On October 5, 2020 Invitae Corporation (NYSE: NVTA), a leading genetics company, reported that on October 2, 2020, it completed the transaction to bring ArcherDX, a leading genomics analysis company, into Invitae to create a comprehensive offering that provides testing services for disease risk, therapy optimization and personalized cancer monitoring to enable precision approaches to cancer treatment (Press release, Invitae, OCT 5, 2020, View Source [SID1234568091]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"With the addition of ArcherDX’s technologies, capabilities and team, Invitae is now well positioned to accelerate the utilization of genetic information throughout a cancer patient’s journey. Starting from risk profiling and diagnostic testing, moving to therapy optimization, monitoring and recurrence surveillance, Invitae can deliver the information needed to enable best-in-class personalized cancer care," said Sean George, Ph.D., co-founder and chief executive officer of Invitae. "Invitae is on a mission to increase access to molecular medicine to all who can benefit, and the addition of the ArcherDX platform builds out an important segment serving the current and future oncology landscape."

In connection with the closing of the acquisition, Jason Myers, Ph.D., has been appointed to Invitae’s Board of Directors, effective October 2, 2020, and will serve as president of oncology.

Transaction Details
Under the terms of the Agreement and Plan of Merger and Plan of Reorganization, Invitae acquired ArcherDX for upfront consideration consisting of 30.0 million shares of Invitae common stock and $325.0 million in cash, subject to certain adjustments. In addition, up to an additional 27.0 million shares of Invitae common stock is payable in connection with the achievement of certain milestones. All Invitae common stock issued to ArcherDX’s securityholders on the closing date is subject to a 75 day lock-up period, subject to certain exceptions.

In connection with the acquisition, Invitae entered into a credit agreement and guaranty with Perceptive Credit Opportunities Holdings III, LP providing for a senior secured term loan facility, and on October 2, 2020, borrowed an aggregate principal amount of $135.0 million under the credit agreement and guaranty. In addition, Invitae issued to Perceptive warrants to purchase 1.0 million shares of Invitae common stock.

In connection with the acquisition, Invitae sold $275.0 million of common stock to certain accredited investors in a private placement.

On October 5, 2020 Trillium Therapeutics Inc. ("Trillium" or the "Company") (NASDAQ/TSX:TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it has received Notices of Allowance from the United States Patent and Trademark Office for two patent applications covering the use of SIRPαFc for the treatment of cancer, U.S. Patent Application No. 13/320,629 (the "629 Application", exclusively licensed to Trillium) and U.S. Patent Application No. 15/962,540 (the "540 Application") (Press release, Trillium Therapeutics, OCT 5, 2020, View Source [SID1234568090]). Trillium has two SIRPαFc biologics, TTI-621 and TTI-622, in clinical development. Both therapeutics target CD47, a "don’t eat me" signal that cancer cells use to evade immune destruction.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The ‘629 method of use Application provides coverage for the use of SIRPαFc biologics to treat all CD47+ cancer cells and tumours, including hematologic and solid cancers. Counterparts of this application have already been granted in Japan, Canada and Australia.

The ‘540 Application has claims that cover TTI-622 composition of matter comprising human SIRPα linked to an IgG4 Fc region, as well as claims covering pharmaceutical compositions that contain TTI-622. A composition of matter patent for TTI-621 (SIRPα linked to an IgG1 Fc) has already been granted in the U.S. (US 9,969,789) and other countries.

"Intellectual property remains a top priority for Trillium, and the allowance of these two important patents further strengthens our position in the SIRPαFc CD47 space," said Jan Skvarka, President and Chief Executive Officer of Trillium. "In addition to our specific composition-of-matter claims covering both of our CD47-targeting agents, we have expanded our coverage to embrace the use of the SIRPαFc class of biologics to treat cancer. We are particularly pleased that the method of use patent also covers treatment of solid tumors."

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.