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

On December 7, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases reported updated efficacy and safety data from the ongoing phase 2 ANCHOR combination study, following an oral presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) virtual annual meeting (Press release, Oncopeptides, DEC 7, 2020, View Source [SID1234572395]). The data showed that a triplet regimen with melflufen (INN melphalan flufenamide) plus dexamethasone in combination with daratumumab or bortezomib in heavily pretreated patients with relapsed refractory multiple myeloma, demonstrated encouraging activity, was well tolerated and had a similar safety profile as when used as a doublet regimen with only melflufen plus dexamethasone. The severe treatment related adverse events reported were primarily hematologic and were clinically manageable with dose reduction.

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The primary objective of the phase 2 ANCHOR study is overall response rate, and a secondary objective is progression free survival. The data represents an analysis of both treatment arms, with a cut-off date of October 19, 2020. The overall response rate for melflufen plus dexamethasone was 73% in combination with daratumumab and 62% in combination with bortezomib. The median progression free survival was 12.9 months when combined with daratumumab. The recommended dose of melflufen for future studies with daratumumab shall be 30 mg. Since the bortezomib arm of ANCHOR still is recruiting, progression free survival has not been reported and the recommended phase 2 dose is yet to be determined. The recruitment is expected to be completed in 2021.

"The ANCHOR data are very promising: both combinations are well tolerated and demonstrated encouraging activity. The data support further development of melflufen in triplet regimens", says Klaas Bakker, MD, PhD, Chief Medical Officer, Oncopeptides AB. "This provides a clear rational for our larger randomized phase 3 LIGHTHOUSE study, which compares melflufen and dexamethasone with subcutaneous daratumumab vs. subcutaneous daratumumab alone. We are preparing study start in close dialogue with relevant authorities and expect to enroll the first patient during the first quarter of 2021".

ANCHOR is a phase 1/2 open label multicenter study evaluating the safety and efficacy of melflufen plus dexamethasone in combination with either daratumumab or bortezomib in patients with relapsed refractory multiple myeloma, who have undergone 1-4 prior lines of therapy. The patients are refractory to an immunomodulatory drug and/or a proteasome inhibitor. They have not received any prior anti-CD38 monoclonal antibody therapy.

On December 7, 2020 JW Therapeutics (stock code: 2126.HK), a leading clinical stage cell therapy company, reported data from the pivotal study (RELIANCE Trial) of relmacabtagene autoleucel ("relma-cel") under IND pathway at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place virtually December 5th – 8th, 2020 (Press release, JW Therapeutics, DEC 7, 2020, View Source [SID1234572394]).

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The RELIANCE Trial was the first study of a CAR-T therapy manufactured in China for the treatment of patients with relapsed or refractory ("r/r") B-cell lymphoma in China. Compared with other anti-CD19 CAR-T therapies approved in the US and EU, relma-cel shows similar efficacy and pharmacokinetic profiles while providing the potential for an improved toxicity profile in heavily-pre-treated patients with r/r LBCL of poor risk features.

Dr. James Li, Co-Founder, Chairman and CEO of JW Therapeutics commented: "The presentation reinforced relma-cel’s significant competitive advantage in the CAR-T market in China, highlighting its competitive efficacy and safety profiles. We are confident that these data will provide strong support to relma-cel’s ongoing New Drug Application (NDA) in China and we look forward to bringing this innovative CAR-T therapy to patients as soon as possible."

Reference

Summary of Pivotal Study Data of Relma-cel

In JWCAR029 pivotal study (RELIANCE Trial), 69 patients were screened, and 59 with r/r large B cell lymphoma were enrolled and treated with relma-cel, with median age of 56.0 years (18-75). The median doses administered in low and high dose groups were 99.7×106 (range, 80.1-101.3) and 150.0×106 (range, 120.0-156.4) CAR+ T cells, respectively.

As of June 17, 2020 data cut-off, Best Overall Response Rate was 75.9% (95% CI, 62.8- 86.1) with Best Complete Response Rate of 51.7% (95% CI, 38.2-65.1) in 58 evaluable patients. With a median follow-up of 8.9 months, median OS were not reached, and 6 month DOR, PFS and OS were 60.0%, 54.2% and 90.8%, respectively.

Of 59 treated patients, 28 patients (47.5%) experienced CRS of any grade. Grade 3 and 4 CRS was observed in 2 patients (3.4%) and 1 patient (1.7%), respectively. The median onset of CRS was at 4.5 days (range 1 to 5) after infusion with a median duration of 7.0 days (range 1 to 18). Neurologic events occurred in 12 patients, with only 3 (5.1%) having severe grade events (all Grade 3). Median onset of NT was at 8.5 days after infusion, with a median duration of 12.5 days (range 1 to 49). CRS and NT were generally manageable and all cases resolved except one patient who died at day 8 of sepsis and ongoing grade 4 CRS.

The RELIANCE Trial provided the first demonstration of licensure-quality CAR-T manufacturing and clinical trial data generation in r/r patients originating in China. These results with relma-cel demonstrate similar preliminary response rates while providing the potential for an improved toxicity profile in heavily-pre-treated patients with r/r LBCL having poor risk features relative to other CD19-specific CAR-Ts approved in the US and EU.

About Relmacabtagene autoleucel ("relma-cel")

Relmacabtagene autoleucel ("relma-cel"), JW Therapeutics’ lead product, is an anti-CD19 CAR-T therapy for third-line treatment for relapsed or refractory ("r/r") B-cell lymphoma. The New Drug Application (NDA) for relma-cel as a third-line treatment for diffuse large B-cell lymphoma ("DLBCL") was accepted for review by China’s National Medical Products Administration ("NMPA") in June 2020 and was granted priority review status in September 2020. Moreover, the NMPA also granted Breakthrough Therapy Designation for relma-cel as a treatment for follicular lymphoma. Relma-cel is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China.