On July 14, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that its investigational CD20xCD3 T-cell engaging bispecific mosunetuzumab has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma who have received at least two prior systemic therapies (Press release, Hoffmann-La Roche, JUL 14, 2020, View Source [SID1234561840]).

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"We are pleased that the FDA has granted Breakthrough Therapy Designation to mosunetuzumab, recognising the promising early efficacy data for this molecule and the remaining unmet need in follicular lymphoma," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Indeed, we are excited by the potential of both our CD20xCD3 bispecific antibodies – mosunetuzumab and glofitamab – in development for difficult-to-treat lymphomas, and remain committed to developing innovative therapies to improve outcomes for patients."

This designation was granted based on encouraging efficacy results observed in the phase I/Ib GO29781 study [NCT02500407] investigating mosunetuzumab in R/R non-Hodgkin lymphoma (NHL). The safety profile of this T-cell engaging bispecific was consistent with its mechanism of action. Results from this study were previously presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 Annual Meeting.

BTD is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies. This is the 34th BTD for Roche’s portfolio of medicines, and the 10th designation for its haematology portfolio.

A robust clinical development programme for mosunetuzumab is ongoing across a number of lymphoma indications and earlier lines of treatment, investigating the molecule alone and in combination to identify where mosunetuzumab may be able to provide benefit over current treatment options. This includes further investigation of mosunetuzumab in combination with Roche’s Polivy (polatuzumab vedotin) and Tecentriq (atezolizumab) as well as with chemotherapy regimens and non-Roche molecules.

About mosunetuzumab
Mosunetuzumab is an investigational CD20xCD3 T-cell engaging bispecific designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. Mosunetuzumab has a structure similar to that of a natural human antibody in that it has two ‘Fab’ regions, but is different from naturally-occurring antibodies in that one ‘Fab’ region targets CD20 and the other ‘Fab’ region targets CD3. A robust clinical development programme for mosunetuzumab is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with CD20-positive B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers.

About the GO29781 study
The GO29781 study [NCT02500407] is a phase I/Ib, multicentre, open-label, dose-escalation study evaluating the safety and pharmacokinetics of mosunetuzumab in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Outcome measures include best objective response rate by revised International Working Group criteria, maximum tolerated dose, and tolerability.

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Polivy (polatuzumab vedotin), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes idasanutlin, a small molecule which inhibits the interaction of MDM2 with p53; T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3; Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

On July 14, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) and Blueprint Medicines Corporation (NASDAQ:BPMC), reported the signing of a licensing and collaboration agreement providing exclusive rights to Roche for global co-development and commercialisation outside the United States (US), excluding Greater China* (Press release, Hoffmann-La Roche, JUL 14, 2020, View Source [SID1234561839]). In the US, Genentech, a member of the Roche Group, will obtain co-commercialisation rights to pralsetinib, Blueprint Medicine’s investigational, once-daily oral precision therapy for the treatment of people with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other types of thyroid cancer, as well as other solid tumours. In addition, pralsetinib has demonstrated tumour-agnostic potential. The companies also plan to expand development of pralsetinib in multiple treatment settings and explore development of a next-generation RET inhibitor under the collaboration.

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RET-activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and MTC, and treatment options that selectively target these genetic alterations are limited. With the ongoing need for more targeted therapies that may offer clinical benefit to people with these types of cancers, this collaboration reflects Roche’s strategy of providing treatments tailored specifically to a patient’s individual tumour profile and delivering truly personalised healthcare.

In lung cancer, pralsetinib will complement Roche’s broad portfolio of already approved medicines, alongside Alecensa, Rozlytrek, Tecentriq, Avastin and Tarceva and will further support our focus on understanding driver mutations in lung cancer through personalised treatment approaches. Beyond lung cancer, pralsetinib’s tumour-agnostic potential further expands Roche’s ongoing commitment to finding new approaches to treat cancer in a more personalised way based on the genetic mutation of the disease, irrespective of the tumour site of origin.

* Greater China encompasses Mainland China, Hong Kong, Macau and Taiwan.

"We are very excited to enter into this collaboration with Blueprint Medicines, a partner we have already been working with for four years, with the goal of bringing a potentially transformative treatment option to patients with rare RET-altered cancers as quickly as possible," said James Sabry, Head of Roche Pharma Partnering. "In bringing pralsetinib to patients, we will leverage our global reach and expertise in oncology, as well as our capabilities in diagnostics and the use of real-world data toward our aim of providing personalised treatments for patients."

"With Roche’s global reach and unparalleled expertise in personalised healthcare, this collaboration will accelerate our ability to bring pralsetinib to patients with significant medical needs around the world and expand development of pralsetinib across multiple treatment settings where there is potential to benefit even broader patient populations," said Jeff Albers, Chief Executive Officer of Blueprint Medicines.

Blueprint Medicines has submitted a new drug application (NDA) for pralsetinib to the US Food and Drug Administration (FDA) and a marketing authorisation application to the European Medicines Agency (EMA) for the treatment of RET fusion-positive NSCLC. The FDA granted priority review with an expected decision date of 23 November 2020. Blueprint Medicines has also submitted an NDA to the US FDA for RET mutation-positive MTC and RET fusion-positive thyroid cancer. The FDA has accepted the MTC application for its Real-Time Oncology Review (RTOR) pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

Under the terms of the agreement, Blueprint Medicines will receive an upfront cash payment of $675 million and a $100 million equity investment in Blueprint Medicines’ common stock. In addition, Blueprint Medicines is eligible to receive up to $927 million in contingent development, regulatory and sales-based milestones, and royalties on net product sales outside the US. Roche and Blueprint Medicines will share global development expenses based on pre-specified cost-sharing percentages and equally share profits and losses in the US.

The closing of a minority portion of the equity investment is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and other customary closing conditions.

About RET-Altered Solid Tumours
RET activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and multiple types of thyroid cancer. RET fusions are implicated in approximately 1 to 2 percent of patients with NSCLC and approximately 10 to 20 percent of patients with papillary thyroid cancer, while RET mutations are implicated in approximately 90 percent of patients with advanced MTC. In addition, oncogenic RET alterations are observed at low frequencies in colorectal, breast, pancreatic and other cancers, and RET fusions have been observed in patients with treatment-resistant EGFR-mutant NSCLC.

About Pralsetinib
Pralsetinib is an investigational, once-daily oral precision therapy designed to selectively target RET alterations, including fusions and mutations, regardless of the tissue of origin. Preclinical data have shown that pralsetinib potently inhibits primary RET fusions and mutations that cause cancer in subsets of patients, as well as secondary RET mutations predicted to drive resistance to treatment. Blueprint Medicines is developing pralsetinib for the treatment of patients with RET-altered NSCLC, various types of thyroid cancer and other solid tumours.

About Roche in Oncology
Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast.

The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa (alectinib); Avastin (bevacizumab); Cotellic (cobimetinib); Erivedge (vismodegib); Gazyva/Gazyvaro (obinutuzumab); Herceptin (trastuzumab); Kadcyla (trastuzumab emtansine); MabThera/Rituxan (rituximab); Perjeta (pertuzumab); Polivy (polatuzumab vedotin-piiq); Tarceva (erlotinib); Rozlytrek (entrectinib); Tecentriq (atezolizumab); Venclexta/Venclyxto (venetoclax); Xeloda (capecitabine); Zelboraf (vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies. For more information on Roche’s approach to cancer, visit www.roche.com.

About Roche in Personalised Healthcare
For more than 20 years, Roche has helped lay the scientific groundwork for personalised healthcare with treatments that target the underlying biology of cancer and other diseases. Now, with profound changes in data and technology transforming how medicines are discovered, developed and delivered to patients, we are uniquely positioned to extend this approach across all of healthcare. With our ability to integrate research and development, personalised diagnosis, disease monitoring and treatment access, we are advancing personalised healthcare for every aspect of the patient experience.

Our strategy is rooted in groundbreaking science that can accelerate drug discovery and development. We are also leveraging technologies such as real-world datasets, artificial intelligence, genomic profiling and digital health across our therapeutic portfolio, with an initial emphasis on oncology, neurology, ophthalmology and diagnostics. Through collaborations with academic institutions, industry partners, patients, physicians and regulatory agencies, our goal is to dramatically improve the performance of the entire healthcare ecosystem and the lives of every patient.

On July 13, 2020 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will report second quarter financial results after the Nasdaq market closes on Monday, August 3, 2020 (Press release, Neurocrine Biosciences, JUL 13, 2020, View Source [SID1234563735]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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Participants can access the live conference call by dialing 877-876-9173 (US) or 785-424-1667 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On July 13, 2020 iCo Therapeutics Inc. (TSXV: ICO) (OTCQB: ICOTF) ("iCo" or "the Company"), reported financial results for the quarter ended March 31, 2020 (Press release, iCo Therapeutics, JUL 13, 2020, View Source [SID1234562021]). Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards ("IFRS").

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Stated William Jarosz, CEO of iCo Therapeutics Inc., "We were pleased with the positive outcome from our Phase 1b study of our oral Amphotericin B asset during the quarter and that we were able to complete the study with encouraging results and minimal disruption given the current Covid-19 pandemic. On iCo-008, we continue to work closely with our partner Alexion in advancing the program."

Q1 2020 Operational and Financial Highlights

In January 2020, the assignment of the IMMUNE sublicense to Alexion was completed. Under the terms of the assignment, Alexion was required to pay US$6 million into the Court in the settlement of IMMUNE’s creditor claims in exchange for IMMUNE’s rights under the IMMUNE License Agreement.

On February 25, 2020 we announced the successful completion of our Phase 1b study with no serious adverse events. On April 15, 2020, we announced the pharmacokinetic data from this study which showed a doubling in the AUC (0-inf), a measure of drug accumulation, after 10 days dosing compared to day 1 dosing.

On March 9, 2020 Andrew Rae, MBA, resigned from his roles as both President & CEO and Director. Ms. Susan Koppy, a member of iCo’s board of directors since 2015, assumed the role of President and Mr William Jarosz, a member of iCo’s board of directors since 2006, assumed the role of CEO.

Financial results for Quarter ended March 31, 2020

We incurred a total comprehensive loss of $ 645,570 for the quarter ended March 31, 2020 compared to a total comprehensive loss of $353,680 for the quarter ended March 31, 2019, representing an increased loss of $291,890. The increase in the loss is primarily the result of higher research and development expenses offset by lower general and administrative expenses and higher research and development tax credits recognized in Q1 2020.

Research and development expenses were $670,690 for the quarter ended March 31, 2020 compared to $85,095 for the quarter ended March 31, 2019, representing an increase of $585,595. The increase related to higher contract research expenses for clinical trials conducted on the Oral Amp B program in the quarter ended March 31, 2020.

The Phase 1b study was conducted in Australia, which provides refundable tax credits for qualifying research and development activities conducted there. The refundable tax credit is calculated at 43.5% of the qualifying expenditures and the Company recognized $238,258 in other income as its estimate of the tax refund related to qualifying expenditures for the quarter ended March 31, 2020.

For the quarter ended March 31, 2020 general and administrative expenses were $216,436 compared to $278,767 for the quarter ended March 31, 2019, representing a decrease of $62,331. The decrease reflects lower professional fees during the period. The Company’s participation in the IMMUNE bankruptcy process last year caused an increase in professional fees in the corresponding quarter of the prior year.

Liquidity and Outstanding Share Capital

As at March 31, 2020, we had cash and cash equivalents of $479,005 compared to $989,937 as at December 31, 2019.

As at July 13th, 2020, we had an unlimited number of authorized common shares with 153,747,713 common shares issued and outstanding.

On July 13, 2020 Revitope Oncology Inc ("Revitope Oncology")., a biotechnology company advancing a new class of precision cancer immunotherapies, its wholly-owned subsidiary Revitope Limited (Revitope Limited, together with Revitope Oncology, "Revitope") and Junshi Biosciences (1877.HK, 688180.SH), a leading innovation–driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported the companies have entered into a strategic research collaboration (Press release, Revitope Oncology, JUL 13, 2020, View Source [SID1234561859]). Revitope will leverage its proprietary protein engineering platform together with Junshi’s novel antibody components to develop first-in-class dual-antigen targeting cancer therapies. Revitope is granting Junshi a world-wide exclusive license on products arising from the research collaboration and will receive up to $160 million in development and commercialization milestone payments for each T Cell Engaging Antibody Circuit (TEAC) molecule selected by Junshi, plus tiered royalties. Junshi also commits to making a direct equity investment in Revitope Oncology in the amount of $10M for 9.99% of total Revitope Oncology shares on an as-converted basis with terms and conditions to be mutually agreed and subject to compliance with all applicable laws.

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"By leveraging Revitope’s unique two component T-cell immunotherapy platform and our in-house antibody capabilities reaching from discovery to commercialization, dual targeting precision-based novel cancer immunotherapies can be brought into clinical trials in the near future," commented Dr. Sheng YAO, Vice President of Junshi Biosciences. "As an innovation-driven company, we believe the collaboration with Revitope will empower us to generate a new generation of first-in-class immunotherapy compounds designed to improve both safety and clinical efficacy."

Revitope’s proprietary T Cell Engaging Antibody Circuit (TEAC) technology platform exploits co-expressed tumor antigens to enable the development of highly specific cancer drugs with improved safety and efficacy over conventional immunotherapeutic approaches. Revitope’s unique approach is based on a pair of tumor-targeted antibodies with a shared T-cell engaging domain which act as inactive pro-drugs unless they encounter cancer cells co-expressing both antigens.

"We are excited to partner with Junshi , a company with state-of-the-art antibody discovery technologies and world-class development capabilities, to advance our unique two-component T-cell engager therapies that have the ability to target tumor cells and deliver more efficacious and safer drugs to patients," said Steve Arkinstall, PhD, CEO, Revitope Oncology.

Under the terms of the Collaboration and License Agreement, Junshi and Revitope will identify development candidate TEAC pairs against agreed upon targets. Revitope will leverage its TEAC protein engineering platform to develop up to five novel TEAC pairs using proprietary sequences from Junshi’s antibodies with best-in-class pharmacological and therapeutic activity. Junshi will receive a world-wide license to the TEAC pairs and will have sole responsibility for IND enabling studies as well as clinical development, manufacturing and commercialization. Revitope will receive up to $160M in clinical development and commercialization milestone payments for each TEAC molecule selected, plus tiered royalties on net sales.

About Revitope’s T-Cell Engaging Antibody Circuit Technology (TEAC): Tumor-specific Immunotherapies

Because tumors typically do not express cell surface proteins unique to the tumor, conventional bispecific antibody therapeutics can generate unwanted and substantial "on-target, off-tumor" toxicity. Revitope’s two-component T-cell engaging antibody circuits (TEACs) are designed to permit specific recruitment and activation of T-cells exclusively by tumor cells. Though developed with traditional tumor targeting domains, TEAC therapies split the CD3 paratope (the T-cell recognition domain) into two halves, with one half on one molecule and the other half on the other molecule. This allows for true dual-antigen targeting to a unique tumor-specific address – two inputs coming together to enable one precision targeted output, i.e. a true "and" gate safety feature. Only when the two molecules come together through binding to their different tumor targets on the same tumor cell can the two halves of the CD3 binding domain recombine and create a fully functional anti-CD3 domain (a TEAC). Normal cells expressing only one or neither of the targeted antigens will not elicit activation of a TEAC pair thereby avoiding unwanted toxicity in healthy tissues.