Oncology therapeutic expertise
Since our inception, oncology has been a core focus of the firm, and over the past decade we have directly supported over 150 clients in their efforts to bring innovative oncology therapeutics to market. Our oncology expertise is extensive and spans across a wide range of tumors and mechanisms, including next-generation and targeted therapies, from early-stage through to commercialization. This has established us as a leading oncology consulting firm and a trusted partner to our clients who are pushing the envelope of what is possible.
Our firm is anchored by partners who bring more than 25 years of oncology drug development experience and have at their disposal our 250-member expert network of specialized consultants. This allows us to offer support at each stage across therapeutic areas, whether that be preclinical guidance and helping best position an early-stage asset for clinical and regulatory success, providing scientific due diligence to help assess and understand potential risks, valuing an oncology drug or program’s commercial potential, or leveraging our wide-ranging network for search and evaluation assistance to help grow an oncology pipeline.
Working with Alacrita, you gain access to the same high-caliber of expertise typically found only in specialist consulting firms, but we replicate it across multiple disciplines in a single place. This allows us to provide you with a broad set of services without any sacrifice in quality, and enables us to support you with greater strategic vision gained from our multi-disciplinary and multi-stage background. For more information on how we can help, please reach out.
We have experience working with a range of modalities:
Our Oncology Consulting Services
Alacrita offers clients a comprehensive level of support that combines the capabilities of the firm's core team with the extensive skillset of our expert network.
The below list of recent oncology projects can help illustrate the type of support we typically provide to clients:
- Virtual Stewardship of a Targeted Cancer Therapy to an IND Submission: An early-stage biotech company developing a targeted cancer therapy engaged Alacrita to provide expertise to help them navigate an upcoming IND submission. An Alacrita partner and medical oncologist with over 25 years of industry experience in drug development was integrated virtually into their team as interim CMO.
Medical oversight support for oncology clinical trials: A listed biotech company conducting Phase III clinical trials in an oncology indication needed Chief Medical Officer support for multiple clinical activities in Europe and the United States.
Defining a clinical strategy in oncology: A venture capital-backed platform technology company wanted to develop its internal pipeline of therapeutic oncology candidates, while allowing prospective partners to access the technology platform through selected R&D collaborations. Alacrita was asked to help create a detailed early clinical plan for the company's lead asset, to be used as a foundation piece of the business strategy.
Independent review of oncology clinical trial data: A small biopharmaceutical company asked us to provide an independent review of data from a recently completed clinical trial. We were to provide a summary report for the company’s management and board of directors. Due to an upcoming board meeting, this request had a tight deadline of only six days from the initial transfer of data to submission of the final report.
Appealing FDA refusal of an orphan drug designation application: A biopharmaceutical company was seeking assistance to prepare a response to the FDA’s initial refusal of its orphan drug designation application for its novel CAR-T therapy intended for use in an orphan subset of a non-orphan condition.
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- Mapping an oncology project opportunity to support fundraising: The technology transfer function of a leading cancer research institute needed a development plan for a promising small molecule lead series against a novel anti-invasion/anti-metastasis target for solid tumors. The plan was required to support fundraising from venture capital investors with the complication of demonstrating the prospective differentiation of inhibitors for this proprietary target versus recent new entrants.
- Business planning on cancer immunotherapy and valuations for a new start-up: An established cancer immunotherapy company needed help with a business plan and valuation for a new company to be setup in collaboration with a major US cancer center.
We provided critical review of numerous drafts of the business plan and were asked by our client to write the commercialization and pricing sections of the business plan. We then developed risk adjusted NPV valuations for three different programs, each of which took an autologous, cell-based multi-epitope approach. We incorporated Monte Carlo simulations into the financial model to account for real-world uncertainty, given these programs were early stage and there were numerous questions about development costs and future product sales. Our Monte Carlo model was able to accommodate uncertainties around clinical trial duration, sales growth scenarios and sales decline scenarios. The business plan and valuation models were key supporting documents as the new company marketed the opportunity to prospective venture investors.
- Commercial development plan for a head and neck cancer CAR-T therapy: Our client was a leading UK Research Institute requiring assistance in assigning internal commercialization funding to the most promising research groups within the university. Alacrita was asked to assess the viability and market attractiveness of selected projects and to develop individual Commercial Development Plans (CDP) that could be reviewed by the funding committee. One such group requiring a CDP was developing a new CAR-T cell therapy for head and neck cancer.
- Fundraising support for an oncology start-up: After a seed investment, a startup biotech had built an IP portfolio in the field of glucosinolates, chemicals found in brassica vegetables, that are potent inducers of cytoprotective enzymes and inhibitors of carcinogenesis. The company was preparing for a Series A financing to support the preclinical and early clinical development of the company’s lead compound and was putting together a business plan to underpin this process.
They asked Alacrita to provide a rational development strategy based on the research data accumulated to date, which suggested that the compound could have efficacy in a broad range of cancer types. The challenge was to identify the lead indication with the strongest scientific, clinical and commercial rationale.
- Developing hypotheses on the breast cancer therapy market: An established US biotech, aware of the importance of incorporating market access factors into clinical trial design, wanted to conduct strategic research for a novel advanced breast cancer therapy about to enter Phase II trials.
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- Providing biotech due diligence of a Phase lll oncology program: A major pharmaceutical company asked us for support in the due diligence and assessment of a Phase III in-licensing opportunity. The drug in question had met its primary endpoint in a pancreatic cancer Phase III clinical trial and our client was seeking ex-US rights to the program. Working to tight timelines, our consultants worked with our client’s internal due diligence team, providing an external perspective and supplementing their internal expertise. We identified some issues and gave recommendations to mitigate those risks. As a result, our client went ahead with the deal, which included a large upfront payment.
- Providing an oncology cell therapy reality check: A venture capital investor needed a reality check on a clinical stage cancer biologic prior to a proposed $10m investment with a very short deadline. Alacrita's cancer immunotherapy expert conducted the analysis within four days, which included a review of a comprehensive data room encompassing preclinical, clinical, regulatory, manufacturing and IP matters. Our report identified the areas of key risk in the project and suggested how to mitigate them. The target company reviewed our report and agreed with the findings including the major areas of risk that we identified.
- Search and licensing support for oncology projects: A listed North American company needed hands-on support with the identification, due diligence and in-licensing of early-stage oncology assets. At the time, the company had three products in clinical development and several programs at various stages of pre-clinical development. Recent data generated for one of the clinical stage programs warranted moving into Phase III trials, however the company needed to raise $10-15m to fund this. The company's board believed that acquiring or in-licensing another complementary program would help catalyse the forthcoming financing event. Our client was keen to engage business development support to supplement its internal capability and expand its geographic reach. Alacrita was therefore tasked with supporting the company with finding suitable candidates for a partnership.
- Scouting for in-licensing opportunities in oncology: A leading precision oncology company developing first-in-class small molecules with a focus on targeting DNA damage repair pathways wanted to bolster its internal pipeline with additional assets via acquisitions or in-licensing. The company had previously only performed passive asset searches, but had recently taken the strategic decision to take a more active approach. The company recognized that a significant investment of time and effort would be required to identify the best opportunities, and thus engaged Alacrita to help.
Valuation of a cancer therapy for licensing deal: A biotech company developing small molecule drugs for oncology was in the process of licensing negotiations with a pharma company for its lead asset. The asset, set to enter the clinic in the next year, was being developed for four CNS cancer indications. The company asked Alacrita to develop a current and future valuation of the lead asset and model various deal term scenarios to guide ongoing licensing discussions.
Oncology consulting case studies
I. Defining a clinical strategy in oncology
Challenge: A venture capital-backed platform technology company wanted to develop its internal pipeline of therapeutic oncology candidates, while allowing prospective partners to access the technology platform through selected R&D collaborations. Alacrita was asked to help create a detailed early clinical plan for the company's lead asset, to be used as a foundation piece of the business strategy.
Solution: Our oncology consultant created a detailed timeline and gap analysis for the company’s initial IND filing and Phase 0-l clinical trial launch. This involved the following:
- Reviewing relevant documents, including the technology; pre-existing corporate, scientific, and clinical goals; and any preclinical data.
- Holding interviews with key stakeholders including company founders, the CEO and the internal R&D team.
- Reviewing potential target cancer indications and establishing up-to-date standards of care.
- Reviewing relevant biomarkers to inform PK/PD activity and patient enrichment strategies.
- Preparing a clinical development plan including prioritization of target indications, design of Phase 0-lla clinical trials and proposal for clinical trial investigators and sites.
- Developing an interval-to-IND filing gap analysis.
Our consultant presented to the board and was retained as an ongoing medical advisor to the company.
II. Valuing a cancer immunotherapy for licensing deal
Challenge: A biotech company developing a cell-based cancer immunotherapy was engaged in out-licensing discussions with a number of major pharma companies. As a key input to the negotiation of deal terms, the biotech company engaged Alacrita to provide them with valuation support.
We developed a risk-adjusted net present value valuation for each development and discovery program that was being considered as part of the transaction. This included a product and market based sales revenue forecast, time-cost-risk assessments for the path to and through market in multiple indications. The valuation incorporated Monte Carlo simulations to reveal the impact of key drivers of uncertainty. The insights gained also provided the client with areas on which to focus in future market research studies.
We also developed a facility for the client to view the split in value between parties, as a function of deal terms. We also considered the type of valuation and deal construct that the buyer/licensee may think appropriate given real-world valuations, precedents and their presumed view of the world. These valuations and scenarios proved pivotal for the client's management team and board of directors in setting internal expectations and guiding the negotiation strategy. We provided ongoing valuation support to help maximize the total value of the deal.
III. Scouting for in-licensing opportunities in oncology, autoimmune diseases and infection
Challenge: For a number of years, Alacrita has been engaged by a well-capitalized Swiss pharma company to scout and identify early stage in-licensing opportunities from the US and UK. Therapeutic areas of interest for our client have included oncology, autoimmune diseases and anti-infectives. Our focus has been to identify new opportunities that are not currently on their radar or easily identifiable through existing industry pipeline databases..
Solution: Alacrita works in close conjunction with the pharma company's internal team of business development professionals, who have benefited from utilizing our wide-reaching network to tap in to very early stage opportunities that are not yet widely known to the industry. Our approach includes maintaining long-term relationships with early stage biotechs, mid-size pharma companies and university technology transfer offices to ensure we are among the first to be made aware of the types of early stage opportunities our client is interested in. We use various channels to do this including regular attendance at relevant scientific meetings and medical conferences, leveraging investor meetings or presentations about non-dilutive financing, searching new and recent literature, and outreach and networking with our industry contacts.
An example of an oncology BD transaction sourced by Alacrita's experts for this client is a small molecule cell cycle checkpoint regulator for which a deal was closed with a biopharma company to collaborate on development of the asset.
IV. Fundraising support for an oncology start-up
Challenge: After a seed investment, a startup biotech had built an IP portfolio in the field of glucosinolates, chemicals found in brassica vegetables, that are potent inducers of cytoprotective enzymes and inhibitors of carcinogenesis. The company was preparing for a Series A financing to support the preclinical and early clinical development of the company’s lead compound and was putting together a business plan to underpin this process.
They asked Alacrita to provide a rational development strategy based on the research data accumulated to date, which suggested that the compound could have efficacy in a broad range of cancer types. The challenge was to identify the lead indication with the strongest scientific, clinical and commercial rationale..
Solution: Alacrita established an indications strategy for the client's novel oncology compound, delivered an expert toxicology report and acted as a ‘technical champion’ during investor presentations.
Following desk research, we worked with two leading oncologists to narrow the number of indications to two. We analyzed them to develop a clinical strategy that would generate value-creating data in a one- to two-year timeframe. This involved an assessment of the cancer biology, a selection of target patient populations, a review of clinical and non-clinical endpoints and determining the effect required to be clinically relevant.
After our client’s board approved the clinical strategy, we used an activity-based model to accurately forecast the time and costs required to execute the development program. The model calculated the overall cost of setting up the trial, recruiting patients, completing the clinical visits, monitoring, data collection, data entry into relevant databases, statistical analysis and clinical report production. We provided costings for a number of different development scenarios.
V. Supporting BLA submissions
Challenge: Our client was nearing the completion of a pivotal Phase III trial with a novel antibody-based therapeutic. The product was designed to delay recurrence in cancer patients with minimum residual disease following debulking surgery and standard chemotherapy. The Phase III trial design had been agreed with the FDA under the SPA procedure and the client had gained fast-track status. In addition, the client had received EMA scientific advice and intended to file for conditional MAA approval, subject to satisfactory Phase III results. Although our client was a fully integrated pharma company, and had significant regulatory experience with small molecules, this was the company’s first biological product candidate to reach the registration stage.
The company was therefore seeking to supplement its existing in-house capabilities with the appropriate external biologics regulatory expertise. Specifically, the company needed to gain a better understanding of the BLA process, clarify the level of detail needed for the various sections of the license application and obtain high-level review and sign-off of the regulatory dossier.
Solution: We prepared and presented an overview of the BLA process to our client’s BLA project team. After the presentation we held a Q&A session on specific areas of the chemistry, manufacturing and controls, nonclinical, and clinical parts of the Common Technical Document. We performed a high-level review and sign-off of each section of the BLA to ensure consistency of message and highlight any areas that could be improved to enhance the licensure process. We then helped our client prepare for, and participate in, a pre-BLA meeting with the FDA. This included drafting key questions for the agency, helping prepare the presentation materials, a presentation rehearsal and participation in the meeting itself.