On November 16, 2019 LIDDS AB (publ) reported that Phase IIb clinical data from the LPC-004 prostate cancer study on LIDDS Liproca Depot were presented in an oral session at the 11th European Multidisciplinary Congress on Urological Cancers, EMUC19 (Press release, Lidds, NOV 16, 2019, View Source [SID1234555900]). The study met both its primary and secondary endpoints as well as demonstrated that a larger proportion of intermediate risk patients, which is the Liproca Depot target group, are PSA responders. The presentation can be accessed through LIDDS webpage and are also attached to this release.

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The phase IIb results from the LPC-004 prostate cancer study was presented as "Late Breaking News" at EMUC in Vienna on November 16, 2019 by Professor Laurence Klotz, a world leading expert in Active Surveillance of prostate cancer patients. Professor Klotz was one of the LPC-004 study investigators and is Professor at the University of Toronto Division of Urology at the Sunnybrook Health Sciences Centre in Canada.

The preliminary data recently released from the phase IIb study, LPC-004, confirms that 90 % of patients receiving 16 ml intraprostatic injection of Liproca Depot experienced a PSA reduction and also that 16 ml is the optimal dosage for future Phase III studies. Further, the study showed no systemic hormonal adverse reactions, that Liproca Depot is safe and well tolerated by the patients, and that 84 % of patients being treated were amenable to a second injection of Liproca Depot.

As LIDDS advances Liproca Depot towards late-stage clinical development, LIDDS intends to target intermediate risk patients in its phase III trial. The LPC-004 study showed that a larger proportion of intermediate risk patients are PSA responders and that this group display a stronger mean PSA decrease compared to low risk patients.

– The results confirm that Liproca Depot can offer a completely novel approach to complement active surveillance in intermediate risk prostate cancer patients. Liproca Depot is well tolerated without the hormonal side effects associated with anti-androgen therapy, and is equally easy to administer as performing a prostate biopsy. Liproca Depot treatment could contribute to the benefit of prostate cancer patients in the future, says Professor Laurence Klotz, a world leading expert and one of the study investigators and Professor at the University of Toronto Division of Urology.

– The results regarding the intermediate risk patients further validate the continued clinical development of Liproca Depot. As announced recently, our licensing partner, Jiangxi Phuong, has decided to progress with the phase III trial in China and we will continue the commercial activities in order to sign further licensing agreements in other major markets, says Monica Wallter, CEO, LIDDS.

About the Phase IIb Liproca Depot clinical trial
The single blind, two-part dose finding study aimed to determine the highest tolerable dose of Liproca Depot in part I and to determine the level of PSA reduction for part II patients at month 5. The study was conducted at eight specialist urology clinics in Canada; Lithuania and Finland. The study involved 61 patients diagnosed with localized non-aggressive prostate cancer who were on Active Surveillance. Patients were followed for six months to assess response and tolerability. Three previous clinical trials (LPC-001, LPC-002 and LPC-003) involved a total of 57 patients and showed promising results for tolerability and effect on tumor tissue, prostate volume and the PSA biomarker.

About prostate cancer and the market
Of the 1.2 million men diagnosed with prostate cancer globally each year, about 420,000 are assessed as intermediate risk and placed on ‘Active Surveillance’ where they are monitored regularly. There is no standard drug treatment for these cancer patients and many treating doctors see an unmet need.

According to market research firm GlobalData, the global market for prostate cancer drugs is expected to grow to USD 8.3 billion annually by 2023. Liproca Depot’s target group is an untapped market potentially exceeding USD 3 billion per year.

About Liproca Depot and NanoZolid
NanoZolid is a safe, flexible and functional method of delivering drugs. When injected, NanoZolid forms a solid depot releasing the active drug over periods of potentially more than six months. As it releases its drug load, the NanoZolid depot dissolves and is absorbed harmlessly into the body.
Liproca Depot combines NanoZolid and 2-HOF (2-hydroxyflutamide), a well-established antiprostate cancer drug. Liproca Depot’s target group is patients under Active Surveillance (AS) with intermediate risk of cancer progression.

On November 16, 2019 Carisma Therapeutics Inc., a preclinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies based on engineered macrophages, reported that it will be participating in three upcoming investor conferences (Press release, Carisma Therapeutics, NOV 16, 2019, View Source [SID1234551403]).

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Stifel 2019 Healthcare Conference, November 19-20, 2019 – Carisma’s management will deliver a presentation on Wednesday, November 20, at 4:45 pm EDT and host one-on-one meetings at the venue. The conference will be held at the Lotte New York Palace Hotel, New York, NY.
Jefferies 2019 London Healthcare Conference, November 20-21, 2019 – Carisma will host one-on-one meetings on November 20 and 21 at the conference venue, at the Waldorf Hilton, London, UK.
Piper Jaffray 31st Annual Healthcare Conference, December 3-5, 2019 – Carisma’s management team will present on Tuesday, December 3, at 4:50 pm EDT. The company will host one-on-one meetings at the conference venue, at the Lotte New York Palace Hotel in New York, NY.
Carisma Therapeutics is pioneering the development of engineered macrophages to transform the treatment of cancer and other serious illnesses through the engagement of both the innate and adaptive immune responses. Carisma’s proprietary chimeric antigen receptor (CAR)-macrophage cell therapy platform is designed to address key challenges involved in the treatment of solid tumors by actively trafficking to the tumor, selectively killing tumor cells through phagocytosis, "warming up" the tumor microenvironment, and triggering a durable response from other immune cells.

Carisma’s first product in development is an autologous HER2-targeted CAR-macrophage expected to enter clinical studies in 2020. Additional CAR-macrophages targeting other solid tumor antigens are in early development.

On November 15, 2019 Skyhawk reported its fifth deal of the year, the company is moving into a new therapeutic area and adding $80 million to its cash reserve (Press release, Skyhawk Therapeutics, NOV 15, 2019, View Source [SID1234626570]). Skyhawk partnered with Celgene to discover and develop small molecules for autoimmune disease and cancer against hard-to-drug targets that have been clinically validated, or genetically associated with a disease.

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Skyhawk Therapeutics Inc. uses its SkySTAR platform to discover and develop small molecules capable of modulating RNA splicing within the spliceosome, dictating which exons are included in the final mRNA transcript and offering drug developers a mechanism to control protein expression at the level of mRNA. The therapeutic approach can be applied broadly to indications where attempts at drugging a target at the protein level have been unsuccessful (see "Splice Time")

On November 15, 2019 Affibody Medical AB (publ) ("Affibody" or "the Company"), a Swedish biotechcompany focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody molecules and Albumod, reported its Interim Report for the third quarter of 2019 (Press release, Affibody, NOV 15, 2019, View Source [SID1234575700]).

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Financial Highlights

Revenue for the 3rd Quarter 2019 amounted to SEK 47.6 (25.6) m, and to 297.6 (85.1) m for the nine-month period
Operating result for the quarter amounted to SEK -17.5 (-58.0) m, and to 110.8 (-103.8) m for the nine-month period
Net result for the quarter amounted to SEK -6.0 (-57.7) m, and to 116.9 (-103.4) m for the nine-month period
Cash flow for the quarter amounted to SEK -27.9 (-30.6) m, and to 298.2 (-85.3) m for the nine-month period
Cash and cash equivalents at the end of the period amounted to SEK 389.2 (91.0) m.
Significant Events during the Reporting Period

In September Affibody announced its relocation to Campus Solna
In September a strategic collaboration with GE Healthcare to develop and commercialize Affibody-based PET imaging tracers, with initial focus on HER2 and PD-L1, was announced
In July, 2019 the completion of the planned 12 week interim analysis in the Company’s Phase 2 proof-of-concept study of its bispecific molecule ABY-035 for moderate-to-severe psoriasis ("AFFIRM-35") was announced.
Significant Events during the rest of the Year

The share issue was completed and fully subscribed in May and brought gross proceeds of SEK 147.4 m to the company
In March 2019, a partnership with Alexion Pharmaceuticals, Inc. to co-develop ABY-039, was announced. Under the terms of the agreement, Alexion has provided Affibody with an upfront payment of $25 million, with the potential for additional development- and sales-based milestones of up to $625 million and tiered low double-digit royalty payments. Alexion will lead joint clinical development of ABY-039 and commercialization activities. Affibody has the option to co-promote ABY-039 in the U.S. and will lead clinical development for an undisclosed indication
In February 2019, the Phase 2 proof-of-concept study of ABY-035 for moderate-to-severe psoriasis completed enrollment of patients.

On November 15, 2019 The board of directors of LIDDS AB reported that it has decided to carry out a directed issue of 562,500 shares at a subscription price of SEK 16 per share (Press release, Lidds, NOV 15, 2019, View Source [SID1234555901]). LIDDS will through the directed share issue receive proceeds amounting to SEK 9.0 million, before transaction costs.

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The board of directors of LIDDS has, based on the authorization given by the annual general meeting on May 16, 2019, decided to carry out a directed issue of 562.500 shares to new and current investors.

The subscription price in the Directed Share Issue is set to SEK 16,00 and has been determined by volume weighted average price during the last 20 business days with a discount of 5%. Through the Directed Share Issue, LIDDS will raise SEK 9.0 million before transaction costs. The Directed Share Issue entails a dilution of approximately 2.4 percent of the number of shares and the votes in the Company. Through the Directed Share Issue, the number of outstanding shares and votes will increase by 562,500 shares from 23,692,388 shares to 24,254,888 shares. The share capital will increase by SEK 29,812.50 from SEK 1,255,696.56 to SEK 1,285,509.07.

The reason for the deviation from the shareholders’ preferential rights, is to strengthen the shareholder base and to finance LIDDS’ exciting development projects. The Directed Share Issue will primarily be used to finance the NZ-TLR9 immuno-oncology project which includes an upcoming Phase I clinical trial.

Subscribers in the Directed Share Issue are new shareholders and existing shareholders.