On May 11, 2022 Targovax ASA reported that members of its executive management team and key scientist are invited to present at upcoming conferences (Press release, Targovax, MAY 11, 2022, View Source [SID1234614188]):

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33rd Annual Cancer Progress Conference, virtual
Panel: Victor Levitsky (CSO)
Panel title: Cancer Vaccines Redux: mRNA, Oncolytic Viruses, Or Good Old-Fashioned Peptides – Is It the Target(s), Immunization Platform, Clin Dev Strategy, or All of the Above?
Date: 11 May 2022
Time: 13:30 CET

Preclinical Immuno-Oncology, virtual
Presentation: Thomas B Hansen (VP Research)
Date: 18 May 2022
Time: 12:25 BST /13:25 CET

ABGSC Life Science Summit 2022, virtual
Presentation: Erik Digman Wiklund (CEO)
Date: 19 May 2022
Time: 10:30 CET

8th Annual Immuno-Oncology Innovation Forum, virtual
Panel: Lubor Gaal (CFO)
Panel title: Optimizing the Inherent Combination Value of Oncolytic Viruses Panel
Date: 25 May 2022
Time: 14:20 EDT / 20:20 CET

The presentations will be available on www.targovax.com after the conferences.

On May 11, 2022 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that it has entered into a clinical collaboration and supply agreement with Agenus Inc. (NASDAQ: AGEN) to combine Targovax’s oncolytic immunotherapy ONCOS-102 with two of Agenus´ checkpoint inhibitors in a multi-cohort phase 2 trial to treat anti-PD1 refractory malignant melanoma (Press release, Targovax, MAY 11, 2022, View Source [SID1234614186]).

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Targovax has previously reported a highly competitive 35% objective response rate (ORR) for ONCOS-102 in a phase 1 trial in anti-PD1 refractory melanoma. Importantly, deep translational analyses revealed broad and powerful ONCOS-102-induced immune activation, which correlated with tumor responses and demonstrated strong scientific evidence for additional combination treatments beyond anti-PD1 blockade. Based on these encouraging clinical findings, Targovax is preparing for a multi-cohort phase 2 trial to test ONCOS-102 with novel immunotherapy combinations in a larger number of patients.

Agenus is an immuno-oncology company with an extensive pipeline of therapeutics designed to activate immune response to cancers and infections. Agenus and Targovax plan to test ONCOS-102 in combination with Agenus´ two proprietary checkpoint inhibitors, balstilimab and botensilimab. Balstilimab is an anti-PD1 blocking antibody currently in clinical development in several solid tumors. Botensilimab is an Fc-enhanced anti-CTLA4 antibody that has shown promising activity in early trials in several treatment-resistant solid tumors as monotherapy and in combination with balstilimab.

Dr. Lone Ottesen, Chief Medical Officer of Targovax, said: "The excellent efficacy, immune activation potency and safety profile of ONCOS-102 argues strongly for moving into later stage development in combination with complementary immunotherapies. Based on our clinical biomarker and genomic data, we firmly believe we can further boost response rates in anti-PD1 refractory melanoma patients with novel combinations. I am particularly excited about the opportunity to work with Agenus´ new anti-CTLA4 candidate botensilimab, which has the potential to significantly improve on both efficacy and toxicity compared to ipilimumab, as well as enhancing the systemic activity of ONCOS-102."

Under the agreement, Targovax will be the sponsor and responsible for operational execution of the combination trial, and Agenus will provide drug supply and scientific support. Following demonstration of competitive clinical efficacy in the planned phase 2 study, the parties intend to extend the collaboration into a registrational development program.

Dr. Erik Digman Wiklund, Chief Executive Officer of Targovax ASA, added: "We are thrilled to extend our existing relationship with Agenus. We were looking for a collaboration partner with a portfolio of innovative, complementary immunotherapies, and in Agenus we have found the perfect fit. Together, we will test novel and differentiated combination treatments in melanoma with the goal to achieve response rates beyond the already observed 35% ORR. We are confident this will confirm ONCOS-102 as a leading candidate to address the growing unmet medical need for immune activators that can effectively reverse resistance to checkpoint inhibitor therapy."

On May 11, 2022 Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported ramps up its clinical development capabilities with the appointment of Dr. Alfredo Zurlo as Chief Medical Officer (CMO) (Press release, Scandion Oncology, MAY 11, 2022, View Source,c3564960 [SID1234614185]). Alfredo Zurlo joins Scandion immediately as part of the company’s Executive Management-team.

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A medical doctor by training, Alfredo Zurlo has more than 20 years of experience in planning and conducting early and late-stage clinical programs in oncology (cancer). He has held several global management positions in a seven-year long career with Roche, including serving as International Medical Director of Oncology and heading the launch of bevacizumab (Avastin) in Europe and the rest of the world for the colorectal indication.

Following his tenure at Roche, Alfredo Zurlo has served as CMO in the two biotech companies Glycotope and Mologen. In addition to his extensive strategic and operational clinical trial experience, he brings a large international network of health care professionals, research scientists and industry experts to Scandion.

"I am delighted to welcome Alfredo Zurlo to Scandion. As we develop both our company and development pipeline, most notably our lead asset SCO-101, it is critical to further strengthen our capabilities in clinical development. With his experience in the field of cancer drug development, Alfredo is an excellent addition to our team, and he will play a key role in the execution of our clinical trials and the planning of pivotal development", says Bo Rode Hansen, President & CEO of Scandion.

"Scandion has a tremendous potential to help address cancer’s resistance to existing treatments, which is perhaps the biggest problem in modern cancer treatment. I am excited by the opportunity to join this company and contribute to the development of new treatments to the benefit of patients, their relatives, health care professionals and society", says Alfredo Zurlo, CMO at Scandion.

Alfredo Zurlo replaces Peter Michael Vestlev, who will continue to work for Scandion in the position of Distinguished Medical Scientist, ensuring an effective handover to Alfredo Zurlo.

On May 11, 2022 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, reported financial results for the quarter ended March 31, 2022 (Press release, RAPT Therapeutics, MAY 11, 2022, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-reports-first-quarter-2022-financial-results [SID1234614183]).

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"As we kick off 2022, we continue to make strong and steady progress in our programs in inflammatory diseases and oncology," said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics. "Recently, at the American Academy of Dermatology annual meeting, we reported biomarker data from our Phase 1b clinical trial of RPT193 in atopic dermatitis that further support the clinical data we reported last June. We are now gearing up to initiate our Phase 2b clinical trial in AD this quarter and to initiate a Phase 2a trial in asthma in the second half of the year. In addition, we are continuing development of FLX475 in several oncology indications, including EBV+ lymphoma, nasopharyngeal cancer and head and neck cancer. We believe our pipeline of promising oral drugs is a key differentiator for RAPT and can serve as a foundation for growth and building stockholder value."

Financial Results for the First Quarter Ended March 31, 2022

First Quarter Ended March 31, 2022

Net loss for the first quarter of 2022 was $20.5 million, compared to $16.5 million for the first quarter of 2021.

Research and development expenses for the first quarter of 2022 were $16.7 million, compared to $13.8 million for the same period in 2021. The increase in research and development expenses was primarily due to higher costs for the RPT193 and FLX475 clinical trials, personnel and facilities, partially offset by a decrease in stock-based compensation expense.

General and administrative expenses for the first quarter of 2022 were $4.7 million, compared to $4.0 million for the same period in 2021. The increase in general and administrative expenses was primarily due to increases in personnel costs, stock-based compensation expense and facilities costs, partially offset by a decrease in consulting expenses.

As of March 31, 2022, the Company had cash, cash equivalents and marketable securities of $173.0 million.

On May 11, 2022 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported financial results for the first quarter of 2022 ended March 31, 2022, and provided an update on the Company’s recent and anticipated future developments (Press release, Pieris Pharmaceuticals, MAY 11, 2022, View Source [SID1234614182]).

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"Pieris and our partners have made steady progress across the pipeline over the past quarter, and we are reiterating guidance on both cinrebafusp alfa phase 2 data in HER2-high gastric cancer in 2023 and PRS-220 clinical initiation this year. With IND acceptance for PRS-344/S095012, enrollment continues as planned and, separately, we are expecting an IND filing for PRS-342/BOS-342 in the next 12 months. At the same time, geopolitical and pandemic-driven challenges are affecting enrollment on certain programs. We are announcing a heightened risk to maintaining current guidance on reporting topline results for PRS-060/AZD1402 this year, despite AstraZeneca’s continued commitment to execute on this program. Additionally, more time is needed for the enrollment of the HER2-low arm for cinrebafusp alfa. Notwithstanding these challenges, with our efficient program funding strategies and committed alliance partners, Pieris can advance its core assets with sufficient cash reach beyond the efficacy readout for PRS-060/AZD1402, which will be a significant milestone for us," said Stephen S. Yoder, President and Chief Executive Officer of Pieris.

PRS-060/AZD1402 and AstraZeneca Collaboration: Enrollment continues for part 2a (efficacy of 1 mg and 3 mg cohorts) and part 1b (safety of 10 mg cohort) of the multi-center, placebo-controlled phase 2a study of dry powder inhaler-formulated PRS-060/AZD1402, an IL-4 receptor alpha inhibitor under development in collaboration with AstraZeneca for the treatment of moderate-to-severe asthma. Given the geopolitical situation, along with broader challenges amidst an ongoing pandemic, there is a heightened risk that more time will be required to deliver the topline study results by the end of the year as planned. AstraZeneca is currently in the process of conducting a thorough timeline reforecast and working on strategies to mitigate any potential delays. Upon completion of the study, which is being sponsored and funded by AstraZeneca, Pieris may choose to exercise its co-development option, which would be on a 25% cost-share basis with a cost cap or a 50% cost-share basis without a cost cap. Separately, Pieris will have a future option to co-commercialize PRS-060/AZD1402 in the United States.
Cinrebafusp Alfa (PRS-343): Enrollment continues in the two-arm, multicenter, open-label phase 2 study of cinrebafusp alfa, a 4-1BB/HER2 Anticalin-based bispecific for the treatment of HER2-expressing gastric cancer. The first arm of the study is evaluating the efficacy, safety, and tolerability of cinrebafusp alfa in combination with standard of care agents ramucirumab and paclitaxel in patients with HER2-high gastric cancer. The Company is reiterating its guidance and expects to report data from this arm in 2023. The second arm of the study is evaluating the efficacy, safety, and tolerability of cinrebafusp alfa in combination with tucatinib in patients with HER2-low gastric cancer. The Company is revising its guidance and now expects to report data from this arm next year due to slower than anticipated enrollment.
PRS-344/S095012 and Servier Collaboration: Enrollment continues and now includes the U.S., where Pieris holds exclusive commercialization rights, in the phase 1/2 study of PRS-344/S095012, a 4-1BB/PD-L1 Anticalin-based bispecific for the treatment of solid tumors that Pieris is developing in collaboration with Servier. Pieris also will receive royalties on any ex-U.S. sales for this program. Additionally, Servier is continuing development of PRS-352/S095025, an OX40/PD-L1 bispecific, for which the companies recently presented preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting 2022. PRS-352/S095025 has demonstrated superior potency to anti-PD-L1 and combination OX40 and PD-L1 therapy benchmarks in different in vitro assays, inhibits the PD-1/PD-L1 pathway with comparable potency to anti-PD-L1 antibodies, stimulates human CD4 T cells, drives T cell stimulation in ex vivo cynomolgus monkey assays, and demonstrated an antibody-like PK profile in vivo.
PRS-220: PRS-220, a proprietary inhaled Anticalin protein targeting connective tissue growth factor for the treatment of IPF, remains on track to enter a phase 1 trial in healthy volunteers this year.
PRS-342/BOS-342: Boston Pharmaceuticals continues to advance PRS-342/BOS-342, a 4-1BB/GPC3 bispecific, towards the clinic, with an IND filing expected within the next 12 months.
First Quarter Financial Update:

Cash Position – Cash, cash equivalents and investments totaled $100.3 million for the quarter ended March 31, 2022, compared to a cash and cash equivalents balance of $117.8 million for the quarter ended December 31, 2021. The decrease is due to funding operations in 2022. The Company believes reported cash is sufficient to fund operations into the fourth quarter of 2023.

R&D Expense – R&D expenses were $14.1 million for the quarter ended March 31, 2022, compared to $16.6 million for the quarter ended March 31, 2021. The decrease is due to lower program costs, as work related to the Company’s sponsored phase 1 trial of PRS-060/AZD1402 was largely complete in 2021, and due to lower manufacturing costs for cinrebafusp alfa. These lower costs were partially offset by higher clinical costs for cinrebafusp alfa and higher clinical and manufacturing costs for PRS-344/S095012. Separately, higher personnel costs due to higher headcount were partially offset by a reduction in consulting and other professional service costs.

G&A Expense – G&A expenses were $4.4 million for the quarter ended March 31, 2022, compared to $4.1 million for the quarter ended March 31, 2021. The increase was driven primarily by higher non-cash amortization of deferred costs related to collaboration revenue earned and partially offset by slightly lower legal and audit costs.

Other Income – For the quarter ended March 31, 2022, $2.1 million of grant income was recorded on PRS-220.

Net Loss – Net loss was $5.1 million or $(0.07) per share for the quarter ended March 31, 2022, compared to a net loss of $4.2 million or $(0.07) per share for the quarter ended March 31, 2021.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM EDT on Wednesday, May 11, 2022, to discuss the first quarter financial results and provide a corporate update. Individuals can join the call by dialing (888) 428-7458 (US & Canada) or (862) 298-0702 (International). Alternatively, a listen-only audio webcast of the call can be accessed here.

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