On April 11, 2023 LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody platform of bispecific gamma-delta T cell engagers, reported recent corporate highlights and financial results for the fourth quarter and year ended December 31, 2022 (Press release, Lava Therapeutics, APR 11, 2023, View Source [SID1234629997]).

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"2022 was a very productive year for LAVA, marked by steady progress in the clinical development of our lead programs, LAVA-051 and LAVA-1207," said Stephen Hurly, president and chief executive officer of LAVA Therapeutics. "We are encouraged by the initial safety and activity signals and will continue dose escalation in these programs as we work toward a recommended Phase 2 dose. We will also continue to advance our pipeline of bispecific gamma-delta T cell engagers for patients with cancer."

"On the corporate front, we strengthened our management team with the additions of two seasoned executives, Dr. Charles Morris as chief medical officer and Fred Powell as chief financial officer. Both executives joined LAVA following several decades of experience and proven track records of success in their prior roles. The Company also appointed three highly accomplished independent members to the Board of Directors, which reflects an important progression in the Company’s evolution," continued Hurly.

Recent Pipeline Highlights

LAVA-051

Gammabody designed to target CD1d-expressing tumors, including multiple myeloma (MM), chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML)

● Initial clinical data for LAVA-051 and presented clinical pharmacokinetic and pharmacodynamic data from the first five patient cohorts of the Phase 1 dose-escalation study that suggest a favorable safety profile, which allowed us to expand the enrollment of patients into planned additional cohorts.
● Potential signs of clinical activity were observed as well as linear PK and on-mechanism PD parameters consistent with Vγ9Vδ2-T cell engagement.
● Clinical trial sites are actively enrolling in North America and Europe.

LAVA-1207

Gammabody designed to target the prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells in patients with metastatic castration-resistant prostate cancer (mCRPC)

● Initial clinical data suggests a favorable safety profile, with no occurrence of high-grade (>2) cytokine release syndrome.
● Initial signs of anti-tumor activity were observed, with iRECIST stable disease (iSD) in 8 out of 14 evaluable patients at week 8 and PSA levels stabilizing or decreasing in heavily pre-treated patients.
● Clinical trial sites are actively enrolling in sites in North America and Europe.

Corporate Update

● LAVA strengthened its executive management team with the following appointments:
o Dr. Charles Morris was appointed as chief medical officer. Dr. Morris is a medical oncologist with over 25 years of oncology drug development experience and has a proven track record of advancing novel oncology product candidates from clinical development through global regulatory approvals.
o Fred Powell was appointed chief financial officer and brings over 25 years of experience as a global CFO in the biopharmaceutical industry, having served in this capacity for several publicly traded biopharmaceutical companies.
o Three new independent directors were appointed to the LAVA Board of Directors: Peter A. Kiener, DPhil, Mary Wadlinger and Christy Oliger. Guido Magni, M.D., Ph.D., and Stefan Luzi, Ph.D., stepped down from the Board.

● In September 2022, we announced an exclusive global license agreement with Seagen pursuant to which we granted a worldwide exclusive license to Seagen to develop, manufacture and commercialize SGN-EGFRd2 (LAVA-1223), an advanced preclinical

asset that utilizes LAVA’s proprietary Gammabody technology to target EGFR-expressing solid tumors. Under the terms of the agreement, LAVA received a $50 million upfront payment and could receive up to approximately $650 million in potential development, regulatory and commercial milestones, and royalties ranging from the high single digits to the mid-teens on future sales.

Fourth Quarter and Year-End 2022 Financial Results

The financial information provided below reflects changes made to previously issued consolidated financial statements to revise immaterial prior period misstatements. Further information regarding the revision is included in our consolidated financial statements, "Note 23 — Revision of Immaterial Misstatements," included in Item 18 of our annual report on Form 20-F.

● As of December 31, 2022, LAVA had cash, cash equivalents and investments totaling $132.9 million compared to cash and cash equivalents of $133.2 million as of December 31, 2021. The cash balance is expected to be sufficient to fund the Company’s activities into 2026.
● Research and license revenue was $2.6 million and $1.1 million for the quarters ended December 31, 2022 and 2021, respectively, and $19.4 million and $5.4 million for the years ended December 31, 2022 and 2021, respectively. The full-year increase was primarily due to $17.9 million in revenue from the Company’s collaboration with Seagen Inc.
● Research and development expenses were $10.5 million and $6.6 million for the quarters ended December 31, 2022 and 2021, respectively, and $40.1 million and $36.9 million for the years ended December 31, 2022 and 2021, respectively. The higher quarterly and full-year expense was due to ongoing activities of the clinical trials for LAVA-051 and LAVA-1207, which were offset by a one-time license fee of $14.4 million triggered in the first quarter of 2021 by the IPO.
● General and administrative expenses were $3.7 million and $3.8 million for the quarters ended December 31, 2022 and 2021, respectively, and $14.1 million and $12.0 million for the years ended December 31, 2022 and 2021, respectively. The increase for the full year 2022 was due to higher personnel-related expenses and the costs of being a public company for a full year compared to only 9 months in 2021.
● Net losses were $15.0 million and $8.2 million for the quarters ended December 31, 2022 and 2021, respectively, or $0.57 and $0.32 net loss per share for the quarters ended December 31, 2022 and 2021, respectively, and $31.9 million and $42.4 million for the years ended December 31, 2022 and 2021, respectively, or $1.23 and $2.14 net loss per share for the years ended December 31, 2022 and 2021, respectively.

On April 11, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported positive topline data from the completed Part A safety lead-in of the Company’s THIO-101 Phase 2 go-to-market trial in advanced Non-Small Cell Lung Cancer (NSCLC) and has commenced recruitment in Part B randomized efficacy/dose selection (Press release, MAIA Biotechnology, APR 11, 2023, View Source [SID1234629981]).

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Topline data from Part A demonstrated that MAIA’s telomere-targeting agent, THIO, administered in sequential combination with Regeneron’s anti-PD-1 therapy, Libtayo (cemiplimab), were generally well-tolerated. No dose-limiting toxicities (DLTs) or significant treatment-related adverse events were observed.

Part A was designed to assess the safety and tolerability of the highest dose of 360 mg/cycle in six patients. Mild toxicities, such as grade 1 fatigue, and muscle pain, were reported, as well as only one occurrence of grade 3 nausea, but no grade 4 adverse events, reported.

"Part A’s safety profile is in sharp contrast with the typical safety profile of chemotherapy treatment where 70-80% of NSCLC patients experience grade 3 and 4 toxicities," said MAIA’s Chief Medical Officer Mihail Obrocea, M.D. "The next dose levels of THIO in Part B are lower compared to Part A. Based on the initial safety profile seen at the highest dose in Part A, we are optimistic about the safety profile of THIO."

"We are pleased with the completion of the safety lead-in portion, which is a very important milestone and catalyst that marks the continued progression of our Phase 2 THIO-101 trial. Recruitment has commenced in the Part B efficacy/dose selection portion of our go-to-market trial, and we anticipate reporting preliminary efficacy data later this year," said MAIA’s Chairman and Chief Executive Officer Vlad Vitoc, M.D.

Part B of the study will allow randomization of patients to three THIO dose levels, including 60 mg, 180 mg and 360 mg, followed by cemiplimab treatment every 3 weeks. Safety and tolerability will continue to be monitored across all THIO doses. The objective of Part B is to determine the most efficacious and safe dose, which will guide Part C of the trial.

THIO-101 is a multicenter, open-label, dose-finding Phase 2 clinical trial designed to evaluate THIO’s potential direct anticancer and immune system activation effects in NSCLC patients by administering THIO in advance of Regeneron’s anti-PD-1 therapy, Libtayo (cemiplimab), thus allowing for immune system activation and sensitivity to the PD-1 inhibitor to take effect. The primary objectives of the trial are to evaluate the safety and tolerability of THIO administered as a direct anti-cancer and priming immune system agent followed by cemiplimab administration, as well as preliminary clinical efficacy of THIO in patients with advanced NSCLC, who either progressed or relapsed through the initial treatments with an immune-check point inhibitor alone, or in combination with chemotherapy. The clinical trial is currently enrolling patients in Australia and the European Union. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About Toxicity Grading in Cancer Treatments

Toxicity is graded 0-5. Toxicity of grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life-threatening, and grade 5 is death.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC), in sequential administration with Regeneron’s anti-PD-1 therapy, Libtayo (cemiplimab). Telomeres play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On April 11, 2023 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that on April 8, 2023, the Compensation Committee of Puma’s Board of Directors approved the grant of inducement restricted stock unit awards covering 22,000 shares of Puma common stock to four new non-executive employees (Press release, Puma Biotechnology, APR 11, 2023, View Source [SID1234629980]).

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The awards were granted under Puma’s 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017 and provides for the granting of equity awards to new employees of Puma. The restricted stock unit awards vest over a three-year period, with one-third of the shares underlying each award vesting on the first anniversary of the award’s vesting commencement date, April 1, 2023, and one-sixth of the shares underlying each award vesting on each six-month anniversary of the vesting commencement date thereafter, subject to continued service. The awards were granted as an inducement material to the new employees entering into employment with Puma, in accordance with Nasdaq Listing Rule 5635(c)(4).

On April 11, 2023 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer reported, an expanded collaboration with Bristol Myers Squibb (NYSE: BMY) to develop Foundation Medicine’s tissue-based test, FoundationOneCDx as a companion diagnostic for Bristol Myers Squibb’s investigational tyrosine kinase inhibitor, repotrectinib (Press release, Foundation Medicine, APR 11, 2023, View Source [SID1234629979]).

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Repotrectinib is an orally administered TKI (tyrosine kinase inhibitor) being evaluated in an ongoing registrational Phase 1/2 trial called TRIDENT-1 for patients with TKI-naive or TKI-pretreated ROS1+ advanced non-small cell lung cancer (NSCLC) and NTRK+ advanced solid tumors. If the companion diagnostic is approved for these indications, and separately, the therapy is approved, oncologists would be able to use FoundationOne CDx to help identify appropriate patients for treatment with repotrectinib.

Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offer physicians blood and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. Currently, Foundation Medicine is the leader in companion diagnostic approvals with approximately 60% of all companion diagnostic approvals for NGS testing in the U.S.

"We’re proud to broaden our collaboration with Bristol Myers Squibb as they work to bring this exciting investigational therapy to patients living with ROS1 positive non-small cell lung cancer and NTRK positive solid tumors," said Jason Adams, Vice President of Biopharma Enterprise Partnerships, Foundation Medicine. "This new collaboration builds on our ongoing research-driven partnership and furthers our shared commitment to deliver more treatment options to patients who need them.

On April 11, 2023 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in oncogene amplified cancers, reported that its President and Chief Executive Officer, Zachary Hornby, will present at the Stifel 2023 Virtual Targeted Oncology Days event which will take place virtually (Press release, Boundless Bio, APR 11, 2023, View Source [SID1234629977]). Presentation details are as follows:

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Date: Tuesday, April 25, 2023
Time: 3:30 – 3:55 PM ET