On May 30, 2022 RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, reported that its phase IIb study in prostate cancer, BRaVac, in spite of the previous positive results related to the compound, failed to demonstrate RV001 (onilcamotide) superiority over placebo in preventing progression in patients with biochemical recurrence (a rise in PSA) after curative intent therapy (Press release, RhoVac, MAY 30, 2022, View Source;bravac-failed-to-meet-its-primary-endpoint-301557156.html [SID1234615221]). Progression was defined as either a doubling of PSA, clinical recurrence, or death. RhoVac will undertake a more thorough analysis of the results, and a clear plan on how to proceed will be communicated end June. The primary outcome analysis, however, regrettably offers little hope of a license or acquisition deal based on the results of this study alone.

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RhoVac started the clinical phase IIb trial (BRaVac) with the company’s drug candidate, RV001 (onilcamotide) late 2019, in prostate cancer patients with biochemical recurrence (a rise in PSA) after curative intent therapy. Positive phase I/II data offered significant hope, and in November of 2020, RhoVac was awarded Fast Track Designation by the FDA for its drug candidate in this cancer indication. The objective of the BRaVac study was to show that onilcamotide could significantly prevent or delay disease progression in these patients, something for which no standard therapy is available today. Interim safety reviews have been conducted, and no unexpected adverse events have been identified, and the end trial results also confirm the anticipated safety of the drug candidate.

On efficacy however, BRaVac, the first placebo controlled study of the drug candidate, failed to deliver on its primary endpoint, which was to demonstrate drug candidate superiority over placebo in reducing the risk of progression, and the primary results did not indicate any significant finding on improved outcomes for the studied patients. RhoVac will now undertake a more thorough analysis of the study results, but the primary outcome analysis obviously offers little hope of a license or acquisition deal based on the results of this study alone. RhoVac will now execute on a cost minimisation contingency plan, while conducting further analyses of the results, aiming to come up with clear recommendations on the future of the project and next steps end June.

RhoVac CEO, Anders Månsson, comments: "Even though we know that benchmarks state that the probability of success for a phase II project in oncology is less than 50% and that clinical development is always a calculated risk, we are surprised and deeply saddened to find that BRaVac failed to meet its primary endpoint. We will immediately minimise expenditure, while further assessing the study data, with the aim of coming up with firm recommendations on how to proceed, and to communicate this end June."

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 29-05-2022 19:53 CET.

On May 30, 2022 Step Pharma, a biotech company developing CTPS1 inhibitors for the safe and effective treatment of cancer, reported that it will be presenting data on its lead candidate STP938 at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress being held from the 9-17 June, 2022 in Vienna, Austria (Press release, Step Pharma, MAY 30, 2022, View Source [SID1234615223]).

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Step Pharma will present three posters on STP938, its potent and highly selective small molecule inhibitor of CTPS1 and its potential as a therapeutic for the treatment of T Cell cancers, Multiple Myeloma and Graft-versus-Host Disease (GvHD).

Full details of the posters are:

Poster presentation: CTPS1 is a novel therapeutic target in myeloma – selective small molecule inhibition delivers single agent activity and synergises with ATR inhibition
Authors: Christina Pfeiffer, Philip Beer, Hélène Asnagli, Arnold Bolomsky, Alexander Grandits, Anja Schneller, Julia Huber, Niklas Zojer, Martin Schreder, Andrew Parker, Heinz Ludwig
Date and Time: Available from June 10, 09:00 CEST and on-demand until Monday, August 15, 2022, on the Congress platform
Session title: Myeloma and other monoclonal gammopathies – Biology & Translational Research

Poster Presentation: CTP synthase 1 is a novel target in T cell cancers, with small molecule inhibition inducing death of neoplastic human T cells in vitro and inhibition of their growth in an in vivo xenotransplant model
Authors: Philip Beer, Hélène Asnagli, Norbert Minet, Eef Hoeben, Andrew Parker, Alain Fischer, Sylvain Latour
Date and Time: Available from June 10, 09:00 CEST and on-demand until Monday, August 15, 2022, on the Congress platform
Session title: Lymphoma Biology & Translational Research

Poster Presentation: Selective small molecule inhibition of CTP synthase 1 (CTPS1) suppresses T cell proliferation and cytokine release, highlighting a novel therapeutic target for graft-versus-host disease

Authors: Philip Beer, Andrew Parker, Hélène Asnagli

Date and Time: Available from June 10, 09:00 CEST and on-demand until Monday, August 15, 2022, on the Congress platform
Session title: Stem cell transplantation – Experimental

On May 30, 2022 Hoffmann-La Roche reported to invite investors and analysts to participate in our virtual event on Monday, 6 June 2022, highlighting Roche data presented during the congress scientific program from June 3 – 7 2022 and our early-stage oncology portfolio (Press release, Hoffmann-La Roche, MAY 30, 2022, View Source [SID1234615225]).

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The webinar will start with a presentation, followed by a Q&A session (live access to the speakers). The slides will be available for download at 15:00 CEST on the day of the event. > click here

Agenda

Oncology late-stage portfolio update
Elena Bernedo-Arzac, SVP, Oncology Therapeutic Area Head

Key Data at ASCO (Free ASCO Whitepaper) 2022
– Glofitamab pivotal Ph1b data in 3L+DLBCL
– Polivy Asian sub-population data from Ph3 POLARIX in 1L DLBCL
Ginna Laporte, MD – VP, Global Head Lymphoma/CLL Clinical Development

Oncology early R&D update
Johanna Bendell, M.D., Head of Roche Pharma Research and Early Development (pRED) Oncology
Andy Chan, M.D., Ph.D. Senior Vice President, Research Biology, Genentech Research & Early Development (gRED)

On May 30, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported the signing of a definitive agreement under which Evotec will acquire 100% of the capital of Rigenerand Srl, a leading cell technology company, for a purchase price of € 23 m (Press release, Evotec, MAY 30, 2022, View Source [SID1234615226]). Founded in 2009 as a spin-off of the University of Modena and Reggio Emilia, Rigenerand is a pioneering company in the field of cGMP manufacturing of cell therapies. The acquisition adds a great team of cell therapy cGMP manufacturing experts to Evotec.

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Rigenerand is based in Medolla, Italy, approx. 100 km south of Evotec’s Campus Levi-Montalcini in Verona. With their highly specialised team, Rigenerand operates a first-class certified facility that integrates state-of-the-art cGMP production with R&D and QC labs and development labs. The production facility, called "cell factory", comprises a series of fully equipped clean rooms for the manufacturing of complex cell-based therapies. In total, the site in Medolla close to Modena comprises 1,200 sqm of high-tech manufacturing space, with potential for significant further expansion.

The acquisition expands Evotec’s cell therapy platform EVOcells by adding a dedicated, high-quality cGMP manufacturing site. The seamless integration of discovery and development of innovative cures combined with in-house capabilities in GMP manufacturing are mandatory within this field. While the revenue contribution will not be significant at the beginning, the manufacturing capability of Rigenerand along with the exceptional R&D power of Evotec will strengthen Evotec’s ability to successfully win new integrated partnerships within the innovative field of cell therapy.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "Cell therapies are an exciting emerging therapeutic modality with broad applicability across many indications. Originating from our leading iPSC platform, Evotec’s EVOcells platform enables the delivery of innovative cell therapeutics from inception to the patient. The acquisition of Rigenerand adds manufacturing capacity and expertise to the EVOcells platform. Our conversations with our partners as well as our own industry observations have made it clear that horizontal expansion and rapid iteration at the scale-up are critical within the cell therapy space. As we see very strong demand for our standalone Just – Evotec Biologics J.PODs in the US and EU, it is strategically the logical step to build separate capability and capacity internally. We warmly welcome the Rigenerand team into the Evotec family and are excited to leverage their skill and expertise for our partners and ultimately the patients."

Prof. Massimo Dominici, founder and CSO of Rigenerand and Professor of Oncology at the University of Modena and Reggio Emilia, said: "The combination of Rigenerand and Evotec is a unique opportunity to grow and a natural evolution for our team. The field of cell therapies is rapidly expanding with new products and novel technologies requiring R&D skills, flexibility in manufacturing and experience in pharmaceutical development. Evotec’s EVOcells platform and Rigenerand’s technologies and capacity to transform cells into therapeutic products combining an R&D vocation and manufacturing skills, is a unique combination with technological and logistic synergies that will make a very relevant impact in the cell therapy field with a state-of-the art cGMP Technological Center for Cell Therapy Manufacturing at a European scale." ‘

Luca Marini, CEO of Xyence Capital SGR, the majority shareholder of Rigenerand, said: "We are very proud of the success of this deal because it shows our expertise in identifying high-potential scientific areas, such as cell therapies, and in providing a fair financial return to our investors that have chosen to contribute to the incubation and growth of Rigenerand since 2016. Evotec is the optimal industrial partner to bring Rigenerand to further global growth. Last but not least, we are happy to have created the conditions for a number of benefits for the local economy, as well as the basis for an evident scientific progress that remains the purpose and ethical core of our investment philosophy."

About Cell Therapy and EVOcells
Cell therapy is a recent and innovative therapeutic modality that has the potential to deliver unprecedented therapeutic effects. Cell therapies can be used as a regenerative strategy, replacing a patient’s dysfunctional cells or are used as adoptive immunotherapy to help the immune system fight cancer. Sources for cell therapeutics range from the patient’s own material, a healthy donor or from stem cells. The advent of induced pluripotent stem cells ("iPS cells" or "iPSCs") that can be generated directly from somatic cells has opened up stem cells as an almost unlimited source of consistent-quality material for such cell therapies. iPSC-derived, off-the shelf therapeutics are considered to be one of the most promising approaches in the cell therapy space.

Building on its many years of experience with iPSCs, Evotec has developed EVOcells as an integrated, versatile platform for the discovery, development and manufacturing of cell therapies. The Company’s aim is to develop innovative but cost-effective therapies for large patient numbers based on human cells to cure life-threatening diseases. Evotec’s current EVOcells project portfolio covers immuno-oncology, metabolic diseases, heart repair as well as exosome-based therapies. Evotec leverages the EVOcells platform for both proprietary and partnered projects, and is aiming to accelerate these projects towards transformative therapies, both within existing and new disease areas.

On May 30, 2022 Herantis Pharma Plc ("Herantis" or the "Company"), an innovative biotech company developing new disease modifying therapies for Parkinson’s disease, reported on 3 May 2022 that the Board of Directors of Herantis had decided to offer Herantis’ shareholders up to 4,831,426 new shares (the "Offer Shares") in a rights issue on the basis of shareholders’ pre-emptive subscription rights in the same proportion as they already hold shares in the Company and secondarily by other shareholders or by other persons (the "Offering") (Press release, Herantis Pharma, MAY 30, 2022, View Source,c3576694 [SID1234615227]). The subscription period for the Offering ended on 24 May 2022 in Sweden and on 27 May 2022 in Finland and according to the preliminary result, Herantis will receive gross proceeds of approximately EUR 7.25 million, from the Offering.

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According to the preliminary results of the Offering, the Offering was subscribed in full. Approximately 79.9 per cent of the 4,831,426 Offer Shares were subscribed for with subscription rights, and approximately 20.1 per cent were subscribed for without subscription rights. The subscription price in the Offering was EUR 1.50 per Offer Share in Finland and SEK 15.60 per Offer Share in Sweden.

"We are pleased with the great interest to participate in the Offering and we are thankful for the continued support of our current shareholders. We will use the net proceeds from this Offering to obtain regulatory approval and perform the first in-human study with the Herantis’ lead product candidate HER-096 that is planned to start in 2023.", comments Frans Wuite, the interim CEO of Herantis.

The final results of the Offering will be published on or about 1 June 2022 after the Board of Directors of Herantis has approved the subscriptions made in the Offering. Allotment of Offer Shares will be made in accordance with the terms and conditions of the Offering. As a result of the Offering, the total number of shares in Herantis will increase by 4,831,426 from 12,078,568 to 16,909,994 provided that the Board of Directors of Herantis approves the subscriptions made in the Offering. The Offer Shares issued in the Offering amount to approximately 28.6 per cent of the outstanding shares in Herantis following the Offering.

The last day of trading in the interim shares on Nasdaq First North Growth Market Finland ("First North Finland") will be on or about 2 June 2022 and on Nasdaq First North Growth Market Sweden ("First North Sweden") on or about 9 June 2022. The Offer Shares will be registered with the Finnish Trade Register maintained by the Finnish Patent and Registration Office on or about 3 June 2022. The interim shares will be combined with the Company’s existing shares once the Offer Shares have been registered with the Finnish Trade Register. The combination will take place on or about 3 June 2022 in Finland and on or about 10 June 2022 in Sweden. The trading in the Offer Shares on First North Finland will commence on or about 3 June 2022 and on First North Sweden on or about 10 June 2022. The Offer Shares confer the same rights as Herantis’ other shares, after being registered with the Finnish Trade Register and delivered on the investor’s book-entry account, on or about 3 June 2022 in Finland and on or about 10 June 2022 in Sweden.

UB Securities Ltd is acting as the lead manager of the Offering. Krogerus Attorneys Ltd is acting as the legal counsel to the Company as to Finnish law and Advokatfirman Cederquist KB as to Swedish law.