On December 7, 2020 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported preclinical findings of ALLO-605, the Company’s first TurboCAR clinical candidate and next-generation AlloCAR T therapy for relapsed or refractory multiple myeloma, will be presented in a poster session today at the 62nd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, Allogene, DEC 7, 2020, View Source [SID1234572474]).

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Allogene developed the TurboCAR technology to further enhance the potency of cell therapies. This technology allows ligand independent, cytokine signaling to be engineered selectively into CAR T cells. TurboCARs have the potential to enhance AlloCAR T cell proliferation and overcome T cell exhaustion. The technology is being deployed initially as part of the Company’s three-pronged approach to targeting BCMA in patients with multiple myeloma. Results from the preclinical studies demonstrated that ALLO-605 showed enhanced cytokine secretion, polyfunctionality, improved serial killing activity in vitro, and enhanced eradication of tumors in animal models of myeloma.

"Allogene continues to innovate across our AlloCAR T platform with next generation technologies that can be applied to multiple programs," said Rafael Amado, M.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. "The advances with TurboCAR not only support our approach to targeting BCMA, but also allow us to potentially enhance the activity of other AlloCAR T candidates. We are eager to bring ALLO-605 into the clinic and anticipate filing our first IND utilizing this novel technology in the first half of 2021."

In a highly aggressive orthotopic mouse model of multiple myeloma, ALLO-605 demonstrated an increase in peak expansion and persistence compared to standard BCMA CAR T cells, resulting in rapid and durable antitumor responses. No bone marrow or extramedullary relapses were seen in mice treated with ALLO-605 which resulted in increased survival. The expansion and persistence of ALLO-605 was dependent upon BCMA expression on the target cells and there was no evidence of TurboCAR T cell expansion in the absence of target engagement.

On December 7, 2020 OncoMyx Therapeutics, a privately-held oncolytic immunotherapy company, reported that The University of Western Ontario (Western) has assigned to OncoMyx the technology and patent rights associated with pioneering research on the use of myxoma virus in the treatment of cancer (Press release, OncoMyx Therapeutics, DEC 7, 2020, View Source [SID1234572370]). This research was led by OncoMyx cofounder Grant McFadden, Ph.D., when he was a Professor at Western and the Robarts Research Institute.

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Lisa Cechetto, the Executive Director of WORLDiscoveriesTM, the technology transfer office for Western, Robarts Research Institute, and Lawson Research Institute, said, "We are pleased to assign these patents to OncoMyx, as it is important that the outputs of pioneering research, such as Dr. McFadden’s use of myxoma virus to create novel oncolytic therapies, be further developed to improve the lives of cancer patients or others who may benefit."

"The assignment of this technology and intellectual property to OncoMyx further reinforces our IP portfolio protecting our use of myxoma virus and our pipeline of myxoma virotherapies for the treatment of cancer," said Steve Potts, Ph.D., MBA, cofounder and chief executive officer of OncoMyx. "The myxoma virus has a number of important attributes that we are leveraging to develop potentially impactful oncolytic immunotherapies with the goal of increasing the number of cancer patients who could benefit from immunotherapies."

"Oncolytic viruses are emerging as a new pillar of cancer care with the potential to expand the effectiveness of immunotherapies, such as immune checkpoint inhibitors," said Dr. McFadden. "I am pleased that OncoMyx has been assigned the patent rights associated with the pioneering myxoma research that was done at Western, as the myxoma virus is unique as a technology platform to build oncolytic immunotherapies."

About Myxoma Virotherapy for the Treatment of Cancer

The myxoma virus is highly immuno-interactive and can selectively infect and kill a broad range of cancer cell types. Because myxoma virus is not pathogenic to humans, myxoma virotherapy does not have to overcome pre-existing immunity. As a large dsDNA poxvirus, myxoma is engineerable to express multiple transgenic payloads, such as immunomodulatory proteins, to target multiple points in the cancer immunity cycle. The company’s preclinical data demonstrates efficacy of multi-armed myxoma virotherapies via intravenous (IV) and intratumoral (IT) delivery in a number of tumor models across multiple cancer indications and supports a pan-tumor approach to expand the therapeutic effectiveness of immunotherapies.

On December 7, 2020 IGM Biosciences, Inc. (NASDAQ: IGMS) reported that it intends to offer and sell $150 million of shares of its common stock and, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of common stock, in an underwritten public offering (Press release, IGM Biosciences, DEC 7, 2020, View Source [SID1234572425]). In addition, IGM intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the securities offered in the offering will be sold by IGM. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Jefferies, Stifel, Guggenheim Securities and RBC Capital Markets are acting as joint book-running managers for the offering. Baird is acting as the lead manager for the offering.

The securities in the offering will be offered by IGM pursuant to a Registration Statement on Form S-3, filed with the Securities and Exchange Commission (SEC) on November 5, 2020 and declared effective on November 12, 2020. IGM will file a preliminary prospectus supplement and accompanying prospectus relating to the proposed offering with the SEC, copies of which can be accessed for free through the SEC’s website at www.sec.gov. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. When available, copies of the preliminary prospectus supplement, the final prospectus supplement and the accompanying prospectuses relating to this offering may also be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658 or by email at [email protected]; or RBC Capital Markets, LLC, 200 Vesey Street, 8th Floor, New York, NY 10281-8098; Attention: Equity Syndicate; by telephone at (877) 822-4089 or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

On December 7, 2020 Boehringer Ingelheim and Proxygen reported they have entered into a collaboration and license agreement to enable the identification of molecular glue degraders against various oncogenic targets (Press release, Boehringer Ingelheim, DEC 7, 2020, View Source [SID1234572405]). The collaboration combines Proxygen’s unique molecular glue degrader discovery platform and its expertise in targeted protein degradation with Boehringer Ingelheim’s long-term strategy to provide first-in-class, breakthrough therapies for cancer patients.

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Molecular glue degraders and PROTACs harness the power of the cell’s recycling machinery to selectively eliminate disease-causing proteins. Molecular glue degraders achieve this by specifically bridging the distance between target proteins and ubiquitin ligases, which consequently flag the target proteins for rapid degradation. Molecular glues orchestrate this protein-protein proximity through highly cooperative binding. They circumvent the need for a defined binding pocket on the surface of the target protein, a requirement for conventional small molecule drugs, allowing pharmaceutical intervention on proteins that were previously considered undruggable.

"Proxygen’s molecular glue degrader platform has the potential to become a valuable component of Boehringer Ingelheim’s cancer research strategy to treat tumors driven by the most frequently mutated cancer-causing proteins that were previously considered undruggable and to further expand our efforts in the area of targeted protein degradation," says Norbert Kraut, Global Head of Cancer Research at Boehringer Ingelheim. "We are very pleased to partner with Proxygen, complementing our efforts in taking difficult-to-treat cancers on."

The identification of molecular glue degraders has been serendipitous up to this point. Proxygen’s highly scalable and broadly applicable molecular glue discovery platform promises a goal-oriented and comprehensive avenue towards an improved identification of molecular glue degrader candidates.

"We are very excited to join forces with Boehringer Ingelheim," says Bernhard Boidol, Chief Executive Officer of Proxygen. "Working together with a leader in innovative oncological research and development not only validates the broad applicability of our molecular glue degrader platform but also allows us to rapidly develop new therapies for the high unmet medical need of many patients with lung and colorectal cancers."

Proxygen’s new method has recently been recognized by Boehringer Ingelheim through its Grass Roots ‘Innovation Prize’ in Vienna, Austria. The ‘Innovation Prize’ recognizes the innovation power of young life-science companies and bio-entrepreneurs to create and sustain pipelines for the next generation of medicines. Launched in 2015, the Grass Roots programs comprise of ‘Office Hours,’ ‘Academy’ and the ‘Innovation Prize.’ As a company dedicated to improving health and quality of life, these programs give Boehringer Ingelheim the opportunity to lend expertise to the early-stage innovation community and offer guidance around the science to help enable ideas to deliver the next breakthroughs.

Proxygen is entitled to receive up-front payments, research and development support and milestone gated development payments, as well as tiered royalties based on future commercial sales of developed products.

On December 7, 2020 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDC") and their associated drug formulations used to safely and effectively destroy various cancers, bacteria and viruses reported that the University of British Columbia ("UBC") Review Ethics Board ("REB") has approved the commencement of a Pivotal Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") Clinical Study to enroll and treat patients who present with Carcinoma In-Situ ("CIS") and who are considered Bacillus Calmette Guerin("BCG")-Unresponsive or are intolerant to BCG Therapy ("Study II") (Press release, Theralase, DEC 7, 2020, View Source [SID1234572397]).

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The University of British Columbia is a global center for teaching, learning and research, consistently ranked among the top 20 public universities in the world and recently recognized as North America’s most international university.

To date 14 patients have been treated in Study II. With the addition of UBC, the Company now has 5 sites open for patient enrollment and treatment in Canada. The Company is in advanced discussions to launch a number of U.S. based clinical study sites in 4Q2020, subject to the United States economy recovering from the COVID-19 pandemic. The U.S. based Trial Management Organization plans to launch 4 to 5 clinical study sites in 4Q2020 and commence Study II patient enrollment and treatment as early as 1Q2021.

Dr. Peter Black, MD, FRCSC, a Urologic Oncologist at Vancouver General Hospital, a Research Scientist at the Vancouver Prostate Centre, and a Professor in the Department of Urologic Sciences at the University of British Columbia stated "I think this is a great opportunity for patients to gain access to a promising new technology and treatment that is easy to deliver and very patient-friendly. We are delighted to be able to offer it to patients in British Columbia."

Shawn Shirazi PhD, Chief Executive Officer, Theralase, stated, "We are extremely pleased that the UBC, REB provided approval to proceed with Study II. We are excited that our recent FDA Fast Track Designation status for Study II could lead to the expedited development of this drug-device combination for NMIBC patients. The TLD-1433 technology represents a paradigm shift in medical technology and an advanced approach to treat NMIBC."

About Study II

Study II utilizes the Therapeutic Dose (0.70 mg/cm2) of TLD-1433 and is focused on the enrollment and treatment of approximately 100 BCG-Unresponsive NMIBC CIS patients in up to 20 clinical study sites located in Canada and the US.

Study II has a:

Primary endpoint of efficacy (defined by Complete Response ("CR") at any point in time
Secondary endpoint of duration of CR at 360 days post-initial CR (approximately 450 days post initial Study treatment, assuming CR is achieved at the 90 day assessment)
Tertiary endpoint of safety measured by incidence and severity of Adverse Events ("AEs") grade 4 or higher that do not resolve within 450 days post-initial treatment
The FDA, in its 2018 guidance to industry has stated that, "For single-arm trials of patients with BCG-unresponsive disease, the FDA defines a CR as at least one of the following:

Negative cystoscopy and negative (including atypical) urine cytology
Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology
For intravesical therapies without systemic toxicity, the FDA includes, in the definition of a CR, negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative.
Intravesical instillation does not deliver the investigational drug to the upper tract or prostatic urethra; therefore, the development of disease in these areas cannot be attributed to a lack of activity of the investigational drug. Thus, sponsors can consider patients with new malignant lesions of the upper tract or prostatic urethra, who have received intravesical therapy to have achieved a CR in the primary analysis; however, sponsors should record these lesions and conduct sensitivity analyses in which these patients are not considered to have achieved a CR."1