On August 2, 2021 InterVenn Biosciences reported the completion of a $201 million Series C financing (Press release, InterVenn Biosciences, AUG 2, 2021, View Source [SID1234585527]).

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The funding round was led by new investors SoftBank Group, Heritage Provider Network, Irving Investors, Highside Capital Management, and backed by existing investors Amplify Partners, Anzu Partners, Genoa Ventures and True Ventures. The proceeds from the financing will be used to accelerate development and commercialization of Dawn, the company’s liquid biopsy assay for immune checkpoint inhibitor response prediction, and to expand the network of partners on the company’s AI-driven glycoproteomics platform.

To date, the InterVenn glycoproteomics platform has been used to develop 16 clinical use cases across oncology and other indications. Dawn is currently under development and is planned to be commercialized in 2022. Bolstered by encouraging early results and promising performance, InterVenn will invest in the development of glycoproteomics-based liquid biopsy solutions across the oncology spectrum of care (screening through therapy response monitoring), as well as non-oncology applications. Additionally, the financing will enable InterVenn to expand investment in a partnership ecosystem to accelerate development and commercialization of new clinical solutions, and broaden insights into new biomarkers and therapies.

"We are thrilled to have such strong support from this global investor group to support the next phase of our evolution," said Aldo Carrascoso, Co-Founder and Chief Executive Officer of InterVenn Biosciences. "Our new investors, as well as our existing investors, recognize the transformative potential of our technology and bring strong industry knowledge that will result in a positive partnership for InterVenn. With this fundraising, we believe InterVenn is ideally positioned to unlock the glycoproteome as a novel and fundamental layer in biology, which will reveal a myriad of new insights on how to diagnose and treat disease."

Cowen served as sole placement agent to InterVenn for the private placement.

On August 2, 2021 Alkermes plc (Nasdaq: ALKS) reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company’s novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, for the treatment of mucosal melanoma (Press release, Alkermes, AUG 2, 2021, View Source [SID1234585525]). Earlier this year, the FDA also granted orphan drug designation to nemvaleukin for the treatment of mucosal melanoma. The company recently initiated enrollment in ARTISTRY-6, a global phase 2 trial evaluating the anti-tumor activity, safety and tolerability of nemvaleukin monotherapy in patients with melanoma who have been previously treated with anti-PD-(L)1 therapy. The study is evaluating intravenously administered nemvaleukin in patients with mucosal melanoma and subcutaneously administered nemvaleukin in patients with advanced cutaneous melanoma.

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"Receiving Fast Track designation from the FDA for nemvaleukin for the treatment of mucosal melanoma is an important milestone for the nemvaleukin development program and underscores nemvaleukin’s potential clinical utility to address an unmet medical need in this difficult-to-treat tumor type," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We are committed to advancing this important research in mucosal melanoma, a rare and aggressive form of melanoma for which there are very limited treatment options, particularly for those patients previously treated with checkpoint inhibitors."

Fast Track is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process and a rolling and/or priority review of its marketing application if relevant criteria are met. For more information on Fast Track designation, please visit the FDA’s website, available at View Source

More information on the ARTISTRY-6 study can be found at www.clinicaltrials.gov, identifier: NCT04830124.

About Nemvaleukin Alfa ("nemvaleukin")
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high-affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3 and ARTISTRY-6.

On August 2, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the second quarter ending June 30, 2021 and recent company developments, along with a business outlook for the remainder 2021 (Press release, TG Therapeutics, AUG 2, 2021, View Source [SID1234585521]).

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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "We are pleased with the progress made throughout the second quarter, including our ongoing launch of UKONIQ in relapsed or refractory MZL and FL, FDA’s acceptance of our BLA/sNDA for the combination of ublituximab and UKONIQ (U2) to treat CLL and SLL, and the continued advancement of our clinical programs. We have built a strong commercialization infrastructure to launch UKONIQ and have received positive feedback from healthcare providers on their experiences with the product and with the TG team. We believe this solid commercialization foundation will support, if approved, the launch of U2 in CLL and ublituximab in relapsing forms of multiple sclerosis."

Mr. Weiss continued, "We look forward to an exciting second half of 2021, during which we plan to submit a BLA for ublituximab to treat patients with relapsing forms of multiple sclerosis, continue executing on the launch of UKONIQ in MZL and FL, and continue preparations for potential commercialization of U2 in CLL and ublituximab in RMS."

2021 Highlights & Recent Developments

UKONIQ (umbralisib) in Relapsed or Refractory Marginal Zone Lymphoma & Follicular Lymphoma

Launched UKONIQ in the U.S. for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.
Generated $2.3M in total net UKONIQ revenue from launch through the end of Q2 2021, approximately 4 months.
Achieved broad U.S. payor coverage for more than 90% of Medicare and commercial lives and inclusion in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for MZL and FL.
Ublituximab plus UKONIQ (U2) in Chronic Lymphocytic Leukemia

Received FDA acceptance of a Biologics License Application (BLA) for ublituximab and a supplemental New Drug Application (sNDA) for UKONIQ, both submissions requesting approval of U2 as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). These applications were primarily based on results from the UNITY-CLL Phase 3 trial, which included both treatment-naïve and relapsed or refractory (R/R) patients. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2022 for both applications.
Completed enrollment in the ULTRA-V Phase 2 trial and launched the ULTRA-V Phase 3 randomized trial evaluating the triple combination of U2 plus venetoclax in patients with treatment-naïve and R/R CLL.
Ublituximab in Multiple Sclerosis

Presented positive results from the ULTIMATE I and II Phase 3 trials at the 2021 American Academy of Neurology (AAN) annual meeting and the 7th Congress of the European Academy of Neurology (EAN). Both trials met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period compared to teriflunomide in patients with relapsing forms of multiple sclerosis (RMS).
TG-1701 in B-cell Malignancies

Presented updated data from TG-1701, our BTK inhibitor, as a monotherapy and in combination with U2 in patients with B-cell malignancies at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, the 2021 European Hematology Association (EHA) (Free EHA Whitepaper) virtual congress and the 16th International Congress on Malignant Lymphoma (ICML).
Remaining Key Objectives for 2021 and Early 2022

Focus on the commercialization of UKONIQ in R/R MZL and FL and expand commercialization capabilities in preparation for a potential launch of U2 in CLL and ublituximab in RMS
Submit a BLA for ublituximab for the treatment of patients with RMS in Q3 2021, based on positive results from the ULTIMATE I and II Phase 3 trials
Obtain approval for U2 in CLL and SLL by the PDUFA goal date of March 25, 2022
Enroll into the newly launched ULTRA-V Phase 3 trial evaluating the triple combination of U2 plus venetoclax
Continue to advance our early pipeline candidates including TG-1501 (cosibelimab), TG-1701 and TG-1801
Financial Results for the Three and Six Months Ended June 30, 2021

Product Revenue, net: Product revenue, net was approximately $1.5 million and $2.3 million for the three and six months ended June 30, 2021, compared to zero during the comparable periods in 2020. Net product revenues represent U.S. sales from our sole commercial product, UKONIQ, which received accelerated approval from the FDA on February 5, 2021.

R&D Expenses: Total research and development (R&D) expense was $44.9 million and $108.0 million for the three and six months ended June 30, 2021, compared to $36.5 million and $72.5 million for the three and six months ended June 30, 2020. The increase was due primarily to licensing milestone fees of approximately $4.0 million and $18.0 million incurred during the three and six months ended June 30, 2021, and an increase in non-cash compensation R&D expense over the comparable periods in 2020.

SG&A Expenses: Total selling, general and administrative (SG&A) expense was $34.0 million and $60.8 million for the three and six months ended June 30, 2021, and $14.4 million and $28.7 million for the three and six months ended June 30, 2020. The increase was due primarily to increased personnel and other selling, general and administrative costs associated with execution of the launch of UKONIQ and planning for the potential launches of U2 in CLL and ublituximab in RMS. We expect our selling, general and administrative expenses to increase for the remainder of 2021 as we continue to prepare for those potential 2022 launches.

Net Loss: Net loss was $78.5 million and $169.1 million for the three and six months ended June 30, 2021, compared to $52.9 million and $104.0 million for the three and six months ended June 30, 2020. Excluding non-cash compensation, the net loss for the three and six months ended June 30, 2021 was approximately $62.2 million and $136.2 million, compared to a net loss of $45.5 million and $85.6 million for the three and six months ended June 30, 2020.

Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $456.2 million as of June 30, 2021, which the Company believes will be sufficient to fund the Company’s planned operations into 2023.
CONFERENCE CALL INFORMATION
The Company will host a conference call today, August 2, 2021, at 8:30 AM ET, to discuss the Company’s second quarter ended June 30, 2021 financial results and provide a business outlook for the remainder of 2021.

To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for a period of 30 days after the call.

On August 2, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will release its second quarter 2021 financial results on Monday, August 9, after the close of the U.S. financial markets (Press release, Syndax, AUG 2, 2021, View Source [SID1234585520]).

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In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET on Monday, August 9, to discuss the Company’s financial results and provide a general business update.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website, www.syndax.com.

On August 2, 2021 T-knife Therapeutics, Inc., a next-generation T-cell receptor company developing a pipeline of innovative therapeutics for solid tumor patients, reported the successful completion of a $110 million Series B financing (Press release, T-Knife, AUG 2, 2021, View Source [SID1234585519]). The financing was led by Fidelity Management & Research Company, LLC., with participation from other new investors including, LSP, Qatar Investment Authority (QIA), Casdin Capital, Sixty Degree Capital, and CaaS Capital, along with existing investors RA Capital Management, Versant Ventures and founding investor Andera Partners. The company plans to use proceeds from the financing to expand its scientific team, increase manufacturing capacity and advance its pipeline of T-cell receptor (TCR) engineered T cell therapies (TCR-T).

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"Over the past year we have made substantial progress toward our goal of building a leading TCR-T company focused on delivering clinically meaningful benefits for patients with solid tumors," stated Thomas M. Soloway, Chief Executive Officer of T-knife. "We are excited to have the support of this group of dedicated life sciences investors to help us fulfill our mission, and we welcome Dr. Karin Kleinhans of LSP to our board of directors."

"T-knife has an elegant and differentiated approach to identifying potent, cancer-specific TCRs with naturally optimized affinity and specificity profiles, creating a next-generation platform for this promising therapeutic field," said Alex Mayweg, Chairman of T-knife and Managing Director at Versant Ventures. "We are pleased to be progressing TK-8001 toward the clinic and to advance our broader portfolio of product candidates."

T-knife is leveraging its proprietary HuTCR transgenic mouse platform to discover and develop a portfolio of TCR-T programs to treat patients with solid tumors. T-knife’s lead program, TK-8001, is a novel TCR-T product candidate targeting MAGE-A1 positive cancers. T-knife plans to begin enrolling patients in the TK-8001 IMAG1NE Phase 1/2 clinical study in the fourth quarter of 2021 and is planning to submit INDs/CTAs for additional product candidates in 2022.

"The field of TCR-T holds significant promise to change the treatment paradigm for many cancer patients," said Karin Kleinhans, PhD, Partner at LSP who joined T-Knife’s board in connection with the Series B financing. "We are highly encouraged by the progress being made at T-knife to advance its important next-generation therapies."

Olivier Litzka, Partner at Andera Partners, commented, "As a founding investor, it is gratifying to witness the continued success at T-knife. The completion of the Series B financing is an important milestone that will enable us to execute on our vision of building a leading transatlantic immuno-oncology company."

About the HuTCR platform
T cells play a key role in the immune response by directly recognizing and eliminating infected, foreign or altered cells, such as cancer cells. To do this, they use their T-cell receptors (TCRs) to scan the surface of other cells for foreign antigens presented on Human Leukocyte Antigen (HLA) complexes. Cancer cells can be recognized by mutated or viral antigens expressed only in the tumor, or self-antigens normally expressed during embryonic development and in non-somatic adult tissues. Genetic engineering of T cells with TCRs recognizing antigens aberrantly or over-expressed in cancers can redirect these T cells to the tumor, potentially offering curative responses to cancer patients.

The ability to identify potent cancer-specific TCRs has been limiting for the field of TCR-T. In the case of self-antigens, T cells bearing those TCRs are eliminated during T cell development to avoid recognition and attack of healthy tissues. For non-self tumor antigens, such as those derived from viral sequences or mutations, the very low T cell frequency in the blood has limited TCR discovery efforts.

To overcome these challenges, T-knife has developed transgenic mice (HuTCR mice) carrying the human TCRαβ gene loci and expressing multiple human HLAs. Immunizing HuTCR mice with human tumor antigens, for which mice are not tolerant, allows for the identification of both CD4+ and CD8+ T cells with TCRs that have optimized affinity / specificity profiles capable of mediating significant anti-tumor activity. The TCRs from HuTCR mice are of higher affinity for tumor self-antigens than TCRs isolated from human donors and are naturally optimized to maintain a high specificity profile, making HuTCR mice a powerful high-throughput platform for rapidly generating TCRs with best-in-class potential.