On March 18, 2021 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial and operating results, including an update on its CD47 clinical programs, for the year ended December 31, 2020 (Press release, Trillium Therapeutics, MAR 18, 2021, View Source [SID1234576872]). All financial amounts in this news release are in United States dollars, unless otherwise stated.

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"2020 was a critical year in Trillium’s evolution, as we completed a wide-ranging transformation program spanning all aspects of our activities, including strategy, governance, leadership, advisory infrastructure, corporate development, funding, investor base, intellectual property and operations," said Jan Skvarka, Trillium’s President and CEO. "At the same time, we substantially advanced dose escalation studies of TTI-622 and TTI-621, which clearly demonstrated class-leading monotherapy activity. Our mission critical goal for 2021 is to rapidly move to proof of concept studies in a range of hematologic malignancy and solid tumor indications. We are incredibly excited about our prospects going forward based upon the unique monotherapy activity of our molecules, which provides a strong foundation for moving to combination studies."

2020 Transformation Program

In 2020, we completed a wide-ranging transformation program under a new leadership, with the following highlights:

Strategy: Reset corporate strategy by discontinuing a lead intra-tumoral cutaneous T-cell lymphoma (CTCL) program, and shifting focus toward large hematological malignancy and solid tumor indications via intravenous administration.
Clinical development: Substantially advanced TTI-622 and TTI-621 dose escalation studies, while demonstrating unique, highly differentiating monotherapy activity; positioned both programs for moving to phase 2 development in 2021.
Corporate development: Received $25 million equity investment from Pfizer, with Dr. Jeff Settleman, Pfizer Oncology Chief Scientific Officer, joining Trillium’s Scientific Advisory Board (SAB).
Governance: Appointed three new directors, including Mr. Paul Walker (partner at NEA), Dr. Mike Kamarck (CTO at Vir Biotechnology, formerly with Merck, Wyeth and Bayer), and Mr. Paolo Pucci (former CEO of ArQule), as well as Dr. Ali Behbahani (NEA partner) as a Board observer.
Leadership: Appointed new Chief Medical Officer, Ingmar Bruns, MD, PhD, a highly experienced and accomplished hematologist-oncologist and drug developer who previously held leadership roles at Pieris Pharmaceuticals and Bayer.
Advisory infrastructure: Formed a highly qualified SAB consisting of Karen Ferrante, MD; Gordon Freeman, PhD; Tom Reynolds, MD, PhD; Steven Rosen, MD; and Jeff Settleman, PhD.
Intellectual property: Solidified leading CD47 SIRPaFc patent estate by receiving a US patent for TTI-622 as a composition of matter, and (to our Licensor) a US patent for the method of using SIRPaFc fusion protein for treating CD47+ cancer including hematologic and solid tumors.
Finance & reporting: Converted functional and reporting currency from CAD to USD, transitioned from foreign private issuer to domestic filer under SEC rules, and converted reporting from IFRS to US GAAP.
Fundraising: Raised more than $300 million through two public fundraising rounds, an equity investment from Pfizer, and the exercise of warrants.
Investor base: Strengthened shareholder base, now consisting primarily of leading specialist life sciences investors.
TTI-622 (SIRPα-IgG4 Fc)

Substantially advanced TTI-622 single agent dose escalation study in relapsed or refractory lymphoma through dose levels from 4 to 18 mg/kg (currently ongoing).
Per the last data update at ASH (Free ASH Whitepaper) 2020 (data cutoff as of November 3, 2020), we reported the following TTI-622 profile:
No major safety concerns and no maximum tolerated dose (MTD) reached through 12 mg/kg dose level;
35% ORR, with six responses (including one complete response) in 17 response evaluable patients, at dose levels of 0.8-12 mg/kg (one patient assessed in 12 mg/kg cohort as of the data cutoff); and
Dose dependent increases in receptor occupancy and TTI-622 serum exposure.
TTI-621 (SIRPα-IgG1 Fc)

Progressed TTI-621 single agent dose escalation study in advanced relapsed or refractory hematologic malignancies through dose levels from 1.0 to 2.0 mg/kg (currently ongoing), though COVID-19 negatively affected the speed of patient enrollment.
As of our last data update at ASH (Free ASH Whitepaper) 2020 (data cutoff as of November 3, 2020), we reported the following TTI-621 profile:
No DLTs reached through dose level 1.4 mg/kg; transient thrombocytopenia observed, though not clinically relevant; and
Monotherapy activity observed in T-cell and B-cell lymphomas, including 17% ORR in CTCL (N=53), 18% ORR in PTCL (N=22%), and 29% ORR in DLBCL (N=9) across dose levels ranging up to 0.5 mg/kg in PTCL and DLBC, and up to 1.4 mg/kg in CTCL.
R&D Day

On April 28, 2021, we plan to hold an R&D Day, at which we will:

Provide a data update for TTI-622 and TTI-621, including data for the 18 mg/kg and 2 mg/kg dose cohorts, respectively;
Announce key strategic priorities in terms of target indications and drug combinations across hematologic malignancies and solid tumors;
Outline clinical development plan and clinical studies to be initiated in 2021.
Annual 2020 Financial Results:

Trillium began reporting its results in accordance with U.S. GAAP effective for the fiscal year ended December 31, 2020. This transition is a result of the Company no longer being classified as a foreign private issuer as defined under the rules of the SEC. As a domestic filer, the Company now prepares consolidated financial statements in accordance with U.S. GAAP, reports with the SEC on domestic forms, and complies with SEC rules and regulations applicable to domestic issuers.

As of December 31, 2020, Trillium had cash and cash equivalents and marketable securities of $291.2 million, compared to $22.7 million at December 31, 2019. The increase in cash and cash equivalents and marketable securities was due mainly to proceeds from financings completed in January 2020 and September 2020.

Net loss for the year ended December 31, 2020 of $59.3 million was higher than the loss of $38.1 million for the year ended December 31, 2019. The net loss was higher due mainly to a non-cash loss of $22.1 million on the revaluation of the deferred share unit liability (reclassified from a liability to equity effective June 30, 2020 on adoption of the new omnibus incentive plan), non-cash stock-based compensation expenses relating to the revaluation of the Company’s stock option liabilities of $12.5 million, and higher manufacturing costs. This was partially offset by lower clinical trial and salary expenses.

On March 18, 2021 Pascal Biosciences Inc. ("Pascal" or the "Company") (TSXV:PAS) (OTC:BIMUF), a biotechnology company that specializes in cancer, cannabinoids, and Covid-19 reported the closing of the second tranche of the non-brokered private placement announced on November 2, 2020, January 19, 2021 and January 22, 2021 (the "Private Placement") (Press release, Pascal Biosciences, MAR 18, 2021, View Source [SID1234576871]). Participants included long-term shareholders, new shareholders, and Company insiders. "This financing will greatly help Pascal move our programs forward. It’s encouraging to see the confidence of our long term shareholders and we welcome our new shareholders", stated CEO Patrick Gray. "Mark van der Horst, our vice president of Corporate Communications, has done a great job of presenting the Pascal story, and we will continue to actively deliver positive messaging to investors."

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The second tranche consists of 1,900,000 units (each a "Unit") for gross proceeds of $190,000. The first tranche closed on February 8, 2021 and the Company issued 5,600,000 Units for gross proceeds of $560,000. Each Unit consists of one common share in the capital of the Company (each a "Share") and one Share purchase warrant (each a "Warrant"). Each Warrant entitles the holder to purchase one additional Share at a price of $0.15 per Share for a period of 24 months from the date of closing, subject to an exercise acceleration clause. Under the exercise acceleration clause, which the Company may exercise once the Units are free of resale restrictions and if the Company’s Shares are trading at or above a volume weighted average price of $0.40 for 10 consecutive trading days, the Warrants will expire upon 30 days from the date the Company provides notice in writing to the Warrant holders via a news release.

The Company paid $1,365 in finder’s fees related to the second tranche of the Private Placement.

Certain directors and officers of the Company acquired 1,255,000 Units under the Private Placement. Any such participation is considered to be a "related party transaction" as defined under Multilateral Instrument 61 -101 Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The transaction will be exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 as neither the fair market value of any shares issued to, or the consideration paid by such persons, will exceed 25% of the Company’s market capitalization.

The proceeds from the sale of Units will be added to working capital in furtherance of the Company’s business.

The securities issued under the Private Placement are subject to a four-month and one day hold period. The private placement is subject to final acceptance by the TSX Venture Exchange upon filing of final documents.

On March 18, 2021 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA; the "Company") reported that ILLUMINATE-301, the Company’s pivotal registration trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma, did not meet its primary endpoint of objective response rate (ORR) (Press release, Idera Pharmaceuticals, MAR 18, 2021, View Source [SID1234576870]). Idera is evaluating its next steps regarding continuation of the trial toward its overall survival (OS) endpoint, which includes evaluating the full data set when it is available. The Company also plans to continue its ILLUMINATE-206 Phase 2 study of tilsotolimod in combination with ipilimumab and nivolumab in patients with microsatellite stable colorectal cancer (MSS-CRC).

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ILLUMINATE-301 is a randomized, global, multi-center, open label Phase 3 trial comparing the efficacy of 8 mg intratumoral tilsotolimod in combination with 3 mg/kg ipilimumab versus 3 mg/kg ipilimumab alone in 481 patients with anti-PD-1 refractory advanced melanoma. The trial has a primary endpoint family of ORR per RECIST v1.1 and OS. Although the primary endpoint of ORR was not met, if the study continues and reaches a positive OS outcome, the Company would expect to discuss with regulatory authorities a potential path forward in this indication.

ILLUMINATE-301 Key Findings:
Patients in the study were randomized and treated either with 8 mg of tilsotolimod in combination with ipilimumab or with ipilimumab alone. Topline results include:

ORR of 8.8% for the combination arm and 8.6% for ipilimumab alone.
Disease control rate (DCR, defined as stable disease or better) of 34.5% for the combination and 27.2% for ipilimumab alone.
Treatment-emergent adverse events (TEAEs) (Grade 3 and above) occurred in 61.1% of patients who received the combination vs. 55.1% of patients who received ipilimumab alone. Immune-related TEAEs (Grade 3 and above) were reported in 37.6% vs. 30.1%, respectively.
More detailed results from ILLUMINATE-301 may be submitted for future publication or presentation.

"We are surprised and disappointed that the response data from ILLUMINATE-301 do not lead us to an accelerated path to a new and much-needed treatment option for these patients," stated Vincent Milano, Idera’s Chief Executive Officer. "We would like to extend our deepest gratitude to everyone involved in this study, especially the many courageous patients who participated and continue in follow up."

Continued Mr. Milano, "Despite today’s news, we are continuing to explore tilsotolimod via our ongoing ILLUMINATE-206 study in order to understand its potential to lead to better outcomes for patients with MSS-CRC."

About Tilsotolimod (IMO-2125)
Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate (Type-I IFN, antigen presentation) and adaptive (T cells) immune activation. Tumors with an active immune response appear to respond better to checkpoint inhibitors (CPIs) than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint inhibitors. For more information on tilsotolimod trials, please visit www.clinicaltrials.gov.

About Anti-PD-1 Refractory Advanced Melanoma
Melanoma is a cancer that begins in a type of skin cell called melanocytes. While melanoma is the least common type of skin cancer, it has a poor prognosis when not detected and treated early. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread, or metastasized, beyond the skin to other parts of the body. According to the American Cancer Society, approximately 100,000 people in the US will be diagnosed with invasive melanoma this year. In recent years, immunotherapies known as CPIs have changed the treatment of advanced melanoma, with anti-PD-1 agents, alone or in combination with anti-CTLA-4, being the most commonly used immunotherapy in the first-line setting. These agents work by increasing the ability of the body’s immune system to help detect and fight cancer cells. However, due to primary or acquired resistance mechanisms that exclude or inhibit anti-tumor immune cells, as many as 60% of patients may not benefit from this type of therapy when used as monotherapy, and up to one-third of initial responders may develop resistance to the therapy and ultimately experience disease progression. Today, these refractory patients are left with few options for further treatment, paving the way for novel investigational therapies such as tilsotolimod.

About MSS-CRC
Colorectal cancer involves the abnormal growth of cells in the colon or rectum. This type of cancer is typically tested to determine its "MSI" status, which will inform treatment approach and prognosis. MSI stands for "microsatellite instable." MSI-High (MSI-H) means that there is a high amount of instability in a tumor, whereas MSS tumors are "microsatellite stable." The American Cancer Society estimates that, annually in the United States, approximately 140,000 people are diagnosed with CRC, of which 85% are MSS, and approximately 50,000 people die due to CRC. MSS-CRC has been shown to be highly immunosuppressive; there are no approved immunotherapy options, and a prior trial of ipilimumab plus nivolumab (Bristol Myers Squibb’s CheckMate 142) yielded overall response rates of 0-10%. Given tilsotolimod’s mechanism of action of activating dendritic cells and therefore triggering innate and adaptive immune responses, it may serve a complementary function to ipilimumab and nivolumab within the immunosuppressive tumor microenvironment of MSS-CRC patients.

On March 18, 2021 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a company pioneering the discovery and development of a new class of medicines targeting genetically determined dependencies within the chromatin regulatory system, reported a corporate update in conjunction with its 10-K filing for the year ended December 31, 2020 (Press release, Foghorn Therapeutics, MAR 18, 2021, View Source [SID1234576869]).

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"With IND clearance for FHD-286 in both relapsed and/or refractory AML and metastatic uveal melanoma, we are currently initiating our first two clinical studies with initial data possible by the end of 2021, a significant milestone for our company," said Adrian Gottschalk, Chief Executive Officer of Foghorn Therapeutics. "At the same time, the IND for our second program, FHD-609, a protein degrader targeting BRD9 for the treatment of synovial sarcoma, is on track for submission in the second quarter. We have a broad pipeline of programs that continue to advance, including both an inhibitor and protein degrader targeting BRM and a protein degrader program targeting ARID1B. These programs represent two of the most prevalent synthetic lethal relationships in cancer."

Using its proprietary Gene Traffic Control platform, Foghorn is advancing a novel class of therapeutics, including targeting multiple transcription factors, exploiting synthetic lethal relationships in the chromatin regulatory system, while in parallel bolstering its protein degradation capabilities. The company is well resourced to achieve several clinical and preclinical milestones over the coming quarters.

Recent Corporate Highlights:

Completed successful initial public offering (IPO): In October, Foghorn completed a successful initial public offering of common stock that raised gross proceeds, before underwriting discounts and commissions, of approximately $135.2 million.
Received IND clearances for FHD-286: Received IND clearance for its first therapeutic candidate, FHD-286, in metastatic uveal melanoma and relapsed/refractory AML in late December and early January, respectively. FHD-286 is a highly potent, selective, allosteric, small molecule inhibitor of BRG1/BRM.
Key Upcoming Milestones

FHD-286 first patient to be dosed: Expect to dose the first patient in the company’s phase I clinical studies, being conducted in metastatic uveal melanoma and relapsed/refractory AML, in the near future. Foghorn expects to report initial data by as early as year-end 2021.
FHD-609 IND submission: FHD-609, a highly potent, selective, intravenous, small molecule protein degrader of BRD9, is initially being developed for the treatment of synovial sarcoma with the intention to expand into additional indications, including SMARCB1-deleted tumors. The company is on track to submit an IND with the FDA in the second quarter of 2021.
Upcoming Events

AACR Conference: Foghorn is scheduled to present a poster and chair a panel at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting 2021, which is being held virtually from April 10-15. The poster presentation, entitled, "Discovery of BAF Inhibitors for the Treatment of Transcription Factor-Driven Cancers," will be available on-demand beginning 8:30AM on Saturday, April 10. In addition, Steve Bellon, Foghorn Therapeutics’ Senior Vice President of Drug Discovery, will chair a panel with an accompanying presentation, "Targeting the BAF Complex in Cancer," on Wednesday, April 14 from 2:30-3:30PM ET.
Financial Condition

Foghorn reported cash, cash equivalents and marketable securities of $185.8 million as of December 31, 2020 compared with $15.0 million as of December 31, 2019.

On March 18, 2021 Pyxis Oncology ("Pyxis" or the "Company") reported that it has entered into a worldwide license agreement with Pfizer Inc. (NYSE:PFE) for the development and commercialization of two antibody-drug conjugate (ADC) candidates and a license to Pfizer’s ADC technology platform, enabling expansion of its ADC portfolio and further strengthening its developmental capabilities (Press release, Pyxis Oncology, MAR 18, 2021, View Source [SID1234576868]).

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"This collaboration represents successful execution of our overarching corporate strategy to marry in-house organic growth with strategic in-licensing and partnerships to develop our multi-asset multi-platform portfolio," said Lara Sullivan, M.D., Chief Executive Officer of Pyxis. "We look forward to advancing these candidates to the clinic and ultimately achieving the company’s vision to bring new treatment options to patients with difficult-to-treat cancer."

Under the terms of the licensing agreement, Pfizer will provide Pyxis with a worldwide, royalty-bearing license to develop and commercialize two innovative ADC candidates, PYX-201 and PYX-203. Pfizer will receive an upfront payment and equity in Pyxis and is eligible to receive development and sales-based milestone payments and tiered royalties on potential sales. As part of this agreement, Pyxis also was granted a license to Pfizer’s ADC platform, including various payload classes, linker technology and site-specific conjugation techniques for the future development of additional ADCs. Pfizer will also continue to support the development and advancement of this portfolio through an equity investment made by Pfizer Ventures.

Ronald Herbst, Ph.D., Chief Scientific Officer of Pyxis, said, "The early generations of ADCs demonstrated significant potency, but considerable room remains for innovation to generate highly effective ADCs with an improved safety profile. PYX-201 and PYX-203 represent the next generation of ADCs that use innovative conjugation technologies. By combining highly specific antibodies targeting clinically validated tumor markers with established linkers and both novel and proven payloads, we are excited to translate the extensive validating preclinical studies conducted by Pfizer to an improved clinical profile for patients."

Jeff Settleman, Ph.D., Pfizer’s Chief Scientific Officer of oncology research & development, added, "The Pyxis team of industry veterans led by Dr. Sullivan and Dr. Herbst has the experience needed to maximize the clinical potential of these therapeutics. This agreement underscores our commitment to ensure these molecules reach patients as quickly as possible. We look forward to the team’s advancement of these therapeutics based on the promise of ADC technology to significantly impact the treatment landscape."

PYX-201 is a first-in-class non-internalizing ADC that targets a tumor-restricted antigen that is overexpressed in several solid tumor types to selectively kill tumor cells while enhancing a robust anti-cancer immune response. PYX-203 is an ADC that targets an antigen expressed in certain hematologic malignancies. PYX-203 utilizes a highly potent DNA-damaging agent designed to reduce the potential development of drug resistance and disease relapse.