benefit millions of patients around the world both as a stand-alone treatment or in combination with existing treatments." The Company expects this new development to have wide-ranging impact in clinical oncology.

On October 2, 2020 Race Oncology Limited reported that Professor Borje S. Andersson has agreed to join Race as Chief Medical Officer and Executive Director (Press release, Race Oncology, OCT 2, 2020, View Source [SID1234568216]). Under this role, Prof. Andersson will be responsible for progressing Race’s clinical development plans for Bisantrene. He will continue to Chair Race’s Clinical Advisory Board and provide ongoing clinical guidance, leadership and counsel to the Race Oncology Board.

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Prof. Andersson was initially engaged as a scientific and clinical consultant to Race in January 2019, before becoming Chair of RAC’s Clinical Advisory Board on 5 December 2019. He joined the Race Board as a Non-Executive Director in January 2020.

Prof. Andersson is a world-recognised research leader in the field of leukaemia and stem cell transplantation at the MD Anderson Cancer Center in Houston, Texas. He is the inventor of IV Busulfan, an FDA-approved drug used in stem cell transplantation. Busulfan was approved in 1999 and has drastically improved survival for patients with leukemias, malignant lymphomas and genetic disorders amenable to stem cell transplantation, helping to reduce the death rate in the first 100 days after transplant from 30-40% to less than 3%.

Chairman, Dr John Cullity commented, "We are very fortunate to have secured this commitment from Borje to join Race as our Chief Medical Officer. The expertise Borje brings in understanding the patient experience and clinical approaches towards drug utilisation will be invaluable to how we structure our clinical development plans for Bisantrene. He continues to make his substantial international network of experts available and we have already significantly benefited from this. I am delighted to welcome Borje to this new role."

Phil Lynch, CEO and Managing Director said, "It is a privilege to have Borje’s guidance and leadership available to us at the Executive team level. As we move forward with our Bisantrene clinical strategy and our clinical workload increases, his CMO appointment provides us with additional expert resource to progress our clinical plans toward commercial outcomes."

Professor Andersson commented, "My experience with Race through the Clinical Advisory Board and Board roles has motivated me to seek broader engagement, and to more directly support the team to progress and optimise our strategic plans. I’m very excited to assume this new and expanded role that the Board has offered me."

On October 2, 2020 Foghorn Therapeutics, a preclinical biotech developing gene therapies for hematologic cancers and solid tumors, reported that it filed on Friday with the SEC to raise up to $100 million in an initial public offering (Press release, Foghorn Therapeutics, OCT 2, 2020, View Source [SID1234568140]).

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Foghorn is developing a new class of medicines targeting genetically determined dependencies within the chromatin regulatory system through its proprietary Gene Traffic Control platform. The company’s two most advanced candidates are FHD-286, a selective allosteric ATPase inhibitor, and FHD-609, a protein degrader. The candidates are being developed for hematologic cancers and solid tumors, and the company plans to file INDs for FHD-286 and FHD-609 in the 4Q20 and 1H21, respectively.

The Cambridge, MA-based company was founded in 2015 and plans to list on the Nasdaq under the symbol FHTX. Goldman Sachs, Morgan Stanley, Cowen and Wedbush PacGrow are joint bookrunners on the deal. No pricing terms were disclosed.

The article Preclinical oncology biotech Foghorn Therapeutics files for a $100 million IPO originally appeared on IPO investment manager Renaissance Capital’s web site renaissancecapital.com.

Investment Disclosure: The information and opinions expressed herein were prepared by Renaissance Capital’s research analysts and do not constitute an offer to buy or sell any security. Renaissance Capital’s Renaissance IPO ETF (symbol: IPO), Renaissance International ETF (symbol: IPOS), or separately managed institutional accounts may have investments in securities of companies mentioned.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.