On January 11, 2022 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported the company has entered into a strategic research collaboration with Pepscan Therapeutics B.V. (Pepscan) to discover novel, peptide-based radiopharmaceuticals for the treatment of various solid tumors (Press release, Fusion Pharmaceuticals, JAN 11, 2022, View Source [SID1234598593]).

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"Fusion’s internal research and develop capabilities combined with expertise in radiopharmaceuticals allow us to create novel targeted alpha therapies (TATs) using a variety of classes of targeting molecules, including antibodies, small molecules and peptides – all of which have been used successfully in radiopharmaceutical development," said Fusion Chief Executive Officer John Valliant, Ph.D. "We are pleased to work with Pepscan who has a proprietary platform for peptide discovery that will enable us to create novel, peptide-based targeted alpha therapies (TATs), further augementing our pipeline of radiopharmaceuticals."

Under the agreement, Fusion has global rights to develop and commercialize any peptides discovered under the collaboration.

On January 11, 2022 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, reported a pipeline milestone update on its TriTAC development programs (Press release, Harpoon Therapeutics, JAN 11, 2022, View Source [SID1234598592]).

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"We are excited to begin 2022 with a catalyst rich year that will be driven by our multiple TriTAC clinical programs, including advancing our HPN217 program into the next phase of development," stated Julie Eastland, President and CEO, Harpoon Therapeutics. "We also expect to submit our first IND for HPN601, targeting EpCAM, from our ProTriTAC technology platform as well as advance an additional preclinical candidate into IND enabling studies as we continue to build out our future clinical pipeline."

Anticipated 2022 Milestones

TriTAC Clinical Programs

HPN328 – Continue dose escalation to determine RP2D by year-end 2022

HPN217 – Select the RP2D and initiate dose expansion cohort during the first half of 2022

HPN536 – Complete dose escalation by year-end 2022

HPN424 – Complete dose escalation during the second half of 2022
Platform Technologies and Next Clinical Candidate

HPN601 – IND submission by year-end 2022

Platform technologies – Advance a clinical candidate into IND enabling studies during the second half of 2022
Corporate Update Events

Harpoon will host an R&D Day during the first half of 2022

On January 11, 2022 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, reported that key strategic priorities and upcoming catalysts to support its lead compound VS-6766 in 2022 (Press release, Verastem, JAN 11, 2022, View Source [SID1234598591]). VS-6766 is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF, potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. VS-6766 is currently in late-stage development.

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"Building on the Breakthrough Therapy designation for VS-6766 with defactinib in recurrent low-grade serous ovarian cancer, the significant progress of our RAMP program in both low-grade serous ovarian cancer and KRAS G12V-mutant non-small cell lung cancer, our clinical collaborations in KRAS G12C-mutant non-small cell lung cancer as well as our ongoing investigator-initiated trials program, we expect to see tremendous progress on behalf of patients in 2022," said Brian Stuglik, CEO of Verastem Oncology. "We plan to efficiently advance our development strategy, report multiple data readouts and further highlight the differentiated potential of VS-6766 across tumor types and mutations."

2022 Strategic Priorities

Gynecologic Oncology Program

Fully enroll Part B of the RAMP 201 trial (LGSOC VS-6766 +/- defactinib).
Expand development program into other RAS pathway-driven gynecologic cancers.
Non-Small Cell Lung Cancer (NSCLC) Program

Select regimen for Part B of the RAMP 202 trial (KRAS G12V NSCLC VS-6766 +/- defactinib).
Initiate and complete dose-finding portions of RAMP 203 (KRAS G12C NSCLC VS-6766 + LUMAKRASTM (sotorasib)) and RAMP 204 (KRAS G12C NSCLC VS-6766 + adagrasib) combination trials.
Provide signal read-out of investigator-sponsored trial of VS-6766 and everolimus in KRAS- mutant NSCLC.
Other Programs

Expand investigator-initiated trial program to include signal-finding studies in other tumor types, including melanoma, breast and colorectal cancers.
Expand clinical combinations with VS-6766.
Anticipated 2022 Development Milestones and Catalysts

1Q-2022

Having completed target enrollment (n=64) in the selection phase (Part A) of the Phase 2 RAMP 201 trial (LGSOC VS-6766 +/- defactinib), the enrollment phase (Part B) is now ongoing with both treatment arms currently advancing.
Complete enrollment in the selection phase (Part A) of the Phase 2 RAMP 202 trial (KRAS G12V NSCLC VS-6766 +/- defactinib).
Initiate RAMP 203 trial (KRAS G12C NSCLC VS-6766 + LUMAKRASTM (sotorasib)) with Amgen.
Q2-2022

Report topline results from Part A of the RAMP 201 trial (LGSOC VS-6766 +/- defactinib), following discussions with regulatory authorities.
Initiate RAMP 204 trial (KRAS G12C VS-6766 + adagrasib) with Mirati.
Present topline results of investigator-initiated trial of VS-6766 and everolimus in KRAS-mutant NSCLC.
Present investigator-initiated FRAME LGSOC translational data.
2H-2022

Complete enrollment in the RAMP 201 trial (LGSOC VS-6766 +/- defactinib).
Report topline results from RAMP 202 trial (KRAS G12V NSCLC VS-6766 +/- defactinib) and initiate the expansion phase (Part B), following discussions with regulatory authorities.
Report initial readout of the RAMP 203 trial (KRAS G12C NSCLC VS-6766 + LUMAKRASTM (sotorasib)) with Amgen.
"We are pleased with the progress of our scientific collaborations and the high level of interest of leading investigators to advance the preclinical synergy data towards clinical evaluation of VS-6766 in combinations across multiple tumor types, including melanoma, colorectal and breast cancers," said Louis Denis, CMO of Verastem Oncology. "These clinical research efforts complement our company-sponsored development program and help to expediently advance our efforts to address an even broader scope of significant unmet medical needs."

About VS-6766

VS-6766 (formerly known as CH5126766 and RO5126766) is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. VS-6766 is currently in late-stage development.

In contrast to other MEK inhibitors, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.1

Verastem Oncology is conducting Phase 2 registration-directed trials of VS-6766 alone and with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS G12V-mutant NSCLC as part of its RAMP (Raf And Mek Program) clinical trials, RAMP 201 and RAMP 202, respectively. Verastem Oncology has also established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and adagrasib in combination with VS-6766 in KRAS G12C-mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively.

On January 11, 2022 Orion Corporation ("Orion") and CuraTeQ Biologics Private Limited ("CuraTeQ"), a wholly-owned subsidiary of Aurobindo Pharma Ltd., reorted that they have expanded their biosimilar distribution agreement to the Baltic countries (Press release, Orion , JAN 11, 2022, View Source [SID1234598590]). The original marketing and distribution agreement signed in 2020 covered the Nordics, Austria, Hungary and Slovenia.

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Under the agreement, Orion will have the right to sell and market CuraTeQ’s biosimilars in the Nordics, the Baltics, Austria, Hungary and Slovenia. All the products under the agreement are still in development or regulatory phases and the launches in Orion territories are estimated to take place in 2023–2026 depending on the success of the development and regulatory approvals.

Virve Laitinen, SVP Specialty Products of Orion Corporation said: "We are pleased to further expand our long-term collaboration with Aurobindo and CuraTeQ. Overall this agreement will strengthen Orion’s position as one of the leading generics providers in the Nordics and Baltics as we can make these cost-effective treatments available for healthcare professionals and patients."

Satakarni Makkapati, CEO of CuraTeQ Biologics said "Orion has a demonstrated and proven track record of successfully commercialising biosimilars in the Nordics and Baltic countries. Orion’s understanding of the biosimilars adoption along with extensive commercial infrastructure in the Nordics and other territories in the EEA make it an ideal partner to expand the accessibility of our biosimilar products in selected markets of Europe, complementing our group’s wide footprint in other European markets."

On January 11, 2022 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that it has received regulatory clearance to start a clinical trial with its lead product candidate, PH-762 (Press release, Phio Pharmaceuticals, JAN 11, 2022, View Source [SID1234598588]). The Company was granted the clinical trial authorization (CTA) by the French National Agency for the Safety of Medicines and Health Products (ANSM – L’Agence nationale de sécurité du médicament et des produits de santé) to proceed with a first-in-human clinical trial for PH-762 to treat patients with melanoma at the Gustave Roussy Institute. The Company expects to dose the first patient in the first quarter of 2022.

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"Receiving this clinical trial authorization is an important milestone for Phio as it is the first clinical study of a new generation of immuno-oncology therapeutics based on our INTASYL self-delivering RNAi platform," said Dr. Gerrit Dispersyn, President and CEO of Phio. "This milestone is the first of several planned for this year, as we continue to accelerate our development of our clinical and preclinical product candidates."

PH-762 activates immune cells to better recognize and kill cancer cells. It does so by reducing the expression of PD-1, a clinically validated target for immunotherapy. PD-1 is expressed by T cells and prevents them from killing other cells, including cancer cells. Therefore, reducing PD-1 expression can reduce the ability of cancer cells to evade T cell detection and killing. In preclinical studies, PH-762 has demonstrated robust and durable efficacy in various in vivo tumor models, and importantly has shown that it can elicit an abscopal effect or systemic immune response after local administration.

The Company’s first clinical trial with PH-762 will be a Phase 1b study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma. There are currently no neoadjuvant treatment options approved for these patients. The study features a dose escalation of PH-762 monotherapy and is designed to allow for a data driven evaluation of the recommended Phase 2 dose.